(61 days)
The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.
The Habib™ VesCoag is a bipolar radiofrequency (RF) device that consists of a catheter, wire connections, hub, Y connector and two ring electrodes are configured with two rings creating proximal and distal heating zones. The Habib™ VesCoag has an attached cable which connects the device to an RF Generator. The catheter is inserted into the vessel and the tissue is coagulated using the RF power. The Habib™ VesCoag is designed for use in surgery and in imaging/radiological procedures and is a single use sterile device.
The provided text is a Fragment of a 510(k) summary for the Habib™ VesCoag. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with specific acceptance criteria and performance metrics.
Based solely on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state predefined acceptance criteria for specific performance metrics of the Habib™ VesCoag in a quantifiable way (e.g., "coagulation time
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.