PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR

K014159 · Philips Medical Systems, Inc. · DSI · Jan 18, 2002 · Cardiovascular

Device Facts

• Record ID: K014159
• Device Name: PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR
• Applicant: Philips Medical Systems, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Jan 18, 2002
• 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. For use in healthcare facilities by healthcare professionals whenever there is a need for monitoring the physiological parameters of adult, pediatric, or neonatal patients.

Device Story

Multi-parameter patient monitoring system; inputs include physiological signals (ECG, blood pressure, CO2, SpO2, respiration, temperature); processes signals via integrated software (CMS C.1) for real-time display, recording, and alarm generation; used in healthcare facilities by healthcare professionals; provides continuous patient status updates; facilitates clinical decision-making through arrhythmia detection, ST segment monitoring, and vital sign tracking; benefits patients through timely identification of physiological changes.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, integration tests, and safety testing based on hazard analysis. Pass/Fail criteria were derived from predicate device specifications; results demonstrated substantial equivalence.

Technological Characteristics

Multi-parameter physiological monitoring system; includes arrhythmia detection, ST segment monitoring, and non-invasive blood pressure measurement. Connectivity via network/communication systems. Software release CMS C.1. Complies with AAMI SP-10 for blood pressure validation.

Indications for Use

Indicated for monitoring, recording, and alarming of physiological parameters in adult, pediatric, and neonatal patients within healthcare facilities.

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

• K003038
• K001333
• K990125
• K981576
• K971910
• K903771

Submission Summary (Full Text)

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## KO14159 JAN 1 8 2002

p/12

## 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 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

> Tel: [phone] 685 5624 Fax: Email: [e-mail]

This summary was prepared on 17 December, 2001

- 2. The names of these devices are:
- Philips M1175A/76A/77A Component Monitoring System ●
- Philips V24/V26 patient monitor .

Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|----------------------------|----------------|---------|-----------------------------------------------------------------------------|
| Panel 73<br>Anesthesiology | 868.1400, II | CCK | Analyzer, Gas, Carbon-<br>Dioxide, Gaseous-Phase |
| | 868.2375, II | BZQ | Monitor, Breathing<br>Frequency |
| | 868.2480, II | LKD | Monitor, Carbon-Dioxide,<br>Cutaneous |
| | 868.2500, II | KLK | Monitor, Oxygen,<br>Cutaneous, for Infant not<br>under Gas Anesthesia |
| Panel 74<br>Cardiovascular | 870.1025, III | DSI | Detector and Alarm,<br>Arrhythmia |
| | 870.1025, III | MLD | Monitor, ST Segment with<br>Alarm |
| | 870.1025, III | MHX | Monitor, Physiological,<br>Patient (with arrhythmia<br>Detection or alarms) |
| | 870.1100, 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 |
| | 870.1915, II | KRB | Probe, Thermodilution |
| | 870.2060, II | DRQ | Amplifier and Signal<br>Conditioner, Transducer<br>Signal |
| | 870.2300, II | DRT | Monitor, Cardiac (incl.<br>Cardiotachometer & Rate<br>Alarm) |
| | 870.2340, II | DPS | Electrocardiograph |
| | 870.2340, II | MLC | Monitor, ST Segment |

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| | 870.2370, II | KRC | Tester, Electrode,<br>Surface,<br>Electrocardiograph |
|---------------------------------|--------------|-----|-----------------------------------------------------------------|
| | 870.2450, II | DXJ | Display, Cathode-Ray<br>Tube, Medical |
| | 870.2600, I | DRJ | System, Signal Isolation |
| | 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 devices are substantially equivalent to the previously cleared monitors in K003038, K001333, K990125, K981576, K971910, and K903771
- 4. The modification provides a choice of validation references, according to subclause 4.4.2.1 of AAMI SP-10 for pediatric and adult patients.
- 5. The new devices have the same intended use as the legally marketed predicate devices. They are intended for monitoring, recording, and alarming of multiple physiological parameters. For use in healthcare facilities by healthcare professionals whenever there is a need for monitoring the physiological parameters of adult, pediatric, or neonatal patients.
- 6. The new devices have the same technological characteristics as the legally marketed predicate devices.
- 7. Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of the new device with respect to the predicates. Testing involved system level tests, integration tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that modified devices meet all reliability requirements and performance claims.

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JAN 1 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dave Osborn Ouality Program Manager Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099

Re: K014159

Trade Name: Philips M1175A/76A/77A Component Monitoring System and Philips V24/V26 Patient Monitor with M1008B and software release CMS C.1 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: December 17, 2001 Received: December 19, 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'Neill

am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page **_ of _**

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Philips M1175A/76A/77A Component Monitoring System and Philips V24/V26 patient monitor with M1008B and software release CMS C.1

Indications for Use: Intended for monitoring, recording, and alarming of multiple physiological parameters. For use in healthcare facilities by healthcare professionals whenever there is a need for monitoring the physiological parameters of adult, pediatric, or neonatal patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

OR

Over-The-Counter

Division of Cardiovascular & Respiratory Devices
510(k) Number K01454

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