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K Number
K163698
Device Name
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
Manufacturer
C.R. BARD INC,
Date Cleared
2017-04-11

(103 days)

Product Code
GDW
Regulation Number
878.4750
Type
Traditional
Panel
SU
Reference & Predicate Devices
K082396,K132134,K142873
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The OptiFix™ Open Absorbable Fixation System is indicated for the fixation of surgical mesh to tissues during open surgical procedures, such as hernia repair.

Device Description

The OptiFix" Open Absorbable Fixation System, hereinafter referred to as "OptiFix" Open", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. The device delivers 20 synthetic absorbable fasteners via a curved shaft. The shaft of the OptiFix™ Open Absorbable Fixation System is 27cm in length. The fasteners are 6.7mm in length, are manufactured from Poly (D, L)-lactide and are dyed with D & C Violet No. 2.

AI/ML Overview

The provided document does not describe the acceptance criteria of an AI device, but rather a medical device (OptiFix™ Open Absorbable Fixation System). It outlines the performance data required to demonstrate substantial equivalence to a predicate device for this non-AI medical device. Therefore, I cannot generate the requested information about acceptance criteria and studies for an AI device based on this input.

The document discusses various tests for the OptiFix™ Open Absorbable Fixation System, including:

  • Biocompatibility testing: This evaluated the absorbable fasteners (long-term implants) and the deployment component (transient tissue contact) against ISO 10993-1. All samples met acceptance criteria.
  • Product Testing: This included performance and functional testing (Actuation (trigger) Torque, Fastener Deployment, Fastener Gap Height, Ball Burst Testing, Single Fastener Pullout (Pluck) Force) and Resorption Profile Assessment (Physical Properties, Mechanical Shear Force). All samples met established acceptance criteria.

The document states that animal studies and clinical studies were not performed for the proposed device, nor for the predicate device. The in vivo performance was supported by studies on previously cleared reference devices. Electrical safety, electromagnetic compatibility, and software verification/validation were not applicable as the device is not electro-mechanical and does not contain software.

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.