(127 days)
K#072502, K#083639
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data management and review tools, not AI/ML capabilities.
No.
The device is a Cardiology Information System used to store, access, manage, review, and edit cardiovascular information and generate reports; it does not provide treatment or direct therapy.
Yes
The device description states that the system manages "adult and pediatric diagnostic cardiology data," and its intended use includes "interpretive 12-lead analysis," which are functions typically associated with diagnostic processes.
No
The device description explicitly states it is a "network PC- based system comprised of a client workstation/server configuration," indicating it includes hardware components beyond just software.
Based on the provided information, the MUSE Cardiology Information System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They perform tests outside of the body.
- MUSE System Function: The MUSE system stores, accesses, and manages cardiovascular information, including measurements, text, and digitized waveforms (like ECGs). It provides tools for reviewing and editing this data. While it processes data from diagnostic equipment, it does not perform the diagnostic test itself on a biological specimen.
- Intended Use: The intended use describes the system as managing and reviewing cardiovascular information, not performing in vitro tests on patient samples.
- Device Description: The description focuses on data management, review, and reporting of diagnostic cardiology data.
The MUSE system is a medical device, but it falls under a different category than IVDs. It's a system for managing and analyzing data generated by other diagnostic devices (like ECG machines).
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, 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 patient monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.
Also: 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)
DQK
Device Description
The MUSE Cardiology Information System is a network PC-based system comprised of a client workstation/server configuration that manages adult and pediatric diagnostic cardiology data by providing centralized storage and ready access to a wide range of data/reports (e.g. Resting ECG, Stress, Holter, 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 and interpretive 12-lead analysis. • Generate formatted management reports, ad-hoc database search reports and clinical patient reports on selected stored data.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, MUSE Cardiology Information System, did not require clinical studies to support substantial equivalence.
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 K#072502, MUSE Cardiology Information System w/ VMWare K#083639
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
§ 870.1425 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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K110132 pg 1 of 2
MAY 2 5 2011
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized and appear to be in a sans-serif font.
GE Healthcare
510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
January 12, 2011 Date:
| Submitter: | GE Medical Systems Information Technologies
9900 Innovation Drive
Wauwatosa, WI 53226 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Kristin Pabst
Regulatory Affairs Manager
GE Medical Systems Information Technologies
Phone: (414) 721-3104
Fax: (414) 721-3863 |
| Secondary Contact
Person: | Patricia Taige
Regulatory Affairs Leader
GE Medical Systems Information Technologies
Phone (414) 721-3222
FAX: (414) 721-3863 |
| Device: Trade Name: | MUSE Cardiology Information System |
| Common/Usual Name: | ECG Analysis Computer |
| Classification Names: | Programmable Diagnostic Computer (21 CFR 870.1425) |
| Product Code: | DQK |
| Predicate Device(s): | MUSE Cardiology Information System K#072502
MUSE Cardiology Information System w/ VMWare K#083639 |
| Device Description: | The MUSE Cardiology Information System is a network PC-
based system comprised of a client workstation/server
configuration that manages adult and pediatric diagnostic
cardiology data by providing centralized storage and ready
access to a wide range of data/reports (e.g. Resting ECG,
Stress, Holter, 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
and interpretive 12-lead analysis.
• Generate formatted management reports, ad-hoc database
search reports and clinical patient reports on selected stored
data. |
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and appear to be in a cursive font. The logo is black and white.
GE Healthcare
510(k) Premarket Notification Submission
The MUSE Cardiology Information System is intended to store, Intended Use: 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.
The proposed MUSE Cardiology Information System employs Technology: the same functional scientific technology as the predicate devices MUSE Cardiovascular Information System (K072502) and MUSE Cardiovascular Information System w/ VMWare (K083639).
Determination of Summary of Non-Clinical Tests:
Substantial Equivalence:
The MUSE Cardiology Information System complies with voluntary standards as detailed in Section 9 and 17 of this premarket submission. 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 devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
GE Medical Systems Information Technologies, Inc c/o Ms. Kristin Pabst Regulatory Affairs Manager 9900 West Innovation Drive Wauwatosa, WI 53226
MAY 2 5 2011
Re: K110132
Trade/Device Name: Muse Cardiology Information System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: May 4, 2011 Received: May 6, 2011
Dear Ms. Pabst:
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.
3
Page 2 - Ms. Kristin Pabst
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
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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K110132 pg lofl
Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background.
GE Healthcare
510(k) Premarket Notification Submission
510(k) Number (if known):
MUSE Cardiology Information System Device Name:
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, 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 patient monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.
Prescription Use_X AND/OR (Part 21 CFR 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular-Device
510(k) Number K110132