(378 days)
OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.
OPTIME®R sutures are intended to be used in suturing in open or laparoscopic surgery. These sutures are available with a disposable needle attachment. OPTIME®R is a sterile, multiple-stranded (multifilament), synthetic bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) used in suturing when short-term support and rapid strength loss are needed. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.
The provided text is an FDA 510(k) Pre-Market Notification for a medical device called OPTIME® R, which is an absorbable surgical suture. The document primarily focuses on establishing substantial equivalence to a predicate device (Safil Quick Aesculap, K031286) based on technological characteristics and performance testing.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document states that the OPTIME® R suture was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures. The following tests and their corresponding USP standards are mentioned:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Diameter (following USP 43 ) | Meets USP performance requirements for absorbable sutures |
| Tensile strength (following USP 43 ) | Meets USP performance requirements for absorbable sutures |
| Needle attachment (following USP 43 ) | Meets USP performance requirements for absorbable sutures |
| Length (following USP 43 - Absorbable surgical suture) | Meets USP performance requirements for absorbable sutures |
| Resorption properties | Essentially complete at 42 days (matches predicate's absorption time) |
| Biocompatibility (following ISO 10993) | Biocompatibility tests performed and results indicate compliance |
| Sterilization methods | Gamma sterilization (matches predicate) |
| Shelf-life | 5 years |
| Ideal storage | Stored in original packaging, |
§ 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.