INTELLIVUE PATIENT MONITOR

K093268 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · MHX · May 11, 2010 · Cardiovascular

Device Facts

• Record ID: K093268
• Device Name: INTELLIVUE PATIENT MONITOR
• Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
• Product Code: MHX · Cardiovascular
• Decision Date: May 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, 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 MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment. The monitors are not intended for home use. They are intended for use by health care professionals.

Device Story

IntelliVue Patient Monitors (MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90) function as multi-parameter physiological monitoring systems. Devices accept inputs from various sensors (ECG, blood pressure, SpO2, CO2, temperature, etc.); process signals to calculate vital signs and detect arrhythmias; and generate real-time visual/audible alarms. Operated by healthcare professionals in hospital settings (including transport). Output displayed on integrated screens for clinical decision-making. Software release G.08 introduces enhancements to the respiration algorithm. Benefits include continuous patient surveillance and timely clinical intervention.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level and regression testing, as well as hazard analysis testing. Pass/Fail criteria were based on specifications cleared for the predicate devices. Results demonstrated substantial equivalence in performance, functionality, and reliability.

Technological Characteristics

Multi-parameter patient monitoring system. Components include ECG, blood pressure, SpO2, CO2, and temperature sensors. Connectivity via network/communication systems. Software release G.08. Class II medical device.

Indications for Use

Indicated for use by health care professionals for monitoring physiological parameters in adult, pediatric, and neonatal patients in hospital environments, including transport. Not for home use.

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 (K030038)
• Philips IntelliVue Patient Monitors (K032858)
• Philips IntelliVue Patient Monitors (K033444)
• Philips IntelliVue Patient Monitors (K033513)
• Philips IntelliVue Patient Monitors (K040304)
• Philips IntelliVue Patient Monitors (K040357)
• Philips IntelliVue Patient Monitors (K041235)
• Philips IntelliVue Patient Monitors (K042845)
• Philips IntelliVue Patient Monitors (K050762)
• Philips IntelliVue Patient Monitors (K051106)
• Philips IntelliVue Patient Monitors (K052801)
• Philips IntelliVue Patient Monitors (K053522)
• Philips IntelliVue Patient Monitors (K060221)
• Philips IntelliVue Patient Monitors (K060541)
• Philips IntelliVue Patient Monitors (K061052)
• Philips IntelliVue Patient Monitors (K061610)
• Philips IntelliVue Patient Monitors (K062283)
• Philips IntelliVue Patient Monitors (K063315)
• Philips IntelliVue Patient Monitors (K062392)
• Philips IntelliVue Patient Monitors (K063725)
• Philips IntelliVue Patient Monitors (K71426)
• Philips IntelliVue Patient Monitors (K72020)

Submission Summary (Full Text)

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## K093268

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

Fax: ++49 7031 463-2442

This summary was prepared on May 10, 2010.

- 2. The names of the devices are the Philips MP2, X2, MP5, MP20, MP30, 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 (with<br>arrhythmia detection or alarms) |
| | §870.1100, II | DSJ | Alarm, Blood Pressure |
| | §870.1110, II | DSK | Computer, Blood Pressure |
| | §870.1130, II | DXN | System, Measurement, Blood-Pressure,<br>Non-Invasive |
| | §870.1435, II | DXG | Computer, Diagnostic, Pre-Programmed,<br>Single-Function |
| | §870.1915, II | KRB | Probe, Thermodilution |
| | §870.2060, II | DRQ | Amplifier and Signal Conditioner,<br>Transducer Signal |
| | §870.2300, II | DRT | Monitor, Cardiac (incl. Cardiotachometer<br>& Rate Alarm) |
| | §870.2340, II | DPS | Electrocardiograph |
| | §870.2340, II | MLC | Monitor, ST Segment |
| | §870.2350, II | DRW | Electrocardiograph, Lead Switching<br>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, Medical |
| | §870.2810, I | DSF | Recorder, Paper Chart |
| | §870.2850, II | DRS | Extravascular Blood Pressure Transducer |
| | §870.2900, I | DSA | Cable, Transducer and Electrode, incl.<br>Patient Connector |
| | - | MSX | System, Network and Communication,<br>Physiological Monitors |

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| Device Panel | Classification | ProCode | Description |
|----------------------------------------------|----------------|---------|----------------------------------------------------------------------------|
| | §870.2910, II | DRG | Transmitters and Receivers, Physiological<br>Signal, Radiofrequency |
| Anesthesiology<br>Devices | §868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide, Gaseous-<br>Phase |
| | §868.1500, II | CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase<br>(Anesthetic Concentration) |
| | §868.1500, II | NHO | Analyzer, Gas, Desflurane, Gaseous-Phase<br>(Anesthetic Concentration) |
| | §868.1500, II | NHP | Analyzer, Gas, Sevoflurane, Gaseous-<br>Phase (Anesthetic Concentration) |
| | §868.1500, II | NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase<br>(Anesthetic Concentration) |
| | §868.1620, II | CBS | Analyzer, Gas, Halothane, Gaseous-Phase<br>(Anesthetic Concentration) |
| | §868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide, Gaseous-<br>Phase (Anesthetic Concentration) |
| | §868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
| | §868.1880, II | BZC | Data calculator Pulmonary-function |
| | §868.2375, II | BZQ | Monitor, Breathing Frequency |
| | §868.2480, II | LKD | Monitor, Carbon Dioxide, Cutaneous |
| | §868.2500, II | KLK | Monitor, Oxygen, Cutaneous, for Infant<br>not under Gas Anesthesia |
| General Hospital and<br>Personal Use Devices | §880.2910, II | FLL | Thermometer, Electronic, Clinical |
| Neurological Devices | §882.1400, II | GWR | Electroencephalograph |
| | §882.1420, II | 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, K71426, K72020.
- 4. The modification is the introduction of software release G.08 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP30, MP60, MP70, MP80, and MP90 including enhancements in the Respiration algorithm.
- 5. The modified devices have the same intended use as the legally marketed predicate devices. The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, 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 MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment. 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.

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- 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 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 IntelliVue Patient Monitors meet all reliability requirements and performance claims.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo includes the department's emblem, which features a stylized caduceus-like symbol with three figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the emblem.

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

Philips Medizin Systeme Boeblingen GmbH c/o Mr. Andreas Suchi Senior Regulatory Affairs Engineer Hewlett-Packard Str. 2 D-71034 Boeblingen Germany

MAY 1 1 2010

Re: K093268

> Trade/Device Name: Philips Intellivue Patient Monitor Models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Regulatory 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: May 4, 2010 Received: May 5, 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

K093268 510(k) Number (if known):

Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, Device Name: MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision G.08.

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

| 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number 5/11/10