U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.03 Silver Spring, MD 20993 www.fda.gov Masimo Corporation Sindura Penubarthi Regulatory Affairs Manager 52 Discovery Irvine, California 92618 Re: K183697 Trade/Device Name: Masimo Rad-97 and Accessories Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA, DPZ, DXN, CCK, BZQ, FLL Dated: April 15, 2019 Received: April 16, 2019 Dear Sindura Penubarthi: 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. 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
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U.S. Food & Drug Administration
10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 0 3
Silver Spring, MD 20993
www.fda.gov
Masimo Corporation
Sindura Penubarthi
Regulatory Affairs Manager
52 Discovery
Irvine, California 92618
Re: K183697
Trade/Device Name: Masimo Rad-97 and Accessories
Regulation Number: 21 CFR 870.2300
Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm)
Regulatory Class: Class II
Product Code: MWI, DQA, DPZ, DXN, CCK, BZQ, FLL
Dated: April 15, 2019
Received: April 16, 2019
Dear Sindura Penubarthi:
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.
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
Masimo Confidential Masimo Rad-97 and Accessories K183697 Page 274 of 396
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
510(k) Number (if known)
Kl83697
Device Name
Indications for Use
Masimo Rad-97 with Accessories
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (PR) to multi parameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
The optional Nomoline Capnography product family is intended to be connected to other medical backboard devices for monitoring of breath rate and C02. The Nomoline Capnography product family is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient room. The intended patient population is adult, pediatric and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:
Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older
FORM FDA 3881 (7/17) Page 1 of2 PSC P\Jblishmg Scn'iccs (301) 4-tl-67-10 EF
Masimo Confidential Masimo Rad-97 and Accessories K183697 Page 275 of 396
The optional Masimo Centroid 02 is intended for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (PR).
The optional Masimo Centroid 02 is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (Sp02) and pulse rate (PR) for use with adult, pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital, hospital-type facilities and home environments. Devices with Masimo technology are only to be used with Masimo sensors and cables.
Type of Use (Select one or both, as applicable)
IZJ 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 Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [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."
FORM FDA 3881 (7117) Page 2 of2
Section 5. 510(k) Summary
Submitter and Address of
Manufacturing Facility:
Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592
Date: December 27, 2018
Contact: Sindura Penubarthi
Regulatory Affairs Manager
Masimo Corporation
Phone: (949) 297-7541
Trade Name: Masimo Rad-97 and Accessories
Common Name: Patient Monitor
Classification Regulation/ Product
Code: 21 CFR 878.2300, Class II/MWI
Additional Product Code: 21 CFR 870.2700, Class II/DQA
21 CFR 880.2910, Class II/CCK
21 CFR 862.3220, Class II/JKS
21 CFR 868.2375, Class II/BZQ
21 CFR 870.1130, Class II/DXN
21 CFR 880.2910, Class II/FLL
Establishment Registration
Number:
2031172
Reason for Premarket
Notification:
New Device
Predicate Device: K180046 – Masimo Rad-97 and Accessories
Reference Predicate: K153225 – Masimo Root Monitoring System and Accessories
Performance Standards No performance standards for the above device have been promulgated
pursuant to Section 514.
5.1. Device Description
The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a
touchscreen display that continuously displays numeric values for the measured monitoring
parameters. The Rad-97 product family can be operated on AC power or internal rechargeable
battery.
The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97
product family) cleared under K180046, and has the same indications for use. The Rad-97
comprises of the same measurement technologies as cleared in the predicate, which includes the
Masimo rainbow SET technology, capnography technology, and noninvasive blood pressure
(NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive
K183697 Page 1 of 10
Section 5. 510(k) Summary
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR),
Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin