Zener® (model ZEN-001-B1)

Zener is a ceiling-mounted UV air purification device intended to reduce bacteria in air within medical facilities. It uses ultraviolet-C light to kill microorganisms and has demonstrated a 4.73 net log-reduction of Klebsiella aerogenes in a 1,060 cubic foot space within 2 hours at specified humidity and temperature conditions.

Zener uses one UV-C optic consuming 11W power with four cylindrical tubes operating at 200-235 nm wavelength, compared to the predicate's two 48W UV-C optics. Zener is ceiling-fixed at minimum 2.25 meters height and relies on ambient air circulation, whereas the predicate uses an internal fan to circulate air through a shielded chamber with a particulate filter. Both use quartz UV-C optics with no chemical additives or electrostatic precipitation.

Performance testing per ASHRAE 241 (modified for bacteria), AHAM AC-5, and FDA GLP; electrical safety per UL 1598 and CSA C22.2 No. 250.0; photobiological safety per IEC 62471 and ANSI/CAN/UL 8802; ozone safety per UL 867 and CSA C22.2 No. 187; electromagnetic compatibility per IEC 60601-1-2, CISPR 11, and FCC; software verification per IEC 62304; and risk management per ISO 14971.

Although Zener's design differs from the predicate (passive ambient air exposure versus active fan-driven circulation, different power consumption, and UV optic configuration), substantial equivalence is demonstrated through: (1) identical mechanism of action (UV light killing microorganisms), (2) same germicidal UV-C technology and wavelength range, (3) comparable performance metrics (4.73 log-reduction versus 4-5 log-reduction), (4) passing all applicable safety certifications and standards, and (5) risk analysis and performance testing confirming these design differences do not raise different safety or effectiveness questions.