PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS

K061610 · Philips Medizin Systeme Boeblingen GmbH · MHX · Aug 14, 2006 · Cardiovascular

Device Facts

• Record ID: K061610
• Device Name: PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS
• Applicant: Philips Medizin Systeme Boeblingen GmbH
• Product Code: MHX · Cardiovascular
• Decision Date: Aug 14, 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 MP20, MP30, 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 / tcpCO2) is restricted to neonatal patients only.

Device Story

IntelliVue patient monitors (MP20-MP90) collect physiological data via various sensors/probes (ECG, blood pressure, SpO2, gas analyzers, EEG, etc.). Device processes signals to provide real-time monitoring, recording, and alarming of patient status. Operated by healthcare professionals in clinical settings; MP20-MP50 models support intra-facility transport. Output displayed on integrated screens for clinician review; facilitates clinical decision-making through continuous surveillance and alarm notification. Benefits include timely detection of physiological changes and improved patient safety through constant monitoring.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities included system-level tests, performance tests, and safety testing based on hazard analysis. Pass/Fail criteria were derived from predicate device specifications.

Technological Characteristics

Multi-parameter physiological monitoring system. Includes ECG, blood pressure, gas analysis, EEG, and oximetry modules. Connectivity via network/telemetry. Software-based signal processing and alarm management. Release D.05 software update.

Indications for Use

Indicated for monitoring, recording, and alarming physiological parameters in adult, pediatric, and neonatal patients in healthcare facilities. 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

• K021778
• K030038
• K032858
• K033513
• K040304
• K041235
• K042845
• K050141
• 050762
• K051106
• K052801
• K053522
• K060221
• K060541
• K061052

Submission Summary (Full Text)

{0}------------------------------------------------

## AUG 1 4 2006

510 (k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the mate 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 Tel: ++49 7031 463-2031 Fax: ++49 7031 463-2442 e-mail: [e-mail]

This summary was prepared on April 13, 2006.

- 2. The names of the devices are the Philips MP20, MP30, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellibury Mr30, MP30, MP50, MP40, 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 |

ಳ 8

{1}------------------------------------------------

| | \$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 |
| | \$868.2375, 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, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, 050762, K051106, K052801, K053522, K060221, K060541 and K061052
- 4. The modification is the introduction of Release D.05 software for the IntelliVue patient monitor devices.
- 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 healthcare facilities and during transport within healthcare facilities.
- 6. The modified devices have the same technological characteristics as the legally marketed predicate devices.

{2}------------------------------------------------

- 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.

{3}------------------------------------------------

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 lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. (USA)" in a sans-serif font. The text is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2006

Philips Medizinsysteme Boeblingen G c/o Mr. Hauke Schik Sr. Regulatory Affairs Engineer Hewlett-Packard-Str. 2 Boeblingen Germany D-71034

Re: K061610

Trade/Device Name: Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II Product Code: MHX Dated: July 13, 2006 Received: July 26, 2006

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.

{4}------------------------------------------------

## 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Luckerman, M.D. Bram D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 Device Name: and MP90 IntelliVue Patient Monitors, Release D.05

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 MP20, MP30, 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 / tcpCO2) is restricted to neonatal patients only.

| 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-Off)
Division of Cardiovascular

| 510(k) Number | K061610 |
|---------------|---------|
|---------------|---------|