Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031 Document: RA DoCa-020 Rev. 05 / DCR 13-503 Climber™ Guiding Catheter Page 1 of 13 This document is the property of PendraCare International B.V. This document contains confidential information that is not to be disclosed to unauthorized persons. Document Release Date: 2014-01-14 Annex to the Declaration of Conformity - Supporting Information – Annex to the “Declaration of Conformity to Directive 93/42/EEC concerning Medical Devices” for Climber™ Guiding Catheter (RA DoC-020 Rev. 05) Legal Manufacturer: PendraCare International B.V., Van der Waalspark 22, 9351 VC Leek, The Netherlands. Supporting documentation Documentation that contains proof of compliance to the aforementioned Directive is described below and is retained under the premises of the manufacturer. I. Technical Information The Regulatory File (Summary of Technical Documentation / STED) 3 rd Generation Guiding Catheters, that was initially reviewed and approved by PendraCare International B.V. on December 23, 2010 demonstrates continuous compliance with the relevant essential requirements of the current Directive 93/42/EEC. The STED is maintained and provides information with respect to changes implemented in the product and its manufacturing processes. The documentation referenced in the STED that contains the evidence of conformity with the applicable regulations is part of the product’s “Design History File” (DHF). The product’s DHF is archived within PendraCare’s Documentation Control System at PendraCare International B.V., Van der Waalspark 22, 9351 VC Leek, The Netherlands. To certify that the type of the products falling within the indicated product category conforms to the provisions of the current Directive 93/42/EEC in accordance with Annex II excluding (4) of the Directive, DEKRA Certification B.V. issued to PendraCare International B.V. a “CE Marking of Conformity” Certificate (2020764CE01) per current Directive 93/42/EEC, Annex II excluding (4) - Full Quality Assurance System for “Cardiovascular Catheters”. The Declaration of Conformity for this Guiding Catheter (Class IIa) is valid in combination with the current CE Marking of Conformity Certificate. The Declaration of Conformity is valid until the expiration date indicated on the CE Marking of Conformity Certificate. This Declaration of Conformity covers: Product Category (collective term): Cardiovascular Catheters Generic Device Group Term: Intravascular Guiding Catheter Product type (family): Climber™ Guiding Catheter
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Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031
Document: RA DoCa-020 Rev. 05 / DCR 13-503
Climber™ Guiding Catheter Page 1 of 13
This document is the property of PendraCare International B.V. This document contains confidential information that is
not to be disclosed to unauthorized persons.
Document Release Date: 2014-01-14
Annex to the Declaration of Conformity - Supporting Information –
Annex to the “Declaration of Conformity to Directive 93/42/EEC concerning Medical Devices” for
Climber™ Guiding Catheter (RA DoC-020 Rev. 05)
Legal Manufacturer:
PendraCare International B.V., Van der Waalspark 22, 9351 VC Leek, The Netherlands.
Supporting documentation
Documentation that contains proof of compliance to the aforementioned Directive is described below and is retained under the premises of the manufacturer.
I. Technical Information
The Regulatory File (Summary of Technical Documentation / STED) 3rd
Generation Guiding Catheters, that was initially reviewed and approved by PendraCare International B.V. on December 23, 2010 demonstrates continuous compliance with the relevant essential requirements of the current Directive 93/42/EEC.
The STED is maintained and provides information with respect to changes implemented in the product and its manufacturing processes.
The documentation referenced in the STED that contains the evidence of conformity with the applicable regulations is part of the product’s “Design History File” (DHF). The product’s DHF is archived within PendraCare’s Documentation Control System at PendraCare International B.V., Van der Waalspark 22, 9351 VC Leek, The Netherlands.
To certify that the type of the products falling within the indicated product category conforms to the provisions of the current Directive 93/42/EEC in accordance with Annex II excluding (4) of the Directive, DEKRA Certification B.V. issued to PendraCare International B.V. a “CE Marking of Conformity” Certificate (2020764CE01) per current Directive 93/42/EEC, Annex II excluding (4) - Full Quality Assurance System for “Cardiovascular Catheters”.
The Declaration of Conformity for this Guiding Catheter (Class IIa) is valid in combination with the current CE Marking of Conformity Certificate.
