(107 days)
The Smith & Nephew, Inc., ENT Division, Vocal Cord Medialization System is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.
The VoCoM System is substantially equivalent to the Montgomery® Thyroplasty Implant System manufactured by Boston Medical Products, Inc. These devices have the same indications for use, medialization of a paralyzed vocal cord. The VoCoM implant and shim are made from Hydroxylapatite, a widely accepted material for Otolaryngological use. The Montgomery Thyroplasty Implant System implants are made of silicone.
The VoCoM System is also substantially equivalent to the Hydroxylapatite Bone Graft Material manufactured by Smith & Nephew, Inc., ENT Division. Both devices are made of hydroxylapatite. The VoCoM device is intended for medialization of a paralyzed vocal cord, while the Hydroxylapatite Bone Graft Material is intended to augment bony deficiencies or reconstruction of bony defects in head and neck applications.
This document (K974311) is a 510(k) premarket notification for a medical device called the "Vocal Cord Medialization (VoCoM®) System." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study presenting acceptance criteria and performance data.
Therefore, the provided text does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth was established for the training set.
The document focuses on establishing substantial equivalence based on:
- Indications for use: Medialization of a paralyzed vocal cord.
- Material: Hydroxylapatite.
- Comparison to predicate devices:
- Montgomery® Thyroplasty Implant System (silicone implants for the same indication).
- Hydroxylapatite Bone Graft Material (hydroxylapatite for bone repair in head and neck, but different indication).
The 510(k) summary explicitly states that "The differences between the VoCoM system and the predicate devices should not affect the safety or effectiveness." This implies that the safety and effectiveness are considered comparable based on the predicate devices, rather than being demonstrated through a separate performance study with specific acceptance criteria outlined in this document.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.