(49 days)
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.
The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
- The extensive treatment of EPA potable water consists of:
- Pre-filtration through two pre-filters:
· Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
· Pre-filter 2 is a surface filter that removes particles/contaminants > 0.1 micron. - UV Irradiation:
· During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water. - 0.1 micron filtration:
· The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
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This document is an FDA 510(k) clearance letter for the STERIS System 1E Liquid Chemical Sterilant Processing System. It does not contain information about acceptance criteria or specific study details proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device and outlines regulatory responsibilities.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory clearance, not a technical report detailing performance criteria and study results.
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.