(21 days)
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 MP5 is also intended for use in transport situations within hospital environments.
The names of the device is the Philips MP5 IntelliVue Patient Monitor
The Philips MP5 IntelliVue Patient Monitor is a patient monitoring device. The provided text outlines the declaration of substantial equivalence for this device to previously cleared devices. It does not contain detailed information about specific acceptance criteria for performance metrics (like accuracy for heart rate, blood pressure, etc.) or a study that specifically proves the device meets those criteria with granular data and methodology.
However, based on the document, we can infer the approach taken:
1. A table of acceptance criteria and the reported device performance:
The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." This indicates that the acceptance criteria for the MP5 IntelliVue Patient Monitor were inherently tied to, and met, the established performance specifications of its predicate devices (Philips MP30 IntelliVue Patient Monitor and its modules).
Since specific numerical acceptance criteria and reported performance values for parameters like arrhythmia detection sensitivity/specificity, blood pressure accuracy, or oxygen saturation accuracy are not provided in this summary, a detailed table cannot be created from the given text. The general statement of "substantial equivalence" is the reported overall performance.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "system level tests, performance tests, and safety testing," but does not detail the number of patients, test cases, or data points used in these tests.
- Data Provenance: Not specified. There is no mention of the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/Not specified. This device is a physiological monitor, and its "ground truth" for parameters like heart rate, blood pressure, or oxygen saturation would typically be established by validated reference methods or other highly accurate medical equipment, not by human experts adjudicating diagnoses. The testing would compare the device's readings against these reference standards. If "safety testing from hazard analysis" involved expert review, it is not detailed.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/Not specified. As mentioned above, "ground truth" for physiological parameters is typically established by reference instruments, not through expert adjudication in the same way as, for example, image interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This device is a patient monitor, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this type of device and was not performed.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: The testing described ("system level tests, performance tests, and safety testing") would inherently evaluate the standalone performance of the device's algorithms and hardware in measuring and reporting physiological parameters. While human interaction is involved in setting up and monitoring, the core performance metrics (e.g., accuracy of readings, alarm thresholds) are assessed based on the device's output. However, the document does not break down the results into explicit "standalone algorithm performance" versus "human-in-the-loop performance."
7. The type of ground truth used:
- Type of Ground Truth: Inferred to be reference standard measurements. For physiological parameters measured by a patient monitor (e.g., ECG, blood pressure, SpO2, temperature, gas analysis), the "ground truth" would generally be established using highly accurate and calibrated reference devices or methodologies. For example, a "true" heart rate might be determined by a known ECG simulator, or blood pressure by an invasive catheter with a calibrated transducer.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/Not specified. This document describes a traditional medical device (patient monitor) and its declaration of substantial equivalence, not a machine learning or AI-based device that typically undergoes a distinct "training" phase with a specific dataset.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable/Not specified. As above, a "training set" and its associated ground truth are primarily concepts in machine learning/AI development, which is not the focus of this 510(k) summary.
In summary, the 510(k) pertains to a traditional patient monitor. The testing performed focused on verifying that the modified device met the established specifications of its predicate devices, thereby demonstrating "substantial equivalence." The details typically requested for AI/ML-based devices (like MRMC studies, expert adjudication, training set specifics) are not applicable or provided for this type of submission.
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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.
SEP - 1 2006
- 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: markus.stacha@philips.com
This summary was prepared on August 14, 2006.
- The names of the device is the Philips MP5 IntelliVue Patient Monitor
Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| CardiovascularDevices | $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 arrhythmia detection oralarms) | |
| $870.1100, II | DSJ | Alarm, Blood Pressure | |
| $870.1110, II | DSK | Computer, Blood Pressure | |
| $870.1130, II | DXN | System, Measurement, Blood-Pressure, Non-Invasive | |
| $870.1435, II | DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | |
| $870.1915, II | KRB | Probe, Thermodilution | |
| $870.2060, II | DRQ | Amplifier and SignalConditioner, Transducer Signal | |
| $870.2300, II | DRT | Monitor, Cardiac (incl.Cardiotachometer & Rate Alarm) | |
| $870.2340, II | DPS | Electrocardiograph | |
| $870.2340, II | MLC | Monitor, ST Segment | |
| $870.2350, II | DRW | Electrocardiograph, LeadSwitching Adapter | |
| $870.2370, II | KRC | Tester, Electrode, Surface,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 PressureTransducer | |
| $870.2900, I | DSA | Cable, Transducer andElectrode, incl. PatientConnector | |
| MSX | System, Network andCommunication, PhysiologicalMonitors |
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| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| AnesthesiologyDevices | $870.2910, II | DRG | Transmitters and Receivers,Physiological Signal,Radiofrequency |
| $868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide,Gaseous-Phase | |
| $868.1500, II | CBQ | Analyzer, Gas, Enflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1500, II | NHO | Analyzer, Gas, Desflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1500, II | NHP | Analyzer, Gas, Sevoflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1500, II | NHQ | Analyzer, Gas, Isoflurane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1620, II | CBS | Analyzer, Gas, Halothane,Gaseous-Phase (AnestheticConcentration) | |
| $868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide,Gaseous-Phase (AnestheticConcentration) | |
| $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, forInfant not under Gas Anesthesia | |
| General Hospitaland Personal UseDevices | $880.2910, II | FLL | Thermometer, Electronic,Clinical |
| NeurologicalDevices | $882.1400, II | GWR | Electroencephalograph |
| $882.1420, I | GWS | Analyzer, Spectrum,Electroencephalogram Signal |
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- The modified device Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP30 IntelliVue Patient Monitor marketed pursuant to K041235, K042845, K050141, K051106, K052801, K052961, K052801, K053522, K060221, K060541, K061052, with Philips Multi-Parameter Module M3001A marketed pursuant to K020531, K030973, K033715 and its Philips M3014A Capnography Measurement Server Extension marketed pursuant to K050762 and K060221.
-
- The modification is the introduction of the model MP5 IntelliVue Patient Monitor.
-
- The modified device has the same intended use as the legally marketed predicate device. It is intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital environment and during transport within hospital environments.
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- The modified device has the same technological characteristics 6. as the legally marketed predicate device.
-
- 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 tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the Philips MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims.
062392 > 3/3
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
SEP - 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medizin Systeme Boblingen GmbH c/o Ms. Linda Stone Philips Medical Systems 3000 Minuteman Road Andover, MA 01810
Re: K062392
Trade Name: MP5 Intellivue Patient Monitor 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: August 14, 2006 Received: August 16, 2006
Dear Ms. Stone:
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 - Ms. Linda Stone
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 s set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ed tonic 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 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmerman 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 Name: Philips MP5 IntelliVue Patient Monitor.
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 MP5 is also intended for use in transport situations within hospital environments.
Prescription Use yes______ AND/OR Over-The-Counter Use No (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)
Bremmer
Division Sian-C Division of Cardiovascular Devices 510/k) Nur
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.