Fresenius Medical Care Renal Therapies Group, LLC · Class II · Cleared Apr 3, 2025
| K-number | K250404 |
| Device name | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch |
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC |
| Product code | KDJ |
| Device class | Class II |
| Decision date | Apr 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.5630 |
The stay•safe catheter extension sets are single-use, sterile, disposable accessories for peritoneal dialysis patients. They connect PD catheters to PD systems using stay•safe PIN technology, enabling dialysate flow and effluent drainage. Available in Safe-Lock and Luer-Lock connector configurations in various lengths (6, 12, or 18 inches), they are intended for use in both healthcare facilities and home settings for patients with acute and chronic end-stage renal disease.
The devices are substantially equivalent to the predicate in intended use, indications for use, design specifications, technological characteristics, principle of operation, and performance requirements. Both the predicate and current devices use silicone tubing, are sterilized with ethylene oxide, provide sterile and non-pyrogenic single-use connections, and are designed for up to 6-month use with potential replacement every 6 months over a 10-year treatment period.
ISO 10993-1:2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) and FDA guidance on the same standard (September 2023). Testing included chemical characterization, cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, hemocompatibility, and carcinogenicity.
The devices are substantially equivalent because they demonstrate identical intended use (connecting PD catheters to stay•safe systems in ESRD patients), the same design and operational principles, and equivalent technological characteristics to predicate K173593. Performance testing (weight, length, clamp function, leak tests, bond strength, dimensional verification) shows no differences raising new safety or efficacy concerns. Biocompatibility endpoints were evaluated per ISO 10993-1, and all materials are well-established in similar devices.
View the full FDA submission: accessdata.fda.gov