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Use the ColoSHIELD during colonoscopy procedures to protect the clinical staff from patient secretions and to help maintain a cleaner procedural site.

The proposed surgical drape is composed of polyethylene film and polypropylene components. The drape is a blue polyethylene sheet with an acrylic copolymer adhesive. The drape has a fluid collection pouch. The middle of the drave has a polypropylene ring approximately 5.25" in diameter. It is used to hold in place a polypropylene plate that reduces the 6.25" diameter down to 1.70" in diameter. The polypropylene plate has a thermo-plastic elastomer (TPE) feature that is molded to the 1.70" polypropylene plate aperture with a 0.375" diameter fenestration that secures. around an endoscope. Attached to the bottom of the plate is a polyethylene reservoir. This reservoir may be used to contain a water-soluble lubricant to aid in the insertion of the scope during the procedure.

The provided text describes the 510(k) summary for the ColoSHIELD Colonoscopy Drape. It primarily focuses on the device's description, intended use, and its substantial equivalence to a predicate device.

However, the document does not contain information about acceptance criteria, detailed study results proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment methods, or any multi-reader multi-case (MRMC) or standalone algorithm performance studies.

The "Summary of testing" section only states: "The adhesive component of the drape was evaluated per the applicable section of ISO 10993-1 for skin contact devices." This is a very high-level statement indicating biocompatibility testing for the adhesive, not performance testing related to the drape's primary function of protecting staff and maintaining a clean site.

Therefore, I cannot provide the requested table and detailed information as the source text does not contain this specific data.

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