ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)

ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) is an absorbable surgical mesh buttress used to reinforce staple lines during soft tissue transection or resection. It is applied to surgical staplers and works as an adjunct to staples to support soft tissue healing. The device is indicated for use in lung resection, bariatric, gastric, small bowel, and colorectal surgical procedures.

The subject device is identical to the predicate in all physical and material characteristics: same absorbable composition (Polyglactin 910 Vicryl knit laminated with Polydioxanone film), same dimensions (65.367 ± 0.30 mm length, 10.4 ± 0.30 mm width), same applicator design, and same 120-day absorption rate. The only differences are increased maximum sterilization dose from 25-30 kGy to 25-40 kGy and extended shelf life from 2 years to 3 years.

ISO 10993-1 for biocompatibility guidance. Non-clinical testing included staple pull-through, buttress alignment, release force, packaging seal strength, and comprehensive biocompatibility studies (cytotoxicity, sensitization, pyrogenicity, genotoxicity, subcutaneous implantation at 4 weeks and 13 weeks). A GLP canine gastric study was conducted at 40 kGy with endpoints at 10, 28, and 120 days to support the increased sterilization dose.

Substantial equivalence is based on identical intended use, indications for use, design, materials, and device performance. There are no modifications to device design or materials compared to predicate K221343. The increased sterilization dose and shelf life are supported by non-clinical biocompatibility and implantation studies demonstrating the device maintains safety and effectiveness. No clinical data were required as the device is substantially equivalent with no new safety or effectiveness questions raised.