Mark Job Responsible Third Party Official Regulatory ...combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

U.S. Food & Drug Administration

10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 0 7

Silver Spring, MD 20993

www.fda.gov

October 9, 2019

phenox Limited

℅ Mark Job

Responsible Third Party Official

Regulatory Technology Services LLC

1394 25th Street NW

Buffalo, Minnesota 55313

Re: K191687

Trade/Device Name: pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

Regulation Number: 21 CFR 870.1330

Regulation Name: Catheter Guide Wire

Regulatory Class: Class II

Product Code: MOF

Dated: September 9, 2019

Received: September 10, 2019

Dear Mark Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced

above and have determined the device is substantially equivalent (for the indications for use stated in the

enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the

enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance

with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a

premarket approval application (PMA). You may, therefore, market the device, subject to the general

controls provisions of the Act. Although this letter refers to your product as a device, please be aware that

some cleared products may instead be combination products. The 510(k) Premarket Notification Database

located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination

product submissions. The general controls provisions of the Act include requirements for annual registration,

listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and

adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We

remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be

subject to additional controls. Existing major regulations affecting your device can be found in the Code of

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements

concerning your device in the Federal Register.

K191687 - Mark Job Page

2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA

has made a determination that your device complies with other requirements of the Act or any Federal

statutes and regulations administered by other Federal agencies. You must comply with all the Act's

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-

mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including

information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-

devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D., M.S.

Director (Acting)

DHT5A: Division of Neurosurgical,

Neurointerventional

and Neurodiagnostic Devices

OHT5: Office of Neurological

and Physical Medicine Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.

510(k) Number (if known)K191687

Device NamepORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

Indications for Use (Describe)The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) [email protected]

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

510(k) Summary, Page 1 of 10

510(k) Summary (21 CFR 807.92)

I. SUBMITTER

phenox Limited, Ballybrit Business Park, Galway, Ireland

Contact Person: Gary Brogan Director of Regulatory Affairs, Phone: +353 91 740103

Date Prepared: May 31st, 2019

II. DEVICE

Name of Device: pORTAL® Steerable Hydrophilic Guidewire and pORTAL® EXT Extension Wire

Common or Usual Name: Catheter Guidewire

Classification: Class II, 21 CFR 870.1330, Catheter Guide wire

Product Code: MOF

III. PREDICATE DEVICE(S)Traxcess 14EX Guidewire and Traxcess Docking Wire, K093397, Cleared Dec 2009.Transend EX Guidewire, K934122, cleared October 1993.

IV. DEVICE DESCRIPTIONThe pORTAL Steerable Hydrophilic Guidewire is a disposable medical device designed for single use only. It is designed to selectively introduce and position catheters and other interventional devices within target vessels. In order to achieve this purpose, the guidewire must be capable of being steered through blood vessels. This necessitates pushing and torqueing capability within the product. The design of the distal section of the guidewire provides steerability, while maintaining the flexibility necessary to negotiate the tortuous path of the blood vessel network. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessels. Two accessories are provided within the package. These are a Torquer device and an introducer Needle. Both can be used to aid in the use of the device.The pORTAL EXT Extension Wire is intended to interface with pORTAL Steerable Hydrophilic Guidewire. It is provided sterile and is sold separately in its own packaging configuration. The 115cm extension wire provides a facility to extend the overall length of the pORTAL guidewire to 315cm (see table 1 for dimensional specifications). This enables the usable length to be extended during use to aid with over-the wire exchange. This facilitates introduction and positioning of catheters and other interventional devices within the target anatomy, while the guidewire retains its working position at the location of intervention. The stiffness of the extension wire is comparable to the proximal, unground section of the pORTAL Guidewire.

