VERIFY STEAM Integrating Indicator

The VERIFY STEAM Integrating Indicator is a single-use chemical indicator strip placed inside sterilization packs to monitor steam sterilization cycles. It chemically reacts to temperature and time parameters, and displays a visible color change in an ACCEPT (OK) window to indicate whether sterilization criteria have been met. If the dark bar enters the acceptance window, the sterilization is successful; if not, materials must be re-sterilized.

The device consists of a backing material with an embossed cavity containing temperature-sensitive chemical and coloring dye, a wicking strip, and a laminated paper cover with labeling and viewing windows. The primary difference from the predicate is a change in the plastic layer material. The indicator agent formulation, sterilization cycles supported, mechanism of action, and endpoint specification (dye migration to marked ACCEPT area) remain identical to the predicate device.

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.

The new device is substantially equivalent because it supports identical intended use (all 18 steam sterilization cycles), uses the same proprietary indicator formulation and mechanism of action, achieves identical endpoint specifications, and demonstrates equivalent performance in all non-clinical testing (stated value testing, simulated use testing, stability testing, and biological indicator comparison). The only material change—the plastic layer—does not affect the device's safety, effectiveness, or performance, as evidenced by passing all established acceptance criteria.