PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER

K033444 · Philips Medical Systems · MHX · Nov 21, 2003 · Cardiovascular

Device Facts

• Record ID: K033444
• Device Name: PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

M3012A Hemodynamic Extension is a module for Philips patient monitor family (M3001A multi-measurement server). Device inputs physiological signals via connected transducers/probes; processes signals to measure parameters; provides real-time monitoring, recording, and alarming. Used in hospital or mobile transport environments by healthcare professionals. Output displayed on monitor to assist clinical decision-making regarding patient status. Benefits include continuous physiological surveillance.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, integration tests, environmental tests, safety testing from hazard analysis, and interference testing. Results demonstrated substantial equivalence to predicate devices and met all reliability requirements and performance claims.

Technological Characteristics

Hemodynamic measurement module for Philips M3001A multi-measurement server. Functions as an extravascular blood pressure transducer, blood pressure computer, thermodilution probe, and signal conditioner. Connectivity via patient cables/connectors. Designed for integration into existing patient monitoring systems. Hardware-based signal processing.

Indications for Use

Indicated for monitoring, recording, and alarming of physiological parameters in adult, pediatric, and neonatal patients in hospital or medical transport environments. Intended for use by healthcare professionals.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• K882609
• K002758
• K020531
• K032858
• K992273

Submission Summary (Full Text)

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NOV 21 2003

K033444

## 510 (k) Summary 9.0

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: Tapan D. Shah Requlatory Affairs Engineer Cardiac and Monitoring Systems 3000, Minuteman Road Andover, MA - 01810 USA Tel: [phone] Fax: [phone] Email: [e-mail]
This summary was prepared on October 27, 2003

- 2. The name of this device is Hemodynamic Extension to the Multi-measurement Server - M3012A.
Classification names are as follows:

| Regulation<br>Number | Classification Name |
|----------------------|-------------------------------------------------------------------|
| 870.2850 | Extravascular Blood Pressure Transducer |
| 870.1435 | Computer, Diagnostic, Pre-Programmed, Single-Function |
| 870.2900 | Cable, Transducer and Electrode, Patient (including<br>connector) |
| 870.1110 | Computer, Blood Pressure |
| 870.1915 | Probe, Thermodilution |
| 870.1100 | Alarm, Blood Pressure |
| 870.2060 | Amplifier and Signal Conditioner, Transducer Signal |
| 870.2600 | System, Signal Isolation |
| 880.2910 | Thermometer, electronic, clinical |

- 3. The new device is substantially equivalent to previously cleared devices marketed pursuant to K882609, K002758, K020531, K032858, and K992273.
- 4. The modification is the creation of a new measurement extension for the Philips patient monitor family (supported by the M3001A multi-measurement server).
- 5. The new device has the same intended use as the legally marketed predicate devices. When used in the hospital environment or mobile environment for patient transport monitoring, the device is intended for measuring and alarming multiple physiological parameters and waves in adult, pediatric, and neonatal patients.
- 6. The new device has the same technological characteristics as the legally marketed predicate devices.

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- 7. Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using simulated systems. Testing included system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices. The test results showed substantial equivalence. The results demonstrate that the Measurement Server Extension meets all the reliability requirements and performance claims.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

NOV 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems c/o Mr. Tapan D. Shah Regulatory Affairs Engineer Cardiac and Monitoring Sytems 3000 Minuteman Road Andover, MA 01810

Re: K033444

Trade Name: Philips Medical Systems M3012A - Hemodynamic Extension to the Multi-Measurement Server Regulation Number: 21 CFR §870.1025 Regulation Name: Patient Physiological Monitor (arrhythmia detection and alarm) Regulatory Class: Class III (three) Product Code: MHX Dated: October 27, 2003 Received: October 29, 2003

Dear Mr. Shah:

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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Page 2 - Mr. Tapan D. Shah

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); 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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 vours.

Nga nep

Zuckerman. N Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3.1 ODE Indications Statement

## Indications for Use Statement

510(k) Number (if known)

- Philips M3012A Hemodynamic Extension to the Device Name Multi-Measurement server
Indications for Use (M3046A): For monitoring, Indications for recording and alarming of multiple physiological Use parameters of adults, pediatrics and neonates in hospital and/or medical transport environments.

> Indications for Use (MP40/50/60/70/90) : Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Mexas Mey
for (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K033444

Prescription Use Use (Per 21 CFR 801.109) OR

Over-The-Counter

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