XOMED SILICONE BLOCK/STRIP

K970910 · Xomed, Inc. · KHJ · May 2, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K970910
• Device Name: XOMED SILICONE BLOCK/STRIP
• Applicant: Xomed, Inc.
• Product Code: KHJ · Ear, Nose, Throat
• Decision Date: May 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Sterile silicone elastomer implants; molded into square or rectangular shapes of varying sizes, thicknesses, and durometers. Used in otorhinolaryngological and head/neck reconstructive surgeries as space-occupying augmentation or surgical repair aids. Implanted by surgeons during procedures. Provides structural support or volume replacement in surgical sites.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence based on material composition and historical clinical use of silicone elastomers in ENT surgery.

Technological Characteristics

Material: Silicone elastomer. Form factor: Molded blocks and strips of varying dimensions and durometers. Sterilization: Sterile.

Indications for Use

Indicated for patients undergoing otorhinolaryngological surgical procedures or reconstructive Head & Neck surgery requiring implant material for surgical repair or space-occupying augmentation.

Regulatory Classification

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.

Predicate Devices

• Xomed Silicone Sheeting (K953013)
• Implantech Silicone Block (K913882)
• Dow Silicone Block
• McGhan Silicone Block

Submission Summary (Full Text)

{0}

MAY - 2 1997
XOMED SURGICAL PRODUCTS
K970910

# 510(k) Summary

1.0 Date Prepared
March 6, 1997

2.0 Submitter (Contact)
David Timlin
Xomed Surgical Products
Jacksonville, FL
[phone]

3.0 Device Name
Proprietary Name: Xomed Silicone Block/Strip
Common Name(s): Silicone Block/Strip
Classification Name: ENT synthetic polymer material

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

5.0 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.

6.0 Intended Use
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.

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.

6743 Southpoint Dr. N., Jacksonville, Florida 32216-0980 • 904-296-9600 Customer Service 1-800-874-5797