The Declaration of Conformity is valid until the expiration date indicated on the CE Marking of Conformity Certificate.
This Declaration of Conformity covers: Product Category (collective term): Cardiovascular Catheters Generic Device Group Term: Intravascular Guiding Catheter Product type (family): Climber™ Guiding Catheter
Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031
Document: RA DoCa-020 Rev. 05 / DCR 13-503
Climber™ Guiding Catheter Page 2 of 13
This document is the property of PendraCare International B.V. This document contains confidential information that is
not to be disclosed to unauthorized persons.
Document Release Date: 2014-01-14
II. Quality Management Systems
The below certificates have been issued by the indicated Notified Bodies to PendraCare International B.V. in respect of the operations (development, manufacturing, final inspection and distribution) at the indicated site and for the products mentioned in the scope of the registration.
Certificate of Registration (2086817), issued by DEKRA Certification B.V. to PendraCare International B.V. to certify that the Quality Management System complies with the relevant requirement of EN-ISO 13485: 2012 for the activities detailed in the scope of the registration.
Certificate “CE Marking of Conformity” (2020764CE01), issued by DEKRA Certification B.V. to PendraCare International B.V. to certify that the manufacturer fulfils the relevant provisions of the current Directive 93/42/EEC, Annex II excluding (4) for the indicated product category “Cardiovascular Catheters”. The necessary information and the reference to the relevant documentation of the products concerned and the assessments performed, are stated in the Certification Notice (2020764CN).
Supporting Information:
Authorized Representative European Community: Not Applicable
Notified Body: The Notified Body that assesses the conformity of PendraCare’s products and PendraCare’s Quality Management System with the requirements of the Directive 93/42/EEC is:
DEKRA Certification B.V. Meander 1051 6825 MJ Arnhem The Netherlands
DEKRA Certification B.V. P.O. Box 5185 6802 ED Arnhem The Netherlands
DEKRA Certification B.V. is part of DEKRA. DEKRA Certification B.V. is registered in Arnhem 09085396
Telephone No.: +31 88 96 83000
Web Address: www.dekra.com www.dekra-certification.com
Notified Body I.D. no: 0344 For supporting information, see the following attachments: 1. Product Characteristics 2. Indications for Use - Statement 3. Catalogue number & Lot number System 4. Device Nomenclature 5. Declaration of Conformity to applied International Standards 6. Statements / Claims
Place of issue: Leek, The Netherlands
Approved by: A. Roossien, MSc., PhD. Manager Quality Assurance & Regulatory Affairs PendraCare International B.V.
Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031
Document: RA DoCa-020 Rev. 05 / DCR 13-503
Climber™ Guiding Catheter Page 3 of 13
This document is the property of PendraCare International B.V. This document contains confidential information that is
not to be disclosed to unauthorized persons.
Document Release Date: 2014-01-14
Attachment 1
Product Characteristics
Brand / Trade Name: Climber™ Guiding Catheter
Regulatory File: PendraCare’s 3rd
Generation Guiding Catheters
Indication for Use (per IFU)
The Guiding Catheter is designed to provide a pathway through which therapeutic and
diagnostic devices are introduced. The Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
Contra-indication: None known.
Class:
Based on classification rule 7 (first indent; short term use) of Annex IX of the current
Directive 93/42/EEC concerning Medical Devices, the device is considered a Class lla device. [Note: the device is used in the Central Circulatory System but it does not control, diagnosis, monitor or correct a defect of the heart or a vessel belonging to the Central Circulatory System.] [Regulatory File has been reviewed & approved by the Notified Body].
Legal Manufacturer:
PendraCare International B.V., Van der Waalspark 22, 9351 VC Leek, The Netherlands. PendraCare International B.V. is part of PendraCare Holding B.V. PendraCare Holding B.V. is part of Wellinq Holding B.V. Manufacturing License Authority: Dutch Chamber of Commerce Manufacturing License Registration numbers:
PendraCare Holding B.V.: 02092853 PendraCare International B.V.: 02086018 EORI-number: NL813700917
Manufacturing Location: Country of Origin: (Final assembly)
Sterilisation location: Sterigenics Belgium SA Zoning Industriel de Petit-Rechain (Chaineux) Avenue du Parc 29, B-4800 Verviers, Belgium
Terumo Europe N.V. Interleuvenlaan 40 3001 Leuven, Belgium
[Note: Local distribution may be organized through “local authorized distributors” as indicated in a country- and distributor-specific “Letter of Authorization” or “Power of Attorney”]
Declared by: A. Roossien, MSc., PhD. Manager Quality Assurance & Regulatory Affairs PendraCare International B.V.
Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031
Document: RA DoCa-020 Rev. 05 / DCR 13-503
Climber™ Guiding Catheter Page 4 of 13
This document is the property of PendraCare International B.V. This document contains confidential information that is
not to be disclosed to unauthorized persons.
Document Release Date: 2014-01-14
Attachment 2
Indications for Use - Statement (Description for Use Statement)
Trade name: Climber™ Guiding Catheter
Device description: The Guiding Catheter is a single use device that facilitates the passage of intravascular devices.
Indication for Use: The Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
Contraindications: None known
Reference: Instructions for Use (Specification SPEC G1-189)
Manufacturer
PendraCare International B.V. Van der Waalspark 22 9351 VC Leek The Netherlands
Declared by: A. Roossien, MSc., PhD. Manager Quality Assurance & Regulatory Affairs PendraCare International B.V.
Date: 2014-01-14
Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031
Document: RA DoCa-020 Rev. 05 / DCR 13-503
Climber™ Guiding Catheter Page 5 of 13
This document is the property of PendraCare International B.V. This document contains confidential information that is
not to be disclosed to unauthorized persons.
Document Release Date: 2014-01-14
Attachment 3
Catalogue numbers & Lot numbers
Trade name: Climber™ Guiding Catheter
Catalogue
Numbering
System:
Meaning of catalogue (REF) numbers:
The catalogue (REF) numbers of PendraCare’s products are composed of a unique identifier composed of an 8 digit number with the following structure: AA-BCDDEEFG, whereby:
AA = Catheter type: GC = Guiding Catheter
B = Manufacturer: P = PendraCare
C = French Size (diameter): 5 = 5F; 6 = 6F; 7 = 7F; 8 = 8F
DD = Tip-Shape Configuration: For tip shape configuration & tip shape curve see list of tip shapes (table “Shape”) EE = Shape curve:
F = Catheter Length: 0 = 100 cm
2 = 125 cm
G = Side holes: N = without side holes
A = 2 “in-line” side holes
Example: GC-P6AL070N indicates a 6F Climber Guiding Catheter. The Climber is a hydrophilic
coated guiding catheter which does not feature side holes (N). The pouch contains one catheter 100 cm in length featuring an AL.75 tip-shape.
Lot
Numbering
System:
Meaning of the LOT code:
Per PendraCare’s Quality Management System, the system used by the manufacturer to identify the manufacturing cycle is called the Device History Record (DHR). The DHR is a compilation of records containing the production history (traceability-records) of a finished device. The lot number of a PendraCare’s device (final assembly) is expressed as a 8-digit number which is hyphenated between the fourth (4
th) and fifth (5
th) number.
The meaning of the lot code # # # # - # # # # is as follows:
Numbers position #1 & #2 The year of manufacturing (13 indicates 2013)
Numbers position #3 & #4 The month of manufacturing (from 01 to 12)
Numbers position #5 thru #8 A non-repeated, sequential (unique) number starting from 0001. At the start of each month, the sequential number starts again from 0001.
Example: On the label “LOT 1305-1234” indicates the 1234th lot manufactured in May 2013.
Lot numbers: This Declaration of Conformity applies to the following lot number: LOT 1305-0213 and beyond
Declared by: A. Roossien, MSc., PhD. Manager Quality Assurance & Regulatory Affairs PendraCare International B.V.
Date: 2014-01-14
Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031
Document: RA DoCa-020 Rev. 05 / DCR 13-503
Climber™ Guiding Catheter Page 6 of 13
This document is the property of PendraCare International B.V. This document contains confidential information that is
not to be disclosed to unauthorized persons.
Document Release Date: 2014-01-14
Catalogue numbers (I)
Device Name: Climber™ Guiding Catheter
Configuration: Single Pack (1 pouch/box), Useable Catheter Length 100cm, Without side holes
Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031
Document: RA DoCa-020 Rev. 05 / DCR 13-503
Climber™ Guiding Catheter Page 10 of 13
This document is the property of PendraCare International B.V. This document contains confidential information that is
not to be disclosed to unauthorized persons.