510(k) Summary, Page 2 of 10

Table 1: Product details of the pORTAL components

Part # Content of Package Description on label Total

Length Outer

Diameter Length of

Hydrophilic Coating

PORT- 14-200-1 1 pORTAL Steerable Hydrophilic

Guidewire 205 cm

0.014” (0.36mm)

35.5 cm (nominal) PORT- 14-200-5 5

PORT- 14-115-1- EX 1 pORTAL EXT Extension Wire

115 cm

0.014” (0.36mm) N/A

PORT- 14-115-5- EX 5

V. INDICATIONS FOR USEThe pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.

IV. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

Table 2: Comparison of pORTAL technological characteristics with predicate device

Parameter Predicate Device (Transend EX)

Predicate Device (Traxcess 14EX) Subject Device Assessment of

differences Model Transend EX Guidewire Traxcess 14EX Guidewire

and Docking wire pORTAL Guidewire and Extension System

Equivalent

510(k) number K934122 K093397 K191687 Equivalent Product Classification

21 CFR 870.1330, Class II

21 CFR 870.1330, Class II

21 CFR 870.1330, Class II

Equivalent

Device Design Steerable hydrophilic guidewire

Steerable hydrophilic guidewire and docking wire

Steerable hydrophilic guidewire and extension system

Equivalent

Indications for Use

The Transend EX guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. The guidewire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. The device is not intended for use in coronary arteries. The torque device (pin vase) is included with the guidewire to facilitate

The Traxcess Guidewire and Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

The pORTAL Steerable Hydrophilic Guidewire and portal EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.

The Indications for Use statement is similar to the predicates with the exception that the treatment indication is reduced to only include neuro as opposed to a general intravascular use, including peripheral. This tightening of the indication statement does not raise any additional questions on safety and effectiveness.

Mode of Action The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters.

The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters.

The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters.

Equivalent

510(k) Summary, Page 3 of 10

Parameter Predicate Device (Transend EX)

Predicate Device (Traxcess 14EX) Subject Device Assessment of

differences Device Sizes Two lengths 182cm and

205cm guidewire 200cm guidewire 115cm docking wire

205cm guidewire 115cm extension wire

The guidewire devices have similar overall lengths. Traxcess may be extended using a docking wire, resulting in comparable length to the pORTAL Extension wire. These minor differences in lengths do not raise any additional questions on safety and effectiveness.

Use Single Use Device Single Use Device Single Use Device Equivalent

Sterilization EO Sterilization EO Sterilization EO Sterilization Equivalent Method of supply Stored with a dispenser

coil, Tyvek Pouch and shipping carton

Stored with a dispenser coil, Tyvek Pouch and shipping carton

Stored with a dispenser coil, Tyvek Pouch and shipping carton

Equivalent

Intended Clinical Environment

Sterile operating theatre Sterile operating theatre Sterile operating theatre Equivalent

Biocompatible Yes Yes Yes Equivalent

V. COMPARISON OF MATERIALS USED WITH THE PREDICATE DEVICES

Table 3: Comparison of pORTAL materials with predicate device

Parameter Predicate Device

(Transend EX) Predicate Device (Traxcess 14EX) Subject Device Assessment of

differences

Wire Material

Guidewire: Scitanium (proprietary alloy) core wire

Guidewire: Stainless-steel core with Nitinol tapered wire

Docking Wire: Stainless-steel core with Nitinol tube on distal end

Guidewire: 35NLT Cobalt Chrome alloy

Extension Wire: Stainless Steel core wire with a Nitinol tube on the distal end

While there are differences in materials, pORTAL uses similar materials which are commonly used in medical devices. DV testing on the pORTAL confirmed it will perform as intended and the difference in materials do not raise questions of safety and effectiveness

Coating Distal: Hydrophilic coating “ICE”

Proximal: PTFE

Distal: Hydrophilic coating Proximal: PTFE

Distal: Hydrophilic coating Proximal: PTFE

The function of each device coating is equivalent. Whilst having different materials, each of the device coatings functions are used equivalent and incorporated in the device to increase the lubricity of the guidewires. The difference in materials do not raise questions of safety and effectiveness

Tip Material

Tapered ribbon Scitanium (proprietary alloy)

Platinum / Nitinol coil Platinum/Tungsten coil The function of each device tip is equivalent. The difference in materials do not raise questions of safety and effectiveness

510(k) Summary, Page 4 of 10

VI. BIOCOMPATIBILITY

Biocompatibility testing for the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire was conducted to conform with the FDA consensus standard, recognition number 2-156, AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices – Part 1:Evaluation and testing within a risk management process, along with the FDA Blue BookMemorandum# G95. Table 4 and 5 below summarizes the biocompatibility testing performed onthe pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire.

