Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)

The Triopsy Biopsy System is a reusable actuator instrument combined with single-use disposable biopsy needles designed to obtain core tissue samples from the prostate for cancer diagnosis and treatment planning. The needle features patented ridges that hold and protect the sample to prevent breakage during collection.

The primary technological differences from the predicate (Bard Magnum) are: (1) variable penetration depth setting on the Triopsy Actuator, allowing adjustment of how far the needle advances, and (2) sample length notches on the Triopsy Needles that enable collection of full-length, unbroken apex-to-base core samples. Both devices are reusable actuators paired with disposable needles for core biopsy sampling.

FDA Guidance Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (February 1993), which specifies testing for depth projection, mechanical durability, penetration, activation force (spring), and sample extraction. Human factors validation was conducted per FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016).

The subject device has identical indications for use and target population as the predicate (core biopsy acquisition from prostate, prescription use only). While two technological differences exist—variable penetration depth and sample length notches—the applicant demonstrated through performance testing that neither difference raises new questions of safety or efficacy. The device passed all testing and performed as well or better than the predicate, demonstrating that these improvements do not introduce safety concerns.