(74 days)
The ArthroCare Topaz ArthroWands are indicated for debridement, resection, ablation, The Arthroom's ropas Firms and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
Procedures: Fasciotomy, Synovectomy, Tendonotomy, Rotator Cuff Tendonotomy, Capsulotomy
Body Structure as described below: Foot, Knee, Wrist, Elbow, Ankle, Shoulder
The ArthroCare Topaz ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
This submission K053567 is for a new indication and labeling for an existing device. As such, it does not include data for performance acceptance criteria or a study to demonstrate that it meets the criteria.
Here's a breakdown of why this information is not present in the provided text:
- Focus of the Submission: The key phrase in the document is "This 510(k) proposes a new indication and labeling for the ArthroCare Topaz ArthroWands. The technology, principle of operation, and sterilization parameters of the ArthroCare Topaz ArthroWands remain the same as those Wand cleared in the predicate 510(k)s." This indicates that the core device's fundamental safety and efficacy were established in previous clearances (K011083, K052686).
- "Substantial Equivalence" Pathway: The 510(k) pathway, particularly for modifications like this, relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This often means showing that the changes (in this case, new indications) do not raise new questions of safety or effectiveness. When the underlying technology and operating principles are unchanged, extensive new performance testing may not be required beyond demonstrating continued performance for the new indications, often through literature review or limited clinical data if applicable.
- Missing from the Documentation: The provided 510(k) summary and the FDA's clearance letter do not contain sections detailing specific performance acceptance criteria or the results of a study designed to meet them for this submission. Such details would typically be found in a separate section of the full 510(k) submission, often titled "Performance Data," "Bench Testing," or "Clinical Data," which is not part of this summary.
Therefore, I cannot provide the requested information from the provided text.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.