(38 days)
The Delphin is to be used for embryo transfer and intra uterine insemination procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.
Emtrac Catheters are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.
Semtrac Sets are to be used for embryo transfer procedures for in Semilac Sets are to be acount. In the substition technology (ART) procedures.
Not Found
I am sorry but this document is a 510(k) clearance letter from the FDA, not a study report. It states that the referenced medical devices (Emtrac, Delfin, and Semtrac Embryo Transfer and IUI Catheters) are substantially equivalent to legally marketed predicate devices.
Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Information on experts used for ground truth or adjudication methods.
- Details on MRMC comparative effectiveness studies or standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets or how ground truth for training sets was established.
§ 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).