InSee

InSee is an accessory device that attaches to the Vyaire Medical AirLife Incentive Spirometer (2500 mL and 4000 mL models). It electronically flags and records successful incentive spirometry attempts, tracks use-related data including number of attempts and maximum inspiratory volumes, and provides patient reminders. The device is intended for hospital use by clinicians and patients to enhance compliance with incentive spirometry therapy.

InSee uses an electronic microprocessor-controlled system with LED display, housed in a thermoplastic enclosure, powered by a rechargeable 1200 mAh DC lithium battery. It measures target volumes and inspiratory volumes across a 250-4000 mL range displayed in 250 mL increments, tracks attempt and success counts, and offers configurable reminder intervals (off, 10, 20, 30, 60, or 120 minutes). It is reusable, weighs 4.2 oz, measures 6.24 x 3.34 x 1.14 inches, and includes a 2-year shelf life.

IEC 60601-1 (medical electrical equipment general requirements), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), ISO 10993-1:2018 (biocompatibility for external skin contact <24 hours), FDA Guidance on Reprocessing Medical Devices, AAMI TIR12:2020, AAMI ST98:2022, and FDA Guidance documents on device software functions and cybersecurity.

InSee is substantially equivalent because it shares the same intended use (accessory to incentive spirometer for recording spirometry data and providing reminders), the same product code (BWF), and identical technological characteristics as the predicate device (CR Bard Calculator with Charger, K781838), including microprocessor control, LED display, reusable thermoplastic construction, rechargeable lithium battery power, and similar reminder intervals and dimensional specifications. A prospective clinical validation study demonstrated 100% accuracy in detecting successful spirometry attempts across the full 250-4000 mL volume range with no adverse events, confirming it performs equivalently to the predicate.