(182 days)
Dyonics Disposable Endoscopic Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.
Curved Small Joint Disposable Endoscopic Surgery Blades are utilized in conjunction with a control console, motor drive unit, footswitch and suction to resect soft and osseous tissues as per indications. The blades can be operated in forward, reverse and oscillate modes and at variable speeds controlled by the surgeon. The rotary action coupled with suction draws tissue into the window of the blade where rotation of the inner blade cleanly excises and evacuates the resected material. Irrigation aids in evacuation of resected materials through the blade.
The provided text is a 510(k) summary for the Dyonics Curved Small Joint Disposable Endoscopic Surgery Blades. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding:
- Acceptance criteria and reported device performance (beyond substantial equivalence to predicate devices).
- Sample size for the test set or data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document focuses on comparing the new device to existing predicate devices (Stryker Endoscopy's Curved Small Joint/ENT Disposable Blades and Linvatec Merlin Disposable Arthroscopic Surgery Blade) in terms of intended use, materials, design, and function to demonstrate substantial equivalence. The FDA letter confirms this determination.
§ 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.