(63 days)
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.
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Equivalence in quality of samples obtained | "Testing confirms that the quality of the samples obtained with the modified notch needles are equivalent to the samples obtained from the standard sample notch needles." (from Section {1}) |
| No significant difference between samples collected | "Test results and report presented in Appendix B of this submission show no significant difference could be detected between the samples collected by a needle with an angled distal sample notch and samples collected by a needle with a radius distal sample notch" (from Section {2}, footnote 3) |
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.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.