Table 4: Biocompatibility Summary for pORTAL Guidewire

pORTAL Steerable Hydrophilic GuidewireTest Test Description Result Summary Conclusion

Chemical Characterization

Exhaustive Extraction in Purified Water (PW), 50%

Isopropyl Alcohol (IPA), and Hexane (Hex) for Total Non-Volatile Residue (NVR)

The exaggerated extractions of the Phenox/LRM 0.014" Neurovascular Guidewire yielded low (<0.24mg) amounts of residue from the PW

extraction vehicle; the EtOH and Hex extraction vehicles yielded a slightly higher amount of NVR

than the PW.

Acceptable

Fourier Transform Infrared (FTIR) Spectroscopy of residues obtained

from the test article extracts

Purified Water: Most closely matches cellulose acetate ester EtOH: Most closely matches

polyurethane Hexane: Most closely matches phenolic antioxidant

Acceptable

Determination of Trace Metals/Elements Using Inductively

Coupled Plasma (ICP) Spectroscopy (PW extract only)

The PW extract of the PORTAL Guidewire contained trace amounts of metallics. The most significant

amount of a metal detected was tungsten which was present at a level of 6.13 x Iff4 mg/device.

Acceptable

Gas Chromatography with Mass Spectrometry (GC/MS) for detection of volatile and semi-volatile organic

compounds from the test article extracts

No semi-volatile compounds were detected in the PW, EtOH And Hex extracts of the pORTAL

Guidewire at a level greater than 1.0 ppm, the detection limit of the method.

Acceptable

Ultra-performance Liquid Chromatography with Mass

Spectrometry (LC/MS) for detection of non-volatile compounds from the test

article extracts

The LC/MS analyses of the EtOH and Hex extracts of the pORTAL Guidewire indicated the presence of

the antioxidant Irganox 1010

Acceptable

Cytotoxicity Cytotoxicity Study Using the ISO Elution Method

The test article extract showed no evidence of causing cell lysis or toxicity and was a grade 0. The test article extract met the requirements of the test

since the grade was less than a grade 2 (mild reactivity).

Pass

Sensitization ISO Guinea Pig Maximisation Sensitisation Test

The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a

sensitizer in the guinea pig maximization test.

Pass

Intracutaneous Reactivity/ irritation

ISO Intracutaneous Study in Rabbits The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding

control extract overall mean score was 0.0 and 0.0 for the SC and SO test article extracts, respectively.

Pass

Acute Systemic Toxicity

ISO Systemic Toxicity Study in Mice There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each

test article extract met the requirements of the study.

Pass

510(k) Summary, Page 5 of 10

pORTAL Steerable Hydrophilic GuidewireTest Test Description Result Summary Conclusion

Hemocompatibility ASTM Hemolysis Study The hemolytic index for the test article in direct contact with blood was 0.0% and the hemolytic

index for the test article extract was 0.3%. Both the test article in direct contact with blood and the test

article extract were non-hemolytic.

Pass

Hemocompatibility In Vivo Thromboresistance Study in Dogs Jugular Vein

Under the conditions of the study, minimal to slight thrombus formation was noted with the test article

and control article. The test and control article appeared equivalent in this exaggerated model with

neither demonstrating thromboresistance. Consequently, these results should be considered with respect to clinical use when assessing clinical

relevance.

Pass

Acute Systemic Toxicity

(Material Mediated Pyrogenicity)

USP Rabbit Pyrogen Study, Material Mediated

The total rise of rabbit temperatures during the 3-hour observation period was within acceptable

USP limits. The test article was judged as nonpyrogenic.

Pass

Table 5: Biocompatibility Summary for pORTAL EXT Extension Wire

pORTAL EXT Extension Wire

Test Test Description Result Summary Conclusion Chemical

Characterization Exhaustive Extraction in Purified

Water (PW), 50% Isopropyl Alcohol, and Hexane for Total Non-Volatile

Residue

The exaggerated extractions of the pORTAL Extension Wire yielded low (0.04 mg) amounts of residue from the PW extraction vehicle; the EtOH

(0.071) and Hex (0.026) extraction vehicles yielded a slightly higher and lower amounts of NVR

respectively than the PW.

Acceptable

Fourier Transform Infrared Spec. of residues obtained from the test article

extracts

Purified Water: No major bands of interest were observed. EtOH: Most closely matches trace

hydrocarbons, Hexane: Most closely matches trace hydrocarbons

Acceptable

Determination of Trace Metal Elements Using Inductively Coupled Plasma Spec.

