K Number
K053636
Manufacturer
Date Cleared
2006-03-14

(75 days)

Product Code
Regulation Number
878.4493
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MANI Needle & Suture Pack (PGA Absorbable) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

Device Description

The MANI Needle & Suture Pack (PGA Absorbable) consists of a stainless steel needle and PGA Absorbable suture, for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "MANI Needle and Suture Pack (PGA Absorbable)". This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

It does not contain information about specific acceptance criteria and a study proving those criteria are met in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot extract the information required for the table and subsequent questions from the provided text. The document acts as a regulatory submission, not a detailed clinical or performance study report.

§ 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.