(30 days)
The V-Patch Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.
The V-Patch Cardiac Monitor ("V-Patch CM") is a continuous electrocardiogram (ECG) recording device to record, store, and transfer single channel ECGs and is designed for remote ECG data collection and remote monitoring. The device is in the form of an ECG patch that records ECG signals and transmits directly to a Bluetooth™ enabled device. The V-Patch CM has Bluetooth module for transferring ECG data from V-Patch CM to a Bluetooth enabled computing or mobile devices to be accessible to healthcare professionals. The V-Patch CM includes a battery powered electronic unit that is used with off-the-shelf (OTS) disposable medical grade gel electrodes for long term monitoring. The adhesive electrodes should be replaced by the user every 24 hours or when it no longer adheres to skin. The V-Patch CM is a prescription use device and the recorded ECG data is intended to be used with other patient data. The device does not provide any automated ECG analysis.
The provided document does not contain information about specific acceptance criteria, device performance, sample sizes used, data provenance, expert involvement, adjudication methods, MRMC studies, or standalone performance for the V-Patch™ Cardiac Monitor.
The document is a 510(k) summary for the V-Patch™ Cardiac Monitor (K222842) and focuses on establishing substantial equivalence to a predicate device (eCordum™ Cardiac Monitor, K193296). It outlines the device description, indications for use, and a comparison of technological characteristics, stating that the two devices are "identical in form and function..., using the same components, materials, and software... and the same manufacturing process."
Instead of presenting performance data against specific acceptance criteria, it lists nonclinical testing activities that were successfully passed, indicating compliance with relevant standards. These tests confirm the device's electrical safety, electromagnetic compatibility, biocompatibility, and functionality for ambulatory ECG recording, but they do not provide quantitative performance metrics against pre-defined acceptance criteria.
The document explicitly states: "No clinical testing is required to demonstrate substantial equivalence to the predicate eCordum Cardiac Monitor (K193296)." This implies that no specific clinical study was conducted to prove primary performance criteria for the V-Patch™ Cardiac Monitor itself.
Therefore, I cannot provide the requested information based on the given text.
§ 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).