(114 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 multi-lead ECG devices. 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 using an Internet browser, Microsoft Internet Explorer. GlobalCardio operates as a client server application. GlobalCardio presents an interface to the user to 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, pacemaker follow-up, cardiac rehabilitation data, diagnosis, trans-telephonic monitoring, ECGs, ECG information, clinical history, physician notes, clinical history and associated reports and queries. GlobalCardio is a comprehensive ECG management system that is to be sold on a per-use or fee-for-service business and will not be shipped and installed, but rather, customer accounts which include user IDs and passwords will be created for each authorized client. All activity on GlobalCardio will be recorded by User ID: User IDs will be provided for each user to access their own secure, firewall protected, warehouse database(s). Databases may reside on the organizations computer network, managed by their own firewall. 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 other port, and stored to and retrieved from any computer media. Data 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 provided text is a 510(k) Summary for the GlobalCardio device (K013354). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain the acceptance criteria, details of a study proving device performance against acceptance criteria, or any of the other requested information such as test set size, expert qualifications, or ground truth establishment.
The document states:
- Device Name: GlobalCardio
- Applicant: CardioComm Solutions Inc.
- Date: January 29, 2002
- Intended Use: "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 cardiac related data acquired from a variety of ECG sources including single and multi-lead ECG devices."
- Key Distinction: "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."
Since GlobalCardio is a data management tool and explicitly states it does not offer diagnosis or medical alarms, and requires competent human intervention for interpretation, it is highly unlikely that a study with "acceptance criteria" for diagnostic performance (such as sensitivity, specificity, or accuracy) was performed or would be required for its 510(k) clearance as a data management system.
The 510(k) clearance process for a device like GlobalCardio typically focuses on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This often involves comparing features, data handling capabilities, security, and general functionality rather than clinical performance metrics for diagnosis.
To answer your specific questions, this document provides none of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. These are details often found in a separate clinical study report or a more detailed submission document, which is not included here.
§ 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).