Device |
brain intraparenchymal infusion cannula |
Definition |
A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy. |
Physical State |
A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device made of various materials (e.g., ceramics, polymers, or metals). |
Technical Method |
A brain intraparenchymal infusion cannula is guided to a target in the brain by stereotaxic navigation and used to deliver a therapy (e.g., biologic or drug product) by connection of the cannula to an infusion pump system. |
Target Area |
Brain parenchyma tissue. |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | SDG |
Premarket Review |
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
510(k)
|
Regulation Number |
882.4110
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|