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K Number
K111223
Device Name
AMSCO CHIMERON SMALL STEAM STERILIZER
Manufacturer
STERIS Corporation
Date Cleared
2011-09-20

(141 days)

Product Code
FLE
Regulation Number
880.6880
Type
Abbreviated
Panel
HO
Reference & Predicate Devices
K030789
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Amsco Chimeron Small Steam Sterilizer models 16, 16CS, 16S, 20, 20C, 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

  • . Prevacuum (Models 16, 16C and 20, 20C) - are equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  • Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20S) are ● equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
Device Description

The Amsco Chimeron Small Steam Sterilizer models 16, 16CS. 16S. 20, 20C. 20CS, and 20S are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are available in two configurations:

  • Prevacuum (Models 16, 16C and 20, 20C) are equipped with Prevacuum. . Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
  • . Steam Flush Pressure-Pulse (SFPP) (Models 16CS, 16S and 20CS, 20CS) – are equipped with SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
    The chamber sizes of the proposed Amsco Chimeron Small Steam Sterilizer Models are as follows:
  • · 16" x 16" x 26" (Models 16, 16C, 16CS, and 16S)
  • · 20" x 20" x 38" (Models 20, 20C, 20CS, and 20S)
AI/ML Overview

The provided text describes the Amsco Chimeron Small Steam Sterilizer and its validation but does not contain information about an AI/ML-enabled medical device. Therefore, it is not possible to extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML device.

The document pertains to the effectiveness and safety validation of a conventional medical device – a steam sterilizer – according to established standards for sterilization equipment.

If you have a document related to an AI/ML-enabled medical device, please provide it, and I will be happy to extract the relevant details.

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).