(150 days)
GlobalCardio 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 multilead ECG devices. GlobalCardio includes a QRS Algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation.
GlobalCardio will be accessed over the Internet and data will be stored at either the client site or at the central GlobalCardio data warehouse. Data will be secure, and with separate data stores for each client. Users will be able to access specific modules for managing patient cardiac related data such as arrhythmia data that fit their patients' needs. GlobalCardio is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GlobalCardio 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.
GlobalCardio is a cardiology software product, delivered over the web using the Application Service Provider (ASP) model. GlobalCardio operates on IBM compatible PCs and runs within an Internet browser, Microsoft Internet Explorer. GlobalCardio operates as a client server application. GlobalCardio presents an interface for health care professionals to input, store, query and output data from a centrally hosted, or client based relational database.
The product is a web-based database system for the secure storage of all aspects of a patient's cardiology record including: arrhythmia follow-up and diagnosis, transtelephonic pacemaker follow-up, implantable cardioverter defibrillator (ICD) follow-up, in-clinic follow-up, 12 Lead ECG testing, cardiac rehabilitation data, stress test data pathological diagnosis, ECGs, ECG information, clinical history, physician notes, clinical history and associated reports and queries.
GlobalCardio is a comprehensive ECG management system. GlobalCardio is sold in two ways:
- Per-use or fee-for-service. Software is not shipped and installed, but instead customer accounts are set up for access and record management from the centrally hosted web application. Login IDs and passwords are created for each authorized client. Databases reside in the secure, firewall protected, warehouse at the application host site.
- Technology licensing. GlobalCardio technology is licensed to another company which then hosts a complete service, as described above, including secure data warehousing.
All activity on GlobalCardio is recorded by User ID. User IDs are provided for each customer to access their own secure database(s).
GlobalCardio is designed as a multi-user system capable of supporting large volumes of simultaneous users.
Data can be entered via keyboard, mouse, bar code reader, sound card, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed.
GlobalCardio 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.
The purpose of this submission is to include the 12 Lead ECG and Digital Device Integration modules.
The provided 510(k) summary for K111320 (GlobalCardio) describes performance testing as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases." It then lists the types of activities:
- Scenario validations
- Report viewing and customization testing
- Algorithm confirmation testing
- Device functional testing
However, specific acceptance criteria (e.g., numerical thresholds for accuracy, sensitivity, specificity, or specific functional requirements) and the quantitative results of these tests are not provided in this 510(k) summary. The summary only confirms that "predetermined acceptance criteria were met in all cases."
2. Sample Size Used for the Test Set and Data Provenance:
The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly mentions "verification and validation activities."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The summary does not specify the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set:
The summary does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
There is no mention of an MRMC comparative effectiveness study being performed. The device is a data management tool and includes a QRS algorithm to produce measurements and textual interpretation, but it explicitly states: "GlobalCardio 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." This suggests the device is not intended as a standalone diagnostic tool that would typically undergo an MRMC study to compare performance with human readers.
6. Standalone (Algorithm Only) Performance:
An "Algorithm confirmation testing" was performed, indicating that the QRS algorithm's performance was evaluated. However, specific metrics, results, or the methodology of this standalone evaluation are not disclosed in this summary. The device's intended use emphasizes human oversight, so while the algorithm was tested, its standalone performance isn't presented as a primary performance metric for regulatory purposes.
7. Type of Ground Truth Used:
The summary does not explicitly state the type of ground truth used for "Algorithm confirmation testing." Given the nature of a QRS algorithm, it would typically involve comparison against a gold standard derived from expert consensus or highly accurate, manually annotated ECG recordings.
8. Sample Size for the Training Set:
The 510(k) summary does not provide any information regarding the sample size used for the training set of the QRS algorithm.
9. How Ground Truth for the Training Set Was Established:
The 510(k) summary does not provide any information on how the ground truth for the training set was established.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).