MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03

K062268 · Philips Medical Systems North America Co. · DQA · Oct 18, 2006 · Cardiovascular

Device Facts

• Record ID: K062268
• Device Name: MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
• Applicant: Philips Medical Systems North America Co.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and healthcare environments.

Device Story

Masimo SET SpO2 module integrates with Philips M3001A Multi-measurement Server; enables pulse oximetry monitoring. Device processes physiological signals to provide real-time SpO2 data; outputs displayed on host patient monitors for clinician review. Used in clinical and transport settings by healthcare professionals to monitor patient status, record data, and trigger alarms. Facilitates clinical decision-making through continuous physiological surveillance; benefits patients by providing reliable oxygen saturation monitoring.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing, including system-level, integration, environmental, and safety testing based on hazard analysis. Pass/Fail criteria were derived from predicate device specifications.

Technological Characteristics

Pulse oximetry module; integrates Masimo SET technology into Philips M3001A Multi-measurement Server. Operates as a plug-in module for host patient monitors. Technological characteristics, sensing principles, and performance specifications are identical to the predicate Masimo SET SpO2 module and Philips M3001A server.

Indications for Use

Indicated for use by health care professionals for monitoring, recording, and alarming physiological parameters in adult, pediatric, and neonatal patients in transport and healthcare environments.

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

• Philips M3001A (K013199, K020531, K030973, K040259)
• Masimo SET SpO2 plug-in module (K040259, K053269, K051439)
• MS-13 Board (K040259, K053269, K051439)

Submission Summary (Full Text)

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## 8.0 510 (k) Summary

K062268

summary of 510 (k) safety and effectiveness information This is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. The submitter of this premarket notification is:

Philips Medical Systems

OCT 1 8 2006

This summary was prepared on 4 August, 2006.

- 2. The name of this device is the Masimo SET SpO2 module for Philips and M3001A Multi-measurement Server option A03. Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|----------------|----------------|---------|---------------------------------|
| Anesthesiology | §868.2375, II | BZQ | Monitor, Breathing<br>Frequency |
| 73 | §870.2700, II | DQA | Oximeter |

- 3. The new device is substantially equivalent to previously cleared Philips devices M3001A marketed pursuant to K013199, K020531, K030973 and K040259 as well as the Masimo SET SpO2 plug-in module and and MS-13 Board pursuant to K040259, K053269 and K051439.
- 4. The modification creates the Masimo SET SpO₂ pulse oximetry module for use in Philips host patient monitors.
- 5. The new device has the same Indications for Use as the legally marketed predicate device: indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and healthcare environments.
- 6. The new device has the same technological characteristics as the legally marketed predicate device.
- 7. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the pulse oximetry module functionality meets all reliability requirements and performance claims.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the organization's role in public health and welfare.

OCT 1 8 2006

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems North America Company C/O Mr. Dave Osborn Programs Manager Philips Medical System 3000 Minuteman Road Andover, Massachusetts 01810

Re: K062268

Trade/Device Name: Masimo SET SpO2 Module for Philips and M3001 A Multimeasurement Server Option A03

Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 22, 2006 Received: September 26, 2006

Dear Mr. Osborn:

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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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle, emphasizing the department's role and national scope.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Page 2 - Mr. Osborn

Food and Drug Administration

Please be advised that FDA's issuance of a substantial equivalence determing 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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

Ching-Lin, Ph.D.

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): 1 120(o 2260

Device Name:

Masimo SET SpO2 module for Philips and M3001A Multimeasurement Server option A03

Indications for Use:

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and healthcare environments.

Prescription Use Over-The-Counter Use yes No AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page (Division Sign-Qff) Division of Anesthesiology, General Hospital Infection Control, Dental D 510(k) Number: