Autoclave Indicator Tape; EO Indicator Tape

The Autoclave Indicator Tape and EO Indicator Tape are single-use, disposable chemical indicators designed for healthcare providers to demonstrate exposure to steam or ethylene oxide sterilization processes. The Autoclave Indicator Tape changes color from yellow to black when exposed to steam sterilization (121°C for 30 minutes or 134°C for 4 minutes), while the EO Indicator Tape changes from orange to green when exposed to EO gas sterilization (55°C, 762 mg/l EO, 40–80% RH, 4 hours). Both devices distinguish between processed and unprocessed units or loads.

Both subject devices are tape-format chemical indicators with diagonal indicator ink lines printed on crepe paper, with adhesive backing. The Autoclave Indicator Tape has a yellow initial color changing to black, while the EO Indicator Tape has orange initial color changing to green. Both are Type 1 ISO indicators with 2-year and 18-month shelf lives respectively. The subject devices support fewer sterilization cycles than the predicate devices (2 steam cycles vs. 6 for the predicate; 1 EO cycle vs. 6 for the predicate), but operate within overlapping temperature and gas concentration ranges.

ISO 11140-1:2014 (sterilization process indicators), ISO 10993-5, ISO 10993-10, and ISO 10993-23 (biocompatibility testing). Testing also referenced FDA guidance on Premarket Notification Submissions for Chemical Indicators.

The subject devices are substantially equivalent because they are identical in device class (Class II), regulation (21 CFR 880.2800), product code (JOJ), and intended use (sterilization process indicators). Both subject and predicate devices use the same Type 1 chemical indicator technology with adhesive tape backing and comply with ISO 11140-1:2014. Although the subject devices support fewer sterilization cycles, the cycles they support are subsets of or overlapping with predicate cycles, demonstrating performance in the same sterilization conditions. Non-clinical testing confirms the subject devices meet performance specifications, pass biocompatibility testing, and perform color changes reliably without ink transfer or adhesion issues, matching predicate performance standards.