(106 days)
The V1 Multi-port Connector is intended to be used primarily in electrophysiology (EP) laboratories as a multi-port connector with switching capabilities for connection to defibrillator, EP study equipment and electrosurgical devices. It provides a stable, focal location for multiple wires, cables and connections. The device allows the defibrillator to be used as a back-up for stimulating and pacing when those pieces of equipment are unavailable.
The V1 Multi-port Connector is intended to be used primarily in electrophysiology (EP) laboratories as a multi-port connector with switching capabilities for connection to defibrillator, EP study equipment and electrosurgical devices. It provides a stable, focal location for multiple wires, cables and connections. The device allows the defibrillator to be used as a back-up for stimulating and pacing when those pieces of equipment are unavailable.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (VI Multiport Connector) and does not include details about acceptance criteria, study findings, sample sizes, expert qualifications, or ground truth establishment.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).