(142 days)
The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode.
Holter Mode
Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation.
Event Recorder
The Telaheart event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once data is recorded, the data is transmitted via telephone for evaluation.
The device includes the Auto Detect feature which can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more events are captured the patient may transmit his/her recordings transtelephonically.
NorthEast Monitoring will offer versions with the Auto Detect feature.
- Telaheart DR200/E-a Event Recorder with Auto Detect feature (using a black background).
- DR200/HE-a Holter and Event Recorder with Auto Detect feature (using white background).
The Auto Detect feature can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more events are captured the patient may transmit his/her recordings transtelephonically. The device stores the events in memory. There is a display counter for the events and an audible beep to remind the user to transmit the data to the physician.
The data obtained during monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring Holter or Event analysis system.
The provided text focuses on a 510(k) summary for the "Auto Detect for Telaheart" device. It outlines the device description, its similarity to predicate devices, and its intended use. However, it does not contain information on acceptance criteria for device performance or a detailed study proving the device meets such criteria.
The document states:
- "The subject device has been subjected to and passed electrical safety and EMC testing requirements." (Page 4)
- "We believe the changes are minor and conclude that the subject device is as safe and effective as the predicate devices" (Page 4)
This implies that the device's performance was deemed adequate based on its substantial equivalence to predicate devices and compliance with electrical safety and EMC standards. There is no mention of a specific performance study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement for the "Auto Detect" feature's clinical performance.
Therefore, I cannot provide the requested information from the given text. The text does not describe a study that proves the device meets specific acceptance criteria related to its "Auto Detect" feature's clinical performance.
§ 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).