(72 days)
SAM Reinforced Facial Implant, Porex MEDPOR Biomaterial, Conical Volume Augmentation (CVA) Implant, Porex MEDPOR Biomaterial, Preformed Craniofacial Implant
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No
The document describes a physical implant made of ePTFE and FEP for the anophthalmic socket. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies focus on the biological response to the material, not on computational performance.
No
The device is described as a corrective prosthesis for the anophthalmic socket, intended to fill space and allow tissue ingrowth. While it has a medical purpose, it does not actively treat a disease or condition in the way a therapeutic device would (e.g., delivering medication, stimulating a body part). It serves a reconstructive and cosmetic function.
No
The device is described as a "corrective prosthesis" and a "space filling" implant, not as a tool for diagnosing medical conditions. Its purpose is to physically correct an anophthalmic socket, not to detect or identify a disease.
No
The device description clearly states the device is a physical implant made of ePTFE and FEP laminate, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, the GORE Spherex Implant is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a corrective prosthesis for the anophthalmic socket." This describes a device that is implanted into the body to replace or augment tissue, not a device used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The description details a physical implant made of ePTFE and FEP, designed for tissue ingrowth and implantation. This is consistent with a surgical implant, not an in vitro diagnostic device.
- Anatomical Site: The anatomical site is the "anophthalmic socket," which is a part of the human body where the device is implanted. IVDs typically interact with biological samples from the body, not within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the GORE Spherex Implant is a surgical implant intended for use within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CORE Spherex Implant is intended to be used as a corrective prosthesis for the anophthalmic socket.
Product codes
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Device Description
The GORE Spherex Implant is an expanded polytetrafluoroethylene (ePTFE ) and fluorinated ethylene propylene ( FEP ) laminate which is intended to be used as a space filling, corrective prosthesis for the anophthalmic socket. The open microstructure of the ePTFE material allows for host tissue ingrowth. The device is machined to create a smooth, spherical structure which is provided in a variety of sizes.
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
anophthalmic socket
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
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Key Metrics
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Predicate Device(s)
SAM Reinforced Facial Implant, Porex MEDPOR Biomaterial, Conical Volume Augmentation (CVA) Implant, Porex MEDPOR Biomaterial, Preformed Craniofacial Implant
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
96224
3 722
Premarket Notification Summary
| Applicant: | W. L. Gore and Associates, Inc.
3750 W. Kiltie Lane
Flagstaff, Arizona 86002
Phone: 520-779-2771
FAX: 520-779-1456 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact: | John W. Nicholson, Associate |
| Date of Preparation: | 8/16/96 |
| Applicant Device : | |
|---|---|
| Trade Name: | CORE Spherex Implant |
| Common Name: | Eye Shphere Implant |
| Classification Name: | Eye Shphere Implant |
Predicate Devices:
For the purposes of determining substantial equivalence, GORE cites the following as predicate devices:
- SAM Reinforced Facial Implant .
- Porex MEDPOR Biomaterial, Conical Volume Augmentation (CVA) Implant ●
- Porex MEDPOR Biomaterial, Preformed Craniofacial Implant ♥
Applicant Device Description:
The GORE Spherex Implant is an expanded polytetrafluoroethylene (ePTFE ) and fluorinated ethylene propylene ( FEP ) laminate which is intended to be used as a space filling, corrective prosthesis for the anophthalmic socket. The open microstructure of the ePTFE material allows for host tissue ingrowth. The device is machined to create a smooth, spherical structure which is provided in a variety of sizes.
Intended Use:
The CORE Spherex Implant is intended to be used as a corrective prosthesis for the anophthalmic socket. This is the same intended use as the predicate Porex CVA implant.
1
Technological Characteristics:
The GORE Spherex Implant is constructed of the same raw materials, undergoes the same manufacturing processes and is subject to the same quality control evaluations as the predicate SAM Reinforced Facial Implant. The devices are configured for their specific applications whether for rhinoplasty, malarplasty, maxilloplasty, orbital reconstruction or as corrective implants for the anophthalmic socket; the only difference is in the shape of the device. Design, material composition and intended performance reveal that the applicant and this predicate device incorporate identical technological characteristics.
The POREX CVA Implant is configured for the same indication as the applicant device. They both create the same therapeutic effect and, though they are not constructed of identical materials, they fulfill their equivalent clinical functions by providing the physician with a synthetic, biocompatible corrective prosthesis. The applicant device components, ePTFE and FBP, have established a successful clinical history in facial plastic reconstruction individually and combined and their use as a corrective prosthesis for the anophthalmic socket poses no new questions regarding safety and efficacy.
Nonclinical Data:
The evaluation of the GORE Spherex Implant reveals that the use of this device as a corrective prosthesis for the anophthalmic socket did not demonstrate any abnormal effects. The biological response was very similar to the response elicited elsewhere in the face when the material has been used in other applications as a plastic and reconstructive prosthetic. The foreign-body tissue response is minimal and there is extensive cellular migration laterally, posteriorly and anteriorly into the material. Vascularization into the eveball is evident with numerous capillaries within the device's interstices. The nonclinical data reveal that the material functioned safely and effectively in this application.
Conclusion:
This submission demonstrates that the applicant device and predicate CVA Implant device have the same indication. The applicant device incorporates the identical technological characteristics as the predicate GORE device and the only difference with the predicate POREX device is in the selection of materials. The successful clinical history of the applicant's components, singly and in combination, and the positive nonclinical implant data reveal that no new safety and effectiveness questions are posed by the use of these materials in this application.