Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set

The Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set is a sterile, single-use winged blood collection device intended for venipuncture to obtain blood specimens from patients. It can also be used for short-term (up to 2 hours) intravenous infusions. The device features a spring-retractable needle that retracts into a protective tube when a pull button is activated, preventing needlestick injury.

The primary difference from the predicate device is that the subject device uses an 'XtraThin Wall' needle with an increased inner diameter (lumen) while maintaining the same outer diameter, compared to the predicate's standard thin-wall needle. All other design features—needle gauge sizes (21G, 23G, 25G), materials, tubing length, safety mechanism, sterilization method, and shelf life—remain identical to the predicate device.

ISO 9626:2016 (needle size and stiffness), ISO 7864:2016 (lumen patency), ISO 10993-1:2019 (biocompatibility), ISO 11135:2014 (sterility), ASTM F1980-21 (accelerated aging), ISO 8536-4:2019 (leak testing), ISO 23908:2011 (sharp injury protection), ISO 80369-7:2021 (intravascular connectors), and ISO 80369-20:2015 (small-bore connectors).

The device is substantially equivalent because the only material change—increased inner diameter with unchanged outer diameter—does not raise new safety or effectiveness questions. Design verification testing demonstrated that the XtraThin wall needle performs equivalently to the predicate. The device maintains identical intended use, principles of operation, materials, sterilization, shelf life, and all other technological characteristics, and meets all relevant ISO and ASTM standards applicable to blood collection devices.