GORE REVOX THYROPLASTY IMPLANT

K983525 · W. L. Gore & Associates, Inc. · MIX · Dec 10, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K983525
• Device Name: GORE REVOX THYROPLASTY IMPLANT
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: MIX · Ear, Nose, Throat
• Decision Date: Dec 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GORE ReVox Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis (UVCP) to improve voice quality.

Device Story

GORE ReVox Thyroplasty Implant is a sterile, synthetic polymer implant used for medialization thyroplasty. Composed of expanded polytetrafluoroethylene (ePTFE), the device acts as a space-filling biomaterial to medialize a paralyzed vocal cord in patients with unilateral vocal cord paralysis. It is implanted by a surgeon using standard surgical techniques and instruments. The microstructure is optimized to facilitate native tissue attachment while remaining removable for potential revision. By physically repositioning the vocal cord, the device improves voice quality. It is intended for prescription use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the established biocompatibility of ePTFE material, supported by a bibliography of over 5,000,000 clinical implants in various surgical applications over two decades.

Technological Characteristics

Material: expanded polytetrafluoroethylene (ePTFE). Form factor: pre-configured sterile implant sizes. Principle: space-filling biomaterial for vocal cord medialization. Sterilization: provided sterile.

Indications for Use

Indicated for patients with unilateral vocal cord paralysis (UVCP) requiring medialization thyroplasty to improve voice quality.

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

• Boston Medical Products Montgomery® Thyroplasty Implant
• Smith & Nephew VoCoM® (Vocal Cord Medialization) System
• GORE Subcutaneous Augmentation Material (S.A.M.)

Submission Summary (Full Text)

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K983525

### SECTION 2

## DEC 1 0 1998

### Premarket Notification Summary

| 1. Submitter: | W. L. Gore & Associates, Inc.<br>3750 West Kiltie Lane<br>Flagstaff, Arizona 86002<br>Phone: [phone]<br>FAX: [phone] |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | John W. Nicholson, Regulatory Affairs<br>Preparation Date: October 7, 1998 |
| 2. Applicant<br>Device: | Trade Name: GORE ReVox Thyroplasty Implant<br>Common Name: Thyroplasty Implant<br>Classification Name: Ear, Nose and Throat Synthetic Polymer |

### 3. Substantially Equivalent Devices:

GORE cites the following as predicate devices to which substantial equivalence will be established:

Material

- Boston Medical Products Montgomery® Thyroplasty Implant .
- Smith & Nephew VoCoM® (Vocal Cord Medialization) System .
- . W.L. Gore & Associates, Inc. - GORE Subcutaneous Augmentation Material (S.A.M.)

### 4. Device Description:

The GORE ReVox Thyroplasty Implant is composed solely of expanded polytetrafluoroethylene (ePTFE), which is extremely inert and has excellent chemical and thermal stability. The carbon-fluorine bond is one of the strongest bonds known among organic compounds. The highly electronegative fluorine atoms form a protective sheath enveloping the chain of carbon atoms. This sheath

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effectively shields the carbon chain from attack by nearly all chemicals and is responsible for the chemical inertness and stability of the polymer. Polytetrafluoroethylene also has excellent thermal stability and can be used at temperatures up to 250°C.

More than 5,000,000 clinical implants of GORE-TEX® ePTFE Medical Products in vascular, cardiac, dural, facial reconstructive, dental and a broad variety of general surgery applications during the past two decades have established a substantial body of knowledge and experience relating to the biocompatibility of ePTFE. A selected bibliography is provided in Section 10.

The GORE ReVox Thyroplasty Implant is provided sterile in a variety of sizes specifically configured for this indication. The applicant device, GORE ReVox Thyroplasty Implant, and its cited predicate devices have the same intended uses and their substantial equivalence is established in Section 5.

### 5. Intended Use:

The GORE ReVox Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis (UVCP) to improve voice quality. This is the same indication as both the VoCoM® System and the Montgomery® Thyroplasty Implant.

#### 6. Technological Characteristics:

A literature review of the recent two decades indicates that the etiology of UVCP reveals two primary causes, neoplasm and surgical trauma. GORE ReVox Thyroplasty Implant is designed to be implanted utilizing current surgical techniques and standard surgical instruments in order to minimize surgeon "retraining". Polytetrafluoroethylene has been used in laryngoplasty procedures since the 1960s, and other treatment modalities include insertion of fat grafts, hydroxylapatite, Gelfoam, blocks of Silastic® and GORE-TEX® ePTFE grafts.

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The predicate devices fulfill their equivalent clinical functions by providing clinicians with a space-filling biomaterial, which medializes the paralyzed vocal cord. GORE-TEX® ePTFE products have been used safely and effectively as spacefilling products in facial plastic and reconstructive applications for the past decade with no known adverse reactions attributable to the product. The microstructure of the applicant product is optimized to provide for surrounding native tissue attachment, while still allowing for device removal if revision or further augmentation is required.

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Image /page/3/Picture/16 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 is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1998

W.L. Gore & Associates, Inc. C/O John W. Nicholson Regulatory Affairs Associate 3750 W. Kiltie Lane P.O. Box 900 Flagstaff, AZ 86002

Re:

K983525

Gore ReVox Throplasty Implant October 7, 1998 Dated: Received: October 8, 1998 Regulatory class: II 21 CFR 874.3620/Procode: 77 MIX

Dear Mr. Nicholson:

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 Federal 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 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 531 through 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 vitto diamostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "https://www.fda.gov/cdr/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reprodu Abdominal, Ear, Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name:_ GORE ReVox Thyroplasty Implant

# Indications For Usc:

For medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Harind h. hegem
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)