Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)

The Forsvall biopsy needle system for prostate biopsy consists of a reusable spring-loaded biopsy gun and single-use disposable needles (16/18 gauge, 10/15/20/25 cm) made of stainless steel. The system is used by medical professionals to obtain soft tissue samples from the prostate through a spring-activated mechanism that advances the needle with a side notch to capture tissue.

The Forsvall system uses a spring-loaded gun with the same principle of action, spring force, design, and materials as the predicate device. The disposable needle is 16/18 gauge with a 20 mm side notch pocket for tissue sampling, matching the predicate's specifications in length, diameter, and sample retrieval mechanism.

Risk management was performed according to ISO 14971. Non-clinical testing included user testing, dimensional verification, needle specifications, sample retrieval validation, needle gap minimization, needle tip quality assessment, and shelf life and transport testing.

Both the Forsvall system and the predicate (Möller Medical Biopsy Needles and Systems) are intended for use by the same user group on the same patient population for the same medical reasons. Although the Forsvall is narrower in scope (prostate only versus multiple uses), this does not constitute a new intended use. The technological design, spring mechanism, needle gauge, sample pocket size, and operational principles are substantially equivalent to the predicate device.