21 CFR 892.5735 — Vaginal Hydrogel Packing System
Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5735
Identification
A vaginal hydrogel packing system is a nonpowered 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 planning and delivery, and to stabilize radiation treatment equipment during radiation therapy planning and delivery.
Classification Rationale
Class II (special controls). The device is granted under De Novo classification (21 CFR 892.5735) as the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QXR | Vaginal Hydrogel Packing System | 2 | 1 |
Special Controls
QXR — Vaginal Hydrogel Packing System
In combination with the general controls of the FD&C Act, the vaginal hydrogel packing system is subject to the following special controls:
De Novo Order DEN220052
