BD Vacutainer® Eclipse™ Blood Collection Needle

The BD Vacutainer® Eclipse™ Blood Collection Needle is a sterile, single-use device for collecting multiple venous blood samples into evacuated tubes for in vitro diagnostic testing. It features a one-piece double-ended stainless steel needle with a manually activated safety shield that pivots to cover the needle after venipuncture, protecting users from accidental needlestick injuries. The device is available in gauges 21G and 22G, with optional pre-attached holder models.

The subject device uses a one-piece 1¼-inch needle configuration with a pivot safety shield (versus the predicate's two-piece ¾-inch needle with spring-activated retractable needle). The subject employs a polystyrene hub and collar with UV-cured adhesive, while the predicate uses polycarbonate hub and heat-cured adhesive. Both are thin-wall, 3-bevel design, but the subject omits infusion capability (product code JKA only, versus predicate's JKA/FPA). The subject has longer shelf life (5 years for non-pre-attached, 3 years for pre-attached versus predicate's 2 years).

ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility); ISO 23908 (sharps injury protection); ISO 9626 (stainless steel needle tubing); ISO 11137 (radiation sterilization); ISO 11607 (packaging); ISO 11737 (sterility testing); FDA Guidance on Sharps Injury Prevention Features (August 2005).

Both devices are Class II blood collection needles with integrated safety features, identical sterility methods (gamma irradiation to 10⁻⁶ SAL), and equivalent intended use for venipuncture. Although the subject has different safety mechanism design (pivot versus retraction) and configuration (one-piece versus two-piece), both comply with ISO 23908 and address the same safety objective. Non-clinical performance testing (cannula-hub pull force, safety shield engagement, hemocompatibility) demonstrated acceptable performance. Material differences (polystyrene hub, polypropylene shield) were evaluated via ISO 10993 biocompatibility testing without raising new safety concerns. The narrower needle gauge range and absence of infusion capability do not introduce new or different safety/effectiveness questions for the stated blood collection indication.