The PW extract of the pORTAL Extension Wire contained trace amounts of metallics. The most

significant amount of a metal detected was aluminium which was present at a level of 5.06 x 10

mg/device.

Acceptable

Gas Chromatography with Mass Spec. for detection of volatile & semi-volatile

organic compounds from the test article extracts

No semi-volatile compounds were detected in the PW, EtOH And Hex extracts of the pORTAL

Extension Wire at a level greater than 1.0 ppm, the detection limit of the method.

Acceptable

Ultra-Performance Liquid Chromatography with Mass Spec. for detection of non-volatile compounds from the test article

extracts

The LC/MS data indicate the presence of numerous incompletely identified compounds in the PW, EtOH,

and Hex extracts of the pORTAL Extension Wire. Analysis of the types of compounds detected indicates that many of the chemical species

detected are structurally related.

Acceptable

Cytotoxicity Cytotoxicity Study Using the ISO Elution Method

The test article extract showed no evidence of causing cell lysis or toxicity and was a grade 0. The test article extract met the requirements of the test

since the grade was less than a grade 2 (mild reactivity).

Pass

Hemocompatibility ASTM Hemolysis Study The hemolytic index for the test article in direct contact with blood was 0.3% and the hemolytic

index for the test article extract was 0.6%. Both the test article in direct contact with blood and the test

article extract were non-hemolytic.

Pass

510(k) Summary, Page 6 of 10

VII. NON-CLINICAL PERFORMANCE DATA

The following non-clinical performance tests were executed to provide support for the substantial equivalence determination. These are summarized below.

PERFORMANCE TESTING - BENCHA full suite of performance testing on the bench was carried out on the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire. This testing included, Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrity & Catheter Compatibility under simulated conditions. The results of this testing demonstrated compliance to all the design attributes as well as demonstrating an acceptable performance outcome. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate substantial equivalence to the cited predicates.

Table 6: DV Summary for pORTAL Guidewire

pORTAL Steerable Hydrophilic Guidewire Test Test Method Summary Results

Dimensional The overall guidewire length, polymer jacket length and overall guidewire diameter were measured.

Dimensional results meet acceptance criteria.

Tip Tensile Strength The distal section of the wire was pulled until it failed.

Results show the tensile strength meets specification.

Catheter Compatibility The guidewire was tested with relevant interfacing devices such as over the wire micro catheters under simulated use.

The guidewires tested performed acceptably and were shown to be compatible with tested microcatheters.

Coating Adherence/Integrity The guidewire was tracked multiple times through a catheter in a simulated anatomy. The coatings were inspected for signs of damage or degradation.

No coating was rubbed off during or after testing of guidewire in any of the microcatheters.

Tip Stiffness (Gram Weight) The distal tip of the guidewire was compressed. The peak load was electronically recorded and reported.

Device stiffness is equivalent or less than predicate device. Device tip stiffness is within specification.

Tip Shape Retention A J-Shape was formed on the distal end of the wire, then recorded using an image measuring system.

The guidewire distal tip retention is better than or equivalent to predicate device. Tip shape retention is within specification.

Lubricity and Durability Test The guidewire, within a microcatheter was tracked multiple times through a 3-Dimensional Neuro Silicone anatomy block. Resulting lubricity was measured.

Lubricity and durability of the guidewire is better than or equivalent to the predicate device. The device meets acceptance criteria on both lubricity and durability.

PTFE Coating Adherence (Saline Soak & Wipe Test)

The entire length was pulled through a fixed clamp. The wire was inspected for PTFE degradation or damage.

All devices passed saline soak & wipe test.

PTFE Coating Mandrel Adhesion Test (Saline Soak & Wrap Test)

The wire was wrapped around a mandrel of a fixed diameter (as defined in ISO11070 standard). The wrapped PTFE coated wire was inspected under a microscope for any signs of flaking, cracking or delamination.

All devices passed saline soak & wrap test.

PTFE Adhesion / Durability Testing (Eraser Test)

The wire was placed in a fixture and subject to a number of cycles underweight. The wire was removed and inspected for failure.

All devices passed eraser test.

Radiopacity The radiopaque distal end of the guidewire was imaged using standard fluoroscopy equipment. An image was taken and reviewed to ensure visibility

Device radiopacity was seen to be comparable to predicate device. Device meets specification.

