Authors: Minocha Dr. Pramodkumar, Kothwala Dr. Deveshkumar, Pandya Kamna, Shinde Divya, Sharma Rahul, Chauhan Sargam, Ladumor Rahul, Kadam Aniket
Abstract: Biocompatibility evaluation is a critical regulatory requirement for establishing the preclinical safety of medical devices in accordance with the ISO 10993 series of standards. The present study aimed to comprehensively assess the biological safety of the OCT Imaging Catheter, in-vitro and in-vivo tests selected based on its intended use and blood-contacting nature. In-vitro cytotoxicity was evaluated using L929 mouse fibroblast cells by qualitative morphological assessment and quantitative MTT assay, followed by in-vivo assessments including skin sensitization, intracutaneous irritation, acute systemic toxicity, and material-mediated pyrogenicity. Hemocompatibility was investigated through hemolysis, platelet activation, coagulation parameters, leukocyte activation, and complement activation studies. Genotoxic potential was assessed using the bacterial reverse mutation (AMES) assay and an in-vitro mammalian chromosomal aberration test in human lymphocytes. The test item demonstrated no cytotoxic effects, with cell viability exceeding ISO acceptance criteria at all extract concentrations. In-vivo studies revealed no evidence of skin sensitization, irritation, systemic toxicity, or pyrogenic response. Hemocompatibility testing confirmed the non-hemolytic nature of the device and showed no adverse effects on platelet function, coagulation pathways, leukocyte activation, or complement system activation. Genotoxicity assessments indicated that the test item was non-mutagenic and non-clastogenic under all test conditions. Collectively, the results demonstrate that the OCT Imaging Catheter exhibits an acceptable biocompatibility profile and is biologically safe for its intended clinical application. These findings support its preclinical risk assessment and provide robust evidence for regulatory submissions in compliance with ISO 10993 requirements.
DOI: http://doi.org/10.5281/zenodo.20708577
