PHILIPS MP5 INTELLIVUE PATIENT MONITOR

K062392 · Philips Medizin Systeme Boeblingen GmbH · MHX · Sep 6, 2006 · Cardiovascular

Device Facts

• Record ID: K062392
• Device Name: PHILIPS MP5 INTELLIVUE PATIENT MONITOR
• Applicant: Philips Medizin Systeme Boeblingen GmbH
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 6, 2006
• 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, pediatrics and neonates in hospital environments. The MP5 is also intended for use in transport situations within hospital environments.

Device Story

Philips MP5 IntelliVue Patient Monitor is a multi-parameter physiological monitor; collects data via sensors/electrodes (ECG, blood pressure, oximetry, capnography, etc.); processes signals to provide real-time monitoring, recording, and alarm generation; used by healthcare professionals in hospital settings and during intra-hospital transport. Output displayed on integrated screen for clinical review; assists clinicians in patient status assessment and decision-making; provides continuous surveillance to improve patient safety.

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 specifications equivalent to the predicate devices.

Technological Characteristics

Multi-parameter physiological monitor; supports ECG, blood pressure, oximetry, capnography, and other physiological measurements. Features integrated alarm system, signal conditioning, and network communication capabilities. Designed for hospital and transport use. Software-based processing for arrhythmia detection, ST-segment monitoring, and physiological data analysis.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospital environments, including intra-hospital transport, requiring monitoring, recording, and alarming of physiological parameters.

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 MP30 IntelliVue Patient Monitor (K041235, K042845, K050141, K051106, K052801, K052961, K053522, K060221, K060541, K061052)
• Philips Multi-Parameter Module M3001A (K020531, K030973, K033715)
• Philips M3014A Capnography Measurement Server Extension (K050762, K060221)

Submission Summary (Full Text)

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## 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 C.F.R. §807.92.

SEP - 1 2006

1. The submitter of this premarket notification is: Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2840 Fax: ++49 7031 463-2442 e-mail: [e-mail]

This summary was prepared on August 14, 2006.

2. The names of the device is the Philips MP5 IntelliVue Patient Monitor

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) |
| | \$870.1100, II | DSJ | Alarm, Blood Pressure |
| | \$870.1110, II | DSK | Computer, Blood Pressure |
| | \$870.1130, II | DXN | System, Measurement, Blood-<br>Pressure, Non-Invasive |
| | \$870.1435, II | DXG | Computer, Diagnostic, Pre-<br>Programmed, Single-Function |
| | \$870.1915, II | KRB | Probe, Thermodilution |
| | \$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 |
| | \$870.2770, II | DSB | Plethysmograph, Impedance |
| | \$870.2800, II | DSH | Recorder, Magnetic tape,<br>Medical |
| | \$870.2810, I | DSF | Recorder, Paper Chart |
| | \$870.2850, II | DRS | Extravascular Blood Pressure<br>Transducer |
| | \$870.2900, I | DSA | Cable, Transducer and<br>Electrode, incl. Patient<br>Connector |
| | | MSX | System, Network and<br>Communication, Physiological<br>Monitors |

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| Device Panel | Classification | ProCode | Description |
|-------------------------------------------------|----------------|--------------------------------------------------------------------|------------------------------------------------------------------------------|
| Anesthesiology<br>Devices | \$870.2910, II | DRG | Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency |
| | \$868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide,<br>Gaseous-Phase |
| | \$868.1500, II | CBQ | Analyzer, Gas, Enflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1500, II | NHO | Analyzer, Gas, Desflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1500, II | NHP | Analyzer, Gas, Sevoflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1500, II | NHQ | Analyzer, Gas, Isoflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1620, II | CBS | Analyzer, Gas, Halothane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-<br>Phase |
| | \$868.1880, II | BZC | Data calculator Pulmonary-<br>function |
| | \$868.2375, II | BZQ | Monitor, Breathing Frequency |
| \$868.2480, II | LKD | Monitor, Carbon Dioxide,<br>Cutaneous | |
| \$868.2500, II | KLK | Monitor, Oxygen, Cutaneous, for<br>Infant not under Gas Anesthesia | |
| General Hospital<br>and Personal Use<br>Devices | \$880.2910, II | FLL | Thermometer, Electronic,<br>Clinical |
| Neurological<br>Devices | \$882.1400, II | GWR | Electroencephalograph |
| | \$882.1420, I | GWS | Analyzer, Spectrum,<br>Electroencephalogram Signal |

- 3. The modified device Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to K020531, K030973, K033715 and its Philips M3014A Capnography Measurement Server Extension marketed pursuant to K050762 and K060221.
- 4. The modification is the introduction of the model MP5 IntelliVue Patient Monitor.
- 5. The modified device has the same intended use as the legally marketed predicate device. It is intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital environment and during transport within hospital environments.

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- The modified device has the same technological characteristics 6. as the legally marketed predicate device.
- 7. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testing 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 MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims.

062392 > 3/3

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP - 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medizin Systeme Boblingen GmbH c/o Ms. Linda Stone Philips Medical Systems 3000 Minuteman Road Andover, MA 01810

Re: K062392

Trade Name: MP5 Intellivue Patient Monitor 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: August 14, 2006 Received: August 16, 2006

Dear Ms. Stone:

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 - Ms. Linda Stone

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 s set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ed tonic 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,

Blymmerman for

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):_____________________________________________________________________________________________________________________________________________________

Device Name: Philips MP5 IntelliVue 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 for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP5 is also intended for use in transport situations within hospital environments.

Prescription Use yes______ AND/OR Over-The-Counter Use No (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bremmer

Division Sian-C Division of Cardiovascular Devices 510/k) Nur