MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE

K083639 · Ge Medical Systems Information Technologies · DQK · Feb 17, 2009 · Cardiovascular

Device Facts

• Record ID: K083639
• Device Name: MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
• Applicant: Ge Medical Systems Information Technologies
• Product Code: DQK · Cardiovascular
• Decision Date: Feb 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended 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 manages cardiovascular data (measurements, text, waveforms) from GE and non-GE diagnostic/monitoring equipment; provides tools for on-screen review, measurement, and editing of ECG procedures, including serial comparison. System operates as a network PC-based client/server configuration. This version introduces an off-the-shelf (OTS) virtualization software layer (VMWare) to host the operating system, allowing multiple OS shells on a single hardware server. Used in hospitals/clinics by trained operators under licensed practitioner supervision. Output assists clinicians in diagnostic review and management reporting. Benefits include centralized data access and efficient workflow for cardiology information management.

Clinical Evidence

No clinical data required; substantial equivalence supported by non-clinical bench testing, including risk analysis, requirements/design reviews, and system verification/validation.

Technological Characteristics

Networked PC-based client/server system. Utilizes off-the-shelf (OTS) virtualization software (VMWare) to host the operating system on server hardware. Functions as a programmable diagnostic computer for ECG data management. Software-based system; no specific hardware materials or sterilization requirements noted.

Indications for Use

Indicated for storage, access, and management of cardiovascular information (measurements, text, digitized waveforms) for adult and pediatric patients. Used in hospitals or care facilities 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 Cardiology Information System (K072502)

Submission Summary (Full Text)

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K083639

# FEB 1 7 2009

## GE Healthcare 510(k) Premarket Notification Submission MUSE Cardiology Information System with VMWare

### 510(k) Summary

In accordance with 21 CFR 807:92 the following summary of information is provided:

| Date: | December 5, 2008 |
|---------------------------|-------------------------------------------------------------------|
| Submitter: | Larry Lepley |
| | Regulatory Affairs - Diagnostic Cardiology |
| | 9900 Innovation Drive |
| | Wauwatosa, WI 53226 |
| Primary Contact Person: | Larry Lepley |
| | Regulatory Affairs - Diagnostic Cardiology |
| | 9900 Innovation Drive |
| | Wauwatosa, WI 53226 |
| | T: [phone] |
| | F: [phone] |
| Secondary Contact Person: | Patricia Taige |
| | Regulatory Affairs - Diagnostic Cardiology |
| | 9900 Innovation Drive |
| | Wauwatosa, WI 53226 |
| | T: [phone] |
| | F: [phone] |
| | |
| Device:<br>Trade Name: | MUSE Cardiology Information System |
| Common/Usual Name: | ECG Analysis Computer, Programmable Diagnostic Computer |
| Classification Names: | 21 CFR 870.1425 |
| Product Code: | DQK |
| Predicate Device(s): | K072502 MUSE Cardiology Information System |
| Device Description: | The MUSE Cardiology Information System is intended to store, |
| | access and manage cardiology information on adult and pediatric |
| | patients. MUSE Cardiology Information System has been |
| | marketed to operate within Microsoft Windows Operating System |
| | (OS) directly interacting with the host hardware. GE Healthcare |
| | intends to change this interaction by running MUSE Cardiology |
| | Information System with an Off the Shelf virtualization software |
| | layer. GE feels that this proposed change alters the principal of |
| | operation of the Operating System. This proposed change will be |
| | marketed as a software only offering, which will utilize an |
| | OTS software that virtualizes the host hardware. This will allow |
| | multiple OS shells to run on a single hardware server, one of |
| | which is the OS hosting the predicate MUSE Cardiology |
| | Information System program. |

17

Page. 1 OF 3

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### GE Healthcare 510(k) Premarket Notification Submission MUSE Cardiology Information System with VMWare

The functional intent of MUSE Cardiology Information System with VMWare will remain the same as the premarket notification reviewed in 2007 (K072502). For conveyance the description for (K072502) is the following:

The MUSE Cardiology Information System is a network PC based system comprised of a client workstation /servor configuration that manages adult and pediatric diagnosis cardiology data by providing centralized storage and ready access U:Ree) from OF HiRes) from GE and non-GE diagnostic and monitoring equipment.

The device provides the ability

- . 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
- To generate formatted management reports, ad-hoc . database search reports and clinical patient reports on selected stored data.

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.

Intended 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 cditing 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.

Technology:

The MUSE Cardiology Information System with VMWare

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## GE Healthcare

### 510(k) Premarket Notification Submission MUSE Cardiology Information System with VMWare

employs a different functional scientific technology as its predicate devices.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The MUSE Cardiology Information System with VMWare and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

- � Risk Analysis
- Requirements Reviews .
- . Design Reviews
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Final acceptance testing (Validation) .
- Performance testing (Verification)
- Safety testing (Verification)

#### Summary of Clinical Tests:

The subject of this premarket submission, MUSE Cardiology Information System with VMWare, did not require clinical studies to support substantial equivalence.

Conclusion:

GE Healthcare considers the MUSE Cardiology Information System with VMWare to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

Page 3 OF 3

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB 1 7 2009

GE Medical Systems Information Technologies c/o Mr. Larry Lepley Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226

Re: K083639

Trade/Device Name: MUSE Cardiology Information System with VMWare Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: December 5, 2008 Received: December 6, 2008

#### Dear Mr. Lepley:

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 approvat of a premailet approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of 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 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

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Page 2 - Mr. Larry Lepley

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 clectronic 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 [phone]. 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 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,

001 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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## GE Healthcare

510(k) Premarket Notification Submission MUSE Cardiology Information System with VMWare

510(k) Number (if known):

K083639

Device Name:

MUSE Cardiology Information System with VMWare

#### 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 (Part 21 CITR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mitchel Stein for B Zuckerman

Division Sian-Offi 2/17/09 Division of Cardlovascular Devices 510(k) Number KO8363

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