PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER

K081793 · Philips Medizin Systeme Boeblingen GmbH · MHX · Oct 14, 2008 · Cardiovascular

Device Facts

• Record ID: K081793
• Device Name: PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER
• Applicant: Philips Medizin Systeme Boeblingen GmbH
• Product Code: MHX · Cardiovascular
• Decision Date: Oct 14, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Device Story

Philips MP5/MP5T IntelliVue Patient Monitors and TRx4841A Telemetry System Transceiver monitor physiological parameters; input data via sensors/electrodes; process signals to generate real-time displays, recordings, and alarms; used by healthcare professionals in hospital settings and during transport. Modification adds wireless connectivity between monitor and transceiver as alternative to existing cable connection. Output allows clinicians to assess patient status, detect arrhythmias, and monitor ST segments; facilitates timely clinical intervention; improves patient safety through continuous monitoring.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities included system-level tests, safety, EMC, performance, environmental, and functionality tests. Pass/Fail criteria were based on specifications cleared for the predicate devices.

Technological Characteristics

Physiological monitoring system; wireless and wired connectivity; includes arrhythmia detection, ST segment monitoring, and signal processing. Components include patient monitors and telemetry transceivers. Software-based signal processing and alarm generation. Complies with safety, EMC, and environmental standards established for predicate devices.

Indications for Use

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

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

• Philips MP5 and MP5T IntelliVue Patient Monitors (K062392, K063725)
• Philips TRx4841A IntelliVue Telemetry System Transceiver (K040357, K041741)

Submission Summary (Full Text)

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# KOS 1793

#### 510 (k) Summary

### OCT 1 4 2008

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: Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Fax: ++49 7031 463-2442 Tel: ++49 7031 463-2840, e-mail: [e-mail]

This summary was prepared on June 23, 2008.

- 2. The names of the devices are: Philips MP5 and MP5T IntelliVue Patient Monitors and Philips TRx4841A IntelliVue Telemetry System Transceiver. Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|---------------------------|----------------|---------|-----------------------------------------------------------------------------|
| Cardiovascular<br>Devices | \$870.1025, II | DSI | Detector and alarm, arrhythmia |
| | \$870.1025, II | MLD | Monitor, ST Segment with Alarm |
| | \$870.1025, II | MHX | Monitor, Physiological, Patient<br>(with arrhythmia detection or<br>alarms) |
| | \$870.1435, II | DXG | Computer, Diagnostic, Pre-<br>Programmed, Single-Function |
| | \$870.2060, II | DRQ | Amplifier and Signal<br>Conditioner, Transducer Signal |
| | \$870.2300, II | DRT | Monitor, Cardiac (incl.<br>Cardiotachometer & Rate Alarm) |
| | \$870.2340, II | DPS | Electrocardiograph |
| | \$870.2340, II | MLC | Monitor, ST Segment |
| | \$870.2350, II | DRW | Electrocardiograph, Lead<br>Switching Adapter |
| | \$870.2370, II | KRC | Tester, Electrode, Surface,<br>Electrocardiograph |
| | \$870.2600, I | DRJ | System, Signal Isolation |
| | \$870.2700, II | DQA | Oximeter |
| | \$870.2800, II | DSH | Recorder, Magnetic tape,<br>Medical |
| | \$870.2810, I | DSF | Recorder, Paper Chart |
| | \$870.2900, I | DSA | Cable, Transducer and<br>Electrode, incl. Patient<br>Connector |
| | - | MSX | System, Network and<br>Communication, Physiological<br>Monitors |
| | \$870.2910, II | DRG | Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency |
| Anesthesiology<br>Devices | \$868.2375, II | BZQ | Monitor, Breathing Frequency |

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- 3. The modified devices are substantially equivalent to previously cleared Philips MP5 and MP5T IntelliVue Patient Monitors and the Philips TRx4841A IntelliVue Telemetry System Transceiver marketed pursuant to K062392, K063725, K040357, and K041741.
- 4. The modification is a change that adds wireless connection between the Philips MP5 and MP5T IntelliVue Patient Monitors and the Philips TRx4841A IntelliVue Telemetry System Transceiver as an alternative to the existing cable connection.
- 5. The modified devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, recording, and alarminq of multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
- 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 devices with respect to the predicates. Testing involved system level tests, safety, EMC, performance, environmental and functionality tests. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results successfully demonstrate that the Philips MP5 and MP5T IntelliVue Patient Monitors with Philips TRx4841A IntelliVue Telemetry System Transceiver meet all reliability requirements and performance claims.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 14

Philips Medizin Systeme Boeblingen GmbH Cardiac and Monitoring Systems c/o Mr. Egon Pfeil Regulatory Affairs Engineer Hewlett-Packard-Str. 2, D-71034 Boeblingen. Germany

Re: K081793

Trade/Device Name: Philips MP5 and MP51 IntelliVue Patient Monitors, and Philips 1 Rx4841 A Intelli Vue Telemetry System Transceiver Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II (Two) Product Code: MHX Dated: September 12, 2008 Received: September 15, 2008

Dear Mr. Stacha:

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.

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

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### Page 2 - Mr. Egon Pfcil

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

2 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K081793

Device Name:

Philips MP5 and MP5T IntelliVue Patient Monitors and Philips TRx4841A IntelliVue Telemetry System Transceiver.

Indications for Use:

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Prescription Use (Part 21 CFR 801 Subpart D)

yes AND/OR Over-The-Counter Use No (21 CFR 807 Subpart C)

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Concurrence of CDRM, Office of Device Evaluation (ODE)

Hth Stin /M Bruckermey

(Division Sign-On) /
Division of Cardiovascular Devices

510(k) Number