(61 days)
The S.A.M. Facial Implant devices are intended to be used for facial plastic and reconstructive surgery.
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.
The provided text describes a 510(k) summary for a medical device called the S.A.M. Facial Implant. This document focuses solely on a proposed labeling change for an existing device and explicitly states that no changes to the device itself or its intended use are being implemented.
Therefore, based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document reiterates multiple times that:
- "No changes to the S.A.M. Facial Implant products will be implemented as a result of this submission's clearance."
- "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."
- "Because this Notification involves only a labeling change, there are no technological changes to the devices which are being implemented."
The submission uses the existing S.A.M. devices as their own substantially equivalent predicate devices because the only change is a contraindication change in the labeling.
In summary, the provided text does not contain any of the requested information regarding acceptance criteria or the study proving the device meets those criteria, as it pertains to a labeling change submission, not a new device or performance claim.
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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 LaneFlagstaff, AZ 86002Phone: 520 - 779 - 2771 |
|---|---|---|
| Contact: | John W. Nicholson, AssociateDate of Preparation: 11/26/96 | |
| 2. a) | Applicant Device: | S.A.M. Facial Implant |
- b) Common Name: Facial Implant Surgical Mesh
3. Predicate Devices:
c) Classification Name:
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.
Device Description: 4.
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.
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§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.