(61 days)
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No
The summary describes a physical implant made of ePTFE and FEP, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an implant used for facial plastic and reconstructive surgery, which is a structural or restorative function, not a therapeutic one that treats a disease or condition.
No
The device is an implant used for facial plastic and reconstructive surgery, not for diagnosing medical conditions.
No
The device description explicitly states the devices are constructed of expanded polytetrafluoroethylene (ePTFE) and fluorinated ethylene propylene (FEP), which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "facial plastic and reconstructive surgery." This describes a surgical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a "Facial Implant" constructed of ePTFE and FEP. This is a physical implant placed within the body, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or instruments for in vitro testing.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This facial implant clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The S.A.M. Facial Implant devices are intended to be used for facial plastic and reconstructive surgery.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
facial
Indicated Patient Age Range
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Intended User / Care Setting
surgeons
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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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 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 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.
1
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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