RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20

K090165 · Masimo Corporation · DQA · Jul 9, 2009 · Cardiovascular

Device Facts

• Record ID: K090165
• Device Name: RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Rainbow Resposable Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Resposable Sensors are indicated for use with adult and pediatric patients during no motion conditions and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Device Story

Rainbow Resposable Pulse CO-Oximeter Sensors provide noninvasive optical assessment of tissue oxygenation; inputs include light signals from emitters processed by detectors; device transforms optical signals into physiological parameters (SpO2, pulse rate, SpMet, SpHb). System consists of reusable emitter/detector/cable assembly and single-patient-use tape assembly. Used in hospitals, mobile, and home environments; operated by clinicians or patients. Output displayed on compatible Masimo Rainbow SET monitors; assists healthcare providers in patient status assessment and clinical decision-making. Benefits include continuous monitoring of hemoglobin parameters without invasive sampling.

Clinical Evidence

Clinical studies conducted on adult and pediatric patients. Accuracy metrics reported for SpO2 (±2-3%), pulse rate (±3 bpm), SpMet (±1%), and SpHb (±1 g/dL) under no-motion and low-perfusion conditions. Biocompatibility testing confirmed non-toxic, non-irritating, and non-sensitizing materials. Environmental, electrical, and mechanical testing passed per FDA guidance.

Technological Characteristics

Noninvasive optical tissue oximetry using emitters and detectors. Compatible with Masimo Rainbow SET monitors. Reusable emitter/detector/cable assembly with single-patient-use tape. Materials equivalent to predicate. Electrical, mechanical, and environmental testing performed per 1993 FDA guidance.

Indications for Use

Indicated for continuous noninvasive monitoring of SpO2, pulse rate, SpMet, and SpHb in adult and pediatric patients. Use restricted to no-motion conditions; applicable for well or poorly perfused patients in hospitals, hospital-type facilities, mobile, and home environments.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Rainbow Adhesive Pulse CO-Oximetry Sensors (K081659)

Submission Summary (Full Text)

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# 510(k) SUMMARY

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>949-297-7000<br>FAX [phone] |
|---------------------------------------|-----------------------------------------------------------------------------------------|
| Company Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | July 7, 2009 |
| Trade Name | Rainbow Resposable Pulse CO-Oximeter Sensors |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700)<br>Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices: | Rainbow Adhesive CO-Oximetry Sensors, 510(k) Number K081655 |

### Device Description

The Rainbow Resposable Sensors are fully compatible sensors for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow Adhesive Sensors in the K0801659 filing.

The Rainbow Resposable Sensors have the similar intended use/indications for use and performance specifications as the Rainbow Adhesive Sensors in the K0801659 filing. The main difference is that the entire Rainbow Adhesive Sensor is single-patient use. However for the Rainbow Resposable Sensor, the tape assembly is single-patient use and the emitter/detector/cable assembly is detachable from the tape assembly. This emitter/detector/cable assembly is reusable. Also, the Rainbow Resposable Sensors are not indicated for the measurement of carboxyhemoglobin saturation and motion conditions.

# Predicate Devices

The predicate devices for this filing are the Rainbow Adhesive Pulse CO-Oximetry Sensors (K081659).

# Intended Use/ Indications for Use

The Rainbow Resposable Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Resposable Sensors are indicated for use with adult and pediatric patients during no motion conditions and for patients who are well or poorly perfused in hospitals. hospital-type facilities, mobile, and home environments.

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# 510(k) SUMMARY

## Technology Comparison

The Rainbow Resposable Sensors are substantially equivalent in intended use, design, principles of operation, materials, and performance to predicate sensors and operate on identical principles of noninvasive optical assessment of tissue oxygenation using emitters and detectors.

They are designed, configured, and manufactured for full compatibility with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeters. The Rainbow Resposable Sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices, with accuracy that is also equivalent to those of the predicate devices.

## Performance Testing

#### Biocompatibility

Test results of all patient-contact materials used in the Rainbow Resposable Sensors demonstrated that the materials were non-toxic, non-irritating, and non-sensitizing.

#### Environmental

Applicable environmental testing per the Reviewers Guidance for Premarket Submissions -November 1993, i.e. electrical, mechanical and environmental were performed and all tests passed.

#### Clinical

Clinical studies for the Rainbow Resposable Sensors are similar to those of the Rainbow Adhesive Sensors, resulting in the following sensor specifications for adult and pediatric patients:

| Measurement | Accuracy<br>Range | Accuracy |
|--------------------------------------------------|-------------------|--------------|
| Arterial Oxygen Saturation (SpO2), No Motion | 60-80% | $\pm$ 3% |
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | $\pm$ 2% |
| Arterial Oxygen Saturation (SpO2), Low Perfusion | 70-100% | $\pm$ 2% |
| Pulse Rate, No Motion | 25-240 bpm | $\pm$ 3 bpm |
| Pulse Rate, Low Perfusion | 25-240 bpm | $\pm$ 3 bpm |
| Methemoglobin (SpMet), No Motion | 1-15% | $\pm$ 1% |
| Total Hemoglobin Concentration (SpHb), No Motion | 8-17 g/dL | $\pm$ 1 g/dL |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2009

Ms. Marguerite Thomlinson Manager. Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

Re: K090165

Trade/Device Name: Rainbow Resposable Pulse CO-Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DSA, JKS Dated: March 31, 2009 Received: April 6, 2009

Dear Ms. Thomlinson:

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. 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.

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.

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# Page 2- Ms. Thomlinson

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050:

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Susan Runpe

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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# Indications for Use

K090165

510(k) Number (if known):

Rainbow Resposable Pulse CO-Oximeter Sensors Device Name:

### Indications For Use:

The Rainbow Resposable Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Resposable Sensors are indicated for use with adult and pediatric patients during no motion conditions and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

| | Prescription Use | | |
|--|--------------------------------|--------|--------------------------------|
| | (Per 21 CFR 801.109 Subpart D) | AND/OR | Over-The-Counter Use |
| | | | (Per 21 CFR 801.109 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---------------------|--------------------------------------------------------|
| (Division Sign-Off) | |
| | Division of Anesthesiology, General Hospital |
| | Infection Control, Dental Devices |
| 510(k) Number: | K090165-Resposable Sensors |

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