The Rainbow Adhesive Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). 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 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 and Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow DCI and Direct Connect (Reusable) Sensors in the K080238 filing and the Rainbow Adhesive CO-Oximetry Sensors in the K071024 filing.

The Rainbow Adhesive Sensors in this filing have the same intended use/indications for use and performance specifications as the Rainbow Reusable Sensors in the K080238 filing. However, The Rainbow Adhesive Sensors in this filing are similar in construction to the Rainbow Adhesive CO-Oximetry Sensors in the K071024 filing. The main difference is that the sensors in the K071024 filing have 8wavelengths and the sensors in this filing have 12-wavelengths.

Similar to the 8-wavelength sensors in this filing include the emitter and detector assemblies connecting to the flex circuit, and an adhesive bandage to allow the sensor to be attached to the patient's finger, hand, foot or toe. Sensor sizing for use with adult, pediatric, infant, and neonatal patients are the same for the sensors in the K071024 and for the sensors in this filing. The patient-contact materials in the Rainbow Adhesive Sensors in this filing are the same that is used in the K071024 filing. Also similar to the sensors in the K071024 filing, the Rainbow Adhesive Sensors in this filing are supplied non-sterile for single patient use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Rainbow Adhesive Pulse CO-Oximeter Sensors (K081659):

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implied)	Reported Device Performance	Patient Population
SpO2 Accuracy (no motion/motion)	< 2% SpO2 ARMS in 70-100% SaO2, < 3% SpO2 ARMS in 60-80% SaO2	< 2% SpO2 ARMS (70-100% SaO2), < 3% SpO2 ARMS (60-80% SaO2)	Adults, Pediatrics, Infants
SpCO Accuracy	< 3% SpCO ARMS in 1-40% SaCO	< 3% SpCO ARMS (1-40% SaCO)	Adults
SpMet Accuracy	< 1% SpMet ARMS in 1-15% SaMet	< 1% SpMet ARMS (1-15% SaMet)	Adults
SpHb Accuracy	< 1 g/dL SpHb ARMS in 8-17 g/dL tHb	< 1 g/dL SpHb ARMS (8-17 g/dL tHb)	Adults
SpO2 Accuracy	< 3% SpO2 ARMS in 70%-100% SaO2	< 3% SpO2 ARMS (70-100% SaO2)	Neonates
SpMet Accuracy	< 1% SpMet ARMS in 0-2.5% SaMet	< 1% SpMet ARMS (0-2.5% SaMet)	Neonates

Note on Acceptance Criteria: The document implies the acceptance criteria are met by stating the device "resulted in an accuracy of" a specific value. Given this is a 510(k) submission for substantial equivalence, the acceptance criteria would typically be aligned with the performance of the predicate devices or established standards.

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

Sample Size for Test Set: Not explicitly stated as a number. The clinical studies included:
- "healthy adult volunteer subjects during motion conditions who were subjected to a progressive induced hypoxia"
- "human blood studies on adult volunteers" for SpCO, SpMet, and SpHb.
- "hospitalized neonatal patients"
Data Provenance: The studies were described as "clinical studies" and "human blood studies" using "healthy adult volunteer subjects" and "hospitalized neonatal patients." While the country of origin is not explicitly stated, the submission is to the U.S. FDA, implying the studies were conducted in a manner compliant with U.S. regulatory standards, likely in the U.S. The studies were prospective as they involved inducing hypoxia and taking blood samples.

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

Number of Experts: Not applicable/not experts.
Qualifications of Experts: The ground truth was established by a "laboratory CO-Oximeter" measuring arterial blood samples, not by human experts.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was established through direct measurement by a laboratory CO-Oximeter against arterial blood samples. There was no mention of human-based adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. This device is a sensor that provides automated measurements. Human readers are not involved in interpreting the output of the device in a way that an MRMC study would assess.

6. Standalone Performance Study (Algorithm Only)

Was a standalone study done? Yes. The clinical performance testing described focuses on the accuracy of the "Masimo Rainbow SET technology with Rainbow Adhesive Sensors" against a laboratory standard, which is a standalone performance assessment of the device.

7. Type of Ground Truth Used

Ground Truth Type: Objective, direct measurement. The ground truth for all reported parameters (SpO2, SpCO, SpMet, SpHb) was established by a laboratory CO-Oximeter analysis of arterial blood samples.

