MUSE CARDIOVASCULAR INFORMATION SYSTEM

• K Number: K980495
• Device Name: MUSE CARDIOVASCULAR INFORMATION SYSTEM
• Manufacturer: MARQUETTE MEDICAL SYSTEMS, INC.
• Date Cleared: 1998-05-07 ( 87 days)
• Product Code: LOS
• Regulation Number: N/A
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: K840932
• Predicate For: K992637

Intended Use

The 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, and digitized waveforms. MUSE CV is intended to be used in a hospital environment by trained operators. MUSE CV is designed for network compatibility and interfaces with other hospital information systems through various communication protocols. MUSE CV provides the ability to serially compare/trend cardiovascular information. Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.

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, and digitized waveforms.

AI/ML Overview

This document describes a 510(k) premarket notification for the "MUSE Cardiovascular Information System". It's important to note that this submission does not contain acceptance criteria or performance study results in the typical sense of evaluating an AI/ML device.

The document states that the MUSE CV system employs the same functional technology as predicate devices, with improvements in "speed, performance and reliability." It also claims compliance with "voluntary standards as detailed in Section 9 of this submission," but Section 9 is not provided in the given text.

The "performance" section mentions quality assurance measures applied during development, but these are general development practices and not specific study results or acceptance criteria for a device performance claim like accuracy, sensitivity, or specificity.

Therefore, many of the requested fields cannot be filled from the provided text because the submission focuses on substantial equivalence to predicate devices based on functional technology and general quality assurance, rather than detailed performance metrics of a novel AI/ML algorithm.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., accuracy, sensitivity, specificity). The criteria appear to be compliance with voluntary standards and demonstrating that the device is "as safe, as effective, and performs as well as the predicate devices."
   • Reported Device Performance: The document only states that "The results of these measurements demonstrated that MUSE CV is as safe, as effective, and performs as well as the predicate devices." No specific quantitative performance values are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not specified. There is no mention of a traditional "test set" or clinical study data.

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. No ground truth establishment process is described as there's no clinical performance study detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No test set or expert adjudication is described.

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:

   • No. This type of study is not mentioned. The device's primary function is described as storing, managing, and facilitating serial comparison/trending of cardiovascular information, not as an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable in the typical AI sense. The device is a "Cardiovascular Information System" for data management, not a standalone diagnostic algorithm. While it performs "serial comparison" and "serial trending," its performance is evaluated against predicate devices based on a broader system functionality, not specific diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable. No ground truth for performance evaluation is described.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set in the typical sense.

9. How the ground truth for the training set was established:

   • Not applicable. As above, no training set is mentioned.

Summary based on available information:

The provided document is a 510(k) summary focused on demonstrating substantial equivalence of the "MUSE Cardiovascular Information System" to existing predicate devices. It emphasizes functional and technological similarity, as well as adherence to general quality assurance and voluntary standards. It does not detail specific performance studies with quantitative metrics, test sets, or ground truth establishment typically associated with the evaluation of AI/ML diagnostic or assistive devices.

Summary

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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.

Submitter:	Marquette Medical Systems, Inc.8200 W. Tower AvenueMilwaukee, WI 53223Telephone: [phone]FAX: [phone]
Contact Person:	Kristin Pabst
Device:	Trade Name: MUSE Cardiovascular Information SystemClassification Name: Computer, diagnostic, programmable Detector and Alarm, Arrhythmia
Predicate Devices:	Marquette MUSE DP K840932Marquette 12SSL - Serial Comparison ECG Analysis Program K8423008/A
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, and digitized waveforms.
Intended Use:	MUSE CV is intended to be used in a hospital environment.MUSE CV is intended to be used 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.The intended use of MUSE CV is identical to the intended use of the predicate devices.

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Technology: 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.

Performance: MUSE CV complies with the voluntary standards as detailed in Section 9 of this submission.

The following quality assurance measures were applied to the development of MUSE CV.

• requirements specification reviews .
• code inspections .
• . software and hardware testing
• . safety testing
• . environmental testing
• . final validation.

The results of these measurements demonstrated that MUSE CV is as safe, as effective, and performs as well as the predicate devices.

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Image /page/2/Picture/10 description: The image shows a partial logo of the U.S. Department of Health and Human Services (HHS). The logo features a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT" is partially visible, suggesting the full text would read "DEPARTMENT OF HEALTH AND HUMAN SERVICES".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pirit -1 13:50

Ms. Kristin Pabst Marquette Medical Systems, Inc. 8200 West Tower Avenue Milwaukee, WI 53223

K980495 Re: Muse Cardiovascular Information System Requlatory Class: III (three) Product Code: 74 LOS Dated: February 6, 1998 Received: February 9, 1998

Dear Ms. Pabst:

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 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 Requlation (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 requlation may result in regulatory 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 - Ms. Kristin Pabst

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callah 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 - 510(k) filed February 6, 1998 510(k) Number (if known):

Device Name: MUSE CV Cardiovascular Information System

Indications For Use:

The 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, and digitized waveforms. MUSE CV is intended to be used in a hospital environment by trained operators. MUSE CV is designed for network compatibility and interfaces with other hospital information systems through various communication protocols. MUSE CV provides the ability to serially compare/trend cardiovascular information.

Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.

(Division Sign Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K980495

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000038

Regulation Number and Section

N/A