Pen Needle

The Pen Needle is a sterile, single-use device intended for use with pen injector devices for subcutaneous injection of drugs. It is available in ordinary and safety configurations with various needle gauges (29G–34G), lengths (3.5mm–12mm), and safety mechanisms including needle shields, covers, springs, and inner cores depending on type.

The subject device differs from the predicate in sterilization method (irradiation vs. ethylene oxide), needle gauges (adds 33G and 34G), needle lengths (adds 3.5mm, 10mm, 12mm), materials (adds UV glue jointing medium and medical silicone-based lubricant), and OTC classification (subset of predicate's OTC/Rx clearance). Core design elements—stainless steel needle tube, polypropylene hub and container, single-use sterile configuration, and 5-year shelf life—remain substantially the same.

ISO 9626, ISO 7864, ISO 11608-1, ISO 11608-2, ISO 23908, ISO 10993-1, ISO 11137-2, ASTM F88/F88M-21, ASTM F1929-15, ASTM F1886/F1886M-16, ASTM F1980-21, FDA Guidance on Sharps Injury Prevention Features, and USP <85> LAL method.

The subject device meets identical non-clinical performance testing standards as the predicate and demonstrates equivalent biocompatibility. Material and sterilization method differences do not raise new safety or effectiveness concerns—irradiation achieves the same SAL 10⁻⁶ as the predicate, and biocompatibility testing confirms no adverse effects. New needle gauges and lengths are supported by reference device K230635 and performance testing. The device has the same intended use and principle of operation, qualifying it as substantially equivalent.