(97 days)
Adaptain FastWrap™ is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.
Adaptain FastWrap™ is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional . handling and manipulation, if so desired. Adaptain FastWrap "" is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain FastWrap " contains no other additives or colorants. Adaptain FastWrap™ is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain FastWrap is provided sterile by irradiation and must not be resterilized.
The provided text describes a 510(k) submission for the Adaptain FastWrap™ and Envelock™ devices. However, it does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily focuses on the administrative aspects of the 510(k) submission, including:
- Identification of the submitting company and contact person.
- Device names, regulation numbers, regulatory class, and product codes.
- Description of the device's composition and form.
- Intended use and indications for use.
- A declaration of substantial equivalence to a predicate device (Ceremed, Inc. Ceretene™ Soluble Implant Material (K120220)).
- Formal FDA correspondence confirming the substantial equivalence determination.
The statement regarding "non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance" is a general declaration, but no specific data, metrics, or study details are provided to support this. Therefore, I cannot construct the table or answer the specific questions based on the provided text.
§ 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.