(132 days)
The Study Watch is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The Study Watch is intended for use by healthcare professionals, adult patients (22 years or older) with known or suspected heart conditions, and health conscious individuals.
The Study Watch is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. The device utilizes a band and proprietary watch that incorporates two dedicated sensing electrodes to obtain a single-channel ECG measurement. In practice, a healthcare professional (HCP) may prescribe the Study Watch to a patient and recommend the capture and transmission of one or more ECG rhythms on a daily basis for analysis by the HCP. The patient uses prompts provided on the graphical user interface (GUI) of the watch to collect a real-time 60-second ECG measurement. While an animated ECG waveform is briefly displayed on the GUI of the watch, the patient will not have direct access to the collected waveform. Using the provided charging dock (Cradle) and Verily's Study Hub device, the ECG measurements are securely transferred to Verily's cloud server and are viewed by the HCP using a web portal. The web portal is solely intended for use by the HCP to view time-stamped ECG waveforms collected by the patient and does not include any analysis features. Collectively, the Study Watch consists of the wearable watch and band, the Study Hub (used to transfer data from the watch to the cloud), a Cradle, and the web portal.
The device in question is the Study Watch, intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of specific acceptance criteria. However, it states that "All tests confirmed that the product met the predetermined acceptance criteria." It also details the clinical performance finding:
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Non-Clinical Performance | Meeting Predetermined Acceptance Criteria: "All tests confirmed that the product met the predetermined acceptance criteria." This included validation of specifications related to software development, sensor performance, stability, and material properties. |
| Clinical Performance (Qualitative) | Qualitative Clinical Equivalence: The Study Watch generates data that meets the clinical quality requirements for an accurate ECG waveform display. The study sufficiently drew a conclusion of substantial equivalence based on meeting qualitative acceptance criteria. |
| Clinical Performance (Quantitative) | Inter-beat Interval (IBI) Bland-Altman Analysis: Bias of 1.2ms and 95% limits-of-agreement |
§ 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).