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, and editing tools including ECG serial comparison and interpretive 12-lead analysis. 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 real-time patient monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.

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. 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 and interpretive 12-lead analysis. • Generate formatted management reports, ad-hoc database search reports and clinical patient reports on selected stored data.

AI/ML Overview

The provided document, K110132, for the GE Healthcare MUSE Cardiology Information System, does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it is a 510(k) Premarket Notification Submission based on substantial equivalence.

The summary explicitly states:

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

Therefore, I cannot provide the requested table or details about a study demonstrating the device meets acceptance criteria derived from this document. The submission relies on demonstrating that the new device employs the same functional and scientific technology as its predicate devices (MUSE Cardiology Information System K#072502 and MUSE Cardiology Information System w/ VMWare K#083639) and complies with voluntary standards and internal quality assurance measures.

Summary

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K110132 pg 1 of 2

MAY 2 5 2011

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GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

January 12, 2011 Date:

Submitter:	GE Medical Systems Information Technologies9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Kristin PabstRegulatory Affairs ManagerGE Medical Systems Information TechnologiesPhone: (414) 721-3104Fax: (414) 721-3863
Secondary ContactPerson:	Patricia TaigeRegulatory Affairs LeaderGE Medical Systems Information TechnologiesPhone (414) 721-3222FAX: (414) 721-3863
Device: Trade Name:	MUSE Cardiology Information System
Common/Usual Name:	ECG Analysis Computer
Classification Names:	Programmable Diagnostic Computer (21 CFR 870.1425)
Product Code:	DQK
Predicate Device(s):	MUSE Cardiology Information System K#072502MUSE Cardiology Information System w/ VMWare K#083639
Device Description:	The MUSE Cardiology Information System is a network PC-based system comprised of a client workstation/serverconfiguration that manages adult and pediatric diagnosticcardiology data by providing centralized storage and readyaccess to a wide range of data/reports (e.g. Resting ECG,Stress, Holter, HiRes) from GE and non-GE diagnostic andmonitoring 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 comparisonand interpretive 12-lead analysis.• Generate formatted management reports, ad-hoc databasesearch reports and clinical patient reports on selected storeddata.

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GE Healthcare

510(k) Premarket Notification Submission

The MUSE Cardiology Information System is intended to store, Intended Use: 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 and interpretive 12-lead analysis. 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 real time monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.

The proposed MUSE Cardiology Information System employs Technology: the same functional scientific technology as the predicate devices MUSE Cardiovascular Information System (K072502) and MUSE Cardiovascular Information System w/ VMWare (K083639).

Determination of Summary of Non-Clinical Tests:

Substantial Equivalence:

The MUSE Cardiology Information System complies with voluntary standards as detailed in Section 9 and 17 of this premarket submission. The following quality assurance measures are applied to the development of the system:

Risk Analysis .
Requirements Reviews .
. Design Reviews
. Code Inspection
Testing on unit level (Module verification) .
. Integration testing (System verification)
Performance testing (Verification) .
Safety testing (Verification)
Simulated use testing (Validation)

Summary of Clinical Tests:

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

Conclusion:

GE Healthcare considers the MUSE Cardiology Information System to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

GE Medical Systems Information Technologies, Inc c/o Ms. Kristin Pabst Regulatory Affairs Manager 9900 West Innovation Drive Wauwatosa, WI 53226

MAY 2 5 2011

Re: K110132

Trade/Device Name: Muse Cardiology Information System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: May 4, 2011 Received: May 6, 2011

Dear Ms. Pabst:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Kristin Pabst

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 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for 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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K110132 pg lofl

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GE Healthcare

510(k) Premarket Notification Submission

510(k) Number (if known):

MUSE Cardiology Information System Device Name:

Indications for Use:

Prescription Use_X AND/OR (Part 21 CFR 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular-Device

510(k) Number K110132

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).