Search Results

The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The Bard® Biopty-Cut® Biopsy Needle and Bard® Biopty-Cut® Needle with Spacer are single-use biopsy needles. The Bard® Biopty-Cut® Biopsy Needle and Bard® Biopty-Cut® Needle with Spacer which are the subject of this Premarket Notification, have a modified sample notch. They are available in various gauges and lengths. The Bard® Biopty-Cut® Needle with Spacer is packaged with a computed topography spacer.

The provided document (K962077) describes a 510(k) premarket notification for a modified Bard Biopty-Cut Biopsy Needle. The core of the submission is to demonstrate that the quality of samples obtained with the modified needle (specifically, a change in the distal end of the sample notch from a radius to an angled configuration) is equivalent to that of the standard sample notch needles.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "no significant difference" in sample quality between the proposed device and the predicate device. The performance is reported as meeting this criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set in numerical terms (e.g., number of biopsies, number of needles tested). It refers to "Test results and report presented in Appendix B of this submission," which is not provided in the excerpt.

• Sample Size: Not explicitly stated in the provided text. It refers to "samples collected."
• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective/prospective). This would typically be detailed in an Appendix or study report.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the excerpt. For a biopsy needle, "ground truth" related to sample quality would likely involve pathological evaluation by qualified pathologists; however, no details about experts or their qualifications are given.

4. Adjudication Method for the Test Set

This information is not provided in the excerpt.

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

This question is not applicable as the device is a biopsy needle, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI component is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a biopsy needle and does not involve any algorithms or standalone performance as an AI system.

7. The Type of Ground Truth Used

The "ground truth" implicitly relates to the "quality of samples obtained." While not explicitly stated, for a biopsy needle, the most relevant ground truth for sample quality would typically be histopathological evaluation (pathology) to assess tissue integrity, cellular architecture, and diagnostic yield.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical biopsy needle, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8.

Ask a specific question about this device