INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90

K091927 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · DSI · Nov 3, 2009 · Cardiovascular

Device Facts

• Record ID: K091927
• Device Name: INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
• Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
• Product Code: DSI · Cardiovascular
• Decision Date: Nov 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Philips MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The monitors are not intended for home use. They are intended for use by health care professionals.

Device Story

IntelliVue Patient Monitors (MP40-MP90) collect physiological data via various sensors (ECG, blood pressure, SpO2, gas analysis, EEG, etc.). System processes signals to provide real-time monitoring, recording, and alarm generation for hospital patients. Operated by healthcare professionals in clinical or transport settings. Modification includes M1011A SO2 module for invasive venous oxygen saturation monitoring and software revision G.07. Output displayed on monitor for clinical assessment; aids in patient status evaluation and decision-making. Benefits include continuous oversight of patient vitals to facilitate timely clinical intervention.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level and regression testing, safety and performance testing, and EMC/environmental testing based on hazard analysis. Pass/Fail criteria were based on specifications cleared for the predicate devices.

Technological Characteristics

Multi-parameter patient monitoring system. Includes M1011A SO2 module and optical module. Supports ECG, blood pressure, gas analysis, EEG, and thermodilution. Connectivity via network/communication systems. Software revision G.07. Testing performed for EMC and environmental compliance.

Indications for Use

Indicated for use by health care professionals for monitoring physiological parameters of adult, pediatric, and neonatal patients in hospital environments, including transport for MP40/MP50 models. The M1011A SO2 module and Philips SO2 optical module are indicated for continuous, invasive monitoring of venous oxygen saturation.

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
• K033444
• K033513
• K040304
• K040357
• K041235
• K042845
• K050762
• K051106
• K052801
• K053522
• K060221
• K060541
• K061052
• K061610
• K062283
• K063315
• K062392
• K063725
• K071426
• K082633
• K083517

Submission Summary (Full Text)

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ICO 9119227

## 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: NOV - 3 2009 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 June 25, 2009.

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

- 3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K041235, K042845, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610, K062283, K063315, K062392, K063725, K071426, K082633, K083517.
- 4. The modification is the introduction of the M1011A Philips SO2 Module / Philips SO2 Optical Module and the introduction of software revision G.07 for the IntelliVue Patient Monitors models MP40, MP50, MP60, MP70, MP80, and MP90.
- 5. The modified devices have the same intended use as the legally marketed predicate devices. The Philips MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP40, and MP50 are

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additionally intended for use in transport situations within hospital environments. The monitors are not intended for home use. They are intended for use by health care professionals.

- 6. The modified devices have 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 devices with respect to the predicate. Testing involved system level and regression tests, safety and performance tests, EMC and environmental tests, such 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 IntelliVue Patient Monitors meet all reliability requirements and performance claims.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Andreas Suchi Senior Regulatory Affairs Engineer Philips Medizin Systeme Boblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Strasse 2 Boblingen D-71034 GERMANY

NOV - 3 2009

Re: K091927

Trade/Device Name: Philips MP40, MP50, MP60, MP70, MP80, and MP90 Intelli Vue Patient Monitors, Software Revision G.07 Regulation Number: 21 CFR 870.1025

Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II Product Code: DSI, DQE

Dated: October 22, 2009

Received: October 26, 2009

Dear Ms. 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. 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/cdrh/mdr/ 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 Internét address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

far

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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## Indications for Use

510(k) Number (if known): _____________________

Philips MP40, MP50, MP60, MP70, MP80, and MP90 Device Name: IntelliVue Patient Monitors, Software Revision G.07.

Indicated for use by health care professionals Indications for Use: whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments.

Additionally the M1011A S02 module together with the Philips S02 optical module is indicated whenever there is a need for continuous and invasive monitoring of the venous oxygen saturation.

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 IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Arbuthnot

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: _ K 09 ( 927