INTELLIVUE PATIENT MONITOR

K101449 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · MHX · Jun 18, 2010 · Cardiovascular

Device Facts

• Record ID: K101449
• Device Name: INTELLIVUE PATIENT MONITOR
• Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
• Product Code: MHX · Cardiovascular
• Decision Date: Jun 18, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Philips MP75 IntelliVue patient monitor is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitor is not intended for home use. It is intended for use by health care professionals.

Device Story

Philips MP75 IntelliVue patient monitor (software revision H.01) is a multi-parameter physiological monitor used in hospital environments. It acquires various physiological signals (e.g., ECG, blood pressure, SpO2, CO2, EEG, temperature) from patients via connected sensors and probes. The device processes these inputs to display real-time waveforms and numerical data, and generates alarms for abnormal physiological conditions. Operated by healthcare professionals, the monitor provides continuous oversight of patient status. Output is visualized on the monitor screen, allowing clinicians to assess patient condition and make informed clinical decisions. The device supports a standard application module to enhance monitoring capabilities. It is not intended for home use.

Clinical Evidence

Bench testing only. Performance, functionality, and reliability were verified through system-level and regression testing, and hazard analysis. Results demonstrated that the device meets all performance claims and reliability requirements consistent with the predicate devices.

Technological Characteristics

Multi-parameter physiological monitor; supports standard application modules. Connectivity includes network and communication systems for physiological signals. Software revision H.01. Class II device. Sterilization not applicable (electronic equipment).

Indications for Use

Indicated for use by health care professionals for monitoring physiological parameters of adult, pediatric, and neonatal patients in hospital environments.

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 (K021778)
• Philips IntelliVue patient monitors (K100939)

Submission Summary (Full Text)

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## 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:

JUN 1 8 2010

Andreas Suchi Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1291 Fax: ++49 7031 463-2442 e-mail: [e-mail]

This summary was prepared on May 20, 2010.

- 2. The name of the device is the Philips MP75 IntelliVue patient monitor
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 |
| Device Panel | Classification | ProCode | Description |
| | - | MSX | System, Network and<br>Communication, Physiological<br>Monitors |
| | §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 | Data calculator Pulmonary-<br>function |
| | §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 |

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- 3. The modified device is substantially equivalent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K021778 and K100939.
- 4. The modification is the introduction and support of a standard application module for the IntelliVue MP75 patient monitor.
- 5. The modified device has the same intended use as the leqally marketed predicate device. The Philips MP75 IntelliVue patient monitor is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitor is not intended for home use. It is intended for use by health care professionals.

10144

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- 6. The modified device has the same technological characteristics as the legally marketed predicate device.
- 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 and regression tests as well as testing from the hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the Philips MP75 IntelliVue patient monitor meets all reliability requirements and performance claims.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

## JUN 1 8 2010

Philips Medizin Systeme Böblingen GmbH c/o Mr. Andreas Suchi Senior Regulatory Affairs Engineer - Patient Monitoring Hewlett-Packard-Str. 2 Böblingen GERMANY 71034

K101449 Re:

> Trade/Device Name: Philips MP75 IntelliVue Patient Monitor (software revision H.01) Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MHX Dated: May 20, 2010 Received: May 24, 2010

Dear Mr. Suchi:

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 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. Andreas Suchi

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

C. Brem 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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K101444

## Indications for Use

510 (k) Number (if known) :

Philips MP75 IntelliVue patient monitor, software Device Name: revision H.01.

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

Prescription Use Over-The-Counter Use Yes No AND/OR (Part 21 CFR 801 Subpart D) (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)

W.W.W.

510(k) N