(173 days)
Insemination Catheters are used for transferring spermatozoa into the uterine cavity.
Not Found
This is a 510(k) premarket notification for a medical device (Morton IUI Catheter) and does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria. The provided document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
The letter acknowledges the submission and allows the device to be marketed, subject to general controls. It does not include:
- Acceptance criteria table or device performance reports.
- Details on sample sizes, data provenance, or ground truth establishment.
- Information on expert qualifications, adjudication methods, or MRMC studies.
- Standalone algorithm performance or training set specifics.
The document is primarily an administrative communication regarding market authorization based on substantial equivalence, not a summary of performance studies.
§ 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).