Torque Strength (Combined Load/Turns to Failure)

The guidewire was loaded into the guide catheter within a simulated neurovascular anatomy. Force is applied and the specimen is rotated to failure.

Device torqueability was demonstrated within specification.

ISO Flex Resistance Test (Bending Durability)

Test method defined in ISO 11070 Annex G. The test region of the wire was wrapped around mandrels in opposing directions a number of times. The wire was removed and examined.

Flex resistance was comparable to predicate device.

510(k) Summary, Page 7 of 10

pORTAL Steerable Hydrophilic Guidewire Test Test Method Summary Results

Corrosion Resistance Test method defined in ISO 11070 Annex B. The products were placed in a beaker of salt water at room temp for 5 hours, and then placed in boiling distilled water for 30 minutes, followed by 48 hours at 37°C. The products were removed, and examined for evidence of corrosion.

Device meets acceptance criteria, no evidence of corrosion on device.

FDA Tip Flexibility This test measures the load required to deflect the distal tip of the guidewire to angles of 45° and 90. A force curve was generated for each specimen at the specified deflection points and were electronically collected.

Tip stiffness properties were shown to be comparable or less atraumatic than predicate device. Peak load was within specification.

Kink Resistance / Flexibility The tip of each device was wrapped around mandrels, until kinking occurs.

Kink resistance was equivalent or better than predicate device.

Particle Residue Following simulated use, particulates generated are collected, and counted by size for each wire.

All parts & calculated tolerance interval are below max specification for ≥10µm particles/device and ≥25µm particles/device and compared to a predicate device control.

Torque Response The test measured the reaction of the distal end of the guidewire when the wire was placed within a simulated anatomy.

Equivalent torque response when compared to predicate device. Both fresh and fatigued devices are within specifications.

Table 7: DV Summary for pORTAL EXT Extension Wire

pORTAL EXT Extension Wire

Test Test Method Summary Results Catheter Compatibility Test The guidewire was tested with relevant interfacing

devices under simulated use. The extension systems performed acceptably and were shown to be compatible with tested microcatheters.

PTFE Coating Mandrel Adhesion Test (Saline Soak & Wrap Test)

The wire was wrapped around a mandrel of a fixed diameter (as defined in ISO11070 standard). The wrapped PTFE coated wire was inspected under a microscope for any signs of flaking, cracking or delamination.

No damage was observed post soak & wrap test. All devices passed.

PTFE Coating Adherence (Saline Soak & Wipe Test)

The entire length was pulled through a fixed clamp. The wire was inspected for PTFE degradation or damage.

No damage was observed post soak & wipe test. All devices passed.

PTFE Adhesion / Durability Testing (Eraser Test)

The wire was placed in a fixture and subject to a number of cycles underweight. The wire was removed and inspected for failure.

No damage was observed post eraser test. All devices passed.

Dimensional Measurements The overall length and maximum diameter of the extension wire were measured.

All dimensional measurements were within specifications.

Pull Test (Glue Joint Strength) The joint strength of the extension wire is measured using a calibrated force tester

Joint strength measurements were within specifications.

Pull Test (Strength of Union) The peak force to separate the guidewire from the extension wire is measured using a calibrated force tester

Strength of union measurements were comparable to predicate device and within specifications.

Hypotube Joint Flex Test This test involves flex testing the integrity of the connecting joint between the extension wire and the guidewire. A force curve is generated for each specimen, and the peak load is electronically calculated and put into a report.

Results have shown comparable joint flex properties between the subject device & predicate device. Device meets specification.

Particulate Residue Test Following simulated use, particulates generated are collected, and counted by size for each wire.

All parts & calculated tolerance interval are below max specification for ≥10µm particles/device and ≥25µm particles/device and compared to a predicate device control.

510(k) Summary, Page 8 of 10

Table 8: Sterility Summary for pORTAL Guidewire and EXT Extension Wire pORTAL Guidewire and Extension System

Test Test Method Summary Results Residual Study for guidewire after 1x sterilisation

Wires were sterilized, then tested for EtO and ECH residual levels.

All test articles passed acceptance criteria.

LAL Testing LAL enhancement and inhibition validation was performed followed by endotoxin testing.

All test articles passed acceptance criteria for endotoxin limits.

Product Bioburden Testing Bioburden validation followed by bioburden testing was carried out on each test article.

