PHILIPS INTELLIVUE MP5 PATIENT MONITOR
Device Facts
| Record ID | K083228 |
|---|---|
| Device Name | PHILIPS INTELLIVUE MP5 PATIENT MONITOR |
| Applicant | Philips Medizin Systeme Boblingen GmbH |
| Product Code | MHX · Cardiovascular |
| Decision Date | Nov 24, 2008 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.
Device Story
Philips IntelliVue MP5 Patient Monitor integrates Microstream side-stream CO2 measurement module. Device monitors, records, and alarms physiological parameters (ECG, blood pressure, CO2, etc.) for adult, pediatric, and neonatal patients. Used in hospital settings and during transport by healthcare professionals. Inputs include physiological signals from sensors/electrodes; device processes signals to provide real-time data display and alarms. Output enables clinicians to assess patient status and make clinical decisions. Integration of CO2 module into MP5 chassis reduces footprint and manufacturing costs.
Clinical Evidence
Bench testing only. Validation performed according to ISO 21647 for CO2 measurement accuracy. System-level performance, functionality, and safety testing conducted via hazard analysis; results demonstrated substantial equivalence to predicate device specifications.
Technological Characteristics
Integrated patient monitor with side-stream CO2 measurement module. Hardware/software adaptations for module integration. Connectivity via network/communication systems. Complies with ISO 21647 for CO2 accuracy. Class II device.
Indications for Use
Indicated for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters in adult, pediatric, and neonatal patients within hospital environments and during 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
- IntelliVue MP5 Patient Monitor (K063725)
- IntelliVue MP5 Patient Monitor (K081793)
- Philips M3015A Measurement Server Extension (K993383)
- Oridion Capnostream20 with A2 Adaptive Averaging Software and Extended CO2 Measurement Range (K072295)
Related Devices
- K050762 — PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 · Philips Medizin Systeme Boeblingen GmbH · Apr 22, 2005
- K062392 — PHILIPS MP5 INTELLIVUE PATIENT MONITOR · Philips Medizin Systeme Boeblingen GmbH · Sep 6, 2006
- K072070 — PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Aug 10, 2007
- K101449 — INTELLIVUE PATIENT MONITOR · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jun 18, 2010
- K151512 — Star 60 · Skanray Technologies Private Limited · Feb 14, 2016
Submission Summary (Full Text)
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## NOV 2 4 2008
## 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:
Dr. Jens-Peter Seher Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2 D-71034 Böblingen, Germany
Tel: ++49 7031 463-2086 Fax: ++49 7031 463-2442 e-mail: jens-peter.seher@philips.com
This summary was prepared on October 29, 2008.
- 2. The name of the device is the Philips IntelliVue MP5 Patient Monitor with Microstream Side Stream CO2 Measurement Module.
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 |
| | \$870.2060, 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 |
| | \$870.2450, II | DXJ | Display, Cathode-Ray Tube,<br>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 |
| | \$870.2850, II | DRS | Extravascular Blood Pressure<br>Transducer |
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| Device Panel | Classification | ProCode | Description |
|-------------------------------------------------|----------------|---------|------------------------------------------------------------------------------|
| | \$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 | \$868.1400, 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 |
| General Hospital<br>and Personal Use<br>Devices | \$880.2910, II | FLL | Thermometer, Electronic,<br>Clinical |
- 3. Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.
- 4. The modified device Philips IntelliVue MP5 Patient Monitor is substantially equivalent to the legally marketed IntelliVue MP5 Patient Monitor (K063725, K081793). The modification consists of the integration of the Microstream CO2 Measurement Module, which is substantial equivalent to the legally marketed Philips M3015A Measurement Server Extension (k993383) and to the Oridion Capnostream2o with A2 Adaptive Averaging Software and Extended CO2 Measurement Range (k072295).
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- 6. The modified device has the same intended use as the legally marketed predicate device. The device is intended for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.
- 7. The modification is the integration of the Microstream CO2 measurement module into the MP5 with minor hardware and software adaptations. The modification leads to a compact patient monitor with integrated side stream CO2 measurement and reduces manufacturing costs.
- 8. The accuracy of the device was validated according to ISO 21647.
- 9. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate device. 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 IntelliVue MP5 Patient Monitor meets all reliability requirements and performance claims.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three legs, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2008
Philips Medizin Systeme Boblingen GMBH Dr. Jens-Peter Seher Senor Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard -Str. 2 D-71034 Boblingen, Germany
Re: K083228
Trade/Device Name: Philips IntelliVue MP5 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: October 29, 2008 Received: November 3, 2008
Dear Dr. Seher:
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 intentate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendinents, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Orug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), You may, therefore, market the device, subject to the general controls provisions of the 11th general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misbaranding 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 11 vire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition JFDA may publish further announcements concerning your device in the Federal Register. Nexe oc advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act array
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Page 2 - Dr. Jens-Peter Seher
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 (2) 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
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): K083228
Device Name: Philips IntelliVue MP5 Patient Monitor.
Indications for Use: Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.
| Prescription Use (Part 21 CFR 801 Subpart D) | yes | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) | No |
|----------------------------------------------|-----|--------|---------------------------------------------|----|
|----------------------------------------------|-----|--------|---------------------------------------------|----|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|------------------------------------|----------|
| Division of Cardiovascular Devices | |
| | 11/24/05 |
| 510(k) Number | K083228 |
