PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER

K033715 · Philips Medical Systems, Inc. · DQA · Feb 13, 2004 · Cardiovascular

Device Facts

• Record ID: K033715
• Device Name: PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
• Applicant: Philips Medical Systems, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 13, 2004
• 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 hospital environments.

Device Story

picoSAT II SpO2 pulse oximetry module; component of patient monitoring systems. Inputs: physiological signals (SpO2). Transformation: FAST pulse oximetry algorithm processes signals to derive oxygen saturation and pulse rate. Output: real-time physiological data, recordings, and alarms. Usage: hospital and patient transport environments; operated by healthcare professionals. Clinical utility: continuous monitoring of patient status; enables timely clinical intervention via alarm notifications. Benefits: improved performance of FAST algorithm over previous iterations.

Clinical Evidence

Clinical validation studies conducted to verify performance and reliability of the updated FAST pulse oximetry algorithm. All verification and validation activities successfully completed.

Technological Characteristics

Pulse oximetry module; utilizes FAST pulse oximetry algorithm. Designed for integration into patient monitoring systems. Class II device (21 CFR 870.2700).

Indications for Use

Indicated for monitoring, recording, and alarming of multiple physiological parameters in adult, pediatric, and neonatal patients in hospital and transport settings. Use by healthcare professionals.

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 (K030973)
• picoSAT module (K021330)
• Masimo SET pulse oximeter (K031330)
• Masimo SET pulse oximeter (K013792)

Submission Summary (Full Text)

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FEB 1 3 2004

K033715

## 8.0 510 (k) Summary

This summary of 510(k) safety and effectiveness information 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: David Osborn Philips Medical Systems Cardiac & Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099 978 659 3178 Fax: [phone] Tel: e-mail: [e-mail]

This summary was prepared on November 24, 2003.

- 2. The name of the device is the picoSAT II SpO2 pulse oximetry module. Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|------------------------------------------------------|----------------|---------|-------------|
| Anesthesiology<br>and Respiratory<br>Therapy (12624) | §870.2700, II | DQA | Oximeter |

3. The new device is substantially equivalent to previously cleared Philips devices M3001A and picoSAT module marketed pursuant to K030973 and K021330 as well as the Masimo SET pulse oximeter marketed pursuant to K031330 and K013792.

4. The modification improves the performance of the FAST pulse oximetry algorithm.

5. The new devices have the same intended use as the legally marketed predicate devices. When used in the hospital or patient transport environments, they are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates.

6. The new devices have the same technological characteristics as the legally marketed predicate devices.

7. Verification testing activities were conducted to establish the performance and reliability characteristics of the new device. Testing involved functional level tests and safety testing from the risk analysis. Clinical validation studies were also conducted. All verification and validation activities were successfully completed.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB 1 3 2004

Mr. David Osborn Quality Program Manager Philips Medical Systems 3000 Minuteman Road Andover, Massachusetts 01810-1099

Re: K033715

Trade/Device Name: PICOSAT II SPO2 Pulse Oximetry Module Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: January 29, 2004 Received: January 30, 2004

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 (sec 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.

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.

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Page 2 - Mr. David Osborn

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/dsma/dsmamain.html

Sincerely yours,

Susan Raasch

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): K033715

picoSAT II SpO2 pulse oximetry module and M3001A Multi-Device Name: Measurement Server

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 hospital environments.

Prescription Use ves (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (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)

S. Ananth

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

510(k) Number:

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