INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90

K082633 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · DSI · Oct 3, 2008 · Cardiovascular

Device Facts

Record IDK082633
Device NameINTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
ApplicantPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN
Product CodeDSI · Cardiovascular
Decision DateOct 3, 2008
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 870.1025
Device ClassClass 2
AttributesPediatric

Intended Use

The Philips MP2, x2, MP5, MP20, MP30, 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 MP2, X2, MP5, MP20, 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) collect physiological data via sensors/electrodes; inputs include ECG, blood pressure, SpO2, respiration, temperature, gas analysis, and EEG. Software release G.02 and IntelliVue XDS application process signals to provide real-time monitoring, waveform display, and alarm generation. Used in hospital settings (OR, ICU, transport) by healthcare professionals. Output displayed on monitor screen; assists clinicians in patient assessment and clinical decision-making. Benefits include continuous patient surveillance and timely intervention for physiological abnormalities.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level and regression testing, as well as hazard analysis, to confirm performance, functionality, and reliability against predicate specifications.

Technological Characteristics

Multi-parameter patient monitoring system; includes ECG, blood pressure, SpO2, gas analysis, and EEG modules. Software-driven signal processing and alarm generation. Connectivity via network/communication systems. Form factor ranges from portable (MP2/X2/MP5) to bedside/modular (MP60-MP90).

Indications for Use

Indicated for use by health care professionals to monitor, record, and generate alarms for physiological parameters in adult, pediatric, and neonatal patients in hospital environments. Includes transport within hospital environments for all models; MP2, X2, and MP5 also indicated for transport outside 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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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 Fax: ++49 7031 463-2442 e-mail: andreas.suchi@philips.com This summary was prepared on Sep 8, 2008. - 2. The names of the devices are the Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors and IntelliVue XDS. 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 | | 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 | {1}------------------------------------------------ - 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, K052881, K063315, K062392, K063725, K71426, K72020. - 4. The modification is the introduction of software release G.02 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP60, and MP90 and the introduction of the IntelliVue XDS application. - 5. The modified devices have the same intended use as the legally marketed predicate devices. The Philips MP2, x2, MP5, MP20, {2}------------------------------------------------ MP30, 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 MP2, X2, MP5, MP20, 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. - 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. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized eagle emblem with three overlapping wing-like shapes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT - 3 2008 Philips Medizin Systeme Böblingen GmbH c/o Mr. Andreas Suchi Senior Regulatory Affairs Engineer, Hewlett-Packard-Str. 2 Boeblingen, 71034 GERMANY Re: K082633 Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Software Revision G.02. 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: DSI Dated: September 8, 2008 Received: September 10, 2008 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 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. {4}------------------------------------------------ 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); 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html . Sincerely yours, uma R. bochner \ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use K082433 510 (k) Number (if known): Device Name: Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision G.02. Indications for Use: Indicated for use by health care professionals 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. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment. Prescription Use Over-The-Counter Use 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) R. Vochmer (Division Sign-Off) Division of Cardiovascular Devices KOB2635
Innolitics
510(k) Summary
Decision Summary
Classification Order
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