(14 days)
The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
The ArthroCare Wands are bipolar, single use, high frequency electrosurgical devices designed for orthopedic, arthroscopic, and spinal, and neurosurgical procedures.
This document is a 510(k) summary for the ArthroCare Wands. It describes modifications to an already cleared device and asserts substantial equivalence to its predicate. The document does not contain information about acceptance criteria or a study proving the device meets them. This type of regulatory submission (510(k)) typically focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than performing new clinical efficacy studies with specific performance metrics and acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
The provided text only includes:
- Device Description: ArthroCare Wands are bipolar, single-use, high-frequency electrosurgical devices.
- Intended Use: Resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
- Modifications: Dimensional specifications, material, and labeling.
- Claim of Equivalence: The modifications are not substantial changes and do not significantly affect safety or efficacy.
- Predicate Device: ArthroCare 8000S Coblator Surgery Systems K053297.
§ 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.