Hudson RCI Comfort Flo® CubCannula™

The Hudson RCI Comfort Flo® CubCannula™ is a single-use nasal cannula designed to deliver heated and humidified respiratory gas to spontaneously breathing pediatric patients (neonates, infants, and children aged birth to 12 years) at flow rates of 1–25 LPM. It features soft prongs, a silicone lariat, and color-coded sizing (XS to XL) and is secured using hydrocolloid adhesive pads (CubPads™). The device is intended for use in professional healthcare environments under physician prescription.

The CubCannula matches the predicate (F&P Optiflow Junior 2/2+) in product code (BTT), regulatory classification, patient population, contraindications, prescription-only status, and single-use, non-sterile design. Minor differences include a 2-year shelf life versus the predicate's 3 years, a 10-day useful life versus 7 days (validated by testing), an ambient operating temperature of 20–26°C versus 18–26°C, and five cannula sizes versus six (excluding the XXL size). Flow rates for all five sizes fall within the predicate's approved ranges.

ISO 10993 series (1, 3, 5, 6, 10, 11, 12, 17, 18) for biocompatibility; ISO 18562 (parts 1–3) for breathing gas pathway biocompatibility; ISO 5356-1:2015 for conical connectors; ISO 80601-2-74:2017 for respiratory device safety; ASTM F1980-21 for accelerated aging; ASTM D4169-22 for shipping container performance testing.

Substantial equivalence is established through identical intended use (delivering heated, humidified gas to the same pediatric populations in healthcare settings), identical regulatory classification and product code, and identical contraindications and patient safety criteria. All performance parameters (flow rates, operating temperature, shelf life, useful life) either match the predicate or fall within its approved ranges, with the extended 10-day useful life supported by additional testing. Comprehensive biocompatibility and bench testing demonstrate safety and performance equivalent to the predicate without introducing new risks.