MP5 INTELLIVUE PATIENT MONITOR
Device Facts
| Record ID | K063725 |
|---|---|
| Device Name | MP5 INTELLIVUE PATIENT MONITOR |
| Applicant | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN |
| Product Code | MHX · Cardiovascular |
| Decision Date | Feb 8, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The modified Philips MP5 IntelliVue Patient Monitor is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during patient transport inside and outside of hospital environment. It is not intended for home use. The monitor is intended for use by health care professionals. The MP5 monitor with interfaced Welch Allyn SureTemp® Plus thermometer module is intended for use with adult and pediatric patients in a hospital environment.
Device Story
Philips MP5 IntelliVue Patient Monitor is a multi-parameter physiological monitor; inputs include various physiological signals (ECG, blood pressure, oximetry, etc.) and temperature data via integrated Welch Allyn SureTemp® Plus module. Device processes signals to display real-time data, generate alarms, and record patient status. Operated by healthcare professionals in hospital settings and during transport (ambulance, aircraft). Output provides clinicians with continuous patient monitoring; facilitates clinical decision-making through real-time physiological assessment and alarm notification. Modification adds transport capability and thermometer module integration.
Clinical Evidence
Bench testing only. No clinical data provided. Verification and validation activities included system-level tests, performance tests, EMC, safety, and environmental testing based on hazard analysis. Pass/Fail criteria were derived from predicate device specifications.
Technological Characteristics
Multi-parameter patient monitor; interfaces with external thermometer module. Supports physiological monitoring including ECG, blood pressure, oximetry, and temperature. Designed for hospital and transport use. Connectivity includes network/communication systems. Safety and performance verified via EMC, environmental, and system-level testing.
Indications for Use
Indicated for monitoring, recording, and alarming of multiple physiological parameters in adult, pediatric, and neonatal patients. Used by healthcare professionals in hospital environments and during transport (inside/outside hospital). Not for home use. Thermometer module indicated for adult and pediatric patients in hospital settings.
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 IntelliVue Patient Monitor (K062392)
- M3/M3046A Compact Portable Patient Monitor (K971910)
- M3/M3046A Compact Portable Patient Monitor (K992273)
- M3/M3046A Compact Portable Patient Monitor (K030973)
- Welch Allyn SureTemp® Plus thermometer module (K031740)
Submission Summary (Full Text)
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K063725
## .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.
- 1. The submitter of this premarket notification is: Markus Stacha Philips Medizin Systeme Boeblingen GmbH FEB 8 2007 Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2840 Fax: ++49 7031 463-2442 e-mail: markus.stacha@philips.com
This summary was prepared on December 13, 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 Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP5 IntelliVue Patient Monitor marketed pursuant to K062392, the M3/M3046A Compact Portable Patient Monitor marketed pursuant to K971910, K992273, K030973, and the Welch Allyn SureTemp® Plus thermometer module marketed pursuant to K031740.
- 4. The modification adds the capability to the MP5 patient monitor to interface to the legally marketed Welch Allyn SureTemp® Plus thermometer module. The modification also adds the capability to the MP5 patient monitor to function in a transport environment outside of hospitals, such as a road ambulance, airplane or helicopter.
- The modified Philips MP5 IntelliVue Patient Monitor is intended 5. for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and
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- neonates in a hospital environment and during patient transport inside and outside of hospital environment. It is not intended for home use. The monitor is intended for use by health care professionals. The MP5 monitor with interfaced Welch Allyn SureTemp® Plus
thermometer module is intended for use with adult and pediatric patients in a hospital environment.
- 6. The modified device has 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. Testing involved system level tests, performance tests, EMC, safety and environmental 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 the modified Philips MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 8 2007
Philips Medizin Systeme Boeblingen GmbH Cardiac and Monitoring Systems c/o Markus Stacha Hewlett-Packard-Str. 2 D-71034 Boeblingen, GERMANY
Re: K063725
Trade Name: Philips MP5 Intelli Vue Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II Product Code: MHX Dated: December 13, 2006 Received: December 15, 2006
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.
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Page 2 - Mr. Markus Stacha
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmarfor
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): JKD (63725
Device Name: Philips MP5 IntelliVue Patient Monitor.
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during transport situations within and outside of hospital environment.
Use (Part 21 CFR 801 Subpart D)
Prescription
- AND/OR
Over-The-Counter Use (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)
Bl.Zimmerman
Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K063205
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