MUSE CARDIOVASCULAR INFORMATION SYSTEM

K992637 · General Electric Medical Systems Information Techn · DSI · Nov 3, 1999 · Cardiovascular

Device Facts

• Record ID: K992637
• Device Name: MUSE CARDIOVASCULAR INFORMATION SYSTEM
• Applicant: General Electric Medical Systems Information Techn
• Product Code: DSI · Cardiovascular
• Decision Date: Nov 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

MUSE CV is a client-server cardiovascular information system; manages measurements, text, digitized waveforms, and angiographic images. Integrates with Accusketch (CardioTrace) to assist physicians/technologists in quantifying coronary artery stenosis and left ventricular function. Enables digitization/storage of video images; supports interactive annotation and reporting of patient cardiac status. Used in hospital environments by trained operators; interfaces with hospital information systems via communication protocols for data continuity. Facilitates serial comparison and trending of patient records to aid clinical review and decision-making.

Clinical Evidence

Bench testing only. Quality assurance measures included requirements specification review, risk analysis, design/software/test plan reviews, code inspections, unit-level testing, software/hardware testing, system integration testing, final acceptance testing, environmental testing, and safety testing.

Technological Characteristics

Client-server computer system; network-compatible; interfaces with hospital information systems via communication protocols. Supports digitization of waveforms and angiographic images. Software-based management system.

Indications for Use

Indicated for adult and pediatric patients requiring access, storage, and management of cardiovascular information, including measurements, text, digitized waveforms, and angiographic images. Used by trained operators in hospital environments for serial comparison, trending, and documentation of cardiac status, including coronary artery stenosis and left ventricular function.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MUSE Cardiovascular Information System (K980495)
• CardioTrace Cardiac Evaluation System (K912829)

Submission Summary (Full Text)

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NOV - 3 1999

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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.

| 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: [phone] |
| | Fax: [phone] |
| 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 trained<br>operators.<br>MUSE CV is designed for network compatibility to facilitate retrieval and<br>distribution of cardiovascular information.<br>MUSE CV is designed to interface with other hospital information systems<br>through various communication protocols to support information continuity<br>and results reporting.<br>MUSE CV can provide serial comparison of cardiovascular information to<br>facilitate review of current and previous records.<br>MUSE CV can provide serial trending of cardiovascular information to<br>facilitate review of current and previous records.<br>Through integration with Accusketch (CardioTrace), MUSE aids the physician<br>or trained technologist in providing and documenting an objective<br>quantification of coronary artery stenosis and measurement and quantification<br>of left ventricular function. Also provided is the ability to digitize and store<br>video images and the ability to interactively annotate and report current and<br>post procedural patient cardiac status.<br>Use of MUSE CV is intended for accessing, storage and management of both<br>adult and pediatric cardiovascular information.<br>The intended use of MUSE CV is identical to the intended use of the predicate<br>devices |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology: | MUSE CV employs the same functional technology as the predicate devices.<br>The only difference being the technological improvements made by<br>manufacturers with respect to speed, performance and reliability. |
| Test Summary: | The MUSE CV complies with voluntary standards as detailed in Section 9<br><i>Specific Standards and Guidances</i> of this submission. The following quality<br>assurance measures were applied to the development of MUSE CV:<br>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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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 [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" (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 [phone] or [phone] 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