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Colonoscope/Sigmoidoscope Sheaths are meant for use in non-sterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.

The Sheathing Technologies, Inc. Polyurethane Colonoscope/Sigmoidoscope Sheath provides a conformal covering to fit various lengths and widths of colonoscopes and sigmoidoscopes (hereafter referred to as 'endoscopes'). The cover is open at the proximal end to allow free use of the endoscope's channels, and open at the distal end for insertion of the endoscope. Various sizes and shapes of Sheaths are offered to address the variations in size of the endoscopes.

This device is an accessory for use in nonsterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.

The cover material is a polyether-blend polyurethane, which is the same blend currently used for Sheathing Technologies probe covers (510(K) K963831 for Sheathes Non-Latex, Non-Sterile and 510(K) K990175 for Sheathes Non-Latex, Sterile).

Product categories/models include

• Rigid sigmoidoscope Sheaths (sterile and non-sterile)
• Flexible sigmoidoscope Sheaths (sterile and non-sterile)
• Colonoscope Sheaths (sterile and nonsterile)

Sheaths are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities. All are intended for non-sterile procedures, and all are for single patient/procedure, disposable use.

The provided text describes a 510(k) submission for a Colonoscope/Sigmoidoscope Sheath. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with strict acceptance criteria often seen with novel high-risk devices.

Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria, as typically understood in a clinical efficacy context, is not present in the provided document. The submission relies on non-clinical bench testing and biocompatibility assessments to support equivalence.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

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

No explicit "acceptance criteria" table with corresponding device performance values for clinical efficacy is provided. The non-clinical tests' conclusions state: "Sheathing Technologies's Polyurethane sigmoidoscope/colonoscope Sheath has sufficient strength and elasticity for the intended application. It is biocompatible according to the ISO 10993-1:2003 biocompatibility standard for contact with skin and mucous membranes for a limited (

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