(83 days)
SAM Facial Implant, Non-Reinforced SAM Facial Implant, SAM Facial Implant with Introducer
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No
The 510(k) summary describes a physical implant with a manufacturing modification (tunnels). There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML medical devices.
Yes.
The device's description states, "the device's therapeutic effect is not altered," implying it has a therapeutic effect.
No
Explanation: The device is described as an implant for plastic and reconstructive surgery, and its function is to provide tissue attachment and facilitate placement. There is no mention of it being used to diagnose a condition, collect data for diagnosis, or assess a disease state.
No
The device description clearly states it is an "implantable prosthesis" and discusses "tunnels within the implanted prosthesis," indicating a physical, hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "plastic and reconstructive surgery," which is a surgical procedure performed on a patient's body.
- Device Description: The device is an "implanted prosthesis" and the modification involves creating "tunnels within the implanted prosthesis." This describes a physical implant placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's function is to physically reconstruct or augment facial features.
N/A
Intended Use / Indications for Use
SAM Facial Implant materials are indicated for plastic and reconstructive surgery. No new intended uses or new indications will be implemented as a result of this submission's clearance.
Product codes
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Device Description
The only change that this optional manufacturing modification proposes is the creation of one or more tunnels within the implanted prosthesis. These tunnels provide additional sites for native tissue attachment and also facilitate in the placement of the implantable prosthesis.
No new materials or technological characteristics are being introduced, the device's therapeutic effect is not altered and the proposed change to the manufacturing process has no deleterious iffects on the safety or efficacy of the devices when they are used as intended. These devices will still continue to meet all product specifications established for the original devices.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
The histological evaluation presented in Attachment 2 reveals that the proposed modification will allow the devices to perform at least as well as the original devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
SAM Facial Implant, Non-Reinforced SAM Facial Implant, SAM Facial Implant with Introducer
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.
0
PREMARKET NOTIFICATION 510(k) SUMMARY
- Submitter Information: W. L. Gore and Associates, Inc. 1. 3750 West Kiltie Lane Flagstaff, Arizona 86002-0900 Phone: (520) 779-2771 Contact: John W. Nicholson Summary Preparation Date: March 27, 1996
- SAM® Facial Implant 2. Device Trade Name: Device Common Name: Facial Augmentation Implant Material Device Classification Name: Surgical Mesh
| 3. Substantially Equivalent
| Predicate Devices: | SAM Facial Implant |
|---|---|
| Non-Reinforced SAM Facial Implant | |
| SAM Facial Implant with Introducer |
Because the proposed manufacturing modification does not materially effect the devices, they serve as their own predicates.
4. Device Description:
The only change that this optional manufacturing modification proposes is the creation of one or more tunnels within the implanted prosthesis. These tunnels provide additional sites for native tissue attachment and also facilitate in the placement of the implantable prosthesis.
No new materials or technological characteristics are being introduced, the device's therapeutic effect is not altered and the proposed change to the manufacturing process has no deleterious iffects on the safety or efficacy of the devices when they are used as intended. These devices will still continue to meet all product specifications established for the original devices.
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- Intended Use:
SAM Facial Implant materials are indicated for plastic and reconstructive surgery. No new intended uses or new indications will be implemented as a result of this submission's clearance.
- Intended Use:
1
Premarket Notification Summary -page two-
Technological Characteristics: 6.
The manufacturing processes which were cleared in the Non-Reinforced SAM Facial Implant submission are identical to those used to produce these devices. There are no technological characteristic changes related to the implanted device and it achieves its clinical function in the same manner. The intraprosthetic tunnels serve merely to provide additional sites for host tissue attachment and to facilitate in device placement.
7. Conclusion:
The devices produced by this optional manufacturing process have the same indications, the same contraindications and enlist the same technological characteristics to achieve their equivalent clinical functions as implants for plastic and reconstructive surgery. The histological evaluation presented in Attachment 2 reveals that the proposed modification will allow the devices to perform at least as well as the original devices. The descriptive characteristics within this submission are precise enough to ensure that the devices produced by this optional process are substantially equivalent to the original devices.
SAM is registered in the United States Patent & Trademark Office