THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90

K061052 · Philips Medical Systems North America, Inc. · MHX · May 26, 2006 · Cardiovascular

Device Facts

• Record ID: K061052
• Device Name: THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: May 26, 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 recording and alarming patients. Intended for monitoring, of of multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments. ST Seqment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCQ2) is restricted to neonatal patients only.

Device Story

IntelliVue Patient Monitors (MP20-MP90) collect physiological signals (ECG, blood pressure, SpO2, CO2, etc.) via sensors attached to patients. Release D.04 software adds Pulse Pressure Variation (PPV) calculation. Monitors process inputs to display real-time waveforms, numerical values, and alarms. Used by clinicians in hospital settings (ICU, OR, transport). Output informs clinical decision-making regarding patient status and hemodynamic stability. Benefits include continuous monitoring and early detection of physiological changes.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, performance tests, and hazard analysis. Pass/Fail criteria were based on predicate device specifications; results demonstrated substantial equivalence.

Technological Characteristics

Multi-parameter patient monitoring system. Includes ECG, blood pressure, SpO2, CO2, and transcutaneous gas modules. Connectivity via network/communication systems. Software-based signal processing and alarm management. Release D.04 adds Pulse Pressure Variation calculation.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospital environments (including transport for MP20-MP50 models) requiring physiological monitoring, recording, and alarming. 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
• K050762
• K051106
• K052801
• K053522
• K060221
• K060541

Submission Summary (Full Text)

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#### 510 (k) Summary

## MAY 26 2006

· Comments of Submittee Barner Station Comments of Children Comments of Children States March 14-

K061052

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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 Fax: ++49 7031 463-2442 Tel: ++49 7031 463-2031 e-mail: [e-mail]

This summary was prepared on April 13, 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 | s870.1025, II | DSI | Detector and alarm, arrhythmia |
| System Devices | \$870.1025, II | MLD | Monitor, ST Segment with Alarm |
| (12625) | \$870.1025, II | MHX | Monitor, Physiological, Patient |
| | | | (with arrhythmia detection or |
| | | | alarms) |
| | 5870.1100,<br>II | DSI | Alarm, Blood Pressure |
| | \$870.1110,<br>II | DSK | Computer, Blood Pressure |
| | \$870.1130, II | DXN | System, Measurement, Blood- |
| | | | Pressure, Non-Invasive |
| | \$870.1435, II | DXG | Computer, Diagnostic, Pre- |
| | | | Programmed, Single-Function |
| | 5870.1915, II | KRB | Probe, Thermodilution |
| | 5870.2060, II | DRQ | Amplifier and Signal |
| | | | Conditioner; Transducer Signal |
| | 5870.2300, II | DRT | Monitor, Cardiac (incl. |
| | | | Cardiotachometer & Rate Alarm) |
| | \$870.2300, II | MSX | System, Network and |
| | | | Communication, Physiological |
| | | | Monitors |
| | \$870.2340, II | DES | Electrocardiograph |
| | \$870.2340, II | MLC | Monitor, ST Segment |
| | \$870.2350, II | DRW | Electrocardiograph, Lead |
| | | | Switching Adapter |
| | \$870.2370, II | KRC | Tester, Electrode, Surface, |
| | | | Electrocardiograph |
| | \$870.2450, II | DXJ | Display, Cathode-Ray Tube, |
| | | | Medical |
| | \$870.2600,<br>I | DRJ | System, Signal Isolation |
| | 5870.2700, | DQA | Oximeter |
| | \$370.0770,<br>! | DSB | Plethysmograph, Impedance |
| | 8330.1400, | DSH | Recorder, Magnetic tape, |
| | | | Medical |
| | \$800.0810, | DSFF | Recorder, Paper Chart |
| | \$672.0450, 11 | DRS | Extravascular Blood Pressure |
| | | | Transducer |
| | | | |
| | \$870.2900, I | DSA | Cable, Transducer and<br>Electrode, incl. Patient<br>Connector |
| | \$870.2910,<br>II | DRG | Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency |
| Anesthesiology<br>and Respiratory | \$868.1400,<br>II | CCK | Analyzer, Gas, Carbon Dioxide,<br>Gaseous-Phase |
| Therapy (12624) | 5868.1500, II | СВО | Analyzer, Gas, Enflurane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1500, II | NHQ | 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) |
| | 5868.1620,<br>II | CBS | Analyzer, Gas, Halothane,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1700,<br>II | CBR | Analyzer, Gas, Nitrous Oxide,<br>Gaseous-Phase (Anesthetic<br>Concentration) |
| | \$868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-<br>Phase |
| | \$868.2375.<br>II | BZQ | Monitor, Breathing Frequency |
| | \$868.2480,<br>II | LKD | Monitor, Carbon Dioxide,<br>Cutaneous |
| | \$868.2500,<br>II | KLK | Monitor, Oxygen, Cutaneous, for<br>Infant not under Gas Anesthesia |
| General Hospital<br>and Personal Use<br>(12520) | 5880.2910,<br>II | FLL | Thermometer, Electronic,<br>Clinical |
| Neurological | \$882.1400,<br>II | GWR | Electroencephalograph |
| (12513) | 5882.1420,<br>I | GMS | Analyzer, Spectrum,<br>Electroencephalogram Signal |

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comments of the consistent of the count

- 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 and K060541
- 4. The modification is the introduction of Release D.04 software for the IntelliVue patient monitor devices including the calculation of the Pulse Pressure Variation.
- The modified devices have the same intended use as the 5. legally marketed predicate devices. They are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital environment and during transport within hospital environments .

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KO61052

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- The modified devices have the same technological 6. characteristics as the leqally marketed predicate devices.
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- Verification, validation, and testing activities establish 7. 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Phillips Medical Systems North America, Inc. c/o Mr. Hauke Schik Sr. Regulatory Affairs Engineer Hewlett-Packard Str. 2 Boeblingen, Germany D-71034

Re: K061052

> Trade Name: The Phillips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Models Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class II (two) Product Code: MHX Dated: May 9, 2006 Received: May 12, 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.

MAY 26 2006

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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 [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,

Bhimman for

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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K061052

## Indications for Use

# 510(k) Number (if known): KobloS2

The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 Device Name: and MP90 IntelliVue Patient Monitors, Release D.04

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters recording and alarming patients. Intended for monitoring, of of multiple physiological parameters of adults, pediatrics and neonates environments. The MP20, MP30, MP40 and MP50 hospital in are use in transport situations additionally intended for within hospital environments.

ST Seqment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCQ2) is restricted to neonatal patients only.

Prescription Use yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (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)

Abimema