(87 days)
K840932, K8423008/A
Not Found
No
The summary describes a system for accessing, storing, and managing cardiovascular information, including serial comparison/trending. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The focus is on data management and comparison, not algorithmic analysis for diagnosis or prediction.
No
The device is described as a computer system that accesses, stores, and manages cardiovascular information; it does not directly treat or diagnose a disease or condition.
No
The device is described as a computer system that accesses, stores, and manages cardiovascular information but does not state that it is used to diagnose conditions itself. It is explicitly stated to "serially compare/trend cardiovascular information", which is an information management function, not a diagnostic one.
Yes
The device is described as a "client server based computer system" that accesses, stores, and manages information. While it operates within a hospital environment and interfaces with other systems, the description focuses solely on the software's function of handling data (measurements, text, digitized waveforms) and does not mention any specific hardware components being part of the device itself. The predicate devices also appear to be software-focused systems for ECG analysis and data management.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- MUSE CV's Function: The description clearly states that the MUSE CV is a computer system that accesses, stores, and manages cardiovascular information, including measurements, text, and digitized waveforms. It does not process or analyze biological specimens.
- Input Modality: The input is described as "digitized waveforms," which are electrical signals representing physiological activity, not biological samples.
The MUSE CV is a system for managing and analyzing existing cardiovascular data, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The 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, and digitized waveforms. MUSE CV is intended to be used in a hospital environment by trained operators. MUSE CV is designed for network compatibility and interfaces with other hospital information systems through various communication protocols. MUSE CV provides the ability to serially compare/trend cardiovascular information.
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)
74 LOS
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, and digitized waveforms.
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
Intended User / Care Setting
trained operators; hospital environment
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)
MUSE CV complies with the voluntary standards as detailed in Section 9 of this submission.
The following quality assurance measures were applied to the development of MUSE CV.
- requirements specification reviews .
- code inspections .
- . software and hardware testing
- . safety testing
- . environmental testing
- . final validation.
The results of these measurements demonstrated that 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.
Marquette MUSE DP K840932, Marquette 12SSL - Serial Comparison ECG Analysis Program K8423008/A
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
N/A
0
Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters, which appears to be a combination of letters and numbers. The sequence reads 'K980495'. The characters are written in a dark ink, contrasting with the white background, and have a slightly rough, uneven texture, suggesting they were written with a pen or marker.
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.
| Submitter: | Marquette Medical Systems, Inc.
8200 W. Tower Avenue
Milwaukee, WI 53223
Telephone: (414) 355-5000
FAX: (414) 362-3553 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristin Pabst |
| Device: | Trade Name: MUSE Cardiovascular Information System
Classification Name: Computer, diagnostic, programmable Detector and Alarm, Arrhythmia |
| Predicate Devices: | Marquette MUSE DP K840932
Marquette 12SSL - Serial Comparison ECG Analysis Program K8423008/A |
| 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, and digitized waveforms. |
| Intended Use: | MUSE CV is intended to be used in a hospital environment.
MUSE CV is intended to be used 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.
The intended use of MUSE CV is identical to the intended use of the predicate devices. |
1
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.
Performance: MUSE CV complies with the voluntary standards as detailed in Section 9 of this submission.
The following quality assurance measures were applied to the development of MUSE CV.
- requirements specification reviews .
- code inspections .
- . software and hardware testing
- . safety testing
- . environmental testing
- . final validation.
The results of these measurements demonstrated that MUSE CV is as safe, as effective, and performs as well as the predicate devices.
2
Image /page/2/Picture/10 description: The image shows a partial logo of the U.S. Department of Health and Human Services (HHS). The logo features a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT" is partially visible, suggesting the full text would read "DEPARTMENT OF HEALTH AND HUMAN SERVICES".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pirit -1 13:50
Ms. Kristin Pabst Marquette Medical Systems, Inc. 8200 West Tower Avenue Milwaukee, WI 53223
K980495 Re: Muse Cardiovascular Information System Requlatory Class: III (three) Product Code: 74 LOS Dated: February 6, 1998 Received: February 9, 1998
Dear Ms. Pabst:
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 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 Requlation (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 requlation may result in regulatory 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 - Ms. Kristin Pabst
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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callah 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 - 510(k) filed February 6, 1998 510(k) Number (if known):
Device Name: MUSE CV Cardiovascular Information System
Indications For Use:
The 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, and digitized waveforms. MUSE CV is intended to be used in a hospital environment by trained operators. MUSE CV is designed for network compatibility and interfaces with other hospital information systems through various communication protocols. MUSE CV provides the ability to serially compare/trend cardiovascular information.
Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.
(Division Sign Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K980495
prescriptions use √
_
Te
000038