(70 days)
No
The summary describes a system for storing, accessing, and managing cardiovascular information, including reviewing and editing ECG data. It focuses on software virtualization and data management functionalities. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an information system for storing, accessing, and managing cardiovascular information, and for reviewing and editing ECG procedures; it does not directly treat or diagnose a disease or condition.
Yes.
The device facilitates the review and editing of electrocardiographic procedures, including ECG serial comparison, which are diagnostic activities. It stores, accesses, and manages cardiology information (measurements, text, digitized waveforms) from diagnostic equipment, indicating its role in supporting the diagnostic process.
Yes
The device description explicitly states that the proposed change will be marketed as a "software only offering" and utilizes off-the-shelf virtualization software. While it interacts with hardware through the OS and virtualization layer, the device itself is presented as a software product.
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 Cardiology Information System's intended use and description clearly state that it is for storing, accessing, and managing cardiovascular information which includes measurements, text, and digitized waveforms (specifically ECGs). It provides tools for reviewing, editing, and comparing this data.
- Lack of Specimen Analysis: The system does not perform any analysis on biological specimens. It works with data that has already been acquired from diagnostic equipment (like ECG machines).
In summary, the MUSE system is a data management and review tool for cardiovascular information, not a device that analyzes biological samples for diagnostic purposes.
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 intended to store, access and manage cardiology information on adult and pediatric patients. MUSE Cardiology Information System has been marketed to operate within Microsoft Windows Operating System (OS) directly interacting with the host hardware. GE Healthcare intends to change this interaction by running MUSE Cardiology Information System with an Off the Shelf virtualization software layer. GE feels that this proposed change alters the principal of operation of the Operating System. This proposed change will be marketed as a software only offering, which will utilize an OTS software that virtualizes the host hardware. This will allow multiple OS shells to run on a single hardware server, one of which is the OS hosting the predicate MUSE Cardiology Information System program.
The functional intent of MUSE Cardiology Information System with VMWare will remain the same as the premarket notification reviewed in 2007 (K072502). For conveyance the description for (K072502) is the following:
The MUSE Cardiology Information System is a network PC based system comprised of a client workstation /servor configuration that manages adult and pediatric diagnosis cardiology data by providing centralized storage and ready access 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.
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.
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
The subject of this premarket submission, MUSE Cardiology Information System with VMWare, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K072502 MUSE Cardiology Information System
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
FEB 1 7 2009
GE Healthcare 510(k) Premarket Notification Submission MUSE Cardiology Information System with VMWare
510(k) Summary
In accordance with 21 CFR 807:92 the following summary of information is provided:
| Date: | December 5, 2008 |
|---|---|
| Submitter: | Larry Lepley |
| Regulatory Affairs - Diagnostic Cardiology | |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Larry Lepley |
| Regulatory Affairs - Diagnostic Cardiology | |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| T: (414) 721-2593 | |
| F: (414) 721-3899 | |
| Secondary Contact Person: | Patricia Taige |
| Regulatory Affairs - Diagnostic Cardiology | |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| T: (414) 721-3222 | |
| F: (414) 721-3899 | |
| Device: | |
| Trade Name: | MUSE Cardiology Information System |
| Common/Usual Name: | ECG Analysis Computer, Programmable Diagnostic Computer |
| Classification Names: | 21 CFR 870.1425 |
| Product Code: | DQK |
| Predicate Device(s): | K072502 MUSE Cardiology Information System |
| Device Description: | The MUSE Cardiology Information System is intended to store, |
| access and manage cardiology information on adult and pediatric | |
| patients. MUSE Cardiology Information System has been | |
| marketed to operate within Microsoft Windows Operating System | |
| (OS) directly interacting with the host hardware. GE Healthcare | |
| intends to change this interaction by running MUSE Cardiology | |
| Information System with an Off the Shelf virtualization software | |
| layer. GE feels that this proposed change alters the principal of | |
| operation of the Operating System. This proposed change will be | |
| marketed as a software only offering, which will utilize an | |
| OTS software that virtualizes the host hardware. This will allow | |
| multiple OS shells to run on a single hardware server, one of | |
| which is the OS hosting the predicate MUSE Cardiology | |
| Information System program. |
17
Page. 1 OF 3
1
GE Healthcare 510(k) Premarket Notification Submission MUSE Cardiology Information System with VMWare
The functional intent of MUSE Cardiology Information System with VMWare will remain the same as the premarket notification reviewed in 2007 (K072502). For conveyance the description for (K072502) is the following:
The MUSE Cardiology Information System is a network PC based system comprised of a client workstation /servor configuration that manages adult and pediatric diagnosis cardiology data by providing centralized storage and ready access U:Ree) from OF 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.
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.
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 cditing 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 MUSE Cardiology Information System with VMWare
2
GE Healthcare
510(k) Premarket Notification Submission MUSE Cardiology Information System with VMWare
employs a different functional scientific technology as its predicate devices.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The MUSE Cardiology Information System with VMWare and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- � Risk Analysis
- Requirements Reviews .
- . Design Reviews
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Final acceptance testing (Validation) .
- Performance testing (Verification)
- Safety testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission, MUSE Cardiology Information System with VMWare, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the MUSE Cardiology Information System with VMWare to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
Page 3 OF 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains an eagle with three stripes on its back. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2009
GE Medical Systems Information Technologies c/o Mr. Larry Lepley Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226
Re: K083639
Trade/Device Name: MUSE Cardiology Information System with VMWare Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: December 5, 2008 Received: December 6, 2008
Dear Mr. Lepley:
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 approvat of a premailet approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of 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 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
4
Page 2 - Mr. Larry Lepley
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 clectronic 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 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,
001 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
GE Healthcare
510(k) Premarket Notification Submission MUSE Cardiology Information System with VMWare
510(k) Number (if known):
Device Name:
MUSE Cardiology Information System with VMWare
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 (Part 21 CITR 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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mitchel Stein for B Zuckerman
Division Sian-Offi 2/17/09 Division of Cardlovascular Devices 510(k) Number KO8363
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