(21 days)
The proposed device is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate.
The proposed device is designed to simultaneously fire a stylet followed by a cannula to capture a biopsy sample of soft organs, tumor or masses for histological analysis. The design includes a handle with a thumb tab activated drive mechanism, a side fire button, a rear fire button, and a cannula with a needle tip. The cannula may have marker bands spaced at 1 cm (10 mm) intervals starting from the stylet tip and extending various lengths depending upon the needle. When the device is fully loaded, the yellow indicator is visible when looking at the top of the handle.
The provided text is a 510(k) Premarket Notification for the EasyCore Biopsy System II. This document focuses on establishing substantial equivalence to a predicate device, not on demonstrating performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and study details is not present in this document.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this document. 510(k) submissions for Class II devices often rely on demonstrating substantial equivalence to a legally marketed predicate device rather than setting new, quantitative performance acceptance criteria that require extensive clinical trials for de novo devices.
- Reported Device Performance: The document states, "The intended use, design, operating principles and materials are similar to devices previously cleared via the 510(k) process." This implies that the device is expected to perform comparably to its predicate device (Easy Core Biopsy System, K040893). No specific performance metrics (e.g., successful biopsy rate, tissue quality, adverse event rates) are reported.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/not provided. This document does not describe a test set or a clinical study with human subjects for performance evaluation.
- Data Provenance: Not applicable/not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not provided, as no test set or ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not 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 is a biopsy system, not an AI-powered diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (biopsy system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/not provided. The document focuses on the physical characteristics and intended use of the device, not its diagnostic accuracy requiring ground truth. The purpose of the biopsy system is to retrieve tissue for histological analysis, where pathology would establish the ground truth of the sample.
8. The sample size for the training set:
- Not applicable/not provided, as no machine learning algorithm development is described.
9. How the ground truth for the training set was established:
- Not applicable/not provided.
In summary, the provided 510(k) document for the EasyCore Biopsy System II primarily asserts substantial equivalence to a predicate device (Easy Core Biopsy System K040893) based on similar intended use, design, operating principles, and materials. It does not contain details of a clinical study with acceptance criteria, ground truth establishment, or performance metrics specific to the new device.
§ 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.