The Silicone Pre-form Blocks are indicated as an implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.

Device Description

Xomed Silicone Pre-form Blocks are sterile supplied implants made from silicone elastomer molded into a pre-form sizes as specified on the product label. Metric graduations on the implant surface helps in sizing the implant for patient need. The implants are to be trimmed and shaped to size by the surgeon for individual patient needs. The devices are intended for single patient use only. As a prescription device, the surgeon should be familiar with the skills and training for laryngeal reconstruction and vocal fold augmentation with silicone implants.

AI/ML Overview

This document describes the Xomed Silicone Pre-form Blocks, a medical device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria.

The provided text is a 510(k) summary and an FDA clearance letter from 1998 for a medical device. This type of regulatory submission primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance data from a clinical or technical study using specific acceptance criteria as you've requested.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study because that information is not present in the provided text.

The document discusses:

Device Name: Xomed Silicone Pre-form Blocks
Intended Use: As an implant material for surgical reconstructions as a space-occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
Substantial Equivalence: To predicate devices (Xomed silicone blocks and strips, and Montgomery Thyroplasty Implants) based on material (silicone elastomer) and intended use.
Device Description: Sterile supplied implants made from silicone elastomer, molded into pre-form sizes, to be trimmed and shaped by the surgeon.

To answer your questions, I would need a different type of document, such as a clinical study report, a special controls guidance document, or a detailed engineering and performance validation report, which are typically more extensive than what's provided in a 510(k) summary for this type of device.

Summary

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K-982294

SEP 1 8 1998

APPENDIX F

510(k) Summary

Date Prepared 1.0

June 25, 1998

2.0 Submitter (Contact) Rov Berens Xomed Surgical Products Jacksonville, FL (904) 296-6454

3.0 Device Name

Proprietary Name:	Xomed Silicone Pre-form Blocks
Common Name(s):	Silicone Block/Strip
Classification Name:	ENT synthetic polymer material

Device Classification 4.0

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

5.0 Device Description

6.0 Intended Use

The Silicone Pre-form Blocks are intended for use as an implant material for surgical to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedure for vocal fold medialization and augmentation.

7.0 Substantial Equivalence

Xomed markets both silicone blocks and strips for implant uses in head and neck surgery by K970910. The Silicone Pre-form Blocks are substantially equivalent to these predicate products in that they are made from the same material which has satisfactory biocompatibility approval for implant applications. Additionally, the Silicone elastomer Pre-form Blocks are similar to the Montgomery Thyroplasty Implants, Boston Medical Products K972317 for the intended use in thyroplasty procedures involving medialization and augmentation of the vocal fold. The difference is the Xomed Pre-form Blocks are to be trimmed to final shape and size by the surgeon for the individual patient needs while the Montgomery silicone elastomer implants are predetermined sized silicone augmentation devices requiring no alteration at surgery.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle are three stylized human figures, possibly representing health, family, and community. The figures are depicted in a simple, abstract manner.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 1998

Roy Berens Manager, Quality System Regulations Xomed Surgical Products, Inc. 6743 Southpoint Drive N. Jacksonville, FL 32216

Re:

K982294 Xomed Silicone Pre-Form Blocks Dated: June 25, 1998 Received: June 30, 1998 Regulatory class: II 21 CFR 874.3620/Procode: 77 KHJ

Dear Mr. Berens:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration .................................................................................................................................................

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdch/dsmam.in.html",

Sincerely yours,

Lillian Yim, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX B

Intended Use Statement

510(k) Number (if known):

Device Name: Silicone Pre-form Blocks

Indications for Use:

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David A. Sigman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

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.