Search Results

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 (<24 hour) contact duration."

This indicates that the performance criteria were met for:

• Strength and Elasticity: Deemed "sufficient for the intended application."
• Biocompatibility: Conforms to ISO 10993-1:2003 for skin and mucous membrane contact (<24 hours).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes "Non-Clinical Tests" which include bench testing and biocompatibility assessments. These are laboratory tests, not clinical studies involving human patients. Therefore, the concept of a "test set" in the context of patient data (sample size, country of origin, retrospective/prospective) does not apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. "Ground truth" in this context typically refers to a definitive diagnosis or outcome for clinical data. As this submission is based on non-clinical, laboratory testing, there is no "ground truth" established by medical experts in the way described. The "truth" is based on established engineering and biocompatibility standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies among expert opinions on patient data. This submission focuses on laboratory testing outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical sheath for endoscopes, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" or standard for evaluation was based on:

• Engineering specifications: For stretch testing and imperforate seams, implying conformity to design requirements for strength and integrity.
• International Standard (ISO 10993-1:2003): For biocompatibility, specifically for contact with skin and mucous membranes for a limited duration.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" as this is not an AI or machine learning device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Ask a specific question about this device