All test articles passed bioburden acceptance criteria.

Table 9: Packaging Integrity Summary for pORTAL Guidewire and EXT Extension Wire pORTAL Guidewire and Extension System

Test Test Method Summary Results Visual Inspection All samples are visually inspected for any damage

or defects. All samples passed visual inspection.

Seal Integrity: Dye Penetration Packaging is exposed to a dye solution and is observed and inspected for leakage. As per ASTM F1929.

All samples passed dye penetration testing.

Pouch Peel Test The force required to separate the two sealed materials is recorded.

All samples passed pouch peel testing.

Seal Tensile Strength The maximum tensile force required to separate the seals is recorded. Test Method as per ASTM F88.

All samples were within seal tensile strength specifications.

Sterilisation Completed products were sterilized, then tested for EtO and ECH residual levels.

All samples passed sterilisation tests.

Seal integrity: Bubble leak test Packaging is pressurized and submerged under water while visually inspecting for streams of escaping bubbles. As per ASTM F2096.

All samples passed the bubble leak test.

Cytotoxicity ISO MEM elution – L929 fibroblast cultures – ISO10993-5

All samples were within cytotoxicity specifications.

Physiochemical The methods for these tests are outlined in The United States Pharmacopeia Convention <661>

All samples were within physiochemical specifications.

Age Testing All samples are visually inspected for any damage or defects.

All samples met age testing criteria.

Table 10: Shelf Life Testing Summary for pORTAL Guidewire for 2 years and 3 months

pORTAL Steerable Hydrophilic Guidewire Test Test Method Summary Results

Dimensional The overall guidewire length, polymer jacket length and overall guidewire diameter were measured.

Dimensional results meet acceptance criteria.

Tip Tensile Strength The distal section of the wire was pulled until it failed.

Results show the tensile strength meets specification.

Catheter Compatibility The guidewire was tested with relevant interfacing devices such as over the wire micro catheters under simulated use.

The guidewires tested performed acceptably and were shown to be compatible with tested microcatheters.

Coating Adherence/Integrity The guidewire was tracked multiple times through a catheter in a simulated anatomy. The coatings were inspected for signs of damage or degradation.

No coating was rubbed off during or after testing of guidewire in any of the microcatheters.

Tip Stiffness (Gram Weight) The distal tip of the guidewire was compressed. The peak load was electronically recorded and reported.

Device stiffness is equivalent or less than predicate device. Device tip stiffness is within specification.

Tip Shape Retention A J-Shape was formed on the distal end of the wire, then recorded using an image measuring system.

The guidewire distal tip retention is better than or equivalent to predicate device. Tip shape retention is within specification.

Lubricity and Durability Test The guidewire, within a microcatheter was tracked multiple times through a 3-Dimensional Neuro Silicone anatomy block. Resulting lubricity was measured.

Lubricity and durability of the guidewire is better than or equivalent to the predicate device. The device meets acceptance criteria on both lubricity and durability.

PTFE Coating Adherence (Saline Soak & Wipe Test)

The entire length was pulled through a fixed clamp. The wire was inspected for PTFE degradation or damage.

All devices passed saline soak & wipe test.

510(k) Summary, Page 9 of 10

pORTAL Steerable Hydrophilic Guidewire Test Test Method Summary Results

PTFE Coating Mandrel Adhesion Test (Saline Soak & Wrap Test)

The wire was wrapped around a mandrel of a fixed diameter (as defined in ISO11070 standard). The wrapped PTFE coated wire was inspected under a microscope for any signs of flaking, cracking or delamination.

All devices passed saline soak & wrap test.

PTFE Adhesion / Durability Testing (Eraser Test)

The wire was placed in a fixture and subject to a number of cycles underweight. The wire was removed and inspected for failure.

All devices passed eraser test.

Radiopacity The radiopaque distal end of the guidewire was imaged using standard fluoroscopy equipment. An image was taken and reviewed to ensure visibility

Device radiopacity was seen to be comparable to predicate device. Device meets specification.

Torque Strength (Combined Load/Turns to Failure)

The guidewire was loaded into the guide catheter within a simulated neurovascular anatomy. Force is applied and the specimen is rotated to failure.

Device torqueability was demonstrated within specification.

ISO Flex Resistance Test (Bending Durability)

Test method defined in ISO 11070 Annex G. The test region of the wire was wrapped around mandrels in opposing directions a number of times. The wire was removed and examined.

