(89 days)
MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images.
MUSE CV is intended to be used in a hospital environment by trained operators.
MUSE CV is designed for network compatibility to facilitate retrieval and distribution of cardiovascular information.
MUSE CV is designed to interface with other hospital information systems through various communication protocols to support information continuity and results reporting.
MUSE CV can provide serial comparison of cardiovascular information to facilitate review of current and previous records.
MUSE CV can provide serial trending of cardiovascular information to facilitate review of current and previous records.
Through integration with Accusketch (CardioTrace), MUSE aids the physician or trained technologist in providing and documenting an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.
Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.
MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images.
The provided text does not contain specific acceptance criteria or a detailed study proving device performance against such criteria for the MUSE Cardiovascular Information System. It focuses on the regulatory submission, intended use, and general safety and effectiveness statement, rather than quantifiable performance metrics.
However, based on the information provided, here's what can be inferred or stated about the study and performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., specific accuracy thresholds for measurements, speed metrics, etc.). Instead, it focuses on qualitative measures and equivalence to predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Overall Safety and Effectiveness | "The results of these measures demonstrate MUSE CV is as safe, as effective, and performs as well as the predicate devices." |
| Functional Equivalence | "MUSE CV employs the same functional technology as the predicate devices. The only difference being the technological improvements made by manufacturers with respect to speed, performance and reliability." |
| Compliance with Voluntary Standards | "The MUSE CV complies with voluntary standards as detailed in Section 9 Specific Standards and Guidances of this submission." |
| Quality Assurance Measures Applied | Requirements specification review, Risk analysis, Design, software and test plan reviews, Code inspections, Testing on unit level, Software and hardware testing, System Integration testing, Final acceptance testing, Environmental Testing, Safety testing. |
2. Sample size used for the test set and the data provenance:
- The document does not specify a sample size for any test set (e.g., number of patient cases, ECGs, angiograms).
- The document does not specify 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:
- The document does not specify the number of experts or their qualifications used to establish ground truth for any test set.
4. Adjudication method for the test set:
- The document does not mention any specific adjudication method for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
- The document describes the device as a "Cardiovascular Information System" that "aids the physician or trained technologist in providing and documenting an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function." It explicitly mentions that it "employs the same functional technology as the predicate devices" with "technological improvements made by manufacturers with respect to speed, performance and reliability."
- There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
- There is no mention of AI or an effect size of how much human readers improve with AI vs without AI assistance. This device predates widespread AI integration in medical devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document describes the device as a system that "aids the physician or trained technologist," implying a human-in-the-loop design.
- There is no mention of a standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state the type of ground truth used for any evaluations. Given the nature of the system (information management and quantification aid), it's likely that the "objective quantification" refers to established clinical methods and expert interpretation, but this is not detailed.
8. The sample size for the training set:
- The document does not mention a training set or its sample size. This is consistent with the device being an "information system" and not an AI/ML-based diagnostic device in the modern sense. The "testing on unit level," "software and hardware testing," and "system integration testing" suggest traditional software development and validation rather than machine learning model training.
9. How the ground truth for the training set was established:
- As no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.
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NOV - 3 1999
Image /page/0/Picture/1 description: The image contains handwritten text. The top line reads 'K992637'. The bottom line reads 'P/2'.
Section 2 Summary and Certification
2.1 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date: | July 30, 1999 |
|---|---|
| Submitter: | GE Marquette Medical Systems |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Laura L McComis |
| Corporate Regulatory Affairs | |
| GE Marquette Medical Systems | |
| Phone: (414) 362-2688 | |
| Fax: (414) 355-3790 | |
| Device: | MUSE Cardiovascular Information System |
| Trade Name: | |
| Common/Usual Name: | Computer, diagnostic, programmable |
| Detector and Alarm, Arrhythmia | |
| Classification Names: | Classification Name: Computer, Diagnostic, Programmable |
| Classification Number: 74DQK | |
| Predicate Devices: | K980495 MUSE Cardiovascular Information System |
| K912829 CardioTrace Cardiac Evaluation System | |
| Device Description: | MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images. |
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| Intended Use: | MUSE CV is intended to be used in a hospital environment by trainedoperators.MUSE CV is designed for network compatibility to facilitate retrieval anddistribution of cardiovascular information.MUSE CV is designed to interface with other hospital information systemsthrough various communication protocols to support information continuityand results reporting.MUSE CV can provide serial comparison of cardiovascular information tofacilitate review of current and previous records.MUSE CV can provide serial trending of cardiovascular information tofacilitate review of current and previous records.Through integration with Accusketch (CardioTrace), MUSE aids the physicianor trained technologist in providing and documenting an objectivequantification of coronary artery stenosis and measurement and quantificationof left ventricular function. Also provided is the ability to digitize and storevideo images and the ability to interactively annotate and report current andpost procedural patient cardiac status.Use of MUSE CV is intended for accessing, storage and management of bothadult and pediatric cardiovascular information.The intended use of MUSE CV is identical to the intended use of the predicatedevices |
|---|---|
| Technology: | MUSE CV employs the same functional technology as the predicate devices.The only difference being the technological improvements made bymanufacturers with respect to speed, performance and reliability. |
| Test Summary: | The MUSE CV complies with voluntary standards as detailed in Section 9Specific Standards and Guidances of this submission. The following qualityassurance measures were applied to the development of MUSE CV:Requirements specification review Risk analysis Design, software and test plan reviews Code inspections Testing on unit level Software and hardware testing System Integration testing Final acceptance testing Environmental Testing Safety testing |
Conclusion:
The results of these measures demonstrate MUSE CV is as safe, as effective, and performs as well as the predicate devices.
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Image /page/2/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 three human profiles merging into a single form, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1999
Laura L. McComis Requlatory Affairs Specialist GE Marquette Medical Systems 8200 W. Tower Avenue Milwaukee, WI 53223
Re: K992637 Muse Cardiovascular Information System Regulatory Class: III (three) Product Code: DSI August 5, 1999 Dated: August 6, 1999 Received:
Dear Ms. McComis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Laura L. McComis
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Celia M. Witten, Ph.D., M.D.
Acting Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Section 11 Intended Use Statement
Unknown-540(tr) filed: July 30, 1999 510(k) Number (if known):
Device Name:
MUSE CV Cardiovascular Information System
Indications For Use:
MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images.
MUSE CV is intended to be used in a hospital environment by trained operators.
MUSE CV is designed for network compatibility to facilitate retrieval and distribution of cardiovascular information.
MUSE CV is designed to interface with other hospital information systems through various communication protocols to support information continuity and results reporting.
MUSE CV can provide serial comparison of cardiovascular information to facilitate review of current and previous records.
MUSE CV can provide serial trending of cardiovascular information to facilitate review of current and previous records.
Through integration with Accusketch (CardioTrace), MUSE aids the physician or trained technologist in providing and documenting an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.
Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Venkatesh. Ch
Cardiovascular, Respiratory,
510(k) Number K992637
§ 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.