8. Sample Size for the Training Set

Sample Size for Training Set: Not explicitly stated. The document describes clinical studies that are primarily for validation (test set) rather than directly detailing a training set for the algorithm. For a device like this, the "training" data would likely be used in the original development and refinement of the Masimo Rainbow SET technology itself, which is referenced as already established. This submission focuses on validating the performance of a new sensor type (12-wavelength) with the existing technology.

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

How Ground Truth for Training Set was Established: Not explicitly detailed in this 510(k) summary. For similar optical technologies, the ground truth for training would typically involve large datasets of paired non-invasive measurements and corresponding invasive arterial blood gas measurements using laboratory-grade CO-Oximeters, similar to how the test set ground truth was established. This data would then be used to develop and refine the algorithms (e.g., spectral analysis, calibration coefficients). However, this specific filing focuses on the validation of the new sensor, presuming the underlying algorithm of the Rainbow SET technology is already established and has its own associated training data.

Summary

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K081659

510(k) SUMMARY

SEP 0 9 2008

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7001
Company Contact:	Marguerite Thomlinson, Manager of Regulatory Affairs
Date Summary Prepared:	June 9, 2008
Trade Name	Rainbow Adhesive Pulse CO-Oximeter Sensors
Common Name	Oximeter Sensor
Classification Name and Product Code:	Oximeter (74DQA) (870.2700)Cable, Transducer and Electrode (74DSA) (870.2900)Carbon Monoxide Test System (JKS) (862.3220)
Substantially Equivalent Devices:	Masimo Rainbow SET Radical 7/ Rad 87/ Rad 57t PulseCO-Oximeters and Accessories, 510(k) Number K080238Masimo Rainbow Adhesive CO-Oximetry Sensors,510(k) Number K071024

Device Description

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510(k) SUMMARY

same for the sensors in the K071024 and for the sensors in this filing. The patient-contact materials in the Rainbow Adhesive Sensors in this filing are the same that is used in the K071024 filing. Also similar to the sensors in the K071024 filing, the Rainbow Adhesive Sensors in this filing are supplied non-sterile for single patient use.

Predicate Devices

Rainbow DCI and Direct Connect Pulse CO-Oximetry Sensors (K080238) and Rainbow Adhesive CO-Oximetry Sensors (K071024).

Intended Use

The Rainbow Adhesive Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). 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.

Technology Comparison

The Rainbow Adhesive 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.

The Rainbow Adhesive Sensors are designed, configured, 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 is equivalent to those of the predicate devices.

Performance Testing

Biocompatibility

Test results of all patient-contact materials used in the Rainbow Adhesive 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 were performed using Masimo Rainbow SET technology with Rainbow Adhesive Sensors on healthy adult volunteer subjects during motion conditions who were

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510(k) SUMMARY

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 laboratory CO-Oximeter.

Clinical testing of the Rainbow Adhesive sensors resulted in an accuracy of less than 2% SpO2 Авмя in the range of 70%-100% SaO2 and less than 3% SpO2 AcMs in the range of 60%-80% SaO2 for adults, pediatrics, and infants.

The Masimo Rainbow SET technology with Rainbow Adhesive Sensors have been validated in human blood studies on adult volunteers against a laboratory CO-Oximeter from 1-40% for carboxyhemoglobin, 1-15% for methemoglobin, and 8-17 g/dL for total hemoglobin. Clinical testing of the Rainbow Adhesive sensors resulted in an accuracy of less than 3% SpCO Aggs in the range of 1%-40% SaCO, an accuracy of less than 1% SpMet Aggs in the range of 1%-15% SaMet, and an accuracy of less than 1 g/dL SpHb ARMs in the range of 8-17 g/dL tHb.

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 ARMs in the range of 70%-100% SaO2 and less than 1% SpMet ARMs in the range of 0% -2.5% SaMet.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, clutching a staff entwined with a serpent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 9 2008

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

Re: K081659

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, DPZ Dated: August 28, 2008 Received: September 2, 2008

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 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 - Ms. Thomlison

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Thimothy Penley

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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Indications for Use

510(k) Number (if known):

Device Name: Rainbow Adhesive Pulse CO-Oximeter Sensors

Indications For Use:

hospital-type facilities, mobile, and home environments.

shl

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081659

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

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).