(91 days)
No reference devices were used in this submission
No
The document describes a cardiology information system for managing and reviewing ECG data, including serial comparison and interpretive analysis, but does not mention AI or ML. The predicate device K141963 is an ECG analysis program, which could potentially use algorithms, but the summary does not indicate AI/ML.
No
The device is a cardiology information management system used to store, access, and manage cardiovascular information, not to provide therapy. Its functions relate to data review, editing, and reporting, and it explicitly states it is "not intended for real-time patient monitoring."
Yes
The device manages and provides access to diagnostic cardiology data, including the review and editing of electrocardiographic procedures and interpretive 12-lead analysis. While it doesn't perform real-time monitoring or acquisition, its function is to process and present data that is used to make diagnoses.
No
The device description explicitly states it 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." This implies interaction with and management of data from hardware devices, making it more than just software.
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 devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc., outside of the living body.
- MUSE System Function: The MUSE system is described as a cardiology information management system. Its primary functions are:
- Storing, accessing, and managing cardiovascular information (measurements, text, digitized waveforms).
- Reviewing and editing electrocardiographic procedures (ECG data).
- Generating reports.
- Transferring data between EMR/HIS systems and acquisition devices.
- Managing workflow in a cardiology department.
- Lack of Specimen Examination: The description does not mention the system performing any tests or analyses on biological specimens. It processes and manages data that is acquired from other devices (like ECG machines), but it doesn't perform the diagnostic test itself on a specimen.
- Focus on Data Management and Review: The core activities of the MUSE system revolve around the management, review, and editing of existing cardiovascular data, particularly ECGs.
Therefore, the MUSE Cardiology Information System falls under the category of a medical device, but not specifically an In Vitro Diagnostic device. It's a system that supports the diagnostic process by managing and presenting data, but it doesn't perform the in vitro diagnostic test itself.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
DOK
Device Description
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.
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 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)
Submitting device did not require clinical studies.
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MUSE Cardiology Information System K130155, 12SL ECG Analysis Program K141963
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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
2
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 Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Amy Yang |
| Regulatory Affairs Program Manager | |
| GE Medical Systems Information Technologies, Inc. | |
| Phone: (414)721-3807 | |
| Fax: (414) 721-3863 | |
| Secondary Contact Person: | Doug Kentz |
| Regulatory Affairs Director | |
| GE Medical Systems Information Technologies, Inc. | |
| Phone: (414)581-8987 | |
| 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) |
| Regulatory Class: | II |
| Product Code: | DQK |
| Predicate Device(s): | MUSE Cardiology Information System K130155 |
| 12SL ECG Analysis Program K141963 | |
| No reference devices were used in this submission |
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| Device Description: | 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. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |