(38 days)
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.
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.
The provided text is a 510(k) Premarket Notification Submission for the GE Healthcare MUSE Cardiology Information System. This document focuses on establishing substantial equivalence to a predicate device and does not contain detailed information on specific acceptance criteria and a study proving device performance in the way typically found for novel AI/ML devices.
However, based on the provided text, here's what can be extracted and inferred regarding the "acceptance criteria" for this specific submission:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a system that leverages existing technology and claims substantial equivalence, the "acceptance criteria" are primarily related to general safety, effectiveness, and functional comparability to its predicate device, rather than specific performance metrics (like sensitivity, specificity, or AUC) for a new algorithm.
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Safety and Effectiveness | "GE Healthcare considers the MUSE Cardiology Information System to be as safe, as effective, and performance is substantially equivalent to the predicate device." |
| Voluntary Standards Compliance | Complies with: - IEC 60601-1-1:2001 (Medical Electrical Equipment - General Requirements for Safety) - IEC 60601-1-2:2007 (Electromagnetic Compatibility) - IEC 60601-1-4:2000 (Programmable Electrical Medical Systems) - ISO 14971:2009 (Risk Management to medical devices) |
| Quality Assurance Measures | Applied: - 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) |
| Functional Equivalence to Predicate | "The proposed MUSE Cardiology Information System employs the same functional scientific technology as the predicate device MUSE Cardiovascular Information System (K110132)." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document explicitly states: "The subject of this premarket submission, MUSE Cardiology Information System, did not require clinical studies to support substantial equivalence." Therefore, no specific test set sample size or data provenance is mentioned as part of a formal clinical study for this submission. The testing mentioned in the Quality Assurance Measures (e.g., performance testing, simulated use testing) would have involved internal validation, but details about sample size or data provenance for these internal tests are not provided in this public summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical studies were required and no specific "test set" with a delineated ground truth is mentioned in the context of proving performance against clinical endpoints, this information is not available in the provided text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No adjudication method is mentioned, as no clinical test set requiring this was conducted for supporting substantial equivalence.
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 performed or cited in this submission. The device is an "ECG Analysis Computer" and "Cardiology Information System" which provides tools for review and editing, including interpretive 12-lead analysis. The submission focuses on its system capabilities and equivalence to its predicate, not on a human-AI collaborative performance study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device description mentions "interpretive 12-lead analysis," which implies an algorithm that performs analysis. However, the submission does not detail any standalone performance study of this algorithm. The overall device is a system that allows reviewing and editing by trained operators under the supervision of a licensed healthcare practitioner. The focus of the submission is on the system's ability to store, access, and manage cardiovascular information, leveraging the same functional scientific technology as its predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. Given that no formal clinical study was required for this submission, there is no mention of how "ground truth" would have been established for performance evaluation (e.g., for the interpretive 12-lead analysis component).
8. The sample size for the training set:
Not applicable or not provided. This submission is for a system that uses "the same functional scientific technology" as its predicate. It does not describe a new AI/ML algorithm that would undergo a separate training process requiring a specific training set size to be detailed in this type of submission.
9. How the ground truth for the training set was established:
Not applicable or not provided, for the same reasons as in point 8.
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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 Technologies9900 Innovation DriveWauwatosa, WI 53226 |
|---|---|
| Primary Contact Person: | Kristin PabstRegulatory Affairs ManagerGE Medical Systems Information TechnologiesPhone: (414) 721-3104Fax: (414) 721-3863 |
| Secondary Contact Person: | Doug KentzRegulatory AffairsGE Medical Systems Information TechnologiesPhone (414) 362-2038FAX: (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-basedsystem comprised of a client workstation/server configuration thatmanages adult and pediatric diagnostic cardiology data by providingcentralized storage and ready access to a wide range of data/reports(e.g. Resting ECG, Stress, Holter, HiRes) from GE and non-GEdiagnostic and monitoring equipment. The device provides the ability to: Review and edit stored data consisting of measurements, text, anddigitized waveforms on screen, through the use of reviewing,measuring, and editing tools including ECG serial comparison andinterpretive 12-lead analysis. |
| Intended Use: | Generate formatted management reports, ad-hoc database searchreports and clinical patient reports on selected stored data. The MUSE Cardiology Information System is intended to store, accessand manage cardiovascular information on adult and pediatric patients.The information consists of measurements, text, and digitizedwaveforms. The MUSE Cardiology Information System provides theability to review and edit electrocardiographic procedures on screen,through the use of reviewing, measuring, and editing tools includingECG serial comparison and interpretive 12-lead analysis. The MUSECardiology 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
.
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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.
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Conclusion:
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Determination of Substantial
Equivalence:
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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.
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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/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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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)
Owen P. Faris -S
§ 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).