MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS

K111621 · Masimo Corporation · DQA · Oct 26, 2011 · Cardiovascular

Device Facts

• Record ID: K111621
• Device Name: MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Masimo ReSposable SpO2 Series Oximetry Sensors are pulse oximetry sensors measuring tissue oxygenation non-invasively. Device utilizes infrared emitters and detectors to capture optical signals from tissue. Sensors are compatible with Masimo SET, Masimo Rainbow SET, Nellcor, and Philips FAST-SpO2 monitoring instruments. Used in hospitals, mobile, and home environments by clinicians or patients. Output consists of SpO2 and pulse rate data displayed on compatible host monitors. Data assists healthcare providers in assessing patient oxygenation status, facilitating clinical decision-making for respiratory or circulatory management. Reusable design features bifurcated structure with separate LED and detector branches.

Clinical Evidence

Clinical and non-clinical testing verified design specifications. Non-clinical testing included biocompatibility, ambient light rejection, electrocautery noise rejection, environmental noise analysis, pulse rate verification, mechanical force testing (retention, insertion, removal, static pull), moisture resistance, and IPX/bleach testing. No specific clinical trial results (e.g., sensitivity/specificity metrics) were detailed in the summary, but testing confirmed performance meets design requirements.

Technological Characteristics

Bifurcated reusable sensor design; infrared emitters and detectors; non-invasive optical sensing principle. Compatible with Masimo SET, Rainbow SET, Nellcor, and Philips FAST-SpO2 technologies. Tested for biocompatibility, moisture resistance, and mechanical durability. No specific software algorithm class or connectivity protocols (e.g., wireless) are described; device functions as a peripheral sensor for host oximetry monitors.

Indications for Use

Indicated for continuous non-invasive monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult, pediatric, infant, and neonatal patients, including those with motion or poor perfusion, in hospital, mobile, and home settings.

Regulatory Classification

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.

Predicate Devices

• Masimo ReSposable Oximetry Sensors (K100617)
• LNCS/M-LNCS Oximetry Sensors (K101896)
• Masimo SET Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and Cables (K012992)

Submission Summary (Full Text)

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

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>949-297-7000<br>FAX [phone] |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Sensors<br>K100617, Masimo ReSposable Oximetry Sensors<br>K012992, Masimo SET Radical Pulse Oximeter with<br>Satshare and Masimo Series of Sensors and Cables |

### 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

## Predicate Devices

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The predicate devices used in this filing are:

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

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### Intended Use/ Indications for Use

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.

#### 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.

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#### 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 [phone] or [phone] 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

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510(k) Number: K111621