Document Release Date: 2014-01-14
Catalogue numbers (III)
Device Name: Climber™ Guiding Catheter
Configuration: Five Pack (5 pouches/box), Useable Catheter Length 125cm, Catheter without side holes.
6F Shape
GC-P6MP102N MP1
GC-P6RN102N RN1
GC-P6RN202N RN2
GC-P6RN302N RN3
GC-P6JR402N JR4
GC-P6IM002N IM
Configuration: Five Pack (5 pouches/box), Useable Catheter Length 125cm, Featuring 2 side holes.
6F Shape
GC-P6MP102A MP1
GC-P6RN102A RN1
GC-P6RN202A RN2
GC-P6RN302A RN3
GC-P6JR402A JR4
GC-P6IM002A IM
Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031
Document: RA DoCa-020 Rev. 05 / DCR 13-503
Climber™ Guiding Catheter Page 11 of 13
This document is the property of PendraCare International B.V. This document contains confidential information that is
not to be disclosed to unauthorized persons.
Document Release Date: 2014-01-14
Attachment 4
Device Nomenclature
Device Category (ISO 15225 & GMDN database):
Codes: Terms:
10 Single Use devices
Device Subcategory - Collective Term (GMDN database):
Code: Term:
CT 477 Cardiovascular Catheters
Generic Device Group (GMDN database):
Preferred Term: Intravascular Guiding Catheter
GMDN Code: GMDN: 17846
ECRI: 17846 [Emergency Care Research Institute Nomenclature]
GMDN Definition (type, appearance, material, purpose & mechanism of action): A flexible tube with a central lumen used for the percutaneous, transluminal passage and placement of guidewires and diagnostic/interventional devices within the vascular system. After the tube is inserted in position, a guidewire is advanced through its lumen and tracked over by a diagnostic/interventional device (e.g., balloon dilatation catheter, stent and delivery system, or embolization device) to the intended location. The distal section of the tube can have a variety of preformed shapes. This is a single-use device.
Device Type:
Trade name: Climber™ Guiding Catheter
Customs HS-Code:
Harmonized Commodity Description & Coding System (HS) of tariff nomenclature per World Customs Organization
HS CODE: 901839: 9018 Medical Devices 901839 Catheters
Declared by: A. Roossien, MSc., PhD. Manager Quality Assurance & Regulatory Affairs PendraCare International B.V.
Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031
Document: RA DoCa-020 Rev. 05 / DCR 13-503
Climber™ Guiding Catheter Page 12 of 13
This document is the property of PendraCare International B.V. This document contains confidential information that is
not to be disclosed to unauthorized persons.
Document Release Date: 2014-01-14
Attachment 5
Declarations of Conformity to applied International Standards PendraCare International B.V. hereby declares that
Climber™ Guiding Catheter meets the applicable requirements of the following International Standards*
Standard: Title:
(EN-) ISO 13485 Quality Systems – Medical Devices –System requirements for regulatory purposes.
EN-ISO/TR 14969
Quality systems – Medical Devices – Guidance on the application of ISO 13485 and ISO 13488.
(EN-) ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
ISO 10555-1 Sterile Single-use intra-vascular catheters; General requirements.
ISO 594-1 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment. Part one: General requirements.
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood.
ISO 10993-5 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11 Biological evaluation of medical devices - Part 11: tests for systemic toxicity
ISO 14155 Clinical investigation of medical devices for human subjects - Good Clinical Practice
EN 1041 Information supplied by the manufacturer with medical devices
ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 11607-1 Packaging for terminally sterilized medical devices. Part-1 Requirements for materials, sterile barrier systems and packages systems.
ISO 17050-1 Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements
ISO 17050-2 Conformity assessment - Supplier's declaration of conformity - Part 2: Supporting documentation
ISO 14644-1 Cleanrooms and associated controlled environments – part 1: classification of air cleanliness
ISO 14644-2 Cleanrooms and associated controlled environments – part 2: Specification for testing and monitoring to prove continued compliance with ISO-14644-1
ISO 14644-3 Cleanrooms and associated controlled environments – part 3: Metrology and test methods.
