The Masimo ReSposable SpO2 Series 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, pediatric, infant and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Device Description

The Masimo ReSposable SpO2 Series Oximetry Sensors are pulse oximetry sensors. They measure tissue oxygenation non-invasively through infrared emitters and detectors. The ReSposable SpO2 Series Oximetry Sensors are fully compatible for use with instruments which include the following technologies:

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

AI/ML Overview

The provided documentation is a 510(k) summary for the Masimo ReSposable SpO2 Series Oximetry Sensors. This document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use and physical characteristics, along with a list of non-clinical and clinical testing performed.

However, the document does not include specific acceptance criteria or the detailed results of a study that proves the device meets those criteria. The available information states that "The following clinical and non-clinical testing was conducted to verify that the Masimo ReSposable SpO2 Series Oximetry Sensors met all design specifications," but it doesn't elaborate on the "design specifications" (acceptance criteria) or the measured performance against them.

Therefore, I cannot populate the table of acceptance criteria and reported device performance, nor can I fully answer questions about sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone performance) because that detailed information is not present in the provided text.

Based on the available information, here's what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Available: The document mentions "all design specifications" were met but does not specify what these acceptance criteria are or present a table of reported device performance against them.

2. Sample size used for the test set and the data provenance

Information Not Available: The document does not provide details on the sample size used for any clinical or non-clinical tests or the data provenance (e.g., country of origin, retrospective/prospective). It only lists the types of tests conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Information Not Available: The document does not describe any expert-based ground truth establishment as typically seen in image analysis or diagnostic studies. The tests listed are primarily related to physical performance, electrical characteristics, and overall biocompatibility and environmental robustness. For SpO2 accuracy, typically arterial blood gas measurements (Gold Standard) are used, but details are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Information Not Available: Not applicable to the type of tests briefly described.

5. 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

Information Not Available: This device is an oximetry sensor, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study with AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Information Not Available: The document mentions "clinical and non-clinical testing" was done, but it doesn't specify if this included a standalone performance evaluation of the sensing algorithm in isolation. For SpO2 devices, standalone performance typically refers to the accuracy of the device's SpO2 readings against a "gold standard" (like arterial blood gas analysis) under various physiological conditions (motion, low perfusion, different SpO2 levels). While clinical tests were conducted, details about this specific type of assessment are not provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Information Not Available: For the SpO2 device, the gold standard for ground truth in clinical testing of SpO2 accuracy is typically arterial blood gas co-oximetry. However, the document does not explicitly state what ground truth method was used for its "clinical testing." For the non-clinical tests (biocompatibility, light rejection, etc.), the ground truth would be established by relevant scientific standards and measurement techniques.

8. The sample size for the training set

Information Not Available: The document does not describe any machine learning or AI component that would require a "training set." Therefore, this information is not applicable and not provided.

9. How the ground truth for the training set was established

Information Not Available: See point 8. Not applicable as no training set is mentioned.

Summary

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510(k) Summary: K111621: Masimo Resposable SpO2 Series Oximetry Sensors

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7592
Company Contact:	Anil Bhalani, Director of Regulatory Affairs
Date Summary Prepared:	September 29, 2011
Trade Name:	Masimo ReSposable SpO2 Series Oximetry Sensors
Common Name:	Oximeter Sensor
Regulation Number:	21 CFR 870.2700
Regulation Name:	Oximeter
Regulation Class:	Class II
Product Code:	DQA
Substantially Equivalent Devices:	K101896, LNCS/M-LNCS Oximetry SensorsK100617, Masimo ReSposable Oximetry SensorsK012992, Masimo SET Radical Pulse Oximeter withSatshare and Masimo Series of Sensors and Cables

Device Description

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

Predicate Devices

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The predicate devices used in this filing are:

1. K100617, Masimo ReSposable Oximetry Sensors
1. K101896, LNCS/M-LNCS Oximetry Sensors
1. K012992, Masimo SET Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and Cables

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Intended Use/ Indications for Use

Comparison to Predicate Devices

Technology Comparison

The Masimo ReSposable SpO2 Series Oximetry Sensors are substantially equivalent to the predicate sensors in the design, principles of operation, and performance. The Masimo ReSposable SpO₂ Series Oximetry Sensors and the predicates operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.

Indications for Use

The Masimo ReSposable SpO2 Series Oximetry Sensors have identical indications for use as the predicate LNCS/M-LNCS oximetry sensors (K101896). Compared to the predicate Masimo ReSposable Oximetry Sensors (K100617), the Masimo ReSposable SpO2 Series Oximetry Sensors have additional indications for use of infant and neonatal populations. The Masimo ReSposable SpO2 Series Oximetry Sensors' indications are different from the predicate Masimo LNOP YI sensor (K012992). This predicate is indicated for continuous and spot-check monitoring, and for use in infant, pediatric, and adult patient populations. The subject device is indicated only for continuous monitoring and for use in adult, pediatric, infant, and neonatal patient populations.

Physical Characteristics

The reusable portion of the subject device most closely resembles the predicate LNOP YI sensor (K012992). Both devices are bifurcated, with one branch ending in the LED, and the other branch ending in the detector. This design is very different from the reusable portion of the other predicates, which have the LED and detector on a single wire, which wraps around the sensor site.

Clinical and Non-clinical Testing

The following clinical and non-clinical testing was conducted to verify that the Masimo ReSposable SpO2 Series Oximetry Sensors met all design specifications: Biocompatibility studies, Ambient light rejection, light transmission or light piping, electrocautery noise rejection, environmental noise analysis, pulse rate verification, sensor retention force, insertion and removal force, static pull force, patient access/contact, sensor removal and plastic removal strength, current transfer ratio, sensor skin temperature, moisture resistance and cleaning, sensor water (IPX) and Bleach Test, drop, storage and operating conditions.

Conclusion:

Based on information provided in this premarket notification, we conclude that the Masimo ReSposable SpO2 Series Oximetry Sensors are substantially equivalent to the predicate devices and that the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

Public Health Service

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

Mr. Anil Bhalani Director of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

OCT 2 6 2011

Re: K111621

Trade/Device Name: Masimo ReSposable SpO2 Series Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 14, 2011 Received: October 19, 2011

Dear Mr. Bhalani:

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 - Mr. Bhalani

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh 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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Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a stylized "M" that incorporates a curved shape. To the right of the logo is the text "MASIMO CORPORATION," followed by "Forty Parker" and "Irvine, CA 92618," indicating the company's address.

Indications for Use Statement 4

510(k) Number (if known):

Device Name: Masimo ReSposable SpO2 Series Oximetry Sensors

Indications for Use:

The ReSposable SpO2 Series is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, 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.

Prescription Use X______________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultze

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

Page 1 of 1

510(k) Number: K111621

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).