SAM FACIAL IMPLANT

K961210 · W. L. Gore & Associates, Inc. · LZK · Jun 19, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961210
• Device Name: SAM FACIAL IMPLANT
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: LZK · General, Plastic Surgery
• Decision Date: Jun 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SAM Facial Implant materials are indicated for plastic and reconstructive surgery. No new intended uses or new indications will be implemented as a result of this submission's clearance.

Device Story

SAM Facial Implant; porous material for facial augmentation; modified via creation of internal tunnels to facilitate tissue ingrowth and surgical placement; implanted by surgeons during plastic/reconstructive procedures; provides structural support/augmentation; no change to therapeutic effect or material composition.

Clinical Evidence

Histological evaluation presented in Attachment 2; demonstrates proposed modification allows devices to perform at least as well as original devices.

Technological Characteristics

Expanded polytetrafluoroethylene (ePTFE) facial implant; features intraprosthetic tunnels for tissue attachment; identical materials and manufacturing processes to predicate; non-resorbable.

Indications for Use

Indicated for patients undergoing plastic and reconstructive surgery requiring facial augmentation implants.

Regulatory Classification

Identification

A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

Predicate Devices

• SAM Facial Implant (K961210)
• Non-Reinforced SAM Facial Implant (K961210)
• SAM Facial Implant with Introducer (K961210)

Submission Summary (Full Text)

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JUN 19 1996
K961210

PREMARKET NOTIFICATION 510(k) SUMMARY

1. Submitter Information: W. L. Gore and Associates, Inc.
3750 West Kiltie Lane
Flagstaff, Arizona 86002-0900
Phone: [phone]
Contact: John W. Nicholson
Summary Preparation Date: March 27, 1996

2. Device Trade Name: SAM® Facial Implant
Device Common Name: Facial Augmentation Implant Material
Device Classification Name: Surgical Mesh

3. Substantially Equivalent
Predicate Devices:
SAM Facial Implant
Non-Reinforced SAM Facial Implant
SAM Facial Implant with Introducer

Because the proposed manufacturing modification does not materially effect the
devices, they serve as their own predicates.

4. Device Description:

The only change that this optional manufacturing modification proposes is the creation
of one or more tunnels within the implanted prosthesis. These tunnels provide
additional sites for native tissue attachment and also facilitate in the placement of the
implantable prosthesis.

No new materials or technological characteristics are being introduced, the device's
therapeutic effect is not altered and the proposed change to the manufacturing process
has no deleterious effects on the safety or efficacy of the devices when they are used as
intended. These devices will still continue to meet all product specifications established
for the original devices.

5. Intended Use:

SAM Facial Implant materials are indicated for plastic and reconstructive surgery. No
new intended uses or new indications will be implemented as a result of this
submission's clearance.

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Premarket Notification Summary
-page two-

6. Technological Characteristics:

The manufacturing processes which were cleared in the Non-Reinforced SAM Facial Implant submission are identical to those used to produce these devices. There are no technological characteristic changes related to the implanted device and it achieves its clinical function in the same manner. The intraprosthetic tunnels serve merely to provide additional sites for host tissue attachment and to facilitate in device placement.

7. Conclusion:

The devices produced by this optional manufacturing process have the same indications, the same contraindications and enlist the same technological characteristics to achieve their equivalent clinical functions as implants for plastic and reconstructive surgery. The histological evaluation presented in Attachment 2 reveals that the proposed modification will allow the devices to perform at least as well as the original devices. The descriptive characteristics within this submission are precise enough to ensure that the devices produced by this optional process are substantially equivalent to the original devices.

*SAM is registered in the United States Patent & Trademark Office