PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS

K072070 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · MHX · Aug 10, 2007 · Cardiovascular

Device Facts

• Record ID: K072070
• Device Name: PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS
• Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
• Product Code: MHX · Cardiovascular
• Decision Date: Aug 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Indicated for use by health care professionals whenever there is a need for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during patient transport inside and outside of hospitals.

Device Story

Philips MP2 and X2 IntelliVue Patient Monitors are multi-parameter physiological monitors; inputs include ECG, blood pressure, SpO2, gas analysis, and other vital signs; device processes signals to provide real-time monitoring, recording, and alarm generation; used by healthcare professionals in hospital environments and during transport (ambulance, air); output displayed to clinicians for patient assessment and decision-making; modification enables operation in transport environments outside hospitals; benefits include continuous patient surveillance during transit.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities included environmental, EMC, safety, and performance testing based on predicate device specifications to confirm functionality in transport environments.

Technological Characteristics

Multi-parameter physiological monitor; includes ECG, blood pressure, gas analysis, and oximetry modules. Connectivity via network/communication systems. Designed for hospital and transport use. Software-based signal processing and alarm management. Testing included EMC and environmental stress testing for transport conditions.

Indications for Use

Indicated for monitoring, recording, and alarming of multiple physiological parameters in adult, pediatric, and neonatal patients in hospital settings and during transport (including road ambulance, airplane, or helicopter). Not for home use. For use by healthcare professionals.

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

• Philips IntelliVue Patient Monitors MP2 (K062392)
• Philips IntelliVue Patient Monitors X2 (K063725)
• Philips IntelliVue Patient Monitors MP5 (K071426)

Submission Summary (Full Text)

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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.

- AUG 1 0 2007 1. The submitter of this premarket notification is: Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2840 Fax: ++49 7031 463-2442 e-mail: [e-mail]
This summary was prepared on July 27, 2007.

- 2. The names of the devices are the Philips MP2 and X2 IntelliVue Patient Monitors. Classification names are as follows:

| Device Panel | Classification | ProCode | Description |
|---------------------------|----------------|---------|-----------------------------------------------------------------------------|
| Cardiovascular<br>Devices | \$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) |
| | \$870.2340, 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 |
| | \$870.2600, 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 |
| | - | MSX | System, Network and<br>Communication, Physiological<br>Monitors |

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072070

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| Device Panel | Classification | ProCode | Description |
|-------------------------------------------------|----------------|----------------|------------------------------------------------------------------------------|
| | \$870.2910, II | DRG | Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency |
| Anesthesiology<br>Devices | \$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 |
| | \$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>Devices | \$880.2910, II | FLL | Thermometer, Electronic,<br>Clinical |
| Neurological<br>Devices | \$882.1400, II | GWR | Electroencephalograph |
| | \$882.1420, I | GWS | Analyzer, Spectrum,<br>Electroencephalogram Signal |

- 3. The modified Philips MP2 and X2 IntelliVue Patient Monitors are substantially equivalent to the previously cleared Philips IntelliVue Patient Monitors MP2, X2, and MP5 marketed pursuant to K062392, K063725, K071426.
- 4. The modification adds to the MP2 and X2 IntelliVue Patient Monitors the capability to function in the transport environments outside of hospitals, such as a road ambulance, airplane or helicopter.
- 5. The modified Philips MP2 and X2 IntelliVue Patient Monitors are intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during patient transport inside and outside of hospitals. The monitors are not intended for home use. They are intended for use by health care professionals.

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- 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 devices with respect to the predicates. Testing involved environmental, EMC, safety and performance tests. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the modified Philips MP2 and X2 IntelliVue Patient Monitors meet all reliability requirements and performance claims.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2007

Philips Medizin Systeme Böblingen GmbH c/o Mr. Markus Stacha Senior Regulatory Affairs Engineer Hewlett-Packard - Str. 2 D - 71034 Boeblingen GERMANY

Re: K072070

Philips MP2 and X2 IntelliVue Patient Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: July 27, 2007 Received: July 30, 2007

Dear Mr. Stacha:

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. Markus Stacha

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.

Bhimamor 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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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Namc: Philips MP2 and X2 IntelliVue Patient Monitors.

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring and recording of, and to whenever enore 15 c, multiple physiological parameters of adults, gencrates and neonates in a hospital environment and during patient transport inside and outside of hospitals.

Over-The-Counter Use _ No Prescription Use yes -- AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.Brumana

diovascular Devices