BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder

The BD Vacutainer® Safety-Lok™ Blood Collection Set is a sterile, single-use winged blood collection needle with flexible tubing and safety shield, intended for venipuncture to obtain blood specimens from patients (including those with difficult vein access) into evacuated tubes or culture bottles. It can also be used for short-term, single infusions under direct clinical supervision. The device is available with or without a pre-attached holder and incorporates a manually activated safety shield to prevent needlestick injury.

The subject device is substantially similar to the predicate (K980414) in design, materials, needle specifications (3-bevel, ¾ inch, 21G/23G/25G gauges), and safety features. Key differences include: non-pre-attached models have Extra Thin Wall needle construction (increased inner diameter) versus the predicate's Thin Wall design; pre-attached holder configurations are new; and pre-attached models have a 2-year shelf life versus 3 years for non-pre-attached models and the predicate. All differences are supported by performance testing demonstrating compliance to ISO 9626.

ISO 80369-7:2021 (small-bore connectors), ISO 9626:2016 (stainless steel needle tubing), EN ISO 23908:2013 (sharps injury protection), ISO 10993 series (biocompatibility including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemocompatibility, particulates), EN ISO 11607 (packaging), EN ISO 11737 (sterilization microbiological methods), EN ISO 11135:2014/A1:2019 (ethylene oxide sterilization), ASTM F1980-16 (accelerated aging), ASTM standards for seal strength and leak testing.

The subject device shares the same intended use, fundamental design, and principles of operation as the predicate device. Both are blood collection sets with integrated safety features for venipuncture and short-term infusion. Non-clinical performance testing demonstrates the subject device meets all design specifications and complies with applicable standards. The needle inner diameter change, pre-attached holder configurations, and shelf life differences do not raise new safety or effectiveness questions, as performance testing validates these modifications and the pre-attached holder is a user convenience using a previously cleared component (K242320). Clinical data from a similar cleared device (K220212) support the expanded indications for difficult vein access.