The Rainbow Adhesive Sensors and Rainbow Pediatric Reusable 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 Adhesive Sensors are indicated 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-type facilities, mobile, and home environments. The Rainbow Pediatic Reusable Sensors are indicated for use with pediatic 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.

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 construction to the predicate devices except that the Rainbow Adhesive Sensors are disposable sensors that are flex circuit and cable based while the Rainbow DCI-DC CO-Oximetry Sensors are cable based. The emitter and detector assemblies are connected to the flex circuit. 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. Two sizes of Rainbow Adhesive Sensors are available for use with adult, pediatric, infant and neonatal patients. The two 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.

The Rainbow Pediatric Reusable Sensor 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 DCI-DC CO-Oximetry Sensors.

The Rainbow Pediatric Reusable Sensor is exactly the same as the predicate sensor (Rainbow DCI-DC sensor) except that the pads in the sensor are smaller to accommodate the digits of pediatric patients. The patient contacting materials in the Rainbow Pediatric Reusable Sensor is exactly the same as the predicate sensor (Rainbow DCI-DC sensor). The Rainbow Pediatric Reusable Sensors are supplied non-sterile.

AI/ML Overview

The information provided in the 510(k) summary is for new Masimo Rainbow Adhesive CO-Oximetry Sensors and Rainbow Pediatric Reusable Sensors, which are intended to be compatible with Masimo Rainbow SET pulse CO-Oximeter monitors. The summary describes performance testing for these new sensors, primarily focusing on SpO2, SpCO, and SpMet accuracy.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
SpO2 Accuracy (for both Rainbow Adhesive and Pediatric Reusable Sensors)	The implicit acceptance criterion is that the accuracy of the new sensors should be equivalent to or better than the predicate devices and meet established standards for pulse oximetry. The provided performance values suggest the goal was to achieve accuracy within clinical ranges previously accepted for Masimo's technology.	Adults, Pediatrics, Infants: < 2% SpO2 Arms in the range of 70%-100% SaO2. < 3% SpO2 Arms in the range of 60%-80% SaO2 and 60%-70% SaO2. Neonates: < 3% SpO2 Arms in the range of 70%-100% SaO2. (Note: The text states "less than 3% AgMs for neonates" which is likely a typo and should be SpO2 Arms given the context. Also, the lower range for neonates for SpO2 is not explicitly stated if different from adults/pediatrics/infants)
SpCO Accuracy (for Rainbow Adhesive Sensors)	The implicit acceptance criterion is that the accuracy of the new sensors should be equivalent to or better than the predicate devices and comparable to Masimo's existing Rainbow SET technology for CO-Oximetry.	< 3.5% SpCO Arms in the range of 1%-40% SaCO.
SpCO Accuracy (for Rainbow Pediatric Reusable Sensors)	Similar to Rainbow Adhesive Sensors.	< 3% SpCO Arms in the range of 1%-40% SaCO.
SpMet Accuracy (for Rainbow Adhesive Sensors)	The implicit acceptance criterion is that the accuracy of the new sensors should be equivalent to or better than the predicate devices and comparable to Masimo's existing Rainbow SET technology for CO-Oximetry.	< 1% SpMet Arms in the range of 1%-15% SaMet.
SpMet Accuracy (for Rainbow Pediatric Reusable Sensors)	Similar to Rainbow Adhesive Sensors.	< 1% SpMet Arms in the range of 1%-15% SaMet.

Study Proving Acceptance Criteria:

Clinical studies were performed to demonstrate the accuracy of the Masimo Rainbow SET technology with the new Rainbow Adhesive Sensors and Rainbow Pediatric Reusable Sensors.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The specific number of subjects (test set sample size) is not explicitly stated in the provided text. It mentions "healthy adult volunteer subjects" for the SpO2 testing and "human blood studies on healthy adult volunteers" for SpCO/SpMet. The number of patients in each category (adult, pediatric, infant, neonatal) is not detailed.
Data Provenance:
- Country of Origin: Not explicitly stated, but clinical studies were performed on "healthy adult volunteer subjects," implying human data, likely prospective as participants were "subjected to a progressive induced hypoxia."
- Retrospective/Prospective: The SpO2 accuracy studies involved "progressive induced hypoxia," which is a prospective experimental design in a controlled environment. The SpCO and SpMet studies were "human blood studies," also suggesting a controlled, prospective setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: This information is not provided.
Qualifications of Experts: This information is not provided. The ground truth for SpO2, SpCO, and SpMet was established using a "CO-Oximeter" (a laboratory device), not by expert human readers.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified. Ground truth was established by a laboratory CO-Oximeter, not through human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device (oximeter sensor) does not involve human interpretation of images or other data for diagnosis. The performance is assessed against a laboratory gold standard.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance testing described is inherently a standalone assessment of the device (sensor + CO-Oximeter algorithm). The accuracy of the sensors is measured directly against a reference laboratory instrument (CO-Oximeter) without human intervention in interpreting the sensor's output for the purpose of the study.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for SpO2, SpCO, and SpMet was established by an (ex-vivo) laboratory CO-Oximeter analysis of arterial blood samples.
- For SpO2: "measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter."
- For SpCO and SpMet: "validated in human blood studies on healthy adult volunteers against a laboratory CO-Oximeter".

