MP5 INTELLIVUE PATIENT MONITOR
Device Facts
| Record ID | K091395 |
|---|---|
| Device Name | MP5 INTELLIVUE PATIENT MONITOR |
| Applicant | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN |
| Product Code | MHX · Cardiovascular |
| Decision Date | Jun 5, 2009 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Philips IntelliVue MP5 Patient Monitor is 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 additionally intended for use in transport situations within and outside of hospital environments. The monitor is not intended for home use. It is intended for use by health care professionals.
Device Story
The Philips IntelliVue MP5 is a multi-parameter patient monitor used by healthcare professionals in hospital and transport environments. It acquires physiological signals (e.g., ECG, blood pressure, SpO2, CO2, EEG, temperature) via connected sensors and transducers. The device processes these inputs to display real-time waveforms and numerical data, and to generate audible/visual alarms when parameters exceed pre-set thresholds. It supports arrhythmia detection, ST-segment analysis, and gas analysis. The system facilitates clinical decision-making by providing continuous patient status updates. The modification introduces software release G.1, maintaining the same core functionality and technological characteristics as previous versions.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing, including system-level verification, validation, and regression testing based on hazard analysis and established performance specifications.
Technological Characteristics
Multi-parameter patient monitor for ECG, blood pressure, SpO2, CO2, EEG, and gas analysis. Features include signal amplification, conditioning, and alarm generation. Connectivity includes network/communication systems for physiological data. Software-based processing with G.1 release. Operates as a Class II device for physiological monitoring.
Indications for Use
Indicated for use by health care professionals for monitoring physiological parameters of adult, pediatric, and neonatal patients in hospital and transport settings. Not for home use.
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 IntelliVue MP5 Patient Monitor (K062392)
- Philips IntelliVue MP5 Patient Monitor (K063725)
- Philips IntelliVue MP5 Patient Monitor (K71426)
- Philips IntelliVue MP5 Patient Monitor (K81793)
- Philips IntelliVue MP5 Patient Monitor (K082633)
- Philips IntelliVue MP5 Patient Monitor (K083228)
Related Devices
- K031481 — THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 · Philips Medizin Systeme Boblingen GmbH · May 29, 2003
- K101449 — INTELLIVUE PATIENT MONITOR · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jun 18, 2010
- K060541 — THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS · Philips Medizin Systeme Boblingen GmbH · Mar 24, 2006
- K083517 — INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jan 16, 2009
- K100939 — INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Apr 30, 2010
Submission Summary (Full Text)
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## KO91395
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:
JUN - 5 2009
Andreas Suchi Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1291 Fax: ++49 7031 463-2442 e-mail: andreas.suchi@philips.com.
This summary was prepared on May 8, 2009.
- 2. The name of the device is the Philips IntelliVue MP5 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 |
| Device Panel | Classification | ProCode | Description |
| | - | 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 |
| | \$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 |
| Devices | \$882.1420, I | GWS | Analyzer, Spectrum,<br>Electroencephalogram Signal |
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- 3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue MP5 Patient Monitor marketed pursuant to K062392, K063725, K71426, K81793, K082633, and K083228.
- 4. The modification is the introduction of software release G.1 for the Philips IntelliVue MP5 Patient Monitor.
- 5. The modified device has the same intended use as the legally marketed predicate device. The Philips IntelliVue MP5 Patient Monitor is 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 additionally intended for use in transport situations
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within and outside of hospital environments. The monitor is not intended for home use. It is intended for use by health care professionals.
- 6. The modified device has the same technological characteristics 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 and regression tests as well as testing from the 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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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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2009
Philips Medizin Systeme Boeblingen GMBH Mr. Andreas Suchi Senior Regulatory Affairs Engineer Philips Healthcare Hewlett-Packard -Str. 2 D-71034 Boeblingen, Germany
Re: K091395
Trade/Device Name: Philips IntelliVue MP5 Patient Monitor, Software Version G.1 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: May 8, 2009 Received: May 11, 2009
Dear Mr. Suchi:
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 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. Andreas Suchi
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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): K091395
Philips IntelliVue MP5 Patient Monitor, Software Device Name: Revision G.1.
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 and outside of hospital environments.
Prescription Use (Part 21 CFR 801 Subpart D)
FR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hollister for B Zuckerman
(Division Sign-Off) 6/5/09
Division of Cardiovascular Devices
510(k) Number K091395
