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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.

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