MASIMO SET REUSABLE OXIMETRY SENSORS

K113596 · Masimo Corporation · DQA · Feb 24, 2012 · Cardiovascular

Device Facts

• Record ID: K113596
• Device Name: MASIMO SET REUSABLE OXIMETRY SENSORS
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 24, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) 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 Story

Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) are reusable sensors designed to interface with pulse oximeter monitors. The device detects light absorption signals to calculate functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. This submission extends compatibility to monitors incorporating Philips FAST SpO2 Technology. The sensors are used in hospitals, mobile, and home environments by clinicians or patients. The output is displayed on the host monitor, providing real-time physiological data to assist healthcare providers in assessing patient oxygenation and heart rate, facilitating clinical decision-making and patient monitoring.

Clinical Evidence

Bench and clinical testing performed using monitors incorporating Philips FAST SpO2 Technology. Results demonstrate that SpO2 and pulse rate accuracy are equivalent to performance data submitted for the previously cleared Masimo sensors.

Technological Characteristics

Reusable soft oximetry sensors; sensing principle based on light absorption (pulse oximetry); compatible with Masimo SET, Nellcor, and Philips FAST SpO2 technology monitors; includes M-LNCS sensors with M-15 connectors.

Indications for Use

Indicated for continuous noninvasive monitoring and spot-checking of SpO2 and pulse rate in adult and pediatric patients, including those well or poorly perfused, in hospital, mobile, and home settings during no-motion conditions.

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 SET Reusable Soft Oximetry Sensors (K090662)

Submission Summary (Full Text)

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#### 1113596 510(k) Summary

| Submitter: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>[phone]<br>Fax: [phone] |
|--------------------|----------------------------------------------------------------------------------------------|
| Company Contact: | David Collette<br>Senior Manager, Regulatory Affairs |
| Date Prepared: | January 25, 2012 |
| Trade Name: | Masimo SET® Reusable Soft Oximetry Sensors |
| Regulation Number: | 21 CFR 870.2700 |
| Regulation Name: | Pulse Oximeter (Oximetry Sensors) |
| Regulatory Class: | Class II |
| Product Code | DQA |
| Cleared Device: | K090662 – Masimo SET Reusable Soft Oximetry Sensors |

### Device Description

The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) have been cleared under K090662 for use with Masimo SET and Masimo SET -compatible pulse oximeter monitors as well as Nellcor and Nellcor compatible pulse oximeter monitors. This submission presents data demonstrating that the DBI/P Sensors also are compatible for use with pulse oximeter monitors incorporating Philips FAST SpO2 Technology. Two additional M-LNCS sensors with M-15 connectors are included in this notification.

### Indications for Use

The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) 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.

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### Comparative Analysis

There are no changes to the design of the device cleared in K090662. Specifically, the principles of operation performance and materials of the device remain unchanged from the existing Masimo SET Reusable Soft Oximetry Sensors.

### Validation Testing

Bench and clinical testing of the Masimo SET Reusable Soft Oximetry Sensors was performed using monitors incorporating Philips FAST SpO2 Technology and the results demonstrate that the SpO2 and pulse rate accuracy is equivalent to the performance data submitted for the previously cleared Masimo sensors.

### Conclusion

Data presented in this submission demonstrate that, when used with pulse oximetry monitors incorporating the Philips FAST Technology, the Masimo SET Reusable Soft Oximetry Sensors are substantially equivalent to the cleared device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. David Collette Senior Manager, Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

FEB 2 4 2012

Re: K113596

Trade/Device Name: Masimo SET® Reusable Soft Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 25, 2012 Received: January 26, 2012

Dear Mr. Collette:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaller by 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de vices mat nat i SAct (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment . For (10) ............................................................................................................................... approval application (11th 1). . The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, requirents for unnual regionant 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 (1 Mrs), it may be sucject to adame Federal Regulations, Title 21, Parts 800 to 898. In device can be found in the Code of Feather regains concerning your device in the Federal Register.

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### Page 2 - Mr. Collette

Please be advised that FDA's issuance of a substantial equivalence determination does not r rease be actived that 12 a determination that your device complies with other requirements moun mat 1 Dr may Federal statutes and regulations administered by other Federal agencies. or the receively 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 (reporting of meated: as not total 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), 11 you acon o sportion w.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 15809.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 Compilation" (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 I ou nike 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh 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

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## Indications for Use

**510(k) Number:** K.113596

# Device Name: Masimo SET® Reusable Soft Oximetry Sensors

#### Indications for Use:

The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive The Mashino SET Kedsable Soft Sensons are installed of arterial hemoglobin (SpOz)
monitoring and spot-checking of functional oxygen saturation of artections during monioring and spor-checking of functional only goss with adult and pediatric patients during and pulse fale (fileasured by an SpO2 sensor) for ass or well or poorly perfused in hospitals, hospitaltype facilities, mobile, and home environments.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 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: | K113596 |
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