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 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.

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.

AI/ML Overview

This 510(k) submission, K083639, for the "MUSE Cardiology Information System with VMWare" from GE Healthcare, describes a software-only offering that virtualizes the host hardware for an already marketed device (K072502).

Here's an analysis of the acceptance criteria and study described:

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

The submission does not provide a table of acceptance criteria or reported device performance in the traditional sense of a clinical or analytical performance study. This is because the submission states:

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

Instead, the acceptance criteria implicitly relate to the demonstration that the new configuration (running the MUSE system with VMWare) is as safe and effective as the predicate device (MUSE Cardiology Information System, K072502). The "performance" in this context refers to the system's intended functions remaining unchanged when operating within the virtualized environment.

The submission focuses on quality assurance measures and non-clinical tests to establish substantial equivalence. These implicitly serve as the "acceptance criteria" for the change being proposed.

Acceptance Criteria (Implied)	Reported Device Performance
Functional intent remains the same as predicate device (K072502).	"The functional intent of MUSE Cardiology Information System with VMWare will remain the same as the premarket notification reviewed in 2007 (K072502)." The device provides the ability to review and edit stored data, generate reports, and manage cardiology data as described for the predicate.
Compliance with voluntary standards.	"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." (Specific standards not detailed in the provided text).
Quality assurance measures applied to development.	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) were all applied.
Safety and effectiveness are substantially equivalent to predicate.	"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)." This is the conclusion drawn from the non-clinical work.

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

Sample Size for Test Set: Not applicable / Not mentioned. This submission did not involve a clinical or performance study with a test set of patient data to evaluate algorithmic performance. The evaluation was primarily engineering-based and focused on the safety and functionality of the software change.
Data Provenance: Not applicable / Not mentioned for a test set.

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 patient data test set requiring expert ground truth was described or used in this submission.

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

Not applicable. No patient data test set requiring adjudication was described or used in this submission.

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 MRMC comparative effectiveness study was done. The device is an information system, not an AI-powered diagnostic tool that assists human readers in interpreting clinical data.

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

This submission describes a software architectural change (virtualization) for an existing information system. It is not an AI algorithm with standalone performance in the typical sense. The "standalone" performance being assessed is the system's ability to continue performing its intended functions (storing, accessing, managing cardiology information, reviewing, editing ECG procedures) within the virtualized environment as it did in the non-virtualized environment. This was established through the non-clinical testing listed (unit, integration, acceptance, performance, safety testing).

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

Not applicable in the context of clinical ground truth for a diagnostic algorithm. The "ground truth" for this submission was the established functionality and safety of the predicate device (MUSE Cardiology Information System, K072502) in its original operating environment. The non-clinical tests aimed to prove that this "ground truth" of functionality and safety was maintained after the virtualization change.

8. The sample size for the training set

Not applicable. This submission does not describe an AI/ML algorithm that requires a training set.

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

Not applicable. No training set was described or used.

Summary

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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: (414) 721-2593
	F: (414) 721-3899
Secondary Contact Person:	Patricia Taige
	Regulatory Affairs - Diagnostic Cardiology
	9900 Innovation Drive
	Wauwatosa, WI 53226
	T: (414) 721-3222
	F: (414) 721-3899

Device: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.

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 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

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains an eagle with three stripes on its back. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle.

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 (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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041' or (240) 276-3150 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:

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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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).