1 – Please refer to the package insert – Instructions for Use (IFU).
2 – Biocompatibility has been demonstrated through appropriate in vitro and in vivo tests, including : cytotoxicity, skin sensitization, acute intracutaneous reactivity, acute systemic toxicity, sub-chronic/sub-acute systemic toxicity, and tissue implantation tests. All tests were performed in compliance with GLP regulations in accordance with ISO 10993-1, Biological evaluations of medical devices part 1: evaluation and testing. The results indicate that the subject device passed toxicity and safety tests and is safe for intended use. Data on File in the 510k application.
3 – Sustained antimicrobial activity for up to 3 days has been demonstrated by relevant standard in vitro microbiological assays in simulated wound fluid. The matrix was shown to be effective in reducing on its surface more than 4 log10 CFUs of a broad spectrum of microbes most frequently associated with wound infections, including, Staphylococcus aureus (ATCC 6538), MRSA (ATCC 33591), VRE (ATCC 55175), Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC 10231), Klebsiella pneumoniae (ATCC 4352), Candida tropicalis (ATCC 750), and Candida albicans (ATCC 10231). The product was determined as being non-pyrogenic. Data on File in the 510k application and at Imbed Biosciences. Data on File at Imbed Biosciences.
4 – Water absorption capacity, water vapor transmission rate, oxygen transmission rate. Data on File in the 510k application.
5 – Field et al, Overview of wound healing in a moist environment. American Journal of Surgery, 1994 Jan;167(1A):2S-6S
6 – Okan et al, The role of moisture balance in wound healing. 2007
7 – https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm?event=BasicSearch.page
8 – Manning et al, WOUNDS 2020, 32(11): 309-318
9 – Chatelain et al, WOUNDS, 2021, 33(10): 245-252
10 – https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=510117&lpcd=FRO
11 – https://www.govinfo.gov/content/pkg/FR-2022-11-23/pdf/2022-23918.pdf – See Table 62 on Page 71982 (Rules and Regulations, Federal Register, Vol 87, No. 225, Nov 23, 2022).