8. The Sample Size for the Training Set

Training Set Sample Size: The document does not provide any information regarding a training set. This is typical for medical device submissions focusing on clinical validation of hardware (sensors) and associated algorithms where the algorithms might have been developed using internal, proprietary datasets, and only the final validation against a reference standard is presented.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Since no training set information is provided, how its ground truth was established is also not available from this document.

Summary

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510(k) SUMMARY

K063140

DEC 2 9 2006

Image /page/0/Picture/3 description: The image shows the logo and contact information for Masimo. The logo is a stylized version of the company name, with a unique design for the letter 'M'. Below the logo is the address: 40 Parker, Irvine, CA 92618. The telephone number is 949-297-7000, and the fax number is 949-297-7001.

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7001
Company Contact:	James J. Cronin, Vice President, Regulatory Affairs
Date Summary Prepared:	October 13, 2006
Trade Name	Rainbow Adhesive CO-Oximetry SensorsRainbow Pediatric Reusable Sensors
Common Name	Oximeter Sensor
Classification Name and Product Code:	Oximeter (74DQA) (870.2700)
Substantially Equivalent Devices:	Masimo SET® Radical 7 Pulse CO-Oximeter with SatShare™ 510(k) Number -K061204

Device Description

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510(k) SUMMARY

contacting materials in the Rainbow Pediatric Reusable Sensor is exactly the same as the predicate sensor (Rainbow DCI-DC sensor). The Rainbow Pediatric Reusable Sensors are supplied non-sterile.

Predicate Devices

Rainbow DCI-DC Reusable CO-Oximetry Sensor

Intended Use

Technology Comparison

The Rainbow Adhesive Sensors and Rainbow Pediatic Reusable Sensors are substantially equivalent in intended use, design, principles of operation, materials, 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 and Rainbow Pediatic Reusable Sensors are designed, and manufactured for full compatibility with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeters. The Rainbow Achesive Sensors and Rainbow Pediatric Reusable Sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

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

Performance Testing

Biocompatibility

Test results of all the patient contactials used in the Rainbow Adhesive Sensors and Rainbow Pediatric Reusable 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 Masimo Rainbow SET technology with Rainbow Adhesive Sensors and Rainbow Pediatric Reusable Sensors on healthy adult volunteer subjects during motion and no 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 and Rainbow Pediatric Reusable Sensors resulted in an accuracy of less than 2% SpO2 Авыз in the range of 70%-100% SaO2 for adults, pediatrics and infants and less than 3% AgMs for neonates. The Saturation accuracy in the range of 60%-80% SaO2 and 60%-70% SaO2 is less than 3% AgMS-

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510(k) SUMMARY

The Masino Rainbow SET technology with Rainbow Adhesive Sensors and Rainbow Pediatric Reusable 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 Adesive sensors result in on an accuracy of less than 3.5% SpCO Arans in the range of 1%-40% Saco and an accuracy of less than 1% Sphet App in the range of 1%-15% SaMet. Clinincal testing of the Rainbow Pediatric Reusable Sensors resulted in an accuracy of less than 3% SpCO Arks in the range of 1%-40% SaCO and an accuracy of less than 1% SpMet App in the racge of 1%-15% SaMet.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2006

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

Re: K063140

Trade/Device Name: Rainbow Adhesive CO-Oximetry Sensors Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, JKS Dated: November 28, 2006 Received: November 30, 2006

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.

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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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Shiela W. Murphy, MD, Mph, Chen Lin, PhD

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

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510(k) Number (if known):

Masimo SET® Radical 7 Pulse CO-Oximeter and Accessories 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, pediatio, 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 (SpO2) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for the display of those devices.

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

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

001

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Vlahos

and and the more in the 12

K063140

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).