LogoFDA 510(k) Search
K Number
K964761
Device Name
S.A.M. FACIAL IMPLANT W/INTRODUCER
Manufacturer
W.L. GORE & ASSOCIATES,INC
Date Cleared
1997-01-27

(61 days)

Product Code
FTL
Regulation Number
878.3300
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The S.A.M. Facial Implant devices are intended to be used for facial plastic and reconstructive surgery.

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.

AI/ML Overview

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.

§ 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.