MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A

K013427 · Philips Medical Systems, Inc. · MHX · Nov 29, 2001 · Cardiovascular

Device Facts

• Record ID: K013427
• Device Name: MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A
• Applicant: Philips Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 29, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital and medical transport environments.

Device Story

Philips M2/M3/M4 Compact Portable Patient Monitor; monitors multiple physiological parameters including ECG, blood pressure, CO2, and temperature. Inputs: physiological signals from patient-connected sensors/transducers. Processing: signal acquisition, analysis, and alarm generation for parameters like arrhythmia and ST-segment. Output: real-time display of waveforms and numerical data; audible/visual alarms. Used in hospital and medical transport settings by clinicians. Healthcare providers use output for patient status assessment and clinical decision-making. Modification includes auscultatory validation reference per AAMI SP-10 for pediatric and adult patients.

Clinical Evidence

Bench testing only. Validation study performed to confirm device performance correlates to the auscultatory reference standard according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.

Technological Characteristics

Compact portable patient monitor; multi-parameter sensing (ECG, NIBP, CO2, temperature). Connectivity: patient-connected transducers/cables. Standards: AAMI SP-10 for blood pressure validation. Software-based monitoring and alarm system.

Indications for Use

Indicated for monitoring, recording, and alarming of multiple physiological parameters in adult, pediatric, and neonatal patients within hospital and medical transport environments.

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

• M3 (K971910)
• M3 (K981576)

Submission Summary (Full Text)

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K013427 p.1/2

## NOV 2 9 2001

510 (k) Summary 8.0

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 CFR §807.92.

1. The submitter of this premarket notification is: Dave Osborn Quality Program Manager Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1085

> 978 659 3178 Tel: [phone] Fax: Email: [e-mail]

This summary was prepared on 15 October, 2001

- 2. The name of this device is Philips M2/M3/M4 Compact Portable Patient Monitor. Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|---------------------------------|----------------|---------|--------------------------------------------------------------------|
| Panel 74<br>Cardiovascular | None | 74 MHX | Physiological<br>Monitor, Patient<br>Monitor |
| | 870.1025, III | 74 DSI | Arrhythmia Detector<br>and Alarm |
| | 870.1025, III | 74 MLD | Monitor, ST Alarm |
| | 870.2350, II | 74 DRW | Electrocardiograph<br>lead switching<br>adapter |
| | 870.1100, II | DSJ | Alarm, Blood-Pressure |
| | 870.1110, II | DSK | Computer, Blood-<br>Pressure |
| | 870.1130, II | DXN | System, Measurement,<br>Blood-Pressure, Non-<br>Invasive |
| | 870.2300, II | 74 DRT | Cardiac Monitor |
| | 870.2340, II | 74 FYW | Electrocardiograph |
| | 870.1435, II | 74 DXG | Computer, Diagnostic,<br>Pre-programmed,<br>Single Function |
| | 870.2900, II | 74 DSA | Cable, Transducer and<br>Electrode, including<br>Patient Connector |
| | 870.2850, II | 74 DRS | Extravascular Blood<br>Pressure Transducer |
| Panel 73<br>Anesthesiology | 868.1400, II | 73 CCK | Carbon Dioxide Gas<br>Analyzer |
| Panel 80<br>General<br>Hospital | 880.2910, II | 80 FLL | Clinical Electronic<br>Thermometer |

- 3. The new device is substantially equivalent to the previously cleared M3 K971910 and K981576.
- 4. The modification provides an auscultatory validation reference, according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.

3.5

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- 5. The new device has the same intended use as the legally marketed predicate devices. M3 is used for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital and medical transport environments.
- 6. The new device has the same technological characteristics as the legally marketed predicate devices.
- 7. The results of the validation study indicate that the device performance correlates to auscultatory reference standard according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.

K013427

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 9 2001

Mr. Dave Osborn Quality Program Manager Philips Medical Systems, Inc. Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01801

Re: K013427

Trade Name: Philips M3000A/M3046A, (M2/M3/M4) Compact Portable Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor Regulatory Class: Class III (three) Product Code: MHX Dated: November 12, 2001 Received: November 13, 2001

### 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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#### Page 2 - Mr. Dave Osborn

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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 yours,

N. O'Keefe Tiller

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K013421

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Philips M3000A/M3046A, (M2/M3/M4) Compact Portable Patient Monitor .

Intended for monitoring, recording, and alarming of multiple physiological Indications for Use: moreations for Ose. " - Intented rowneonates in hospital and medical transport environments.

### (Please do not write below this line-continue on another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Usc Use V V CFR 801.109) (Optional Format 1-2-96) OR

Over-The-Counter

Division of Cardiovascular & Respiratory Devices
510(k) Number K013427