The Masimo Resposable Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Device Description

The Masimo Resposable Oximetry Sensors (S2 Sensors) are fully compatible for use with instruments which include or compatible with the following technologies:

· Masimo SET technology
· Masimo Rainbow SET technology
· Nellcor technology
· Philips FAST-SpO2 technology
The S2 Sensors and the predicates (K051212), the LNCS Oximetry Sensors (LNCS Sensors), have the same indications for use/ intended use. The S2 Sensors also have the same sensor design as the predicates (K090165), the Masimo Rainbow Resposable Sensor (R2 Sensors). The reason for this filing is to modify the LNCS Sensor design.

AI/ML Overview

The Masimo Resposable Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The study summarized in this 510(k) evaluates the performance of the device against established accuracy ranges for SpO2 and pulse rate under various conditions.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are defined by the "Accuracy Range" columns in the tables below for each measurement type and technology. The "Accuracy" column represents the reported device performance, indicating the maximum deviation from the true value.

Masimo SET Technology and Masimo Rainbow SET Technology (Adults > 30kg, Pediatrics 10-50kg)

Measurement	Accuracy Range	Reported Accuracy
Arterial Oxygen Saturation (SpO2), No Motion	70-100%	± 2%
Arterial Oxygen Saturation (SpO2), Motion	70-100%	± 3%
Arterial Oxygen Saturation (SpO2), Low Perfusion	70-100%	± 2%
Pulse Rate, No Motion	25-240 bpm	± 3 bpm
Pulse Rate, Motion	25-240 bpm	± 5 bpm
Pulse Rate, Low Perfusion	25-240 bpm	± 3 bpm

Nellcor Technology and Philips FAST SpO2 Technology (Adults > 30kg, Pediatrics 10-50kg)

Measurement	Accuracy Range	Reported Accuracy
Arterial Oxygen Saturation (SpO2), No Motion	70-100%	± 2%
Pulse Rate, No Motion	25-240 bpm	± 3 bpm

The device meets its acceptance criteria as the reported accuracy values fall within the expected performance limits for similar oximetry sensors.

Study Details

The provided 510(k) summary (K100617) states that "The S2 Sensors comply with the voluntary standards as detailed in this submission" and lists "Performance Testing" as one of the quality assurance measures applied. However, the summary does not provide detailed information about the specific study(ies) (sample size, data provenance, ground truth establishment, etc.) used to derive these accuracy values.

Based on the provided text, the following information is not available:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document does not specify the number of subjects or types of data (e.g., patient data, simulated data) used for performance testing, nor does it mention the origin or retrospective/prospective nature of the data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: There is no mention of any adjudication method.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an oximeter sensor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Accuracy" values listed are inherently standalone performance metrics for the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): While not explicitly stated, for oximetry accuracy, ground truth is typically established through direct measurement of arterial blood gas (ABG) values (e.g., co-oximetry). The document does not confirm this.
The sample size for the training set: As this is a medical device approval and not a machine learning model specific 510(k), the concept of a "training set" in the context of AI models is not directly applicable. Performance is evaluated against established physical and physiological principles.
How the ground truth for the training set was established: Not applicable, as no training set in the AI sense is explicitly mentioned.

Summary

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510(k) SUMMARY

K100617

Submitted by:	Masimo Corporation	MAY 2 8 2010
	40 Parker
	Irvine, CA 92618
	949-297-7000
	FAX 949-297-7592
Company Contact:	Marguerite Thomlinson, Manager of Regulatory Affairs
Date Summary Prepared:	March 2, 2010
Trade Name:	Masimo Resposable Oximetry Sensors
Common Name:	Oximeter Sensor
Regulation Number:	21 CFR 870.2700
Regulation Name:	Oximeter
Regulation Class:	Class II
Product Code:	DQA, DSA
Substantially Equivalent Devices:	LNCS Oximetry Sensors, 510k) No. K051212
	Masimo Rainbow Resposable Sensors, 510(k) No. K090165

Device Description

The Masimo Resposable Oximetry Sensors (S2 Sensors) are fully compatible for use with instruments which include or compatible with the following technologies:

· Masimo SET technology
· Masimo Rainbow SET technology
· Nellcor technology
· Philips FAST-SpO2 technology

The S2 Sensors and the predicates (K051212), the LNCS Oximetry Sensors (LNCS Sensors), have the same indications for use/ intended use. The S2 Sensors also have the same sensor design as the predicates (K090165), the Masimo Rainbow Resposable Sensor (R2 Sensors). The reason for this filing is to modify the LNCS Sensor design.

Predicate Device

The predicate devices used in this filing are:

· The LNCS Oximetry Sensors (LNCS Sensors), 510(k) No. K051212
· The Masimo Rainbow Resposable Sensors (R2 Sensors), 510(k) No. K090165.

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510(k) SUMMARY

Intended Use/ Indications for Use

The Masimo Resposable Oximetry Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients, during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Technology Comparison

The S2 Sensors are substantially equivalent to the predicate sensors in the design, principles of operation, and performance. The S2 Sensors and the predicates operate on identical principles of noninvasive optical assessment of tissue oxygenation using emitters and detectors.

Specifications

The specifications for the S2 Sensors are as following:

Masimo SEI Technology and Masimo Rainbow SEI Technology/(Adults > 30kg, Pediatrics 10-50kg)
Measurement	Accuracy Range	Accuracy
Arterial Oxygen Saturation (SpO2), No Motion	70-100%	+ 2%
Arterial Oxygen Saturation (SpO2), Motion	70-100%	+ 3%
Arterial Oxygen Saturation (SpO2), Low Perfusion	70-100%	+ 2%
Pulse Rate, No Motion	25-240 bpm	+ 3 bpm
Pulse Rate, Motion	25-240 bpm	+ 5 bpm
Pulse Rate, Low Perfusion	25-240 bpm	+ 3 bpm
Nellcor Technology and Philips FAST SpO2 Technology/(Adults > 30kg, Pediatrics 10-50kg)
Measurement	Accuracy Range	Accuracy
Arterial Oxygen Saturation (SpO2), No Motion	70-100%	+ 2%
Pulse Rate, No Motion	25-240 bpm	+ 3 bpm

Test Summary

The S2 Sensors comply with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the S2 Sensors:

Risk Analysis .
Design Reviews .
Biocompatibility Testing .
Performance Testing �
Safety Testing .

. .

Conclusions

The information in this 510(k) submission demonstrates that the S2 Sensors are substantially equivalent to the predicate devices, with respect to safety, effectiveness, and performance.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which consists of a staff with a snake entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

MAY 2 8 2010

Re: K100617

Trade/Device Name: Masimo Resposable Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 26, 2010 Received: April 29, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Marguerite 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

Anthony D. Watson, B.S., M.S., M.B.A. 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):

Masimo Resposable Oximetry 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 Evaluations (ODE)

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

510(k) Special, 3/2/2010 Resposable SpO2 Sensors Page 14 of 152

510(k) Number:

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).