MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM

K072502 · Ge Medical Systems Information Technologies · DQK · Nov 19, 2007 · Cardiovascular

Device Facts

• Record ID: K072502
• Device Name: MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
• Applicant: Ge Medical Systems Information Technologies
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. The MUSE Cardiology Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.

Device Story

MUSE Cardiology Information System is a network PC-based client/server system for centralized management of adult/pediatric diagnostic cardiology data (Resting ECG, Stress, Holter, HiRes). Inputs include digitized waveforms and data from GE and non-GE equipment. System processes data to generate median waveforms, ECG measurements, and management/clinical reports. Features include on-screen review/editing tools, serial comparison, and an Interval Editor for manual parameter measurement. Used in hospitals/clinics by trained operators; output viewed by clinicians to support diagnostic decision-making. Modifications include XML-based 12-lead ECG processing, additional QTc calculation method, and workflow enhancements.

Clinical Evidence

No clinical data. Bench testing only, including risk analysis, requirements/design reviews, integration testing, and final validation/performance testing.

Technological Characteristics

Networked PC-based client/server architecture. Processes digitized waveforms and measurements. Features include XML-based data ingestion, QTc calculation, and manual interval editing tools. Software-based diagnostic computer (21 CFR 870.1425).

Indications for Use

Indicated for storage, access, and management of cardiovascular data (measurements, text, digitized waveforms) for adult and pediatric patients. Used in hospitals/care facilities by trained operators under licensed practitioner supervision. Contraindicated for primary monitoring and pediatric serial comparison.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• MUSE Cardiovascular Information System (K050614)

Submission Summary (Full Text)

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K072502

Special 510(k) Premarket Notification Special 510(K) Tremantet Notification
GE Healthcare – MUSE Cardiology Information System
September 4, 2007

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NOV 1 9 2007

## Attachment B

#

| Submitter: | GE Medical Systems Information Technologies<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Taige<br>Sr. Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared | September 4, 2007 |
| Device Names: | Proprietary Name: MUSE Cardiology Information System<br>Common/Usual Name: ECG Analysis Computer<br>Classification Name: Programmable Diagnostic Computer (21 CFR 870.1425 - Product Code DQK) |
| Predicate Device: | MUSE Cardiovascular Information System (K050614) |
| Device Description: | The MUSE Cardiology Information System is a network PC-based system comprised of a client workstation/server configuration that manages adult and pediatric diagnostic cardiology data by providing centralized storage and ready access to a wide range of data/reports (e.g. Resting ECG, Stress, Holter, HiRes) from GE and non-GE diagnostic and monitoring equipment.<br>The device provides the ability <ul><li>To review and edit stored data consisting of measurements, text, and digitized waveforms on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison.</li><li>To generate formatted management reports, ad-hoc database search reports and clinical patient reports on selected stored data.</li></ul> This modification will provide the capability to generate median waveforms and ECG measurements from 12-lead ECG data received in a GE specified XML format. Other added functionality includes an additional QTc calculation method, a refined tool (Interval Editor) to manually measure, review, and document ECG waveform parameters, and workflow enhancements. |
| Indications for Use: | The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care.<br>The MUSE Cardiology Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison. |
| Technology: | The proposed MUSE Cardiology Information System employs the same functional scientific technology as the predicate device MUSE Cardiovascular Information System (K050614). |

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KC72502

Special 510(k) Premarket Notification GE Healthcare - MUSE Cardiology Information System September 4, 2007

| | Test Summary: | Non-clinical Tests: The MUSE Cardiology Information System complies with the<br>voluntary standards as detailed in Section 3.2 of this<br>submission. The following quality assurance measures<br>were applied to the development of the device modification<br>subject to this submission: |
|--|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | • Risk Analysis |
| | | • Requirements Reviews |
| | | • Design Reviews |

- Design Reviews
- Integration Testing (System verification)
- Final acceptance testing (Validation) ●
- Performance testing .

#### None required Clinical Tests:

Conclusion:

Based on the results of the performed testing it is concluded that the MUSE Cardiology Information System with the modifications subject to this submission is substantially equivalent to and is as safe, as effective, and performs as well as the currently marketed predicate device cleared in K050614.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2007

GE Medical Systems Information Technologies c/o Patricia Taige Sr. Regulatory Affairs Specialist 9900 Innovation Dr. Wauwatosa, WI 53226

Re: K072502

Trade/Device Name: Muse Cardiology Information System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 16, 2007 Received: October 17, 2007

Dear Ms. Taige:

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.

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

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Page 2 - Ms. Patricia Taige

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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. A. Hillebenne

- 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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Special 510(k) Premarket Notification GE Healthcare - MUSE Cardiology Information System September 4, 2007

## Attachment E

### Indications for Use

510(k) Number (if known): K072502 Device Name: __ MUSE Cardiology Information System Indications for Use:

The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. The MUSE Cardiology Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. L. Hillebrenner

(Division Sian-Off) Division of Cardiovascular Devices

510(k) Number_Ko72502

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