(273 days)
The Biopsy Handy and MRI Biopsy Handy are intended to obtain diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure. Both devices are indicated to be used with ultrasound or CT-Guidance techniques. Only the MRI Biopsy Handy is indicated to be used with magnetic resonance imaging (MRI) techniques.
The Biopsy Handy and the MRI Biopsy Handy are sterile, single use, semiautomatic percutaneous soft tissue biopsy systems each consisting of the following major components: a device handle, a cannula, a stylet button, a stylet with a specimen chamber, a hub of the cannula, a guide bush, a slide and a pressure spring. In addition, the cannulas of the proposed devices will be delivered with a protective tube.
This document pertains to the 510(k) summary for the Biopsy Handy / MRI Biopsy Handy devices, establishing their substantial equivalence to predicate devices. As such, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical trial or performance study would for an AI/ML device.
Instead, the submission focuses on demonstrating safety and effectiveness through establishing substantial equivalence to previously cleared predicate devices. The "study" in this context refers to the comparison made between the new device and the predicate devices, rather than a clinical trial with specific performance metrics.
Therefore, many of the requested categories about acceptance criteria, sample sizes, ground truth, and expert adjudication are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not applicable for performance metrics. This document does not detail specific acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) in a clinical context, nor does it report such performance metrics. The "acceptance criteria" for this submission would be related to meeting the FDA's requirements for demonstrating substantial equivalence, including biocompatibility, sterility, packaging, and MR-testing.
| Acceptance Criteria Category (for Substantial Equivalence) | Reported Device Performance/Compliance |
|---|---|
| Intended Use (Match Predicate) | Identical |
| Technology, Design, Material (Similarity to Predicate) | Identical or similar |
| Biocompatibility | Demonstrated safety and effectiveness |
| Sterility | Demonstrated safety and effectiveness |
| Packaging | Demonstrated safety and effectiveness |
| MR-testing (for MRI Biopsy Handy) | Demonstrated safety and effectiveness |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a comparison to predicate devices, not a clinical study with a "test set" of patient data.
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)
- Not applicable. This information is not relevant to a substantial equivalence submission comparing device characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" or adjudication process described in this document in the context of clinical performance evaluation.
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 semi-automatic biopsy system, not an AI/ML-driven diagnostic tool. Therefore, an MRMC study related to AI assistance 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 medical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. "Ground truth" in the context of clinical performance evaluation is not relevant to this submission. The "ground truth" here is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML or data-driven model.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" described.
§ 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.