| Device |
in situ polymerizing peripheral nerve cap |
| Definition |
An in situ polymerizing peripheral nerve cap is a prescription use only device composed of precursor materials that polymerize when delivered to the end of a peripheral nerve to function as a physical barrier to the surrounding in vivo environment to reduce the risk of formation of a symptomatic neuroma. |
| Physical State |
The device is a polymeric, sterile, absorbable, in situ formed, hydrogel cap composed of water and polyethylene glycol. |
| Technical Method |
The device is prepared and in situ polymerized at the time of the surgery to form a hydrogel via a chemical reaction. The hydrogel is then delivered around the end of a peripheral nerve within a temporary silicone mold. |
| Target Area |
Peripheral Nerves |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | SBG |
|---|
| Premarket Review |
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5260
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
