(91 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 patient care. The MUSE Cardiology Information System is not intended for real-time patient monitoring. The MUSE Cardiology Information System is not intended for pediativ serial comparison.
The MUSE Cardiology Information System is a network based cardiology information management system that manages adult and pediatric diagnostic cardiology data by providing centralized storage and ready access to a wide range of data types and reports from GE and non-GE data acquisition devices. The MUSE Cardiology Information System 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. Translates and transfers patient demographic and administrative data from EMR/HIS systems to clinical acquisition devices and translates and transfers tests results from clinical acquisition devices to EMR/HIS systems. Configurable workflow capabilities for managing administrative and clinical tasks in the diagnostic cardiology department, including order/patient demographic management, clinical test review/edit, clinical report distribution, and billing.
This looks like a 510(k) summary for the MUSE Cardiology Information System (K152993). Based on the provided document, here's an analysis of the acceptance criteria and supporting studies, or lack thereof:
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data typical of PMA submissions.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria or quantitative performance metrics for the MUSE Cardiology Information System and its features (like ECG serial comparison or interpretive 12-lead analysis).
Instead, the submission focuses on demonstrating that the subject device (MUSE Cardiology Information System K152993) has the same technological elements and intended use as its predicate device (MUSE Cardiology Information System K130155 and 12SL ECG Analysis Program K141963).
The "performance" is implicitly demonstrated by the claim of substantial equivalence to the predicate device, which is already legally marketed and presumed to have acceptable performance.
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "The subject of this premarket submission, MUSE Cardiology Information System, did not require clinical studies to support substantial equivalence."
This indicates that there was no specific clinical "test set" used for a performance study of the new device features directly. The evaluation appears to be based on a comparison to the predicate device and internal testing of software functionality and safety.
Therefore, sample size and data provenance for a clinical test set are not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Given that explicit clinical studies with a designated "test set" to establish new performance metrics were not required or conducted for this 510(k) submission, information about experts for ground truth establishment is not provided.
4. Adjudication Method for the Test Set:
As no explicit clinical test set requiring ground truth establishment was conducted for the new device as part of this submission, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a MRMC comparative effectiveness study. The focus is on demonstrating equivalence, not on comparing the new device's performance with human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document does not describe a standalone performance study for the algorithm (e.g., the 12SL ECG Analysis Program within MUSE) in isolation. The device is a "Cardiology Information System" intended for use under the direct supervision of a licensed healthcare practitioner, implying human-in-the-loop operation. The 12SL ECG Analysis Program provides "computerized measurements and interpretive diagnostic statements that assist the physician interpreting the ECG," indicating an assistive role rather than a standalone diagnostic role for the system's output.
7. Type of Ground Truth Used:
Since clinical studies to establish new performance metrics were not conducted for this submission, there's no mention of the type of ground truth used for such a study.
For the predicate device's 12SL ECG Analysis Program (K141963), it is generally understood that such interpretive algorithms would have been developed and validated against a ground truth established by expert cardiologists' interpretations of ECGs, possibly correlated with clinical outcomes or pathology in historical training/validation sets. However, this document does not detail the predicate's ground truth.
8. Sample Size for the Training Set:
The document does not specify a sample size for a training set. As mentioned, no new clinical studies for performance were conducted as part of this submission. Any training sets would have been associated with the development of the embedded 12SL ECG Analysis Program, which is a component inherited from the predicate. Details of the training sets for these pre-existing components are not typically included in a 510(k) for an information system unless significant modifications to the analytical algorithms are being introduced and require re-validation.
9. How Ground Truth for the Training Set Was Established:
Similar to point 8, the document does not provide details on how ground truth was established for any training set. This information would pertain to the development of the analytical algorithms (like the 12SL program) that the MUSE system incorporates, rather than the information system itself.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2016
GE Medical Systems Information Technologies, Inc. Amy Yang Regulatory Affairs Program Manager 9900 West Innovation Drive Wauwatosa, Wisconsin 53226
Re: K152993
Trade/Device Name: Muse Cardiology Information System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: December 10, 2015 Received: December 14, 2015
Dear Amy Yang:
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 - Amy Yang
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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 vours.
Sincerely yours,
Mitchell Stein
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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Indications for Use
510(k) Number (if known) K152993
Device Name MUSE Cardiology Information System
Indications for Use (Describe)
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 patient care. The MUSE Cardiology Information System is not intended for real-time patient monitoring. The MUSE Cardiology Information System is not intended for pediativ serial comparison.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | 09 October 2015 |
| Submitter: | GE Medical Systems Information Technologies, Inc.9900 Innovation DriveWauwatosa, WI 53226 |
| Primary Contact Person: | Amy YangRegulatory Affairs Program ManagerGE Medical Systems Information Technologies, Inc.Phone: (414)721-3807Fax: (414) 721-3863 |
| Secondary Contact Person: | Doug KentzRegulatory Affairs DirectorGE Medical Systems Information Technologies, Inc.Phone: (414)581-8987Fax: (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) |
| Regulatory Class: | II |
| Product Code: | DQK |
| Predicate Device(s): | MUSE Cardiology Information System K13015512SL ECG Analysis Program K141963No reference devices were used in this submission |
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| Device Description: | The MUSE Cardiology Information System is a network basedcardiology information management system that manages adult andpediatric diagnostic cardiology data by providing centralized storageand ready access to a wide range of data types and reports from GEand non-GE data acquisition devices. The MUSE CardiologyInformation System 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. Translates and transfers patient demographic and administrative data from EMR/HIS systems to clinical acquisition devices and translates and transfers tests results from clinical acquisition devices to EMR/HIS systems. Configurable workflow capabilities for managing administrative and clinical tasks in the diagnostic cardiology department, including order/patient demographic management, clinical test review/edit, clinical report distribution, and billing. |
|---|---|
| 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 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 monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison. |
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Comparison of Technological Characteristics with the predicate device:
At a high level, the subject and predicate devices are based on the following same technological elements:
- . Incorporated12SL ECG Analysis Program provides computerized measurements and interpretive diagnostic statements that assist the physician interpreting the ECG.
- . 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.
- . Translates and transfers patient demographic and administrative data from EMR/HIS systems to clinical acquisition devices and translates and transfers tests results from clinical acquisition devices to EMR/HIS systems.
- Configurable workflow capabilities for managing . administrative and clinical tasks in the diagnostic cardiology department, including order/patient demographic management, clinical test review/edit, clinical report distribution, and billing.
The following technological differences exist between the subject and predicate devices:
- The DICOM communication services provide workflow . functionality for managing ECG Test orders and results as an alternative to HL7.
- . eDOC connection feature provide the ability for the user to create custom test types and import test data using industry standard formats.
- . LDAP/AD authentication and authorization provide user the ability to log into the MUSE system using the customer's AD infrastructure.
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GE Healthcare 510(k) Premarket Notification Submission
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| Technology: | The proposed MUSE Cardiology Information System is a software device that runs on IT hardware employing the same functional scientific technology as the predicate device MUSE Cardiovascular Information System (K130155). |
|---|---|
| Determination of Substantial Equivalence: | Summary of Non-Clinical Tests:The MUSE Cardiology Information System complies with voluntary standards:IEC 62304:2006 – Medical device software – Software life-cycle processes IEC 62366:2007 – Medical devices – Application of usability engineering to medical devices. EN ISO 14971:2012 Medical devices – Application of risk management to medical devices 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. | |
| Conclusion: | GE Healthcare considers the MUSE Cardiology Information System to be as safe, as effective, and performance is substantially equivalent to the predicate device. |
§ 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).