| Device |
hydrogel spacer |
| Regulation Description |
Absorbable perirectal spacer. |
| Definition |
The perirectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. The perirectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time. |
| Physical State |
Synthetic, absorbable polyethylene glycol (PEG)-based hydrogel supplied in a single use tray |
| Technical Method |
Injected in tissue found between the rectum and prostate. The injected liquid solidifies creating a space between the rectum and prostate during radiation therapy to protect vulnerable tissue. It gradually liquifies and is absorbed. |
| Target Area |
Between the prostate and the rectum |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | OVB |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Division of Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.5725
|
|---|
| 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 |
