(14 days)
Indicated for central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
M3290A IntelliVue Information Center Software Release G.00 (for DataBase Server with Alert Data Integration)
The provided 510(k) summary (K050742) for the M3290A IntelliVue Information Center Software Release G.00 primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain specific acceptance criteria and detailed study results in the format requested.
The summary states:
"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, integration tests, environmental 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 web software interface functionality meets all reliability requirements and performance claims."
This indicates that testing was performed and that pass/fail criteria existed, but these criteria and the specific performance results are not detailed in the provided document. The document primarily attests to the fact that such testing was done and that the device was found to be substantially equivalent to its predicate.
Therefore, I cannot populate the table or provide detailed responses to most of the specific questions as the information is not present in the provided text.
The following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: While the document states "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence," the specific criteria and performance metrics are not provided.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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 mentioned. This device is described as software for an "Information Center" and "Physiological Monitor," not specifically an AI-powered diagnostic tool, so an MRMC study might not be applicable or expected in this context.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not mentioned.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
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summary of 510(k) safety and effectiveness information This i s 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:
Philips Medical Systems
This summary was prepared on 21 March, 2005.
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- The name of this device is the M3290A IntelliVue Information Center Software Release G.00 (for DataBase Server with Alert Data Integration). Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| None | 74 MHX | Physiological Monitor, PatientMonitor |
| 870.1025, II | 74 DSI | Arrhythmia Detector and Alarm |
| 870.1025, II | 74 MLD | Monitor, ST Alarm |
| 870.2800, II | 74 DSH | Recorder, Magnetic Tape, Medical |
| 870.2300, II | 74 MSX | System, Network and Communication,Physiological Monitors |
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- The modification is a change that provides different alert data export via the hospital LAN.
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- The new device has the same Indications for Use as the legally marketed predicate device. For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms .
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- The new device has the same technological characteristics as the legally marketed predicate device.
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- 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, integration tests, environmental 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 web software interface functionality meets all reliability requirements and performance claims.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
APR - 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Phillips Medical Systems c/o Mr. Dave Osborn Quality Program Manager Cardiac & Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K050742
R050142
Trade Name: M3290A Intellivue Information Center Software Release G.00 (for Database Server with Alert Data Integration) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: II (two) Product Code: MHX Dated: March 21, 2005 Received: March 22, 2005
Dear Mr. Osborn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn 910(s) perceise is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or to commerce price to May 20, 1978, in excordance with the provisions of the Federal Food, DNAA de vices that have been require approval of a premarket approval application (PMA). alle Cosmetic Act (Tec) that to not require to the general controls provisions of the Act. The I ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of the rece 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 if your device is classified (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FIA thay be subject to sueri additional controller , Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous overnming your device in the Federal Register.
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Page 2 - Mr. Dave Osborn
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 may be obtained 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,
B Zimmerman 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
K050742 510(k) Number (if known):
M3290A IntelliVue Information Center Software Release G.00 Device Name: (for DataBase Server with Alert Data Integration)
Indications for Use:
Indicated for central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
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)
B/Hummerter
scular Devices
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§ 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.