(16 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 Wands are bipolar, single use, high frequency electrosurgical devices.
The provided text is a 510(k) summary for the ArthroCare® SpineWand™, a high-frequency electrosurgical device. The document states that this is a Special 510(k) submission proposing modifications to the packaging and labeling of the device. Crucially, it explicitly states:
"The indications for use, materials, technology, sterilization, principle of operation, and performance specifications of the Wands remain the same as in the predicate cleared 510(k)."
This indicates that the current submission (K070851) is not for a new device requiring a new study to prove performance against acceptance criteria. Instead, it's a modification to an already cleared device, and thus relies on the substantial equivalence determination to its predicate devices (ArthroCare Wands K060823 and ArthroCare System 2000 K001588).
Therefore, the input document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria for the K070851 submission. If such a study or acceptance criteria existed, they would have been part of the predicate 510(k) submissions, not this Special 510(k) for packaging/labeling changes.
Based on the provided text, I cannot complete the requested information for acceptance criteria and a study to prove the device meets these criteria because the K070851 submission is for packaging and labeling modifications, and explicitly states that performance specifications remain the same as the predicate devices.
§ 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.