(51 days)
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.
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.
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.
§ 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.