| Device |
vaginal hydrogel packing system |
| Definition |
A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery. |
| Physical State |
Flexible container filled with hydrogel to create space in the vaginal cavity |
| Technical Method |
Placed in the vaginal cavity for radiation therapy treatment. The hydrogel material is injected into a flexible container, which creates space within the vaginal cavity to aid in the reduction of dose to adjacent pelvic organs during radiation therapy. |
| Target Area |
Vaginal cavity |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | QXR |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Division of Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.5735
|
|---|
| 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 |
