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 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.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Measurement	Acceptance Criteria (Accuracy)	Reported Device Performance (Accuracy)	Conditions
Arterial Oxygen Saturation (SpO2)	$\pm$ 3% (for 60-80% range)	$\pm$ 3%	No Motion
Arterial Oxygen Saturation (SpO2)	$\pm$ 2% (for 70-100% range)	$\pm$ 2%	No Motion
Arterial Oxygen Saturation (SpO2)	$\pm$ 2% (for 70-100% range)	$\pm$ 2%	Low Perfusion
Pulse Rate	$\pm$ 3 bpm	$\pm$ 3 bpm	No Motion
Pulse Rate	$\pm$ 3 bpm	$\pm$ 3 bpm	Low Perfusion
Methemoglobin (SpMet)	$\pm$ 1% (for 1-15% range)	$\pm$ 1%	No Motion
Total Hemoglobin Concentration (SpHb)	$\pm$ 1 g/dL (for 8-17 g/dL)	$\pm$ 1 g/dL	No Motion

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

The document states: "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."

Sample Size (Test Set): The specific sample sizes for the clinical studies are not provided in this document. It only mentions "adult and pediatric patients."
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states "Clinical studies for the Rainbow Resposable Sensors are similar to those of the Rainbow Adhesive Sensors," implying that new studies were conducted, making them likely prospective, but this is not explicitly stated.

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

This information is not provided in the document. For non-invasive oximetry, the "ground truth" for SpO2 is typically established by arterial blood gas (ABG) analysis, not by human experts. The document does not specify how ground truth was established for the other parameters (SpMet, SpHb, Pulse Rate), but it's generally based on direct measurement or established clinical methods.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. As mentioned above, ground truth for oximetry is usually based on direct physiological measurements (like ABG) rather than expert adjudication of images or clinical assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable/provided. This device is a sensor for direct physiological measurement, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The entire performance assessment described is for the device in a standalone capacity (sensor and its associated algorithm performing measurements). So, yes, a standalone performance assessment was done. The listed accuracy specifications represent the device's performance directly.

7. The Type of Ground Truth Used:

The document doesn't explicitly state the type of ground truth used for each measurement. However, based on the nature of the device:

SpO2: Highly likely to be established using arterial blood gas (ABG) analysis, which is the gold standard for arterial oxygen saturation.
Pulse Rate: Likely established using a reference ECG (electrocardiogram) or direct palpation/auscultation with a stopwatch in a controlled setting.
SpMet and SpHb: Likely established using co-oximetry from arterial blood samples (different from functional SpO2), which are laboratory-based measurements.

8. The Sample Size for the Training Set:

The document does not specify a training set size. While the device utilizes algorithms, this submission focuses on the performance of the product, not the development or training of its underlying algorithms. Clinical studies are typically test sets to validate the final device.

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

This information is not provided in the document, as it does not detail the algorithm development or training process.

Summary

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510(k) SUMMARY

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7001
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)Cable, Transducer and Electrode (74DSA) (870.2900)
Substantially Equivalent Devices:	Rainbow Adhesive CO-Oximetry Sensors, 510(k) Number K081655

Device Description

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.

K090165-Resposable Sensors Masimo, 7/7/09 Page 2 of 3

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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	AccuracyRange	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 (800) 638-2041 or (240) 276-3150 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:

	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

Resposable Sensor Masimo, 7/7/09 Page 1 of 3

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).