(206 days)
The ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server. Specifically, the ECG Check is indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms: Skipped Beats, Pounding Heart (Palpitations), Heart Racing or Irregular Pulse, Lightheadedness or Faintness, History of Arrhythmias.
The ECG Check model ECG01-4S is a personal 1 lead ECG Event Monitor specifically designed to operate with an iPhone 4S handset and allows transmissions to the ECG Check web center. Future iterations will be designed for other handsets, but will not change the fundamental features and capabilities described herein. It will record a preselected amount of user ECG activity, as directed by the user. Typical configuration is to record 30 seconds of ECG per event. The ECG Check, when used in conjunction with the ECG Check web center, uses standard analysis of ECG by the web-based engine for objective assessment of the user in terms similar to a stoplight (Green, Yellow, Red). With a physician prescription, the user will be provided access to be able to trend their results and generate reports to provide to their physician or other caregivers. While performing the recording, the results are continuously sent to the iPhone by secure Bluetooth connection technology and, with a physician prescription, displayed for quality and observation purposes on the iPhone ECG Check application. Users without a physician prescription will not be able to view the waveform. The data can then be stored locally and/or transmitted to the ECG Check web center for analysis and assessment by qualified professionals. The ECG Check web center provides privacy and protection for user medical information and the ability to interact with Cardiac Designs, LLC technicians and engineers, as well as with their own caregivers. The ECG Check Model ECG01-4S is intended for users that seek to manage their heart rate and rhythms over long periods of time.
The provided text does not contain specific acceptance criteria for device performance or a study demonstrating that the device meets such criteria. Instead, it details the device's indications for use, its technical features, and a comparison to a predicate device for substantial equivalence.
The text states that the "ECG CHECK device successfully passed safety and essential performance testing as required by: IEC 60601-1, IEC 60601-2-47 - Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems. ISO 10993-5:2009 Cytotoxicity - MEM Elution Test, ISO 10993-10:2010 Maximization Test for Delayed Hypersensitivity, ISO 10993-10:2010 Intracutaneous (Intradermal) Reactivity Test." However, it does not provide specific performance metrics or acceptance thresholds.
Therefore, the following information cannot be extracted from the provided document:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).