Sam Brusco, Associate Editor08.14.23
Andersen Sterilizers and sister company Andersen Scientific, a contract sterilization specialist, were awarded the first master file in the U.S. Food and Drug Administration’s (FDA) 510(k) ethylene oxide (EO) Sterility Change Master File Program.
With this clearance, 510(k) holders of devices labeled as sterile that want to begin using the company’s EO-Flexible Chamber Technology (EO-FCT) systems to sterilize authorized Class I or Class II devices can reference the Andersen Sterilizers master file instead of submitting a new 510(k) for the sterilization change.
"We were awarded the FDA Innovation Challenge 2 for reducing ethylene oxide emissions with our proprietary technology three years ago," Ted May, Andersen Products’ CEO told the press. "The FDA asked how they could help us as we further this mutual goal. We mentioned the hurdle (or perceived hurdle) for potential new customers worried that they will need to submit a new 510(k) if they switch from a traditional sterilization system to either Andersen Sterilizer's EOGas 4 or EOGas 3 in-house systems or to Andersen Scientific's contract sterilization services. This master file makes it official, switching to Andersen just got even easier."
The company’s sterilization systems leverage a proprietary flexible chamber that requires less EO than established EO systems to support the FDA’s mission of minimizing EO use.
Andersen Sterilizers designs and manufactures tabletop and refrigerator-sized EO gas sterilizers for the manufacturing, research, medical, and veterinary markets. Andersen Scientific offers small- to medium-lot sterilization, custom cycles, and quick turnaround.
With this clearance, 510(k) holders of devices labeled as sterile that want to begin using the company’s EO-Flexible Chamber Technology (EO-FCT) systems to sterilize authorized Class I or Class II devices can reference the Andersen Sterilizers master file instead of submitting a new 510(k) for the sterilization change.
"We were awarded the FDA Innovation Challenge 2 for reducing ethylene oxide emissions with our proprietary technology three years ago," Ted May, Andersen Products’ CEO told the press. "The FDA asked how they could help us as we further this mutual goal. We mentioned the hurdle (or perceived hurdle) for potential new customers worried that they will need to submit a new 510(k) if they switch from a traditional sterilization system to either Andersen Sterilizer's EOGas 4 or EOGas 3 in-house systems or to Andersen Scientific's contract sterilization services. This master file makes it official, switching to Andersen just got even easier."
The company’s sterilization systems leverage a proprietary flexible chamber that requires less EO than established EO systems to support the FDA’s mission of minimizing EO use.
Andersen Sterilizers designs and manufactures tabletop and refrigerator-sized EO gas sterilizers for the manufacturing, research, medical, and veterinary markets. Andersen Scientific offers small- to medium-lot sterilization, custom cycles, and quick turnaround.