LF Process Indicator Tape for Steam Sterilization

The LF Process Indicator Tape for Steam Sterilization is a lead-free process indicator tape used to seal sterilization packs and visually distinguish between processed and unprocessed items. The green indicator lines turn dark brown/black when exposed to steam sterilization, providing a visual confirmation that packages have undergone the sterilization process.

The device is made of saturated crepe paper printed with non-lead-based indicator ink and coated with synthetic, solvent-free adhesive. It is provided in natural and blue colors in widths of approximately 0.75 inches and 1 inch. The subject device differs from the predicate only in labeling, which has been expanded to include additional validated steam sterilization cycles (e.g., 132°C for 3, 4, 10, and 15 minutes; 134°C for 3 and 4 minutes; and 135°C for 3 and 10 minutes).

Testing was performed in accordance with ANSI/AAMI/ISO 11140-1:2014 (Sterilization of health care products — Chemical indicators — Part 1: General requirements) and FDA Guidance for Industry and FDA Staff Premarket Notification [510(k)] Submissions for Chemical Indicators. Additional testing included PSTC-101 and PSTC-131 International Tape Standards for adhesion.

The subject device has identical intended use, materials, manufacturing process, and performance specifications as the predicate device (K161024). The only difference is expanded labeling for additional validated steam sterilization cycles. All non-clinical testing passed predetermined acceptance criteria, demonstrating the device is as safe and effective as the predicate.