(a) Identification. A rectal control system is a prescription device intended to treat fecal incontinence by controlling the size of the rectal lumen. The device is inserted in the vagina and includes a portion that expands to reduce the rectal lumen to prevent stool leakage and retracts to allow normal passage of stool. The device includes an external regulator to control the state of expansion.

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

(1) Clinical testing must document the device acceptance data and the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.

(2) The elements of the device that contact vaginal tissue must be demonstrated to be biocompatible.

(3) The cleaning and disinfection instructions for the device must be validated.

(4) Non-clinical (bench) testing must demonstrate that the device performs as intended under anticipated conditions of use.

(5) Non-clinical (bench) testing must demonstrate that the device does not:

(i) Enhance the growth of Staphylococcus aureus.

(ii) Increase production of Toxic Shock Syndrome Toxin-1 by S. aureus.

(iii) Alter the growth of normal vaginal flora.

(6) Labeling must include:

(i) Specific instructions, contraindications, warnings, cautions, limitations, and the clinical training needed for the safe use of the device.

(ii) The intended patient population and the intended use environment.

(iii) Information on how the device is to be fitted, how the device operates, and recommendations on device maintenance.

(iv) A detailed summary of the clinical testing pertinent to the use of the device, including a summary of the device- and procedure-related complications or adverse events related to use of the device, as well as relevant safety and performance information.

(7) Patient labeling must be provided and must include:

(i) Relevant contraindications, warnings, precautions, and adverse events/complications.

(ii) Information on how the device operates and the recommended device maintenance (i.e., care instructions), including cleaning and disinfection.

(iii) Information on the patient population for which there was a favorable benefit/risk assessment.

(iv) The potential risks and benefits associated with the use of the device.

[80 FR 30933, June 1, 2015]