Search Results

The Wilson-Cook Double Lumen Biliary Cytology Brush is intended to collect cells in the biliary system.

The proposed Cytology Brush is a modification to existing cytology brushes currently marketed by Wilson-Cook. The Double Lumen Cytology Brush is supplied sterile and intended for single use only.

This 510(k) summary for the Wilson-Cook Double Lumen Biliary Cytology Brush does not include acceptance criteria or a detailed study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (Wilson-Cook Cytology Brushes, K896318).

Here's an analysis of the provided text in relation to your questions:

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

• No specific acceptance criteria or performance data are provided. The document states: "We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility." This implies that the performance characteristics were compared to the predicate, but the specific metrics and targets (acceptance criteria) for this comparison are not detailed.

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

• No information provided. The document does not describe any specific test set, its sample size, or data provenance.

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)

• No information provided. Since no specific test set is detailed, there is no mention of experts or ground truth establishment.

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

• No information provided.

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 cytology brush, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is irrelevant.

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

• Not applicable. This device is a physical cytology brush.

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

• No information provided.

8. The sample size for the training set

• No information provided.

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

• No information provided.

Summary of what is present:

The document focuses on establishing substantial equivalence based on the following:

• Identical materials of basic composition: The new brush uses the same materials as the predicate.
• Same operating principal: Both devices function in the same way to collect cells.
• Same technological characteristics: The underlying technology is considered equivalent.
• Intended Use: Both devices are for collecting cells in the biliary system.
• Biocompatibility: This is mentioned as a characteristic where the devices are considered equivalent, implying that biocompatibility testing was either conducted for the new device or referenced from the predicate.

In essence, this 510(k) submission is a "modification to existing cytology brushes" where the manufacturer believes the changes are minor enough that the new device shares the same fundamental characteristics and performance as the previously cleared predicate, thus not requiring new, extensive performance data with specific acceptance criteria beyond demonstrating this equivalence. The FDA concurred with this assessment.

Ask a specific question about this device