(55 days)
Indicated for use by health care professionals whenever there is a need for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during transport situations within and outside of hospital environment.
The modified Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP5 IntelliVue Patient Monitor marketed pursuant to K062392, the M3/M3046A Compact Portable Patient Monitor marketed pursuant to K971910, K992273, K030973, and the Welch Allyn SureTemp® Plus thermometer module marketed pursuant to K031740. The modification adds the capability to the MP5 patient monitor to interface to the legally marketed Welch Allyn SureTemp® Plus thermometer module. The modification also adds the capability to the MP5 patient monitor to function in a transport environment outside of hospitals, such as a road ambulance, airplane or helicopter.
The provided document is a 510(k) summary for the Philips MP5 IntelliVue Patient Monitor. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the specific details about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications that you requested for a detailed study description.
The document broadly states: "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, EMC, safety and environmental testing from 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 modified Philips MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims."
This statement is very general and does not provide the specific quantitative information you are looking for. It confirms that testing was done and performance claims were met, but it lacks the detailed breakdown of the acceptance criteria and results.
Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document is a regulatory submission summary, not a detailed technical study report.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General Performance | "Pass/Fail criteria were based on the specifications cleared for the predicate devices" | "Test results showed substantial equivalence. The results demonstrate that the modified Philips MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims." |
| Specific Parameters | (Not provided in this summary) | (Not provided in this summary) |
| Reliability | (Implied by "reliability requirements") | "meets all reliability requirements" |
| Functionality | (Implied by "functionality characteristics") | (Not specified quantitatively) |
| EMC | (Implied requirements) | Tested, assumed to pass given overall conclusion |
| Safety | (Implied requirements) | Tested, assumed to pass given overall conclusion |
| Environmental | (Implied requirements) | Tested, assumed to pass given overall conclusion |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. The device manufacturer is in Germany, but the testing details are not provided.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. This document pertains to a patient monitor, which would likely be evaluated against reference standards (e.g., highly accurate sensors, calibrated equipment) rather than expert human interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. (See point 3)
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
- Not applicable/Not specified. This is a patient monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The testing described, "system level tests, performance tests, EMC, safety and environmental testing," generally refers to standalone device performance against specifications. There's no mention of a human-in-the-loop study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly defined, but for patient monitors, the "ground truth" for physiological parameters (like ECG, blood pressure, temperature) would typically be established by highly accurate and calibrated reference measurement devices.
8. The sample size for the training set
- Not applicable/Not specified. This device is not described as having a "training set" in the context of machine learning or AI. Its core technology would be signal processing and hardware integration, not learned algorithms from a dataset.
9. How the ground truth for the training set was established
- Not applicable/Not specified. (See point 8)
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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.
-
- The submitter of this premarket notification is: Markus Stacha Philips Medizin Systeme Boeblingen GmbH FEB 8 2007 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 December 13, 2006.
- The submitter of this premarket notification is: Markus Stacha Philips Medizin Systeme Boeblingen GmbH FEB 8 2007 Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2840 Fax: ++49 7031 463-2442 e-mail: markus.stacha@philips.com
-
- The names of the device is the Philips MP5 IntelliVue Patient Monitor
Classification names are as follows:
- The names of the device is the Philips MP5 IntelliVue Patient Monitor
| 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 |
Page 1 OF 3
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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 |
-
- The modified Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP5 IntelliVue Patient Monitor marketed pursuant to K062392, the M3/M3046A Compact Portable Patient Monitor marketed pursuant to K971910, K992273, K030973, and the Welch Allyn SureTemp® Plus thermometer module marketed pursuant to K031740.
-
- The modification adds the capability to the MP5 patient monitor to interface to the legally marketed Welch Allyn SureTemp® Plus thermometer module. The modification also adds the capability to the MP5 patient monitor to function in a transport environment outside of hospitals, such as a road ambulance, airplane or helicopter.
- The modified Philips MP5 IntelliVue Patient Monitor is intended 5. for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and
PAGE 2 OF 3
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-
neonates in a hospital environment and during patient transport inside and outside of hospital environment. It is not intended for home use. The monitor is intended for use by health care professionals. The MP5 monitor with interfaced Welch Allyn SureTemp® Plus
thermometer module is intended for use with adult and pediatric patients in a hospital environment. -
- The modified device has the same technological characteristics as the legally marketed predicate devices.
-
- 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, EMC, safety and environmental testing from 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 modified Philips MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims.
PAGE 3 OF 3
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 8 2007
Philips Medizin Systeme Boeblingen GmbH Cardiac and Monitoring Systems c/o Markus Stacha Hewlett-Packard-Str. 2 D-71034 Boeblingen, GERMANY
Re: K063725
Trade Name: Philips MP5 Intelli Vue Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II Product Code: MHX Dated: December 13, 2006 Received: December 15, 2006
Dear Mr. Stacha:
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 - Mr. Markus Stacha
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 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,
Bhimmarfor
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
510(k) Number (if known): JKD (63725
Device Name: Philips MP5 IntelliVue Patient Monitor.
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during transport situations within and outside of hospital environment.
Use (Part 21 CFR 801 Subpart D)
Prescription
- AND/OR
Over-The-Counter Use (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)
Bl.Zimmerman
Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K063205
PAGE 1 OF 1
No
§ 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.