(89 days)
Not Found
No
The summary describes a system for accessing, storing, and managing cardiovascular information, including measurements, text, waveforms, and images. It mentions serial comparison and trending, and integration with a system for quantifying stenosis and ventricular function. However, it does not mention any AI or ML algorithms being used for analysis, interpretation, or decision support. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a computer system for accessing, storing, and managing cardiovascular information. It aids in documentation and information continuity but does not directly provide therapy.
No
Explanation: The device manages and stores cardiovascular information, and aids in quantifying stenosis and ventricular function based on pre-existing data, but it does not independently acquire or analyze raw physiological signals to produce a diagnostic output.
No
The device description explicitly states it is a "client server based computer system" and mentions "hardware testing" in the performance studies summary, indicating it includes hardware components beyond just software.
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 MUSE CV is a computer system for accessing, storing, and managing cardiovascular information. It handles measurements, text, digitized waveforms, and angiographic/video images. It aids in documenting and quantifying information derived from these sources.
- Device Description: The description reinforces that it's a computer system for managing cardiovascular information.
- Lack of In Vitro Activity: An IVD is a device intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes. MUSE CV does not perform any such examination of biological specimens. It processes and manages data and images obtained from other sources (like ECGs, angiograms, etc.).
While the system processes and presents information that can be used for diagnostic purposes by a physician, the system itself is not performing the in vitro diagnostic test. It's a tool for managing and presenting the results of other diagnostic procedures.
N/A
Intended Use / Indications for Use
MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images.
MUSE CV is intended to be used in a hospital environment by trained operators.
MUSE CV is designed for network compatibility to facilitate retrieval and distribution of cardiovascular information.
MUSE CV is designed to interface with other hospital information systems through various communication protocols to support information continuity and results reporting.
MUSE CV can provide serial comparison of cardiovascular information to facilitate review of current and previous records.
MUSE CV can provide serial trending of cardiovascular information to facilitate review of current and previous records.
Through integration with Accusketch (CardioTrace), MUSE aids the physician or trained technologist in providing and documenting an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.
Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.
Product codes (comma separated list FDA assigned to the subject device)
74DQK, DSI
Device Description
MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic images, video images
Anatomical Site
coronary artery, left ventricular
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
hospital environment by trained operators, physician or trained technologist
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 CV complies with voluntary standards as detailed in Section 9 Specific Standards and Guidances of this submission. The following quality assurance measures were applied to the development of MUSE CV: Requirements specification review Risk analysis Design, software and test plan reviews Code inspections Testing on unit level Software and hardware testing System Integration testing Final acceptance testing Environmental Testing Safety testing The results of these measures demonstrate MUSE CV is as safe, as effective, and performs as well as the predicate devices.
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.
K980495 MUSE Cardiovascular Information System, K912829 CardioTrace Cardiac Evaluation System
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.
Not Found
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
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
NOV - 3 1999
Image /page/0/Picture/1 description: The image contains handwritten text. The top line reads 'K992637'. The bottom line reads 'P/2'.
Section 2 Summary and Certification
2.1 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date: | July 30, 1999 |
|---|---|
| Submitter: | GE Marquette Medical Systems |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Laura L McComis |
| Corporate Regulatory Affairs | |
| GE Marquette Medical Systems | |
| Phone: (414) 362-2688 | |
| Fax: (414) 355-3790 | |
| Device: | MUSE Cardiovascular Information System |
| Trade Name: | |
| Common/Usual Name: | Computer, diagnostic, programmable |
| Detector and Alarm, Arrhythmia | |
| Classification Names: | Classification Name: Computer, Diagnostic, Programmable |
| Classification Number: 74DQK | |
| Predicate Devices: | K980495 MUSE Cardiovascular Information System |
| K912829 CardioTrace Cardiac Evaluation System | |
| Device Description: | MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images. |
1
| Intended Use: | MUSE CV is intended to be used in a hospital environment by trained
operators.
MUSE CV is designed for network compatibility to facilitate retrieval and
distribution of cardiovascular information.
MUSE CV is designed to interface with other hospital information systems
through various communication protocols to support information continuity
and results reporting.
MUSE CV can provide serial comparison of cardiovascular information to
facilitate review of current and previous records.
MUSE CV can provide serial trending of cardiovascular information to
facilitate review of current and previous records.
Through integration with Accusketch (CardioTrace), MUSE aids the physician
or trained technologist in providing and documenting an objective
quantification of coronary artery stenosis and measurement and quantification
of left ventricular function. Also provided is the ability to digitize and store
video images and the ability to interactively annotate and report current and
post procedural patient cardiac status.
Use of MUSE CV is intended for accessing, storage and management of both
adult and pediatric cardiovascular information.
The intended use of MUSE CV is identical to the intended use of the predicate
devices |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology: | MUSE CV employs the same functional technology as the predicate devices.
The only difference being the technological improvements made by
manufacturers with respect to speed, performance and reliability. |
| Test Summary: | The MUSE CV complies with voluntary standards as detailed in Section 9
Specific Standards and Guidances of this submission. The following quality
assurance measures were applied to the development of MUSE CV:
Requirements specification review Risk analysis Design, software and test plan reviews Code inspections Testing on unit level Software and hardware testing System Integration testing Final acceptance testing Environmental Testing Safety testing |
Conclusion:
The results of these measures demonstrate MUSE CV is as safe, as effective, and performs as well as the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles merging into a single form, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1999
Laura L. McComis Requlatory Affairs Specialist GE Marquette Medical Systems 8200 W. Tower Avenue Milwaukee, WI 53223
Re: K992637 Muse Cardiovascular Information System Regulatory Class: III (three) Product Code: DSI August 5, 1999 Dated: August 6, 1999 Received:
Dear Ms. McComis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Laura L. McComis
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Acting Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Section 11 Intended Use Statement
Unknown-540(tr) filed: July 30, 1999 510(k) Number (if known):
Device Name:
MUSE CV Cardiovascular Information System
Indications For Use:
MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images.
MUSE CV is intended to be used in a hospital environment by trained operators.
MUSE CV is designed for network compatibility to facilitate retrieval and distribution of cardiovascular information.
MUSE CV is designed to interface with other hospital information systems through various communication protocols to support information continuity and results reporting.
MUSE CV can provide serial comparison of cardiovascular information to facilitate review of current and previous records.
MUSE CV can provide serial trending of cardiovascular information to facilitate review of current and previous records.
Through integration with Accusketch (CardioTrace), MUSE aids the physician or trained technologist in providing and documenting an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status.
Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Venkatesh. Ch
Cardiovascular, Respiratory,
510(k) Number K992637