(114 days)
Under supervision of a healthcare professional
· NeuroShield[TM] is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries. When hydrated, NeuroShield™ is easy to handle, soft, pliable, nonfriable, porous and transparent.
NeuroShield™ is provided as a sterile, non-pyrogenic rectangular sheet in the size of 40 x 30 x 0.03 mm and is intended for single use.
NeuroShield™ is perforated to support the transport of physiological liquid through the wall of the device thereby easing the attachment to nerve tissue. With a diameter of 0.2 mm the holes make up 0.8% of the surface area of NeuroShield™.
NeuroShield™ can easily be placed over the injured nerve, and can be sutured if necessary. Furthermore, the device can be trimmed or shaped to the appropriate size to fit the nerve tissue to be treated.
The Monarch Bioimplants GmbH NeuroShield device is a chitosan membrane intended for the repair of peripheral nerve injuries where no gap exists or where a gap can be closed by flexing the extremity.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative "acceptance criteria" for the device's performance in a pass/fail format. Instead, it presents summaries of various tests and their results, consistently concluding that NeuroShield™ is "as safe as" and "performs as well as" or shows "substantial equivalence" to its legally marketed predicate devices (Cova™ORTHO-NERVE, Reaxon® Plus, and Nerbridge™).
However, based on the described results, we can infer the implied acceptance criteria for each test:
| Acceptance Criteria (Implied) | Reported Device Performance (NeuroShield™) |
|---|---|
| Biocompatibility: | |
| Cytotoxicity: Grade less than 2 (mild reactivity) | Only slight evidence of cell lysis or toxicity (grade 1). Met requirements. |
| Acute Systemic Toxicity: No mortality or systemic toxicity | No mortality or evidence of systemic toxicity. Met requirements. |
| Sensitization: No evidence of delayed dermal contact sensitization | No evidence of causing delayed dermal contact sensitization. Not considered a sensitizer. |
| Irritation/Intracutaneous Reactivity: Difference between test and control mean scores |
§ 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).