THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
Device Facts
| Record ID | K032858 |
|---|---|
| Device Name | THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. |
| Applicant | Philips Medizin Systeme Boblingen GmbH |
| Product Code | DSI · Cardiovascular |
| Decision Date | Oct 10, 2003 |
| 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 hospital environments. EASI 12-lead ECG is only for use on adult and pediatric patients. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.
Device Story
IntelliVue MP40, MP50, MP60, MP70, and MP90 are multi-parameter patient monitors; used in hospital environments by healthcare professionals. Devices collect physiological signals (ECG, blood pressure, gas analysis, thermodilution, oximetry, EEG, etc.); process data to provide real-time monitoring, recording, and alarming. Output displayed for clinical review; assists providers in patient assessment and clinical decision-making. Benefits include continuous patient surveillance and timely notification of physiological changes.
Clinical Evidence
Bench testing only. System-level tests, performance tests, and safety testing from hazard analysis were conducted. Results demonstrated that the device meets all reliability requirements and performance claims established for the predicate devices.
Technological Characteristics
Multi-parameter patient monitoring system. Supports various physiological measurements including ECG, blood pressure, gas analysis, and EEG. Connectivity via network/communication systems. Software-based (Release B.0).
Indications for Use
Indicated for monitoring physiological parameters in adult, pediatric, and neonatal patients in hospital environments. EASI 12-lead ECG restricted to adults/pediatrics; ST segment monitoring restricted to adults; transcutaneous gas measurement (tcpO2/tcpCO2) 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
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
- 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
- K060221 — THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS · Philips Medizin Systeme Boeblingen GmbH · Feb 17, 2006
- K053522 — PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00 · Philips Medizin Systeme Boeblingen GmbH · Jan 10, 2006
Submission Summary (Full Text)
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**OCT 1 0 2003**
## 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: Hauke Schik Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany ++49 7031 463-2442 Tel: ++49 7031 463-2031 Fax: e-mail: hauke.schik@philips.com
This summary was prepared on September 8, 2003.
- 2. The names of the devices are the Philips MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitor. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|------------------------------------------|-----------------|---------|-----------------------------------------------------------------------------|
| Circulatory<br>System Devices<br>(12625) | \$870.1025, III | DSI | Detector and alarm, arrhythmia |
| | \$870.1025, III | MLD | Monitor, ST Segment with Alarm |
| | \$870.1025, III | 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 |
| | \$870.2450, 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 |
| | \$870.2900, I | DSA | Cable, Transducer and<br>Electrode, incl. Patient<br>Connector |
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| | | MSX | System, Network and<br>Communication, Physiological<br>Monitors |
|------------------------------------------------------|----------------|-----|------------------------------------------------------------------------------|
| 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 |
| | \$868.2375, 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 |
- The new devices are substantially equivalent to previously 3. cleared Philips devices marketed pursuant to K001664, K021778, K030038 and K031481.
- 4. The modification is the introduction of Release B.0 software for the IntelliVue patient monitor devices, MP60, MP70 and MP90, and the introduction of the models MP40 and MP50.
- 5. The new devices have the same intended use as the leqally marketed predicate devices. When used in the hospital environment, they are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates.
- 6. The new devices have the same technoloqical characteristics as the legally marketed predicate devices.
- 7. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the
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Testing involved system level tests, performance predicate. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design that resembles an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Philips Medizin Systeme Böblingen GmbH c/o Mr. Hauke Schik Sr. Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard-Str. 2 71034 Böblingen GERMANY
Re: K032858
Trade Name: The Philips Intellivue M40, M50, MP60, MP70 and MP90 Patient Monitors, Release B.0. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: September 9, 2003 Received: September 12, 2003
Dear Mr. Schik:
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. Hauke Schik
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 (301) 594-4646. 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 may be obtained 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/dsma/dsmamain.html
Sincerely vours.
Mefremyr
C. Peter R. Zohman, M.D.
fa
D. Zuckerman, M.D. Bram Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: The Philips IntelliVue MP40, MP50, MP60, MP70, and MP90 Patient Monitors, Release B.0.
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 hospital environments.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mesa May
Prescription Use CFR 801.109)
Over-The-Counter (Per 21
510(K) Number K032856
(Optional Format 1-2-96)
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