THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS
Device Facts
| Record ID | K060541 |
|---|---|
| Device Name | THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS |
| Applicant | Philips Medizin Systeme Boblingen GmbH |
| Product Code | MHX · Cardiovascular |
| Decision Date | Mar 24, 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 patients. Intended for monitoring, recording and alarming of of multiple physiological parameters of adults, pediatrics and neonates healthcare facilities. The MP20, MP30, MP40 and MP50 are in additionally intended for use in transport situations within healthcare facilities. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCC2) is restricted to neonatal patients only.
Device Story
IntelliVue Patient Monitors (MP20-MP90) collect physiological data via various sensors/probes (ECG, blood pressure, gas, etc.); process signals to provide real-time monitoring, recording, and alarming. Used by healthcare professionals in hospital environments; MP20-MP50 models support intra-hospital transport. Output displayed on integrated screens for clinical decision-making; facilitates continuous patient status assessment. Modification introduces Release D.03 software.
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 based on specifications cleared for the predicate devices. Results demonstrate substantial equivalence.
Technological Characteristics
Multi-parameter patient monitoring system. Supports ECG, blood pressure, gas analysis, and other physiological measurements. Connectivity via network/communication systems. Software-driven (Release D.03). Class II device.
Indications for Use
Indicated for monitoring, recording, and alarming of physiological parameters in adult, pediatric, and neonatal patients in healthcare facilities. MP20-MP50 models also indicated for intra-hospital transport. ST segment monitoring restricted to adults; transcutaneous gas measurement 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
- K053522
- K060221
- K053204
Reference Devices
- Dräger Medical M1019A IntelliVue G5 Anesthesia Gas Monitor
Related Devices
- K063315 — INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 · Philips Medizin Systeme Boeblingen GmbH · Nov 20, 2006
- K060221 — THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS · Philips Medizin Systeme Boeblingen GmbH · Feb 17, 2006
- K051106 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS · Philips Medizin Systeme Boeblingen GmbH · Jul 1, 2005
- K031481 — THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 · Philips Medizin Systeme Boblingen GmbH · May 29, 2003
- 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
Submission Summary (Full Text)
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K06054/
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 February 24, 2006.
- 2. The names of the devices are the Philips MP20, MP30, 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 |
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| \$870.2900, I | DSA | Cable, Transducer and Electrode, incl. Patient Connector | |
|------------------------------------------------------|----------------|------------------------------------------------------------------|------------------------------------------------------------------------|
| \$870.2910, II | DRG | Transmitters and Receivers, Physiological Signal, Radiofrequency | |
| Anesthesiology<br>and Respiratory<br>Therapy (12624) | \$868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide, Gaseous-Phase |
| | \$868.1500, II | CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) |
| | \$868.1500, II | NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) |
| | \$868.1500, II | NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) |
| | \$868.1500, II | NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) |
| | \$868.1620, II | CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Concentration) |
| | \$868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide, Gaseous-Phase (Anesthetic Concentration) |
| | \$868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
| | \$868.1880, II | BZC | Data calculator Pulmonary-function |
| | \$868.2375, II | BZQ | Monitor, Breathing Frequency |
| | \$868.2480, II | LKD | Monitor, Carbon Dioxide, Cutaneous |
| | \$868.2500, II | KLK | Monitor, Oxygen, Cutaneous, for Infant not under Gas Anesthesia |
| General Hospital<br>and Personal Use<br>(12520) | \$880.2910, II | FLL | Thermometer, Electronic, Clinical |
| Neurological<br>(12513) | \$882.1400, II | GWR | Electroencephalograph |
| | \$882.1420, I | GWS | Analyzer, Spectrum, 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 , K053522, K060221, and K053204 to Dräger Medical M1019A IntelliVue G5 Anesthesia Gas Monitor
- The modification is the introduction of Release D.03 software 4 . for the IntelliVue patient monitor devices, MP20, MP30, 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
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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.
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Public Health Service
Image /page/3/Picture/2 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, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2006
Philips Medizin Systeme Boeblingen GmbH c/o Herbert van Dyk Sr. Regulatory Affairs Engineer Hewlett-Packard-Str. 2 D-71034 Boeblingen GERMANY
Re: K060541
Trade Name: Philips MP20, MP30, MP40, MP50, MP60, MP70. MP80, and MP90 IntelliVue Patient Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Paticnt Monitor w/ Arrhythmia Detection or Alarms Regulatory Class: Class II (two) Product Code: MHX, CCK, CCL, CBQ, NHO, NHP, NHQ, CBS, CBR, BZQ Dated: February 24, 2006 Received: March 1, 2006
Dear Mr. van 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. Herbert van 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 vours,
Bram D. Zuckerman, M.D.
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): Ko 60 5 Yi
Device Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release D.03
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of of multiple physiological parameters of adults, pediatrics and neonates healthcare facilities. The MP20, MP30, MP40 and MP50 are in additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCC2) is restricted to neonatal patients only.
Prescription Use yes AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use ___No___ (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)
ivision Sign-Off 510(k) Nur
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