(52 days)
The OptiCLEAN Lens Irrigator is a disposable device to be used in combination with a 10 mm diameter scope to prevent dimming and fogging of the lens.
The OptiDOCK Tissue Ligator is a disposable device intended to pass an absorbable suture loop during endoscopic procedures.
The MedChannel OptiCLEAN Lens Irrigator is a single lumen endoscopic lens irrigator, designed for attachment to 10 mm diameter endoscopes. The irrigator comes in two sizes 285 mm or 305 mm, depending on surgeon's preference. The lens irrigator provides irrigation to the lens of an endoscope to prevent dimming and fogging of the lens during endoscopic surgical procedures.
The MedChannel OptiDOCK Tissue Ligator is a single use disposable suture passer, designed for use during endoscopic procedures. The OptiDOCK Tissue Ligator is pre loaded with PGA suture (USP 2-0).
The provided text is a 510(k) summary for the MedChannel OptiCLEAN Lens Irrigator and OptiDOCK Tissue Ligator. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices, describing the intended use, and listing the standards achieved (such as ISO 10993 for biocompatibility and AAMI 11135 for sterilization). It outlines the regulatory classification and the FDA's decision to clear the devices for marketing based on substantial equivalence.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and the study proving it, as that information is not present in the provided text.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.