Predicate Devices

K#110132

Reference Devices

K#110132

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data management, review, and editing tools, not AI/ML capabilities.

Therapeutic

No
The device is described as an information system for storing, accessing, and managing cardiovascular information, and for reviewing and editing electrocardiographic procedures. It does not perform any therapeutic function.

Diagnostic

Yes

The device description explicitly states that the system manages "adult and pediatric diagnostic cardiology data" and provides capabilities like "interpretive 12-lead analysis," which are functions used in diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "network PC-based system comprised of a client workstation/server configuration," which implies hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the MUSE Cardiology Information System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
MUSE System Function: The MUSE system's primary function is to store, access, and manage cardiovascular information, specifically measurements, text, and digitized waveforms from diagnostic cardiology equipment (like ECGs). It provides tools for reviewing, editing, and analyzing this data.
Lack of Specimen Analysis: The description does not mention the system analyzing any biological specimens. It works with data generated by other diagnostic devices.

Therefore, the MUSE Cardiology Information System falls under the category of a medical device that manages and processes data from other diagnostic devices, rather than performing in vitro diagnostic tests itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

DQK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and pediatric patients.

Intended User / Care Setting

Used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

MUSE Cardiology Information System K#110132

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

K130155 Page 1 of 2

MAR 1 2013 ·

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

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

Date: January 17, 2012

| Submitter: | GE Medical Systems Information Technologies
9900 Innovation Drive
Wauwatosa, WI 53226 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Kristin Pabst
Regulatory Affairs Manager
GE Medical Systems Information Technologies
Phone: (414) 721-3104
Fax: (414) 721-3863 |
| Secondary Contact Person: | Doug Kentz
Regulatory Affairs
GE Medical Systems Information Technologies
Phone (414) 362-2038
FAX: (414) 362-2585 |
| 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#110132 |
| 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. |
| Intended Use: | 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 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 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 |

..

1994 - 1998 - 1999 - 1999 :

supervision of a licensed healthcare practitioner, by trained operators in

.

Image /page/0/Picture/11 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white, with the letters and border appearing in white against a black background.

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K130152

Page 2 of 2

GE Healthcare

510(k) Premarket Notification Submission

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 the same Technology: functional scientific technology as the predicate device MUSE Cardiovascular Information System (K110132).

Summary of Non-Clinical Tests:

The MUSE Cardiology Information System complies with voluntary standards:

. IEC 60601-1-1:2001Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems, 200 Edition
. IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, Edition 3
IEC 60601-1-4:2000 Medical Electrical Equipment Part 1-4: . General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems, Edition 1.1
. ISO 14971:2009 Medical devices - Application of risk management to medical devices, 2nd Edition

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.

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

Image /page/1/Picture/25 description: The image is a blank white space. There are no objects or figures in the image. The image does not contain any text.

Conclusion:

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18

Image /page/1/Picture/27 description: The image shows a black and white drawing of a circular design. The design features a spiral pattern with intricate details. The spiral is tightly wound in the center and gradually expands outwards. The drawing is simple and lacks shading or color.

Determination of Substantial

Equivalence:

2

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

March 1, 2013

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

Re: K130155

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: DOK Dated: January 18, 2013 Received: January 25, 2013

Dear Ms. Kristin 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.

3

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/CDRHOffices/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,

Owen P. Faris -S

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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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Number: K130155

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 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.

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)