(29 days)
The Super Revo® Herculine™ Suture Anchor is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.
The Super Revo® Herculine™ Suture Anchor is a titanium suture anchor implant pre-threaded with undyed (white) and colored (white with blue stripe), nonabsorbable, braided, ultra-high molecular weight, polyethylene suture. It is provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. The Super Revo® Herculine™ Suture Anchor is supplied sterile and single use.
The modification described in this Special 510(K) is to supply the Super Revo® suture anchor with the ultra-high molecular weight polyethylene suture.
The provided text is a 510(k) summary for a medical device (Super Revo® Herculine™ Suture Anchor) and does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document states that the modification to the device (the type of suture used) "does not raise any new issues regarding safety and effectiveness" and that "Testing has been conducted to assure that providing the suture anchor with the ultra-high molecular weight, braided, polyethylene suture does not raise any new issues regarding safety and effectiveness." However, it does not provide details about what tests were conducted, their acceptance criteria, or the results.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of your specific questions. The document mainly focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.