Vitrolife Sweden AB · Class II · Cleared Jul 23, 2025
| K-number | K243373 |
| Device name | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) |
| Applicant | Vitrolife Sweden AB |
| Product code | MQF |
| Device class | Class II |
| Decision date | Jul 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 884.6110 |
The EmbryoCath Embryo Transfer Catheter (ETC) Assortment is a sterile, single-use device designed to deliver in vitro fertilized embryos into the uterine cavity during assisted reproduction procedures. The assortment includes three catheter variants (one pre-curved 230 mm and two straight malleable lengths of 180 mm and 230 mm) along with two stylet variants (180 mm and 230 mm) that provide stiffening support during uterine access.
The subject device uses polyethylene and silicone for straight guides, thermoplastic polyurethane and silicone for pre-curved guides, and TPU with polyamide for catheters, compared to the predicate's fluoric resin and stainless steel construction. The subject is sterilized by E-beam radiation with a 3-month shelf-life versus the predicate's ethylene oxide sterilization and 3-year shelf-life. Outer diameters are slightly smaller (catheter 1.45 mm vs 1.55 mm) and lengths differ slightly, but both have distance markings and echogenic visibility for ultrasound guidance.
ISO 11137-1:2006/(R)2015 and ISO 11137-2:2013 (sterilization validation); ISO 11607-1:2019 and ISO 11607-2:2019 (packaging integrity); ASTM F1886, F1929-15, F88/F88M-23 (seal testing); ASTM 4169-22 (transportation); ISO 10993-5, 10993-10, 10993-23 (biocompatibility); USP <85> and <161> (endotoxin); 2021 FDA Mouse Embryo Assay guidance; ASTM F1980-21 (aging); ISO 80369-7:2021 (Luer lock); EN 1618 (catheter performance).
Although the devices differ in materials, sterilization method, shelf-life, and shelf-life, they share the same intended use of transferring embryos to the uterine cavity. Both devices passed equivalent biocompatibility testing (non-cytotoxic, non-sensitizing, non-irritating), identical Mouse Embryo Assay specifications (≥80% development to expanded blastocyst at 96h), and identical endotoxin limits (<20 EU/device). Performance testing confirmed compatibility, functionality, and safety across all variants. The dimensional differences and alternative materials do not raise different questions of safety or effectiveness because both accomplish the same clinical function with equivalent biological and performance characteristics.
View the full FDA submission: accessdata.fda.gov