(29 days)
The Heart 2006 is a long-term portable electrocardiogram monitor intended to be used for long-term cardiac out-patient management. The unit records a period of electrocardiogram whenever the patient feels symptoms, as indicated to him by a physician, and presses a button on the unit. The electrocardiograms are then sent to the physician by telephone.
The unit is indicated whenever it is desired to have electrocardiograms of a symptomatic patient at the time of the symptoms. There are no known contraindications.
The Heart 2006 is a battery-powered ECG event recorder and transmitter that is capable of storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station. It records a portion of the ECG both before and after a "Record" button is depressed.
The H2006 is a battery powered ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as Aerotel's Heartline Receiving Station (FDA # K022073) or equivalent. It records portions of the ECG both before and after the Record button is depressed.
The provided text states that no clinical tests were performed for the Heart 2006 device. Therefore, a study proving the device meets acceptance criteria, as well as specific acceptance criteria related to clinical performance, a test set, expert involvement, and ground truth, cannot be described from this document.
The document indicates that the device's modifications were validated through non-clinical tests, specifically by repeating IEC 601-1 and IEC 601-1-2 tests (electrical safety and electromagnetic compatibility) and the electrical characteristic tests of standard EC38. The conclusion drawn from these non-clinical tests was that the Heart 2006 is equivalent in safety and efficacy to its predicate device, Heart 2005.
Since no clinical study was conducted, the following information cannot be provided:
- A table of acceptance criteria and the reported device performance: No clinical acceptance criteria are mentioned, and no clinical performance data is reported.
- Sample size used for the test set and the data provenance: No clinical test set existed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No clinical test set existed, thus no ground truth establishment by experts.
- Adjudication method for the test set: No clinical test set existed.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No clinical study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No clinical study was performed, and the device is a hardware event recorder, not an AI algorithm.
- The type of ground truth used: No clinical ground truth was established.
- The sample size for the training set: The device is a hardware event recorder, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable, as detailed above.
§ 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).