Search Results

Input:
The GORE ReVox Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis (UVCP) to improve voice quality.

The GORE ReVox Thyroplasty Implant is composed solely of expanded polytetrafluoroethylene (ePTFE), which is extremely inert and has excellent chemical and thermal stability. The carbon-fluorine bond is one of the strongest bonds known among organic compounds. The highly electronegative fluorine atoms form a protective sheath enveloping the chain of carbon atoms. This sheath effectively shields the carbon chain from attack by nearly all chemicals and is responsible for the chemical inertness and stability of the polymer. Polytetrafluoroethylene also has excellent thermal stability and can be used at temperatures up to 250°C. The GORE ReVox Thyroplasty Implant is provided sterile in a variety of sizes specifically configured for this indication.

This 510(k) premarket notification does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously marketed predicate devices.

The key points from the provided text are:

• Device Name: GORE ReVox Thyroplasty Implant
• Intended Use: For medialization thyroplasty in patients with unilateral vocal cord paralysis (UVCP) to improve voice quality.
• Material: Expanded polytetrafluoroethylene (ePTFE).
• Predicate Devices: Boston Medical Products Montgomery® Thyroplasty Implant and Smith & Nephew VoCoM® (Vocal Cord Medialization) System. W.L. Gore & Associates, Inc. - GORE Subcutaneous Augmentation Material (S.A.M.) is also cited for material equivalence.
• Demonstration Method: The submission relies on the established safety and efficacy of ePTFE in other medical applications (over 5 million clinical implants over two decades) and the fact that the predicate devices, which use similar technology and have the same intended use, are already marketed.

Therefore, I cannot provide the requested table or study details because they are not present in this 510(k) submission. The FDA letter confirms that the device is deemed "substantially equivalent" for the stated indications, allowing it to be marketed, rather than requiring a new clinical study to establish pre-defined acceptance criteria for performance.

Ask a specific question about this device