Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

The Terragene® Bionova® Photon Process Challenge Devices (PCD225-2 and PCD225-C) are disposable, pre-assembled packages containing a self-contained biological indicator with Geobacillus stearothermophilus spores, a chemical integrator, and a record card. They are designed to provide a defined challenge resistance equivalent to a 16-towel test pack and are intended for routine monitoring of steam sterilization processes at specified temperature and exposure time combinations. The devices are read using the Terragene® Bionova® Photon Auto-reader Incubator (BPH), which provides a 7-second fluorescent readout after 60°C incubation.

The subject devices differ from the predicate in three key areas: (1) they contain a newer Bionova® Photon Biological Indicator (BT225) with indirect growth detection using a non-enzymatic fluorophore (ANS binding to spore proteins) instead of the predicate's enzymatic α-glucosidase mechanism; (2) they have a shorter readout time of 7 seconds versus 20 minutes in the predicate; (3) they are used with a different auto-reader incubator (BPH). Both use identical chemical integrators, spore strains (10⁶ Geobacillus stearothermophilus), incubation temperature (60 ± 2°C), and biological resistance characteristics.

FDA Guidance for Industry on Biological Indicator (BI) Premarket Notification [510(k)] Submissions (October 4, 2007); FDA Guidance on Chemical Indicators [510(k)] Submissions (December 19, 2003); ISO 11140-1:2014 (chemical and biological indicators classification); ANSI/AAMI ST79:2017 (comprehensive guide to steam sterilization and sterility assurance).

The devices are substantially equivalent because they maintain identical intended use (routine steam sterilization monitoring), identical resistance characteristics and spore population to the predicate, and equivalent performance in the same claimed sterilization cycles. Although the biological indicator uses a different fluorophore mechanism and shorter readout time with a different incubator, comparative performance testing demonstrated that the Photon devices provide equivalent challenge resistance to both standalone indicators and the AAMI 16-towel reference pack, and perform identically to the predicate devices (PCD224-2 and PCD224-C) in all claimed cycles. The differences are technological improvements that do not affect the safety or effectiveness of the device for its intended purpose.