(36 days)
The Boyie Button Remote Hand Switch is intended for use to remotely activate the CUT and COAOULATION model of an election Technological generator to deliver monopolar Radiofrequency current. The switch also serves as the connection between the electrosurgical accessory and the generator.
The Bovie Remote Hand Switch is a sterile, single-use electrosurgical accessory that is used to activate the CUT and COAGULATION modes of an electrosurgical generator, which operates an attached monopolar accessory. The switch also serves as the connection between a monopolar electrosurgical accessory and the generator. The Bovie Remote Hand Switch provides an alternative to the use of footswitch control to deliver RF energy to an attached monopolar accessory.
No acceptance criteria or study information for a medical device are provided in the input text. The provided documents are a 510(k) summary and an FDA clearance letter for the "Bovie Remote Hand Switch". These documents primarily focus on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria or performance study results for the new device itself.
The key points from the provided text are:
- Device Description: The Bovie Remote Hand Switch is a sterile, single-use electrosurgical accessory used to activate CUT and COAGULATION modes of an electrosurgical generator and serves as a connection between a monopolar accessory and the generator.
- Substantial Equivalence Claim: It is claimed to be substantially equivalent to the Valleylab Inc. E0520 Trigger Switch and Cord (K970140) in operation, intended use, materials, energy source, components, and safety/performance.
- Testing for Substantial Equivalence: "Testing performed on the Bovie Remote Hand Switch indicates that the device is substantially equivalent in its performance and method of operation to the Valleylab Inc. F.0520 Trigger Switch and Cord (K970140)."
- Hazard Analysis: "Hazard analysis evaluations were performed on the Bovie Remote Hand Switch. There are no new hazards presented with the use of the Bovie Remote Hand Switch as compared with the predicate device."
- Standard Compliance: Both the Remote Hand Switch and the predicate device "were designed and tested to meet the ANSI/AAMI HF18 Electrosurgical Device standard."
Without a detailed performance study or specific acceptance criteria, it is not possible to fill in the requested table or answer the specific questions about sample sizes, ground truth, expert opinions, or MRMC studies, as these types of studies are typically associated with performance evaluations of diagnostic or AI-driven devices, which is not what this device is. The focus here is on demonstrating equivalence to an already approved device through design, materials, and compliance with a recognized standard.
§ 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.