(86 days)
The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is an accessory to the Cook Vascular PERFECTA™ Electrosurgical Dissection System. The intended use of the Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is to add the option of continuous or intermittent activation to the Electrosurgical Dissection System when the footswitch is depressed. The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is supplied nonsterile and is reusable.
The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is an accessory that can be used with the Cook Vascular PERFECTA™ Electrosurgical Dissection System. This device adds the option to automatically activate the Valley(ab Force FX electrosurgical generator at a predetermined rate when the footswitch is depressed.
The provided text is a 510(k) Premarket Notification for the "Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set), and effect sizes of AI assistance cannot be extracted from this document.
The document states:
- Substantial Equivalence: "This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency."
- Predicate Device: ArthroCare Timer (510(k) DC# K021519).
The basis for clearance is demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device. This typically involves non-clinical performance data (e.g., electrical safety, EMC, biocompatibility) and comparison to the predicate, rather than a clinical study with acceptance criteria and a detailed statistical analysis of performance metrics.
§ 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.