(85 days)
Not Found
No
The description focuses on data management, storage, retrieval, and display, with no mention of AI or ML algorithms for analysis or interpretation. The text explicitly states that clinical judgment and experience are used to check and interpret the data.
No
GEMS is a data management tool for storing, retrieving, communicating, and reporting ECG and ECG data, and does not offer diagnosis or medical alarms, nor is it a life-supporting or life-sustaining system. Its purpose is to manage data, not to provide therapy.
No
GEMS is explicitly stated to not offer diagnosis or medical alarms, and it is a data management tool for cardiologists and other healthcare professionals.
Yes
The device description explicitly states "GEMS is a software product" and details its operation on standard computer operating systems and hardware, without mentioning any proprietary or integrated hardware components that are part of the medical device itself. It functions as a data management tool for data acquired from external ECG sources.
Based on the provided information, GEMS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that GEMS is a data management tool for storing, retrieving, communicating, and reporting ECG and ECG data. It explicitly states that GEMS does not offer diagnosis or medical alarms. The emphasis is on providing data for competent human intervention and clinical judgment.
- Device Description: The description reinforces that GEMS is a software product for managing patient cardiology records. It focuses on data input, storage, and output. It also explicitly states that GEMS is not a life-supporting or life-sustaining system and relies on human intervention for any health impact.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. GEMS deals with electrical signals from the heart (ECG data), not biological specimens.
While GEMS is a medical device used in a clinical setting and plays a role in managing patient data related to diagnosis and treatment, its function is data management and presentation, not the analysis of in vitro specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices, including diagnostic 12-lead devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients' needs. The ECG module may be licensed to other software developers as an ECG viewer for their products. GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GEMS does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.
Product codes (comma separated list FDA assigned to the subject device)
74 DPS
Device Description
GEMS is a software product designed for Microsoft Windows 98, Windows NT, and Windows 2000 operating systems running on an IBM compatible platform. GEMS is compatible with industry standard client server database management systems and as such will operate standalone or on a local or wide area networks. GEMS consists of a user interface that enables health care professionals to input, store, and output data from a relational database.
The product consists of a set of modules that can be installed as required to customize the application to individual users' needs. Modular design has the benefit of encapsulating changes within the overall application. If a module changes, then in most cases the change will affect only that module and will not affect the rest of the program. This permits more efficient and controlled development and testing, and prevents new and unknown safety issues and anomalies from being introduced. This stability contributes to the safety and reliability of the product.
GEMS is capable of multi-tasking and supports the linking and embedding of related information objects in the ECG. The software stores all aspects of a patient's cardiology record including: arrhythmia diagnosis, pathological diagnosis, ECGs, ECG information, physician notes, clinical history, pacemaker/ICD data and associated reports.
Data can be entered via keyboard, mouse, bar code reader, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed.
GEMS is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the 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
Not Found
Intended User / Care Setting
GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers. GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate.
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)
Only one feature of GEMS cannot be found in the predicate device: heart rate calculation in software. Testing for calculation of heart rate in software has been completed and submitted according to the relevant sections of AAMI EC38.
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.
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
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
APR 3 0 2002
Image /page/0/Picture/1 description: The image shows the logo for CardioComm Solutions Inc. The logo features a stylized heart shape above the company name. The heart shape is formed by two curved lines that meet at the bottom and top, creating a heart-like silhouette. Below the heart shape, the words "CARDIOCOMM" and "SOLUTIONS INC" are printed in a bold, sans-serif font.
11020366 01/2
Submitter
| Name: | CardioComm Solutions Inc. |
|---|---|
| Address: | 201 – 3060 Cedar Hill Road |
| Victoria, B.C., Canada | |
| V8T 3J5 | |
| Phone: | (250) 744-1822 |
| Fax: | (250) 744-1866 |
| Contact: | Angela Halwas |
| Date: | January 30, 2002 |
510(k) SUMMARY
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.
The assigned 510(k) number is: K982384.
Device
Global ECG Management System II (GEMS) Name:
Brentwood PC-ECG (K955023) Substantial Equivalence is claimed to:
Description:
GEMS is a software product designed for Microsoft Windows 98, Windows NT, and Windows 2000 operating systems running on an IBM compatible platform. GEMS is compatible with industry standard client server database management systems and as such will operate standalone or on a local or wide area networks. GEMS consists of a user interface that enables health care professionals to input, store, and output data from a relational database.
The product consists of a set of modules that can be installed as required to customize the application to individual users' needs. Modular design has the benefit of encapsulating changes within the overall application. If a module changes, then in most cases the change will affect only that module and will not affect the rest of the program. This permits more efficient and controlled development and testing, and prevents new and unknown safety issues and anomalies from being introduced. This stability contributes to the safety and reliability of the product.
GEMS is capable of multi-tasking and supports the linking and embedding of related information objects in the ECG. The software stores all aspects of a patient's cardiology record including: arrhythmia diagnosis, pathological
cV
1
GEMS (K982384) -- 510(k) Summary
diagnosis, ECGs, ECG information, physician notes, clinical history, pacemaker/ICD data and associated reports.
Data can be entered via keyboard, mouse, bar code reader, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed.
GEMS is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.
Intended Use:
GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices, including diagnostic 12lead devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients' needs. The ECG module may be licensed to other software developers as an ECG viewer for their products. GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GEMS does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.
Technological Characteristics:
Only one feature of GEMS cannot be found in the predicate device: heart rate calculation in software. Testing for calculation of heart rate in software has been completed and submitted according to the relevant sections of AAMI EC38.
All other features of GEMS are present in the predicate. GEMS is therefore substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2002
Ms. Angela Halwas Quality System Manager CardioComm Solutions, Inc. 201 - 3060 Cedar Hill Road Victoria, B.C., Canada V8T 3J5
Re: K020366
Trade Name: Global ECG Management System II (GEMS) Regulation Name: Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulatory Class: Class II (two) Product Code: 74 DPS Dated: January 31, 2002 Received: February 4, 2002
Dear Ms. Halwas:
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.
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.
3
Page 2 - Ms. Angela Halwas
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dri brisaantes vour device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any 1 coolar bakated that egirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT rat 6077, idoomig (DI CFR Part 820); and if applicable, the electronic 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) This letter will anow you to ough finding of substantial equivalence of your device to a legally premainst notification " 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of ICP article of the stime on the promotion and advertising of Compliance at (301) 594-4639 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regaration on information on your responsibilities under the Act may be obtained from the Oiner general miormation on your nernational and Consumer 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,
V. Craig Tiller, Ph.D.
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of
KOZO368 510(k) Number (if known):
Global ECG Management System (GEMS) Device Name:
Indications For Use:
GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices, including diagnostic 12-lead devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients' needs. The ECG module may be licensed to other software developers as an ECG viewer for their products. GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GEMS does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020362
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)