(173 days)
The K-C Hemostatic Biopsy System is indicated for use endoscopically or percutaneous to retrieve tissue sampling of soft organs/tumors or masses for histological analysis and deliver a hemostatic material to the biopsy site to reduce bleeding from the biopsy site. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate. It is not intended for use in bone.
The proposed device consists of a mechanism to capture a biopsy sample of soft tissue, soft organs, tumor or masses for histological analysis and a co-axially configured syringe containing a hemostatic agent to be delivered into the biopsy tract upon removal of the biopsy sample.
The provided document is a 510(k) premarket notification for the K-C Hemostatic Biopsy System. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain any information regarding specific acceptance criteria for device performance or a study that proves the device meets such criteria.
The document primarily focuses on establishing substantial equivalence based on the technological characteristics, intended use, design, operating principles, and materials being similar to predicate devices. It lists several predicate devices for hemostatic delivery, aspiration, and cutting needles.
Therefore, I cannot provide the requested table and study details based on the information given.
Here's a breakdown of what could not be answered based on the provided text:
- A table of acceptance criteria and the reported device performance: No performance criteria or results are mentioned.
- Sample size used for the test set and the data provenance: No test studies or data are described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is mentioned for any performance testing.
- Adjudication method for the test set: No test sets are described.
- 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 device is a biopsy system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No performance testing requiring ground truth is described.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device in the context of typical training sets.
- How the ground truth for the training set was established: Not applicable.
The submission claims that "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." However, it does not detail what "data gathered" refers to in terms of specific performance metrics or studies. It relies on the assertion of similarity to predicate devices.
§ 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.