The Silicone Blocks/Strips are intended for use as an implant material to aid in surgical repairs in various otorhinolaryngological surgical procedures and space occupying augmentation in reconstructive Head & Neck surgery.

Device Description

Xomed Silicone Block/Strip are sterile, implants produced from silicone elastomer molded into a squares and/or rectangular shapes of various sizes and thicknesses and durometer as specified on each product label.

AI/ML Overview

This document is a 510(k) summary for a medical device (Xomed Silicone Block/Strip), not a study report on a new AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as typically found in studies for AI/ML devices.

The document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and argues for its similarity to existing products.

Therefore, it is impossible to provide the requested information based on the given input.

The input only contains:

Device Name: Xomed Silicone Block/Strip
Intended Use: For use as an implant material to aid in surgical repairs in various otorhinolaryngological surgical procedures and space occupying augmentation in reconstructive Head & Neck surgery.
Device Description: Sterile implants produced from silicone elastomer molded into squares and/or rectangular shapes of various sizes, thicknesses, and durometer.
Substantial Equivalence: Argument based on similar intended use and base material to previously marketed Xomed products and other manufacturers' silicone blocks.

Summary

{0}------------------------------------------------

MAY - 2 1991

Image /page/0/Picture/1 description: The image shows the logo for XOMED Surgical Products. The logo is in black and white and features the word "XOMED" in large, bold letters. Below the word "XOMED" is the phrase "SURGICAL PRODUCTS" in smaller letters. Below the phrase is a circular design with four arrows pointing outwards.

K970910

510(k) Summary

1.0 Date Prepared

March 6, 1997

Submitter (Contact) 2.0 David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532

3.0 Device Name

Proprietary Name:

Silicone Block/Strip Common Name(s):

Classification Name: ENT synthetic polymer material

4.0 Device Classification

21 CFR 874.3620 Tier 3 Class II : Procode 77 ENT : Unclassified General and Restorative:

Xomed Silicone Block/Strip

5.0 Device Description

6.0 Intended Use

7.0 Substantial Equivalence

Both silicone sheeting and silicone block were marketed by Xomed prior to May 16, 1976. A reinforced version of the Silicone Sheeting was introduced in 1995 via 510(k) [K953013]. The Silicone Block and Strip proposed in this submission are substantially equivalent to these predicate products in that they have the same intended use and are made from essentially the same base material. Additionally, the proposed devices are similar to predicate products from other manufacturers, i.e. Implantech Silicone Block (K913882), Dow Silicone Block and McGhan Silicone Block (510k unknown). Again, the intended use and base materials are essentially identical.

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.