(69 days)
The Embryo Transfer Catheters/Sets are used to place embryos into the uterine cavity.
The Embryo Transfer Catheters/Sets are used for transferring IVF embryos into the uterine cavity. The materials used in these devices are NRT (TFE), polyethylene, Echosight polyethylene, and stainless steel. Biocompatibility is assured.
This document is a 510(k) Premarket Notification for an embryo transfer catheter/set. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets those criteria.
The provided text focuses on the regulatory submission process, device description, and substantial equivalence, not performance testing against specific acceptance criteria. Therefore, the requested information cannot be extracted from this document.
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).