(60 days)
The core needle biopsy 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® Monopty® Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow = 20 gauge, Pink = 18 gauge, Purple = 16 gauge and Green = 14 gauge, and Light Blue = 12 gauge.
The Bard® Max-Core® Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color coded according to the various gauge sizes, e.g., Yellow = 20 gauge, Pink = 18 gauge, Purple = 16 gauge and Green = 14 gauge.
The provided text describes a 510(k) premarket notification for a core biopsy instrument, primarily focusing on its substantial equivalence to a predicate device. It briefly mentions performance testing but does not detail acceptance criteria or specific study results in a quantitative manner as typically found in a clinical study report.
Therefore, much of the requested information cannot be extracted directly from this document.
Here's a breakdown of what can and cannot be provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Not explicitly stated for all) | Reported Device Performance |
|---|---|---|
| Dimensional | Not explicitly stated | Met design inputs |
| Sample Quality | Not explicitly stated | Met design inputs |
| Durability | Not explicitly stated | Met design inputs |
| Needle to Device Tensile Strength | Not explicitly stated | Met design inputs |
| Echogenicity | Not explicitly stated | Met design inputs |
| Functional Requirements | Not explicitly stated | Met functional requirements |
| User Needs Requirements | Not explicitly stated | Met user needs requirements |
Explanation: The document states, "Results of this testing demonstrate that the design outputs continue to meet the design inputs and user need requirements." This is a general statement and does not provide specific numerical acceptance criteria or performance metrics. It indicates successful performance against internal criteria, but those criteria themselves are not detailed in this public summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The document only mentions "representative samples of the device underwent bench testing," but does not specify the number of samples, whether the data was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the described testing is bench testing of the device's physical and functional properties, not a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists for medical images).
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench testing of the device itself, not a study of human readers' performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a core biopsy instrument, a physical medical device, not an algorithm, so standalone algorithm performance is not relevant here. The testing described is for the physical device's performance.
7. The Type of Ground Truth Used
The concept of "ground truth" (e.g., pathology, outcomes data) is not applicable in the context of the described bench testing. The testing evaluated the device's performance against its design inputs and functional requirements, which would involve quantitative measurements of physical properties rather than complex diagnostic accuracy.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical instrument, not an AI/ML 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 reason as point 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.