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HALYARD® SMART-FOLD Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

• Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 30 minutes.
• 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 110° F/43.3ºC.

STERIS V-PRO® Low Temperature Sterilization Systems.

• · STERIS® V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS® V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS® V-PRO® 1 (Lumen Cycle)

• · STERIS® V-PRO® 1 Plus (Lumen and Non-Lumen Cycle)

• · STERIS® V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle)

• · STERIS® V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycle)

• Advanced Sterilization Products STERRAD® Sterilization System

• STERRAD® 100S

• · STERRAD® NX®, (Standard Cycle, Advanced Cycle)

• · STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle)

• · STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GL Cycle)

• STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GI Cycle)

HALYARD* ONE-STEP, QUICK CHECK and SEQUENTIAL Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600.

• · 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 43.3℃.
  · STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles.

• · STERIS V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS V-PRO® 1 (Lumen Cycle)

• · STERIS V-PRO® 1 Plus (Lumen and Non-Lumen Cycle)

• · STERIS V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle)

• · STERIS V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycle)

· Gravity steam at 250°F/121°C for 30 minutes (25 minute dry time for Models 100, 200 and 30 minute dry time for Models 400, 500 and 600)

• · Advanced Sterilization Products STERRAD® Sterilization System
• · STERRAD® 50, 100S, and 200
• · STERRAD® NX®, (Standard Cycle, Advanced Cycle)
• · STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle)
• · STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle)
• · STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, EXPRESS Cycle, DUO Cycle)
• · STERILUCENT® HC80TT Sterilization Cycles (Lumen and Flexible Cycles)
• · Stryker Sterizone® VP4 Sterilizer Cycle 1

HALYARD SEQUENTIAL Sterilization Wrap is supplied to the customer as bulk packages of single sheets, where in accordance with standard hospital practices, two sheets are then used to wrap a medical device or a collection of medical devices for sterilization. HALYARD ONE-STEP, HALYARD QUICK CHECK and HALYARD SMART-FOLD Sterilization Wraps are comprised of two sheets of HALYARD* SEQUENTIAL Sterilization Wrap. This allows for convenient wrapping with two sheets simultaneously.

The HALYARD ONE-STEP, QUICK CHECK and HALYARD SMART-FOLD Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider.

The document describes the regulatory submission for HALYARD sterilization wraps. It focuses on demonstrating substantial equivalence to a predicate device through performance testing. No AI/ML algorithm is involved in the device. Therefore, a complete response is not possible for all aspects of your request.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

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