PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B

K013199 · Philips Medical Systems, Inc. · MHX · Nov 28, 2001 · Cardiovascular

Device Facts

• Record ID: K013199
• Device Name: PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B
• Applicant: Philips Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 28, 2001
• 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 health care facilities.

Device Story

M1275B Component Compact Monitor; modular physiological monitoring system. Inputs: ECG, blood pressure, gas, temperature, oximetry, plethysmography signals. Operation: processes physiological data to provide real-time monitoring, recording, and alarms. Used in health care facilities by clinicians. Output: visual display of patient parameters and alarm notifications. Benefits: enables continuous patient surveillance, facilitating timely clinical intervention. Modification from predicate: new display unit and modified rack.

Clinical Evidence

Bench testing only. Performance, functionality, and reliability were verified through hazard analysis and performance testing. Pass/Fail criteria were based on predicate device specifications; results demonstrated substantial equivalence.

Technological Characteristics

Modular physiological monitor. Components include display unit and rack. Supports multi-parameter sensing (ECG, BP, gas, SpO2, temperature). Connectivity via network/communication system. Software-based monitoring and alarm processing. Sterilization not applicable (non-invasive).

Indications for Use

Indicated for use by health care professionals for monitoring physiological parameters in adult, pediatric, and neonatal patients. EASI 12-lead ECG restricted to adult and pediatric patients. ST segment monitoring restricted to adult patients. Transcutaneous gas measurement (tcpO2/tcpCO2) restricted to neonatal patients.

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/M4 (M3046/3000A) (K971910)
• M1175/76A (K001057)

Submission Summary (Full Text)

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## NOV 2 8 2001

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## 9.0 510 (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 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 21 September, 2001

- 2. The name of this device is the Philips Medical Systems, M1275B Classification names are as follows: Component Compact Monitor.

| Device Panel | Classification | ProCode | Description |
|----------------------------|----------------|---------|-----------------------------------------------------------------------|
| Panel 73<br>Anesthesiology | 868.1400, II | CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| | 868.2375, II | BZQ | Monitor, Breathing Frequency |
| | 868.2480, II | LKD | Monitor, Carbon-Dioxide, Cutaneous |
| | 868.2500, II | KLK | Monitor, Oxygen, Cutaneous, for Infant not under Gas Anesthesia |
| Panel 74<br>Cardiovascular | 870.1025, III | DSI | Detector and Alarm, Arrhythmia |
| | 870.1025, III | MLD | Monitor, ST Segment with Alarm |
| | 870.1025, III | MHX | Monitor, Physiological, Patient (with arrhythmia Detection or alarms) |
| | 870.1100, II | DSJ | Alarm, Blood-Pressure |
| | 870.1110, II | DSK | Computer, Blood-Pressure |
| | 870.1130, II | DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| | 870.1435, II | DXG | Computer, Diagnostic, Pre-Programmed, Single-Function |
| | 870.1915, II | KRB | Probe, Thermodilution |
| | 870.2060, II | DRQ | Amplifier and Signal Conditioner, Transducer Signal |
| | 870.2300, II | DRT | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| | 870.2340, II | DPS | Electrocardiograph |
| | 870.2340, II | MLC | Monitor, ST Segment |
| | 870.2370, II | KRC | Tester, Electrode, Surface, Electrocardiograph |
| | 870.2450, II | DXJ | Display, Cathode-Ray Tube, Medical |
| | 870.2600, I | DRJ | System, Signal Isolation |

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| Device Panel | Classification | Product Code | Description |
|---------------------------------|----------------|--------------|-----------------------------------------------------------------|
| | 870.2700, II | DQA | Oximeter |
| | 870.2770, II | DSB | Plethysmograph, Impedance |
| | 870.2800, II | DSH | Recorder, Magnetic Tape,<br>Medical |
| | 870.2810, I | DSF | Recorder, Paper Chart |
| | - | MSX | System, Network and<br>Communication,<br>Physiological Monitors |
| Panel 80<br>General<br>Hospital | 880.2910, II | FLL | Thermometer, electronic,<br>clinical |

- 3. The new device is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, creared , and K990972, K991773, K992273, K993383, K000822, R981370 , und K903621, as well as M1175/76A pursuant to
K001057, K001333, and K003621, as well 2011, x000135 R001037, K0015337, Kra K088, K923682, K925910, K941811, K990125, к990476, к992595, к001722.
- The modification is a new display unit and a modified rack. 4 .
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- The new device has the same Indications for Use, for use by 5. health care professionals whenever there is a need for monitoring the physiological parameters patients, as the legally marketed predicate device.
- 6. The new device has the same technological characteristics as the legally marketed predicate device.
- 7. Verification, validation, and testing activities establish the verformance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved che new device me, 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 Component Compact Monitor meets all reliability requirements and performance claims.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2001

Mr. Dave Osborn Phillips Medical Systems, Inc. Cardiac and Monitoring Systems 3000 Minuteman Rd. Andover, MA 01810-1099

K013199 Re:

Trade Name: M1275B Component Compact Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm 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 we nave roviewed your becamed 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,

Denta Tille

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

Enclosure

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_ of _________________________________________________________________________________________________________________________________________________________________________ Page _

Over-The-Counter

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Philips Medical Systems, M1275B Component Compact Monitor, Release A.01.

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

Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.

EASI 12-lead ECG is only for use on adult and pediatric patients.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.

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

OR

Prescription Use Usc (Per 21 CFR 801.109) (Optional Format 1-2-96)

Telh
Division of Cardiovascular & Respiratory Devices
510(k) Number K013199