Section 884.6165 - Intravaginal culture system(a)Identification. An intravaginal culture system is a prescription device intended for preparing, holding, and transferring human gametes or embryos during intravaginal in vitro fertilization or intravaginal culture procedures.(b)Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate the following:(i) Comfort and retention of the intravaginal culture device;(ii) Adverse vaginal tissue reactions associated with intravaginal culture;(iii) Maximum number of gametes and/or embryos that can be placed in a device; and(iv) Rates of embryo development to the designated stage, implantation rates, clinical pregnancy rates, live birth rates, and any adverse events or outcomes.(2) Nonclinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:(i) Mouse embryo assay testing to assess embryotoxicity by evaluating the gamete and embryo-contacting device components effect on the growth and development of mouse embryos to the blastocyst stage;(ii) Endotoxin testing on gamete and embryo-contacting components of the device;(iii) Cleaning and disinfection validation of reusable device components;(iv) Sterility maintenance of the culture media within the device throughout the vaginal incubation period and subsequent embryo extraction; and(v) Ability of the device to permit oxygen and carbon dioxide exchange between the media contained within the device and the external environment throughout the vaginal incubation period.(3) The patient-contacting components of the device must be demonstrated to be biocompatible.(4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.(5) Shelf life testing must demonstrate that the device maintains its performance characteristics and the packaging of device components labeled as sterile maintain integrity and sterility for the duration of the shelf life.(6) Labeling for the device must include:(i) A detailed summary of the clinical testing, including device effectiveness, device-related complications, and adverse events;(ii) Validated methods and instructions for reprocessing of reusable components;(iii) The maximum number of gametes or embryos that can be loaded into the device;(iv) A warning that informs users that the embryo development is first evaluated following intravaginal culture; and(v) A statement that instructs the user to use legally marketed assisted reproductive technology media that contain elements to mitigate the contamination risk (e.g., antibiotics) and to support continued embryonic development over the intravaginal culture period.(7) Patient labeling must be provided and must include:(i) Relevant warnings, precautions, and adverse effects and complications;(ii) Information on how to use the device;(iii) The risks and benefits associated with the use of the device; and(iv) A summary of the principal clinical device effectiveness results.