(74 days)
Not Found
No
The document describes a system for storing, managing, and reviewing cardiovascular data, including ECGs. It mentions tools for reviewing, measuring, and editing, and generating reports. There is no mention of AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data to perform tasks like diagnosis or prediction. The modifications described are related to data format handling, calculation methods, and manual editing tools.
No.
The device is described as an information system for storing, accessing, managing, reviewing, and editing cardiovascular information, not for providing therapy.
Yes
Explanation: The device description states that it manages "adult and pediatric diagnostic cardiology data," and the intended use includes the ability to "review and edit electrocardiographic procedures" and "ECG serial comparison," which are diagnostic activities.
Yes
The device description explicitly states it is a "network PC-based system comprised of a client workstation/server configuration" that manages data and provides tools for review and editing. While it interacts with diagnostic equipment, the device itself is described as a software system for data management and analysis, with no mention of included hardware components.
Based on the provided information, the MUSE Cardiology Information System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is typically used for diagnosis, monitoring, or screening.
- MUSE System Function: The MUSE system stores, accesses, and manages cardiovascular information, primarily ECG data (measurements, text, and digitized waveforms). 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. Its input is digitized physiological data (ECG waveforms) and associated information, not samples taken from the body.
- Intended Use: The intended use focuses on managing and reviewing existing cardiovascular data, not on performing tests on biological samples.
Therefore, the MUSE Cardiology Information System falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
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. 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.
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. To generate formatted management reports, ad-hoc database search reports and clinical patient reports on selected stored data. 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.
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
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
Non-clinical Tests: The MUSE Cardiology Information System complies with the voluntary standards as detailed in Section 3.2 of this submission. The following quality assurance measures were applied to the development of the device modification subject to this submission:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Integration Testing (System verification)
• Final acceptance testing (Validation) ●
• Performance testing .
Clinical Tests: None required
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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K072502
Special 510(k) Premarket Notification Special 510(K) Tremantet Notification
GE Healthcare – MUSE Cardiology Information System
September 4, 2007
NOV 1 9 2007
Attachment B
| Submitter: | GE Medical Systems Information Technologies
9900 Innovation Drive
Wauwatosa, WI 53226 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Taige
Sr. Regulatory Affairs Specialist
GE Medical Systems Information Technologies
Phone: (414) 721-3222
Fax: (414) 721-3899 |
| Date Prepared | September 4, 2007 |
| Device Names: | Proprietary Name: MUSE Cardiology Information System
Common/Usual Name: ECG Analysis Computer
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.
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. 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.
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
voluntary standards as detailed in Section 3.2 of this
submission. The following quality assurance measures
were applied to the development of the device modification
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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human figures in its body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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 (800) 638-2041 or (240) 276-3150 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
4
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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