M3046B COMPACT PORTABLE PATIENT MONITORS

K052707 · Philips Medical Systems · MHX · Oct 20, 2005 · Cardiovascular

Device Facts

• Record ID: K052707
• Device Name: M3046B COMPACT PORTABLE PATIENT MONITORS
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Oct 20, 2005
• 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 healthcare environments. Additionally, the monitor may be used in transport situations within a healthcare facility.

Device Story

Philips M3046B Compact Portable Patient Monitor; monitors, records, and alarms physiological parameters. Inputs include various physiological signals (ECG, blood pressure, oximetry, gas, temperature). Device processes signals to provide real-time patient data and alarms to healthcare professionals. Used in clinical healthcare environments and during intra-facility transport. Output enables clinicians to assess patient status and make clinical decisions. Benefits include continuous patient surveillance and timely notification of physiological changes.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, performance tests, and safety testing based on hazard analysis. Results demonstrated that the device meets all reliability requirements and performance claims consistent with the predicate devices.

Technological Characteristics

Compact portable patient monitor. Supports multi-parameter physiological monitoring (ECG, blood pressure, SpO2, gas, temperature). Software-based (Release B.00). Connectivity for patient data monitoring and alarming. Operates as a standalone or networked monitor in clinical environments.

Indications for Use

Indicated for use by health care professionals for monitoring physiological parameters of adult, pediatric, and neonatal patients in healthcare environments, including during transport within a facility.

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

• K971910
• K981576
• K990972
• K991773
• K992273
• K993383
• K000822
• K001057
• K001333
• K003621

Submission Summary (Full Text)

{0}------------------------------------------------

K052707 p.112

## 7.0 510(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 CFR 807-92.

1. The submitter of this pre-market notification is: Michael J. Doyle Philips Medical Systems - Cardiac & Monitoring Systems 3000 Minuteman Road Andover, MA 01810 United States Tel: [phone] Fax: [phone] Email: [e-mail]

This summary was prepared on September 26, 2005.

2. The names of the devices are the Philips M3046B Compact Portable Patient Monitors. Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|--------------------------------------------|----------------|---------|-----------------------------------------------------------------------------|
| Circulatory<br>System Devices | 870.1025, II | MHX | Monitor, Physiological,<br>Patient (with arrhythmia<br>detection or alarms) |
| | 870.1110, II | DSJ | Alarm, Blood Pressure |
| | 870.1110, II | DSK | Computer, Blood Pressure |
| | 870.1130, II | DXN | System, Measurement,<br>Blood Pressure, Non-<br>Invasive |
| | 870.1435, II | DXG | Computer, Diagnostic,<br>Pre-programmed, Single-<br>function |
| | 870.2300, II | DRT | Monitor, Cardiac (incl.<br>Cardiotachometer & Rate<br>Alarm |
| | 870.2340, II | DPS | Electrocardiograph |
| | 870.2700, II | DQA | Oximeter |
| | 870.2850, II | DRS | Extravascular Blood<br>Pressure Transducer |
| | 870.2900, I | DSA | Cable, Transducer and<br>Electrode, incl. Patient<br>connector |
| Anesthesiology<br>& Respiratory<br>Therapy | 868.1400, II | CCK | Analyzer, Gas, |
| General<br>Hospital and<br>Personal Use | 880.2910, II | FLL | Thermometer, Electronic,<br>Clinical |

3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K971910,

{1}------------------------------------------------

К981576, К990972, К991773, К992273, К993383, К000822, К001057, K001333, and K003621.

4. The modification is the introduction of Release B.00 software for the Philips M3046B Compact Portable Patient Monitors and Accessories.

5. The modified devices have the same intended use as the legally marketed predicate devices. They are intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatric, and neonates in healthcare environments and during transport within healthcare environments.

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

7. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testinq involved system level tests, performance 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 Philips M3046B Compact Portable Patient Monitors meets all reliability requirements and performance claims.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.

OCT 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems c/o Mr. Michael J. Doyle Regulatory Specialist 3000 Minuteman Road Andover, MA 01810

Re: K052707

Trade Name: M3046B Compact Portable Patient Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: September 27, 2005 Received: September 29, 2005

Dear Mr. Doyle:

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.

{3}------------------------------------------------

Page 2 - Mr. Michacl J. Doyle

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]. 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 yours.

Mesa Aoy
Bram D. Zuckerman, M.D.

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

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K052707

Device Name: Philips M3046B Compact Portable Patient Monitor

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

Intended use: For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor may be used in transport situations within a healthcare facility.

| Prescription Use: | <b>Yes</b> |
|-----------------------------|------------|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-the Counter Use: | <b>No</b> |
|------------------------|-----------|
| (21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Moth
(Division Sign-Off)

Division of Cardiovascular Devices

**510(k) Number:** K052707

Page ***_*** of **_**