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
Indications for 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.
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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.
