S.A.M. FACIAL IMPLANT W/INTRODUCER

K964761 · W. L. Gore & Associates, Inc. · FTL · Jan 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964761
• Device Name: S.A.M. FACIAL IMPLANT W/INTRODUCER
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jan 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The S.A.M. Facial Implant devices are intended to be used for facial plastic and reconstructive surgery. This intended use is identical to that already cleared for these devices.

Device Story

S.A.M. Facial Implant consists of expanded polytetrafluoroethylene (ePTFE) and fluorinated ethylene propylene (FEP) in select configurations. Device used by surgeons for facial plastic and reconstructive procedures. Material properties (node and fibril structure) facilitate host tissue attachment. Device serves as inert implant to address reconstructive needs. No changes to device design or technology implemented; submission limited to labeling contraindication update.

Clinical Evidence

No clinical data provided; submission limited to labeling change for existing cleared device.

Technological Characteristics

Materials: expanded polytetrafluoroethylene (ePTFE) and fluorinated ethylene propylene (FEP). Inert biomaterial with node and fibril structure for tissue attachment. No technological changes implemented.

Indications for Use

Indicated for facial plastic and reconstructive surgery applications.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• S.A.M. Facial Implant (K964761)

Submission Summary (Full Text)

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JAN 27 1997
K964761

# PREMARKET NOTIFICATION (510(k) SUMMARY)

Pursuant to 21 CFR Part § 807.92, the following data are presented:

1. **Applicant:**
W. L. Gore & Associates, Inc.
3750 W. Kiltie Lane
Flagstaff, AZ 86002
Phone: 520 - 779 - 2771

**Contact:**
John W. Nicholson, Associate
Date of Preparation: 11/26/96

2. a) **Applicant Device:**
S.A.M. Facial Implant

b) **Common Name:**
Facial Implant

c) **Classification Name:**
Surgical Mesh

3. **Predicate Devices:**

Because the only change that will result from this submission’s clearance is the contraindication change discussed above in the devices’ labeling, the individual S.A.M. devices will serve as their own substantially equivalent predicate devices. No changes to the S.A.M. Facial Implant products will be implemented as a result of this submission’s clearance.

4. **Device Description:**

The applicant GORE S.A.M. Facial Implant devices are constructed of expanded polytetrafluoroethylene (ePTFE) and, in select configurations, fluorinated ethylene propylene (FEP) also. These devices are indicated for a broad variety of facial plastic and reconstructive applications. Expanded PTFE is acknowledged as one of the most inert biomaterials available to surgeons and its clinical performance in facial surgery demonstrates an essentially benign native tissue response to the material. The staggering of the node and fibril structure of ePTFE determines the degree and celerity with which host tissue attachment occurs.

The labeling changes proposed will not expand the devices’ indicated uses and, therefore, no new safety and effectiveness questions arise as a result of this submission’s clearance.

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5. Intended Use:

The S.A.M. Facial Implant devices are intended to be used for facial plastic and reconstructive surgery. This intended use is identical to that already cleared for these devices.

6. Technological Characteristics:

Because this Notification involves only a labeling change, there are no technological changes to the devices which are being implemented.