Marquee™ Disposable Core Biopsy Instrument and Instrument Kit

The Marquee Disposable Core Biopsy Instrument and Kit is a single-use core biopsy device used to obtain tissue samples from soft tissues including breast, liver, kidney, prostate, spleen, lymph nodes, and soft tissue tumors. It comes in multiple needle gauge sizes (12G, 14G, 16G, 18G, 20G) with color-coded cannula releases and is available as a standalone instrument or as a kit with a compatible disposable coaxial biopsy needle.

The Marquee shares the same intended use, patient population, principle of operation, duration of use, sterility assurance level, and sterilization method as its predicates. Differences include new labeling modifications to the Indications for Use statement, design changes to the patient/use interface, needle length, sample notch length and penetration depth, material changes with addition of colorants, additional performance specifications, and the addition of a Convenience Kit option.

ISO 10993-1:2018 for biocompatibility testing, which included cytotoxicity, sensitization, intracutaneous reactivity, acute system toxicity, and material mediated pyrogenicity assays.

Substantial equivalence is supported by identical intended use and similar indications for use, patient population, and principle of operation as the predicate devices (Bard Monopty and Bard Mission). Performance testing demonstrated comparable safety and effectiveness through in vitro testing of penetration depths, tensile strength, needle protection, sterile barrier integrity, and shelf life. Ex-vivo porcine tissue testing confirmed sample quality comparable to predicates, and a systematic literature review supported the breast biopsy indication. The design and material changes do not alter the fundamental function or safety profile of the device.