(25 days)
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 E.1 (for DataBase Server with Alert Data Export). The modification is a change that provides different alert data export via the hospital LAN.
The provided text (K031403) describes a 510(k) summary for a software release, not a study presenting "acceptance criteria and the study that proves the device meets the acceptance criteria" in the traditional sense of a clinical performance study with specific metrics like sensitivity, specificity, etc.
The submission is for a minor modification to an existing device (M3290A IntelliVue Information Center Software Release E.1), specifically a change in how alert data is exported. The primary claim for regulatory approval is substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as a comprehensive performance study with quantified acceptance criteria and statistical analysis of device performance against ground truth is not detailed in this summary.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functionality meets specified requirements. | "web software interface functionality meets all reliability requirements and performance claims." |
| Reliability and performance claims are met. | "web software interface functionality meets all reliability requirements and performance claims." (Repeated in text) |
| Substantial equivalence to the predicate device. | "Test results showed substantial equivalence." |
| Performance, functionality, and reliability characteristics are established. | "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device..." |
| Pass/Fail criteria for testing match predicate device specifications. | "Pass/Fail criteria were based on the specifications cleared for the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: Not specified. The document only mentions "system level tests, integration tests, environmental tests, and safety testing from hazard analysis." It does not indicate if patient data was used, its origin, or if 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 specified.
- Qualifications of Experts: Not specified.
- Rationale: This type of information is typically part of a clinical validation study, which is not detailed in this 510(k) summary. The submission focuses on technical changes and substantial equivalence.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
- Rationale: Adjudication methods are relevant for studies establishing ground truth for diagnostic devices, which is not the focus of this submission.
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, an MRMC comparative effectiveness study was not done or is not reported in this summary.
- Rationale: This device is a software release for an information center, primarily affecting data export, not a diagnostic AI tool for image interpretation that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No, a standalone algorithm-only performance study (in the context of diagnostic accuracy, for example) was not done or is not reported.
- Rationale: The device is described as an "Information Center Software" for "central monitoring" and "alert data export." Its function is to process and export physiological monitoring data rather than performing a standalone diagnostic task that would typically have an "algorithm only" performance metric. The testing mentioned (system, integration, environmental) refers to the software's operational characteristics and reliability, not its diagnostic accuracy in a standalone mode.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated as "ground truth" in terms of reference standard patient outcomes or pathology. The "ground truth" for this submission appears to be the specifications and performance of the legally marketed predicate device.
- Rationale: The submission states, "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." This implies that the 'truth' against which the new device was evaluated was its ability to perform equivalently to the existing, cleared device's established specifications.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable and not specified.
- Rationale: This device is not described as utilizing machine learning or AI that would require a "training set" in the context of diagnostic algorithm development. The software is a release for an existing information center.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): Not applicable and not specified.
- Rationale: As mentioned above, a "training set" and associated ground truth establishment are not relevant to the type of device and submission described here.
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9.0 510 (k) Summary
safety and effectiveness information This summary of 510(k) 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:
Philips Medical Systems
- The submitter of this premarket notification is:
This summary was prepared on 1 May, 2003.
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- The name of this device is the M3290A IntelliVue Information Center Software Release E.1 (for DataBase Server with Alert Data Export). Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| None | 74 MHX | Physiological Monitor, PatientMonitor |
| 870.1025, III | 74 DSI | Arrhythmia Detector and Alarm |
| 870.1025, III | 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 new device is substantially equivalent to the previously cleared IntelliVue Information Center Software cleared under K011093.
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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 leqally 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.
-
- 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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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2003
Philips Medical Systems Cardiac and Monitoring Systems c/o Mr. Dave Osborn Quality Program Manager 3000 Minuteman Road Andover, MA 01810-1099
Re: K031403
Trade Name: M3290A IntelliVue Information Center Software Release E. I (for DataBasc Server with Alert Data Export) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector Or Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: May 2, 2003 Received: May 5, 2003
Dear Mr. Osborn:
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. 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 (301) 594-4646. 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 vours.
K. Quentin
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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Page ⊥ of ╱
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
M3290A IntelliVue DataBase Server Software for M3154 Device Name: with alert data export, Release E.1
For central monitoring of multiple Indications for Use: 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801, 109) | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K031403 |
§ 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.