(118 days)
VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue.
VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant.
VersaWrap Nerve Protector is designed to be flexible and conformable for placement around a peripheral nerve.
This document is an FDA 510(k) clearance letter for a medical device called "VersaWrap Nerve Protector." It states that the device is substantially equivalent to a legally marketed predicate device.
The provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.
This document is specifically for a physical medical device (a nerve cuff), and the content focuses on regulatory clearance based on substantial equivalence to an existing physical predicate device. It addresses aspects like:
- Device Name: VersaWrap Nerve Protector
- Regulation Number/Name: 21 CFR 882.5275, Nerve Cuff
- Product Code: JXI
- Indications for Use: "management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue."
- Predicate Device: VersaWrap Nerve Protector K201631
- Device Description: "thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant."
- Functional and Safety Testing: States "No additional functional or safety testing was required," implying that the substantial equivalence argument, based on the predicate device, was sufficient.
- Comparative Technological Characteristics: Highlights material (Calcium alginate and hyaluronic acid), intended use, physical structure (sheet), and precautions, showing they are identical to the predicate.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML device based on this input, as this document is not about an AI/ML device.
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).