Flex resistance was comparable to predicate device.

Corrosion Resistance Test method defined in ISO 11070 Annex B. The products were placed in a beaker of salt water at room temp for 5 hours, and then placed in boiling distilled water for 30 minutes, followed by 48 hours at 37°C. The products were removed, and examined for evidence of corrosion.

Device meets acceptance criteria, no evidence of corrosion on device.

FDA Tip Flexibility This test measures the load required to deflect the distal tip of the guidewire to angles of 45° and 90. A force curve was generated for each specimen at the specified deflection points and were electronically collected.

Tip stiffness properties were shown to be comparable or less atraumatic than predicate device. Peak load was within specification.

Kink Resistance / Flexibility The tip of each device was wrapped around mandrels, until kinking occurs.

Kink resistance was equivalent or better than predicate device.

Particle Residue Following simulated use, particulates generated are collected, and counted by size for each wire. T

All parts & calculated tolerance interval are below max specification for ≥10µm particles/device and ≥25µm particles/device.

Torque Response The test measured the reaction of the distal end of the guidewire when the wire was placed within a simulated anatomy.

Equivalent torque response when compared to predicate device. Both fresh and fatigued devices are within specifications.

Packaging Inspection The packaging should not incur any damage or defects that may have a detrimental impact on the use or performance of the product.

The packaging did not incur any damage or defects that may have a detrimental impact on the use or performance of the product.

Table 11: Shelf Life Testing Summary for pORTAL Extension Wire 5 years

pORTAL EXT Extension Wire

Test Test Method Summary Results Catheter Compatibility Test The guidewire was tested with relevant interfacing

devices under simulated use. The extension systems performed acceptably and were shown to be compatible with tested microcatheters.

PTFE Coating Mandrel Adhesion Test (Saline Soak & Wrap Test)

The wire was wrapped around a mandrel of a fixed diameter (as defined in ISO11070 standard). The wrapped PTFE coated wire was inspected under a microscope for any signs of flaking, cracking or delamination.

No damage was observed post soak & wrap test. All devices passed.

PTFE Coating Adherence (Saline Soak & Wipe Test)

The entire length was pulled through a fixed clamp. The wire was inspected for PTFE degradation or damage.

No damage was observed post soak & wipe test. All devices passed.

PTFE Adhesion / Durability Testing (Eraser Test)

The wire was placed in a fixture and subject to a number of cycles underweight. The wire was removed and inspected for failure.

No damage was observed post eraser test. All devices passed.

510(k) Summary, Page 10 of 10

pORTAL EXT Extension Wire

Test Test Method Summary Results Dimensional Measurements The overall length and maximum diameter of the

extension wire were measured. All dimensional measurements were within specifications.

Joint Strength / Tensile Test The joint strength of the extension wire is measured using a calibrated force tester

Joint strength measurements were within specifications.

Strength of Union The peak force to separate the guidewire from the extension wire is measured using a calibrated force tester

Strength of union measurements were comparable to predicate device and within specifications.

Joint Flex Test This test involves flex testing the integrity of the connecting joint between the extension wire and the guidewire. A force curve is generated for each specimen, and the peak load is electronically calculated and put into a report.

Results have shown comparable joint flex properties between the subject device & predicate device. Device meets specification.

Particulate Residue Test Following simulated use, particulates generated are collected, and counted by size for each wire.

All parts & calculated tolerance interval are below max specification for ≥10µm particles/device and ≥25µm particles/device.

Packaging Inspection The packaging should not incur any damage or defects that may have a detrimental impact on the use or performance of the product.

The packaging did not incur any damage or defects that may have a detrimental impact on the use or performance of the product.

VIII. CONCLUSIONS

The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire has an intended use and technological characteristics equivalent to the predicate devices. The subject device demonstrates product performance through successful bench testing. The pORTAL Guidewire device demonstrates it is safe for use for 2 years 3 months and the pORTAL Extension Wire is safe for 5 years. All packaging tests support the claimed shelf life. Device use is identical to the predicate devices and performance of the new device is comparable.

Taking this information into account, it is concluded that the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is substantially equivalent to the predicate devices, the Traxcess 14EX Guidewire and Traxcess Docking Wire (K093397) and Transend EX Guidewire (K934122).