2477P

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Medical Materials & Technologies BIOCOMPATIBILITY SUMMARY Product N ame 3M™ Medical Silicone Tape 2477P Effective: December 2020 P a g e The adhesive used in 3M™ Medical Silicone Tape 2477P has been subjected to the following preclinical biocompatibility testing by an outside laboratory under GLP: Cytotoxicity Study Using the ISO Direct Contact Method (Acrylic Adhesive Tested) The test article was evaluated to determine the potential for cytotoxicity. This study was conducted based on the requirements of ISO 10993 5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. Cu lture wells of a 6 well tissue culture plate that contained a subconfluent monolayer of L 929 mouse fibroblast cells were used for testing. Triplicate wells were dosed with either a test article section, high density polyethylene as a negative control or l atex as a positive control. Each article was placed in direct contact with the L 929 cells. After incubating for 24 26 hours, the cultures were examined microscopically (100X) for any abnormal cell morphology and cell lysis in proximity to the articles. Re sults: The test article showed no evidence of causing cell lysis or cytotoxicity to L 929 cells. The test article met the requirements of the test since the grade was less than a grade 2 (mild reactivity). CLIN RPT FINAL INV US 405329 Cytotoxicity Stud y Using the ISO Elution Method Silicone and Acrylic Adhesive Tested) The test article was evaluated for potential cytotoxic effects using an in vitro mammalian cell culture test. This study was conducted following the guidelines of ISO 10993 5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. A single preparation of the test article was extracted in single strength Minimum Essential Medium (1X MEM) at 37 C for 24 hours. The negative control, reagent control, and positive control were similarly extracted. Triplicate monolayers of L 929 mouse fibroblast cells were dosed with each extract and incubated at 37 C in the presence of 5% CO for 48 hours. Following incubation, the monolayers were examined microscopically for abnorm al cell morphology and cellular degeneration. Results: The test article extract showed no evidence of causing cell lysis or toxicity and had a grade of 0 (no reactivity). The test article met the requirements of the test since the grade was less than a grade 2 (mild reactivity). CLIN RPT FINAL INV US 405559 ISO Skin Irritation Study in Rabbits (Acrylic Adhesive Tested) The test article was evaluated for primary skin irritation in rabbits. This study was conducted in accordance with the guidelines of ISO 10993 10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. Two 25 mm x 25 mm sections of the test article and control article were topically applied to the skin of each of three rabbits and left in place for a minimum of 23 hours and a maximum of 24 hours. The sites were graded for erythema and edema at 1, 24, 48 and 72 hours after removal of the single sample application. Results: There was non e to well defined erythema and no edema observed on the skin o f the animals treated with the test article. The Primary Irritation Index (PII) for the test article was calculated to be 0.5 /8.0 . The response of the test article was categorized as slight. CLIN RPT FINAL INV US 409807

Medical Materials & Technologies BIOCOMPATIBILITY SUMMARY Product N ame 3M™ Medical Silicone Tape 2477P Effective: December 2020 P a g e ISO Guinea Pig Maximization Sensitization Test (Silicone and Acrylic Adhesive Tested) The test article was evaluated for the potential to cause delayed dermal contact sensitization in a guinea pig maximization test. This study was conducted based on the requirements of I SO 10993 10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. The test article was extracted in 0.9% sodium chloride USP and sesame oil, NF. Each extract was intradermally injected and occlusively patched to ten test guinea pigs (per extract). The extraction vehicle was similarly injected and occlusively patched to five control guinea pigs (per vehicle). Following a recovery period, the test and control animals received a challenge patch of the appropriate tes t article extract and the vehicle control. All sites were scored for dermal reactions at 24 and 48 hours after patch removal. Results: The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a dermal sensitizer in the guinea pig maximization test. CLIN RPT FINAL INV US 411272 The adhesive used in 2477P, as part of a different construction, has also been subjected to the following pre clinical biocompatibility tes ting by an outside laboratory under GLP: Cytotoxicity Study Using the ISO Agarose Overlay Method (Silicone Adhesive Tested) The test article was evaluated to determine the potential for cytotoxicity based on the requirements of ISO 10993 5, Biological eva luation of medical devices Part 5: Tests for in vitro cytotoxicity. Triplicate wells were dosed with a 1 cm x 1 cm portion of the test article. Triplicate wells were dosed with a 1 cm length of high density polyethylene as a negative control. Triplicate wells were dosed with a 1 cm x 1 cm portion of latex as a positive control. Each was placed on an agarose surface directly overlaying a subconfluent monolayer of L 929 mouse fibroblast cells. After incubating at 37 C in the presence of 5% CO for 24 hours, the cultures were examined macroscopically and microsc opically for any abnormal cell morphology and cell lysis. Results: The test article showed no evidence of causing any cell lysis or toxicity. The test article met the requirements of the test since the grade was less than or equal to a grade 2 (mild reacti vity). CLIN MISC US 224879 ISO Skin Irritation Study in Rabbits (Silicone Adhesive Tested) The test article was evaluated for primary skin irritation in accordance with the guidelines of ISO 10993 10, Biological evaluation of medical devices Par t 10: Tests for irritation and skin sensitization. Two 25 mm x 25 mm sections of the test article and control article were topically applied to the skin of each of three rabbits and left in place for a minimum of 23 and a maximum of 24 hours. The sites wer e graded for erythema and edema at 1, 24, 48 and 72 hours after removal of the single sample application. Results: There was no erythema and no edema observed on the skin of the animals treated with the test article. The Primary Irritation Index (PII) for the test article was calculated to be 0.0 /8.0 . The response of the test article was categorized as negligible. CLIN MISC US 224889 It is the responsibility of our customers to determine final suitability of our products for their application. Final te sting of a converted device made with this material is the responsibility of the custom er.