VERIFY ASSERT STEAM Process Challenge Device

• K Number: K162945
• Device Name: VERIFY ASSERT STEAM Process Challenge Device
• Manufacturer: STERIS Corporation
• Date Cleared: 2017-04-28 ( 189 days)
• Product Code: OWP
• Regulation Number: 880.2805
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The VERIFY™ Assert™ STEAM Process Challenge Device (PCD) is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers.

The validated steam sterilization cycles include:

• 270°F (132°C) 4-minute dynamic air removal
• 275°F (135°C) 3-minute dynamic air removal

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for a medical device (VERIFY Assert STEAM Process Challenge Device) and an "Indications for Use" statement. It does not contain information about acceptance criteria, study details, or device performance against those criteria. Therefore, I cannot extract the requested information from this document.

Regulation Number and Section

N/A