(75 days)
The embryo transfer catheter set is a sterile, single use device designed for in vitro fertilized (IVF) embryo transfer into the uterine cavity.
The trial transfer catheter is a sterile, single use device which is designed for ensuring a free passage through the cervix prior to the embryo transfer.
The stylet is a sterile, single-use device designed to support in initial placement of the guide catheter prior to the embryo transfer.
Embryo Transfer Catheter Set: The Swemed Embryo Transfer Catheter Set is manufactured by Swemed of medical grade polymers. The device consists of a two piece assembly comprised of an embryo transfer catheter and a detachable guide catheter (outer sheath). The overall length of the assembly ranges from 190 mm to 250 mm. The outer diameter of the transfer catheter is approximately 1.4 mm and the outer diameter of the guide catheter is approximately 2.3 mm. The catheter sets are packaged separately or assembled in an double barrier sterilisation pouch/wrapping. All devices are sterilized using e-beam irradiation.
Trial Transfer Catheter Set: The Swemed Trial Transfer Catheter Set is manufactured by Swemed and is identical to the Swemed Transfer Catheter Set except for tip design and packaging configuration. The differences are that the tip is closed, i.e. no hole, and that it is packaged in a single barrier, i.e. an outer sterilization pouch/wrapping only. All devices are sterilized using e-beam irradiation.
Stylet: The Swemed stylet is manufactured by Swemed of medical grade polymers and stainless steel. The stylet consists of a handle (polyurethane) and polymer (polytetraflourethene) covered stainless steel wire. The Swemed stylet is packaged in a single barrier, i.e. an outer sterilization pouch/wrapping only. All devices are sterilized using e-beam irradiation.
The provided document is a 510(k) summary for the Swemed ClearVision™ Embryo Transfer Catheter Set and accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving that the device meets specific acceptance criteria in terms of performance metrics.
Therefore, the document does not contain the requested information regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth details for testing or training sets.
The summary of the document states:
"Swemed Lab International AB, believes that the subject devices are substantially equivalent to the predicate devices. The subject devices has the same intended use/indications for use, in principle the same dimensions, complies with the same standards/special controls. The differences are the sterilization method used and a minor difference in material composition. Based on the comparison of the Swemed Clearvision™ Embryo Transfer Catheter Set and accessories to the predicate devices the conclusion is made that no new questions of safety and effectiveness are raised. Therefore, it is concluded that the requirements for substantial equivalence for the proposed devices are met."
This indicates that the "study" proving the device meets its "acceptance criteria" (in the context of a 510(k)) is a comparative analysis of the device's technical characteristics, intended use, and indications for use against existing predicate devices. The acceptance criteria, in this case, are implicitly met by demonstrating that the new device is as safe and effective as the predicate devices, despite minor differences in sterilization method and material composition.
Without specific performance metrics being the basis for the 510(k) submission, the requested table and detailed study parameters are not applicable or extractable 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).