MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS

K071024 · Masimo Corporation · DQA · Jun 29, 2007 · Cardiovascular

Device Facts

• Record ID: K071024
• Device Name: MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Disposable pulse CO-oximeter sensors; attach to patient finger, hand, foot, or toe via adhesive bandage. Utilize 8-wavelength optical emitters and detectors to measure tissue oxygenation. Designed for use with Masimo Rainbow SET compatible monitors. Sensors transform optical signals into data for continuous monitoring of SpO2, pulse rate, SpCO, and SpMet. Used in hospitals, mobile environments, and homes; operated by clinicians or patients. Output displayed on compatible multi-parameter monitors to assist healthcare providers in assessing patient status and making clinical decisions regarding oxygenation and hemoglobin saturation levels.

Clinical Evidence

Clinical studies conducted on healthy adult volunteers and hospitalized neonates. Subjects underwent progressive induced hypoxia. Primary endpoints: accuracy of SpO2, SpCO, and SpMet compared to laboratory CO-Oximeter blood samples. Results: SpO2 accuracy <2% (70-100% range) and <3% (60-80% range) for adults/pediatrics/infants; <3% for neonates. SpCO accuracy <3% (1-40% range). SpMet accuracy <1% (1-15% range for adults; 0-2.5% range for neonates).

Technological Characteristics

Disposable adhesive sensors; 8-wavelength optical emitter/detector assembly. Materials identical to Masimo LNCS/LNOP lines; biocompatible. Non-sterile. Compatible with Masimo Rainbow SET monitors. Sensing principle: non-invasive optical assessment of tissue oxygenation.

Indications for Use

Indicated for continuous non-invasive monitoring of SpO2, pulse rate, SpCO, and SpMet in adult, pediatric, and neonatal patients, including those with poor perfusion, in hospital, mobile, and home settings.

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 CO-Oximetry Sensors (K063140)

Submission Summary (Full Text)

{0}------------------------------------------------

K071024

# 510(k) SUMMARY

JUN 2 9 2007

Image /page/0/Picture/3 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the address "40 Parker, Irvine, CA 92618". The phone number is "949-297-7000" and the fax number is "949-297-7001".

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>949-297-7000<br>FAX [phone] |
|---------------------------------------|-----------------------------------------------------------------------------------------|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs |
| Date Summary Prepared: | June 28, 2007 |
| Trade Name | Rainbow Adhesive Pulse CO-Oximeter Sensors |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700) |
| Substantially Equivalent Devices: | Rainbow Adhesive CO-Oximetry Sensors 510(k) Number - K063140 |

### Device Description

The Rainbow Adhesive Sensors are fully compatible disposable sensor for use with Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow DCI-DC CO-Oximetry Sensors.

The Rainbow Adhesive Sensors are similar in the predicate devices except for a recessed emitter. The emitter and detector assemblies are connected to the sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger, hand, foot or toe. The same emitters (with 8 wavelengths) are used in Rainbow Adhesive Sensors. Four sizes of Rainbow Adhesive Sensors are available for use with adult, pediatric, infant and neonatal patients. The four sensors are essentially identical except for the emitter and detector spacing and size and orientation of the patient contacting materials in the Rainbow Adhesive Sensors are the same that is used in Masimo's LNCS and LNOP single use sensor lines. The Rainbow Adhesive Sensors are supplied non-sterile for single patient use.

#### Predicate Devices

Rainbow Adhesive CO-Oximetry Sensors

#### Intended Use

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

{1}------------------------------------------------

# 510(k) SUMMARY

#### Technology Comparison

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

The Rainbow Adhesive Sensors are designed, and manufactured for full compatibility with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeters. The Rainbow Adhesive Sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

The accuracy of the Rainbow Adhesive Sensors are equivalent to those of the predicate devices.

### Performance Testing

## Biocompatibility

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

#### Environmental Testing

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 Testing

Clinical studies were performed using Rainbow SET technology with Rainbow Adhesive Sensors on healthy adult volunteer subjects during motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. Clinical testing of the Rainbow Adhesive sensors resulted in an accuracy of less than 2% SpO2 Agys in the range of 70%-100% SaO2 and less than 3% SpO2 Apps in the range of 60%-80% SaO2 for adults, pediatrics and infants.

Additional clinical studies were performed using Masimo Rainbow SET technology with Rainbow Adhesive Sensors on hospitalized neonatal patients resulted in an accuracy of less than 3% SpO2 Aross in the range of 70%-100% SaO2.

The Masimo Rainbow SET technology with Rainbow Adhesive Sensors have been validated in human blood studies on healthy adult volunteers against a laboratory CO-Oximeter from 1-40% for carboxyhemoglobin and 1-15% for methemoglobin. Clinincal testing of the Rainbow Adhesive sensors resulted in an accuracy of less than 3% SpCO Agos in the range of 1%-40% SaCO and an accuracy of less than 1% SpMet ABMS in the range of 1%-15% SaMet.

Additional clinical studies were performed using Masimo Rainbow SET technology with Rainbow Adhesive Sensors on hospitalized neonatal patients resulted in an accuracy of less than 1% SpMet ArMs in the range of 0% - 2.5% SaMet.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the HHS logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the logo.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Mr. James J. Cronin Vice President, Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

JUN 2 9 2007

Re: K071024

Trade/Device Name: Rainbow Adhesive Pulse CO-Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, JKS Dated: June 1, 2007 Received: June 4, 2007

Dear Mr. Cronin:

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 such 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.

{3}------------------------------------------------

# Page 2 - Mr. Cronin

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Srite K. Michau Omd

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## 510(k) Number (if known):

Rainbow Adhesive Pulse CO-Oximeter Sensors Device Name:

Indications For Use:

The Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo SET® Radical 7 Pulse CO-Oximeter and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for the display of those devices.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

0011

. . .

(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: K071024