ISO 14644-4 Cleanrooms and associated controlled environments – part 4: Design, construction and start up
EN 556-1 Sterilization of medical devices – Requirements for medical devices to be labelled “STERILE” - Part 1: Requirements for terminally sterilized medical devices
ISO 11737-1 Sterilization of medical devices – Microbiological methods – Estimation of population of micro-organisms on products (Bio-burden).
ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
* The revision numbers of the applied standards are indicated in the “list of standards” within the Essential Requirements Checklist
Declared by: A. Roossien, MSc., PhD. Manager Quality Assurance & Regulatory Affairs PendraCare International B.V.
Date: 2014-01-14
Annex to the Declaration of Conformity FORM 141-04 / DCR 11-031
Document: RA DoCa-020 Rev. 05 / DCR 13-503
Climber™ Guiding Catheter Page 13 of 13
This document is the property of PendraCare International B.V. This document contains confidential information that is
not to be disclosed to unauthorized persons.
Document Release Date: 2014-01-14
Attachment 6
To whom it may concern
PendraCare International B.V. hereby declares the following for the
Climber™ Guiding Catheter
Sterilisation: PendraCare’s catheters are sterilized using Ethylene oxide (EtO) sterilization process. The sterilization process is validated per ISO 11135-1 with Sterility Assurance Level (SAL) of 10-6 (SAL = 10E-6). The products are, therefore, considered “STERILE”.
EtO-residuals: PendraCare’s Catheters meet the criteria for Ethylene Oxide sterilization residuals as laid down in ISO 10993-7 whereby the device is considered a “Limited Exposure Device” for which the average daily doses of
EO and ECH to the patient does not exceed 4 mg and 9 mg, respectively.
Packaging: The catheter is mounted on a mounting card within a single barrier (heat-sealed) pouch and placed with an “Instructions for Use” in a carton-box. The packaging meets ISO 11607-1& ISO 11607-2 “Packaging for terminally sterilized medical devices”.
Shelf life: Product’s sterility, safety and performance are guaranteed for a period of 36 months (three years) after sterilization. The shelf life - expiration date is printed on the product labels near the “Use By Date” (hour glass) symbol. This symbol is accompanied by a date to indicate that the device should not be used after the end of the year (yyyy) and month (mm) shown adjacent to the symbol (ISO 15223-1).
“Use-By-Date”
Symbol
PendraCare’s Catheter is a Cardiovascular Catheter for single use, i.e., single-patient, single procedure and single purpose use. The catheters should not be reprocessed, re-sterilized, and re-used.
PendraCare’s Catheter is labelled non-pyrogenic. The product does not result in bacterial endotoxin-mediated (USP<85>, USP<161>) or material-mediated (ISO 10993-11, USP <151>) pyrogenic responses.
PendraCare’s Catheter does not incorporate, as an integral part, a medicinal product. PendraCare’s Catheter does not contain tissue of biological origin, i.e., does not contain tissue of animal origin
or (human) blood derivatives. PendraCare’s Catheter is latex-free and does not contain phthalates. This statement comprises the medical
device, its packaging as well as its manufacturing processes. No latex or phthalates (e.g., DEHP) are used within PendraCare’s production-lines.
PendraCare’s Catheter does not contain soft-ware. Biocompatibility of PendraCare’s Catheter is confirmed by successful test results from biocompatibility testing
conducted per “current” ISO 10993 standards, including: ISO 10993-1 Biological Evaluation of Medical Devices (USP <1031>); ISO 10993-4 Haemocompatibility; ISO 10993-5 Cytoxicity (USP <87>); ISO 10993-7 Ethylene Oxide residues; ISO 10993-10 Sensitization and Irritation (USP <1184>) & Intracutaneous reactivity (USP <88>); ISO 10993-11 Systemic toxicity (acute); USP <661> Packaging (plastic containers – leachables)
PendraCare’s Catheter’s packaging meets the requirements of the Packaging & Packaging Waste Directive 94/62/EC (as amended by 2004/12/EC) and Standard EN 13427.
Declared by: A. Roossien, MSc., PhD. Manager Quality Assurance & Regulatory Affairs PendraCare International B.V.