(59 days)
The 18 gauge Tru-Cut Biopsy Needle is a device that introduces a cannula into the soft tissue such as breast, lungs, lymph nodes and prostate, etc. for diagnostic evaluation.
The 18 gauge Tru-Cut Biopsy needle is comprised of a cannula and stylet assembly connected to a handle for ease of insertion into the soft tissue.
The provided submission describes a medical device, the 18 Gauge Tru-Cut Biopsy Needle, and asserts its substantial equivalence to a predicate device (Baxter 14 Gauge Tru-Cut Biopsy Needle) based on identical intended use and performance attributes. However, it does not contain information about acceptance criteria or a study demonstrating the device's performance against those criteria in the way typically expected for a software or AI-driven medical device.
Instead, the document focuses on:
- Substantial Equivalence: Claiming that the 18 gauge Tru-Cut Biopsy Needle is substantially equivalent to the 14 gauge version because their intended use and performance attributes are the same.
- Material Biocompatibility Testing: Listing a series of biological qualification safety tests performed on the materials used in the device's fabrication, adhering to ISO 10993 Part-1 standards. These tests (USP Plastics Class VI, Implant, Hemolysis, Tissue Culture, Pyrogenicity, Ocular Irritation, and Guinea Pig Maximization) found the materials "acceptable for the intended use."
Therefore, I cannot provide the requested information as it pertains to acceptance criteria and performance studies in the context of diagnostic accuracy, which is not described in this document. This submission is for a physical medical device (biopsy needle) and focuses on material safety and manufacturing equivalence, not a software or AI component requiring performance metrics like sensitivity, specificity, or reader studies.
§ 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.