Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small

The Hudson RCI® Comfort Flo Nasal Cannula (Premature, Infant sizes) and Hudson RCI® Comfort Flo Plus Cannula (Extra Small size) are single-use nasal cannulas designed to deliver heated and humidified air/oxygen mixtures to spontaneously breathing patients. The Premature/Infant cannula is indicated for patients birth to 2 years in professional healthcare settings; the Plus cannula is indicated for adult and pediatric patients 12 years and above. Both are used with a humidification system and are non-sterile, disposable devices.

Both proposed devices are non-sterile, single-use, disposable nasal cannulas with flow rate ranges of 1–8 LPM (Premature/Infant) and 1–60 LPM (Plus Extra Small). The Premature/Infant size has a 30-day useful life and 5-year shelf life; the Plus has the same parameters. Key design differences from predicate include extended useful life (30 days vs. 7 days) and shelf life (5 years vs. 3 years). Flow specifications are similar to predicate ranges, with upper pediatric limits matching at 20 LPM and adult ranges covered by a reference device.

ISO 10993-1:2018 (biological evaluation framework), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation/sensitization), ISO 10993-11:2017 (systemic toxicity), ISO 10993-6:2016 (implantation), ISO 10993-3:2014 (genotoxicity/carcinogenicity), ISO 10993-12:2012 (sample preparation), ISO 10993-17:2002 (leachable substances), ISO 18562-1/2/3:2017 (breathing gas pathway biocompatibility and emissions). Bench testing included visual inspection, humidity output, thermal overshoot, connection strength, leak testing, headgear testing, shelf-life and useful-life studies, and transportation simulation.

The proposed devices share the same intended use (delivery of heated/humidified gas to spontaneously breathing patients), same regulatory classification (Class II, BTT product code, 21 CFR 868.5450), same patient setting (professional healthcare), and same prescription-only status as the predicate F&P Optiflow Junior 2/2+. Although patient populations differ slightly (Premature/Infant vs. pediatric across broader age ranges; adult populations added in Plus size), the fundamental mechanism—nasal cannula interface delivering high-flow therapy—is identical. Biocompatibility and performance testing demonstrate safety and effectiveness equivalent to predicate across all material contact pathways and operating conditions.