(26 days)
Not Found
No
The document describes a system for storing, accessing, and managing cardiovascular data, including reviewing and editing ECGs. There is no mention of AI or ML in the intended use, device description, or any other section. The performance studies focus on standard software development quality assurance measures and comparison to a predicate device, not on AI/ML model performance.
No
The device is an information system for managing cardiovascular data, not a direct therapeutic intervention. It stores, accesses, and manages information, and provides tools for reviewing and editing, but does not provide treatment.
Yes.
The device description states its purpose is to "manage diagnostic cardiology data." It also mentions providing access to data/reports from "diagnostic and monitoring equipment." While the system itself is not generating the initial diagnostic data, it is explicitly described as managing and enabling the review of diagnostic information, such as Resting ECG, Stress, Holter, etc., which are used for diagnosis.
Yes
The device description explicitly states it is a "network PC-based system" and describes its function as managing and providing access to data. It does not mention any hardware components being part of the device itself, only that it receives data from diagnostic and monitoring equipment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for storing, accessing, and managing cardiovascular information (measurements, text, and digitized waveforms) and reviewing/editing electrocardiographic procedures. It is used under the supervision of a healthcare practitioner in a hospital or facility.
- Device Description: The description reinforces that it's a system for managing diagnostic cardiology data from various equipment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs are specifically designed for analyzing biological samples.
The MUSE Cardiology Information System is a medical device, but it falls under the category of a Cardiology Information System used for managing and reviewing patient data, not for performing in vitro diagnostic tests on biological samples.
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 comprises a client workstation/server configuration whose purpose is to manage diagnostic cardiology data. The MUSE Cardiology Information System is a network PCbased system that provides 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiovascular
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The MUSE Cardiology Information System complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the device:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration Testing (System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
- Environmental Testing
The results of these measurements demonstrated that the MUSE Cardiology Information System is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
R/1
Section 2 Summary
APR - 5 2005
510(k) Summary of Safety and Effectiveness
March 7, 2005 Date:
- GE Medical Systems Information Technologies Submitter: 8200 West Tower Avenue Milwaukee, WI 53223 USA
- Lisa M. Baumhardt Contact Person: Regulatory Affairs Specialist GE Medical Systems Information Technologies Phone: (262) 293-1699 Fax: (262) 293-1460
| Device: | Trade Name: | MUSE Cardiology Information System |
|---|---|---|
| Common/Usual Name: | ECG Analysis Computer | |
| Classification Names: | 21 CFR 870.1425 Computer, Diagnostic, Programmable | |
| Predicate Device: | MUSE Cardiovascular Information System (K992637) |
The MUSE Cardiology Information System comprises a client Device Description: workstation/server configuration whose purpose is to manage diagnostic cardiology data. The MUSE Cardiology Information System is a network PCbased system that provides 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 MUSE Cardiology Information System is intended to store, access and Intended Use: 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 Cardiclogy Information System is not intended for primary 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 (K992637).
The MUSE Cardiology Information System complies with the voluntary Test Summary: standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the device:
- Risk Analysis ●
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration Testing (System verification) �
- Final acceptance testing (Validation) .
- Performance testing .
- Safety testing .
- Environmental Testing .
- The results of these measurements demonstrated that the MUSE Cardiology Conclusion: Information System is as safe, as effective, and performs as well as the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines resembling an abstract human figure or a bird in flight.
Public Health Service
APR - 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
General Electric Medical Systems Information Technologies c/o Ms. Lisa Baumhardt Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K050614
Trade 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: March 22, 2005 Received: March 23, 2005
Dear Ms. Baumhardt:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars and ment date of the Medical Device Amendments, or to commerce prof to hay 28, 1976, the encomes with the provisions of the Federal Food. Drug. devices mat have been rechasined in accee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercere, market the Act include requirements for annual registration, listing of getteral controls provisions of the 110 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 If your device is classified (500 a00 ro) ins existing major regulations affecting your device can may be subject to suell additional ocultions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oods neements concerning your device in the Federal Register.
2
Page 2 - Ms. Lisa Baumhardt
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issumter of a beadswice complies with other requirements of the Act that I DA has made a decommancir that your rederal agencies. You must or ally recetal statutes and regulations and limited to: registration and listing (21 comply with an the Act 31equirements, 01); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro nevice (seting your device as described in your Section 510(k) This letter witi anow you to begin maxioning your as a review of your device to a legally premarket notheation: "The PDF miding of castion 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 If you desire specific acrite for your acceller. Also, please note the regulation entitled, Coliable of Computers of Compullion in (21CFR Part 807.97). You may obtain Misolanding by reference to premanteentibilities under the Act from the Division of Small other general information on your respective Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
Bhimmar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KO50614
510(k) Number (if known):
Device Name:
MUSE Cardiology Information System
Indications For Use:
The MUSE Cardiology Information System is intended to store, access and manage cardiovascular I he MOSE Catulology information Oystems. The information consists of measurements, text, and motimation on adult and pockate partials gy Information System provides the ability to review and digitized wavelorms. The MODE Catalotogy attrough the use of reviewing, measuring, and editing edit electrocandiographic procedures on serees, the onganisation System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital used ulticity providing patient of a nooned Cardiology Information System is not intended for of facility providing patient care. The MOSE of and intended for pediatic serial comparison.
Prescription Use__X__ (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 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)
Bhummer
ivision Sian-Off Division of Cardlovascular Devices 510(k) Numbe