PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00
Device Facts
| Record ID | K053522 |
|---|---|
| Device Name | PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00 |
| Applicant | Philips Medizin Systeme Boeblingen GmbH |
| Product Code | MHX · Cardiovascular |
| Decision Date | Jan 10, 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, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02) is restricted to neonatal patients only.
Device Story
IntelliVue MP40-MP90 monitors collect physiological signals (ECG, blood pressure, gas, etc.) from patients in hospital settings. Device processes inputs to provide real-time monitoring, recording, and alarming of patient status. Operated by healthcare professionals at bedside or during intra-hospital transport. Output displayed on integrated screen for clinical review; alerts notify staff of parameter deviations. Facilitates clinical decision-making by providing continuous physiological data; enables timely intervention for patient safety.
Clinical Evidence
Bench testing only. Verification and validation activities included system-level tests, performance tests, and safety testing based on hazard analysis. Pass/Fail criteria were derived from cleared predicate specifications; results demonstrated substantial equivalence.
Technological Characteristics
Multi-parameter patient monitoring system. Includes modules for ECG, blood pressure, gas analysis, and transcutaneous monitoring. Connectivity via network/communication systems. Software-based processing for arrhythmia detection, ST-segment analysis, and physiological alarms. Form factor varies by model (MP40-MP90).
Indications for Use
Indicated for monitoring physiological parameters of adult, pediatric, and neonatal patients in healthcare facilities. ST segment monitoring restricted to adults; transcutaneous gas measurement (tcpO2) restricted to neonates.
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
- K014159
- K021778
- K030038
- K032858
- K040304
- K040183
- K040357
- K041235
- K41741
- K042845
- K050141
- 050762
- K051106
- K052801
Reference Devices
- Respironics Novametrix Flow Sensors PN 6716.-.6720
- NICO, Model 7300 (K960831, K963380, K982499, K030886)
Related Devices
- K061610 — PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS · Philips Medizin Systeme Boeblingen GmbH · Aug 14, 2006
- K041235 — PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS · Philips Medizin Systeme Boeblingen GmbH · Jun 4, 2004
- K050762 — PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 · Philips Medizin Systeme Boeblingen GmbH · Apr 22, 2005
- K032858 — THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. · Philips Medizin Systeme Boblingen GmbH · Oct 10, 2003
- K062392 — PHILIPS MP5 INTELLIVUE PATIENT MONITOR · Philips Medizin Systeme Boeblingen GmbH · Sep 6, 2006
Submission Summary (Full Text)
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## 8.0 510 (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: Herbert van Dyk Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1734 Fax: ++49 7031 463-2442 e-mail: herbert.van_dyk@philips.com
This summary was prepared on December 16, 2005.
- 2. The names of the devices are the Philips MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|------------------------------------------|----------------|---------|-----------------------------------------------------------------------------|
| Circulatory<br>System Devices<br>(12625) | \$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) |
| | \$870.2300, II | MSX | System, Network and<br>Communication, Physiological<br>Monitors |
| | \$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 |
COMPANY CONFIDENTIAL
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| | \$870.2900, I | DSA | Cable, Transducer and<br>Electrode, incl. Patient<br>Connector |
|------------------------------------------------------|----------------|-----|------------------------------------------------------------------------------|
| | \$870.2910, II | DRG | Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency |
| Anesthesiology<br>and Respiratory<br>Therapy (12624) | \$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>(12520) | \$880.2910, II | FLL | Thermometer, Electronic,<br>Clinical |
| Neurological<br>(12513) | \$882.1400, II | GWR | Electroencephalograph |
| | \$882.1420, I | GWS | Analyzer, Spectrum,<br>Electroencephalogram Signal |
- 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K051106, K052801 , and to Respironics Novametrix Flow Sensors "PN 6716.-.6720" and Monitor Device "NICO, Model 7300″ (K960831, K963380, K982499, and K030886)
- 4. The modification is the introduction of Release D.00 software for the IntelliVue patient monitor devices, MP40, MP50, MP60, MP70, MP80, and MP90
- 5. The modified devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital
## COMPANY CONFIDENTIAL
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environment and during transport within hospital environments.
- 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 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 IntelliVue Patient Monitor meets all reliability requirements and performance claims.
## COMPANY CONFIDENTIAL
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle or bird-like figure with three stylized lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the central emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2006
Mr. Herbert Van Dyk Senior Regulatory Affairs Engineer Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Street 2 D-71034 Boeblingen, Baden-Wttbg GERMANY
Re: K053522
Trade/Device Name: The Philips MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release D.00 Regulation Number: 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Mesasurement and Alarm) Regulatory Class: II Product Code: MHX Dated: December 16, 2005 Received: December 19, 2005
Dear Mr. Dyk:
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. Dyk
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suita Y. Michael Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
The Philips MP40, MP50, MP60, MP70, MP80 and MP90 Device Name: IntelliVue Patient Monitors, Release D.00
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, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02) is restricted to neonatal patients only.
| Prescription<br>(Part 21 CFR 801 Subpart D) | Use ___ yes_______________________________________________________________________________________________________________________________________________________________________ AND/OR |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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053522
