(201 days)
The CardioPAL is a pager-sized, handheld or patient-worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature. Since the CardioPAL is patient-activated, the device is not intended for use by patients who are unable to activate the Record switch when they are experiencing a symptom.
The CardioPAL is a pager-sized, handheld or patient-worn device designed specifically to record and transmit ambulatory ECG signals.
The provided text is an FDA 510(k) clearance letter for the CardioPAL (Model PM20) Event/Loop Recorder. This letter approves the marketing of the device based on its substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT contain information about specific acceptance criteria or a study proving the device meets those criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. It typically relies on comparison to a predicate device, sometimes supported by performance data, but it does not usually include a detailed report of a study establishing new acceptance criteria or proving performance against them in the way described in your request.
Therefore, I cannot extract the requested information as it is not present in the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the device's performance against specific metrics.
§ 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).