(a) Identification. 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.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance data must demonstrate the device performs as intended under anticipated conditions of use and evaluate the following:

(i) Radiation dose to adjacent organs at risk;

(ii) Device stability;

(iii) Ability to deploy, expand, and remove the device; and

(iv) Patient comfort.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:

(i) Testing to evaluate the effect of therapeutic radiation levels on device integrity;

(ii) Bioburden testing to demonstrate the device does not pose an infection risk, if the device is not provided sterile; and

(iii) Structural integrity testing of the container, including tensile strength, container leakage, and burst strength.

(3) Performance testing must demonstrate space creation and maintenance for the duration of a radiation treatment fraction.

(4) The patient-contacting components of the device must be demonstrated to be biocompatible.

(5) Performance data must demonstrate the sterility of patient-contacting components of the device that are provided sterile.

(6) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the labeled shelf life.

(7) Labeling must include:

(i) Warnings that:

(A) A three-dimensional imaging method is needed to ensure the device is placed correctly; and

(B) Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.

(ii) Instructions on how to proceed if the device fails to perform as intended;

(iii) A summary of clinical data relevant to the device, including device-related complications; and

(iv) An expiration date or shelf life.

[91 FR 57510, Sept. 10, 2026]