(24 days)
The Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle is intended for obtaining a percutaneous soft tissue biopsy.
The subject device is a sterile disposable product featuring a stationary stylet that punctures, a spring activated cannula that cuts and a SNARECOIL that captures tissue. The device functions by pulling back the pull ring until the trigger cocks and pressing the trigger until the device fires. The biopsy is captured by the snare located inside the outer needle cannula.
The provided text indicates that the device, the Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle, did not undergo a clinical study. Instead, its acceptance was based on non-clinical performance verification testing and a demonstration of substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Acceptability (Non-Clinical) | Performance verification testing demonstrated that the SNARECOIL Soft Tissue Biopsy (GSS) Needle is functionally acceptable. |
| Substantial Equivalence to Predicate Devices | Based on similarities in materials, design, operating principles, biocompatibility, and sterilization method, the GSS Biopsy Needle has been shown to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The document explicitly states "Clinical Data: Not Applicable." The performance verification was non-clinical.
- Data Provenance: Not applicable, as no clinical data was used. The non-clinical data would have been generated internally by Ranfac Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No experts were mentioned for establishing ground truth as there was no clinical test set. The functional acceptability for the non-clinical testing would have been evaluated against internal company specifications and standards.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set or human interpretation involved to require an adjudication method.
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
- No. The document explicitly states "Clinical Data: Not Applicable," and there is no mention of AI assistance or human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical biopsy needle, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance verification, the "ground truth" would have been established by the device's functional specifications and engineering requirements (e.g., successful tissue capture, firing mechanism functionality, material integrity). This isn't external pathology or outcomes data but internal test results against predefined criteria.
8. The sample size for the training set
- Not applicable. The device is a physical medical instrument, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there was no training set for an AI or algorithm.
§ 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.