(266 days)
The Embryo Transfer Catheter is intended for introduction of in vitro fertilized embryo(s) into the uterine cavity.
The stylet is intended to be used with Vitrolife's Embryo Transfer Catheters to assist in uterine access of the guide during an embryo transfer procedure.
Vitrolife´s Embryo Transfer Catheter (ETC) Assortment consists of three embryo transfer catheters (ETCs), one pre-curved variant (Model 17500, 230 mm) and two straight variants (REFs 17501, 17502) in different lengths (180 mm and 230 mm); and two stylets (Stylets) (REFs 17510, 17511) in different lengths (180 mm and 230 mm). ETC and Stylet are sterile, single-use devices used to deliver in vitro fertilized embryos to the uterine cavity.
Embryo Transfer Catheter consists of:
- A guide, also referred as outer sheath. The guide is used to navigate through the cervix canal. The guide has a distance marking, a stopper and a rounded tip to facilitate proper positioning. The guide is available in two different variants:
- Pre-curved - stiff
- Straight - soft and malleable
- A catheter, also referred as inner catheter. The catheter is loaded with the embryo(s) in a small volume of transfer medium and inserted through the guide to gently deposit the embryo(s) into the uterine cavity. The transfer catheter is soft, flexible and approximately 50 mm longer than the guide. The tip of the catheter has an echogenic marking to enable ultrasound guidance.
Embryo Transfer Catheter Stylet consists of:
- A plastic-coated metal wire, which is malleable. The stylet is an accessory that can be used together with Vitrolife's guides to make them stiffer.
The 17500 variant includes a stylet. The 17501 and 17502 variants do not include stylets, but the stylet can be purchased separately.
The FDA Clearance Letter for Vitrolife Sweden AB's Embryo Transfer Catheter (ETC) Assortment primarily describes the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device. This letter does not describe an AI/ML-based device, nor does it detail studies involving human experts, ground truth adjudication, or MRMC studies typically associated with AI/ML medical devices.
Therefore, many of the requested details regarding acceptance criteria and study information (particularly points 2-9 related to AI/ML device testing) cannot be extracted from the provided text.
However, I can provide the acceptance criteria and reported performance for the non-clinical tests that were performed, as outlined in the document.
Summary of Device Acceptance Criteria and Performance (Based on Non-Clinical Testing):
The acceptance criteria for this device are based on its physical properties, sterility, biocompatibility, and functionality, demonstrating its substantial equivalence to an existing (predicate) device. The studies described are primarily bench performance tests, material tests, and sterilization/packaging validations.
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization | Sterilization Validation (E-Beam) | Compliance with ISO 11137-1:2006/(R)2015 and ISO 11137-2:2013 | Performed according to standards. (Implied compliance for clearance.) |
| Packaging Integrity | Visual Inspection | Compliance with ASTM F1886/F1886M-16 | Met predetermined acceptance criteria. |
| Dye Penetration | Compliance with ASTM F1929-15 | Met predetermined acceptance criteria. | |
| Seal Strength | Compliance with ASTM F88/F88M-23 | Met predetermined acceptance criteria. | |
| Transportation | Transportation Simulation Testing | Compliance with ASTM 4169-22 and subsequent package integrity testing | Met predetermined acceptance criteria. |
| Biocompatibility | Cytotoxicity | Non-cytotoxic (per ISO 10993-5) | Non-cytotoxic. |
| Sensitization | Non-sensitizing (per ISO 10993-10) | Non-sensitizing. | |
| Irritation | Non-irritating (per ISO 10993-23) | Non-irritating. | |
| Endotoxin | Bacterial Endotoxin Assay (BEA) | and USP ) |
§ 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).