Device |
lymph node location system during sentinel biopsy procedure |
Definition |
Locating lymph nodes draining a tumor as part of the sentinel lymph node biopsy procedure |
Physical State |
The solution is considered a combination product. The iron particle is surrounded by a carboxydextran coating. The carboxydextran coating is considered a drug. The nanoparticles are then mixed in a saline solution. The system uses an electronic base device with a magnetic probe. |
Technical Method |
The solution is composed of iron nanoparticles which is injected peri-tumor. The nanoparticles are taken up by the lymphatic system and remains there. The magnetic probe is used to locate the iron nanoparticles which should collect in the lymph nodes. |
Target Area |
Cancer tumor |
Review Panel |
General & Plastic Surgery |
Product Code | PUV |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |