| Device |
scalp cooling system |
| Regulation Description |
Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia. |
| Definition |
A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used. |
| Physical State |
a cooling cap which is placed on the patients head and a cooling system that houses the cooling liquid, controls the temperature, and has a user interface |
| Technical Method |
A cooling cap with cooling fluid running through the cap cools the scalp. A cooling tank consists of a computer controlled system that includes a refrigerated tank containing the cooling agent that maintain the temperature of the cooling fluid. |
| Target Area |
The scalp |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | PMC |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4360
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
