(21 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments and during transport within hospital environments.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
The Philips MP40 and MP50 patient monitors. The modification is the merging of existing battery operation functionality for the IntelliVue patient monitor models MP40 and MP50.
Here's the analysis of the provided text regarding the acceptance criteria and study for the Philips IntelliVue MP40 and MP50 Patient Monitors:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) summary) does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on a qualitative statement of substantial equivalence to previously cleared predicate devices.
| Acceptance Criteria Category | Acceptance Criteria (as implied) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Overall Performance | Substantial equivalence to predicate device performance. | "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims." |
| Reliability | Meets reliability requirements of the predicate device. | "meets all reliability requirements" |
| Functionality | Maintains functionality of predicate device. | Established through "system level tests, performance tests, and safety testing." |
| Safety | Meets safety standards and maintains safety of predicate device. | Established through "safety testing from hazard analysis." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "system level tests, performance tests, and safety testing," but does not quantify the number of units or test cases involved.
Similarly, the data provenance (e.g., country of origin, retrospective or prospective) is not explicitly detailed. The device submitter is located in Germany, but it doesn't specify if the testing data originated from there or elsewhere.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for testing. The evaluation appears to be based on engineering tests against established specifications.
4. Adjudication Method for the Test Set
No adjudication method is described, as the testing focuses on meeting technical specifications rather than subjective interpretation or diagnostic accuracy assessments that would typically require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission is for a patient monitor, not an AI-assisted diagnostic tool, and the focus is on demonstrating equivalence to existing hardware rather than improving human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The concept of a "standalone algorithm" is not applicable here. This submission is for a hardware patient monitor with existing functionality, not a new algorithm or AI-driven feature. The testing described focuses on the overall performance of the integrated device.
7. The Type of Ground Truth Used
The ground truth used for testing appears to be based on the specifications and performance of the legally marketed predicate devices. The document states, "Pass/Fail criteria were based on the specifications cleared for the predicate device." This means the "ground truth" was the expected, documented performance of the equivalent earlier models.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Philips IntelliVue MP40 and MP50 are patient monitors, which are hardware devices, not AI/ML models that require training sets in the typical sense. The "modification is the merging of existing battery operation functionality."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
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MAR - 1 2004
510 (k) Summary
This summary of 510(k) safety and effectiveness information is is Submitted in Gossiano - C.F.R. $807.92.
- The submitter of this premarket notification is: Hauke Schik naaks s Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany ++49 7031 463-2442 Tel: ++49 7031 463-2031 Fax: e-mail: hauke.schik@philips.com
This summary was prepared on February 05, 2004.
-
- The names of the devices are the Philips MP40 and MP50, The names of the devices a. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| CirculatorySystem Devices(12625) | $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 | |
| $870.2450, II | DXJ | Display, Cathode-Ray Tube,Medical | |
| $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 |
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| MSX | System, Network andCommunication, PhysiologicalMonitors | ||
|---|---|---|---|
| Anesthesiologyand RespiratoryTherapy (12624) | $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 | |
| $868.2375, 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 Use(12520) | $880.2910, II | FLL | Thermometer, Electronic,Clinical |
| Neurological(12513) | $882.1400, II | GWR | Electroencephalograph |
| $882.1420, I | GWS | Analyzer, Spectrum,Electroencephalogram Signal |
-
- The modification is the merging of existing battery operation functionality for the IntelliVue patient monitor models MP40 and MP50.
-
- The new devices have the same intended use as the legally marketed predicate devices. They are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates when used in the hospital environment or during transport within the hospital setting.
-
- The new devices have the same technological characteristics as the legally marketed predicate devices.
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K040304
page 3 of 3
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new 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 IntelliVue Patient Monitor meets all reliability requirements and performance claims.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Phillips Medizin Systeme Boeblingen GmbH c/o Mr. Hauke Schik Sr. Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard-Str. 2 D-71034 Boeblingen GERMANY
Re: K040304
Trade Name: Phillips Intellivue MP40 and MP50 Patient Monitors, Release B.0., Battery Release Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: 74 MHX Dated: February 05, 2004 Received: February 09, 2004
Dear Mr. Schik:
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, labcling, 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
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Page 2 - Mr. Hauke Schik
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.
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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
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
510(k) Number (if known): K040304
The Philips IntelliVue MP40 and MP50 Patient Device Name: Monitors, Release B.O., Battery Release
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, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments and during transport within hospital environments.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Division of Cardiology
510(k) Number K040302
Page of
§ 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.