Cary

Cary is a handheld, battery-powered medical suction device designed to remove fluids from the upper airway during emergency care. It consists of a reusable drive unit powered by a rechargeable lithium-ion battery, a disposable collection container (pumpister), and disposable tubing. The device creates negative pressure (vacuum) to draw fluids into the collection canister for disposal and is intended for use by physicians or licensed practitioners such as Emergency Medical Technicians.

Cary operates continuously (unlike the predicate's 30-min ON/30-min OFF cycle) and achieves similar vacuum levels (<600 mmHg high vacuum, ≤100 mmHg low vacuum) and flow rates (≥20 L/min high, <20 L/min low). Key differences include a lithium-ion battery (14.4V, 2900mAh) versus the predicate's NiMH battery, longer runtime (3 hours vs. 45 minutes), improved ingress protection (IP54 vs. IP33), ability to operate in any position versus upright-only positioning, and a toggle switch for vacuum adjustment instead of a vacuum regulator. Collection capacity (300 mL) and suction tubing diameter (8 mm ID) are comparable.

ISO 10079-1 (Fourth edition 2022-03) for electrically powered suction equipment; ISO 10079-4 (First edition 2021-08) for general requirements; ISO 10993-1, -5, -10, -11, -18, -23 for biocompatibility; IEC 62304:2006+AMD1:2015 for software life cycle processes; IEC 60601-1-2:2014+AMD1:2020 and IEC 60601-1:2005+AMD1:2012+AMD2:2020 for EMC and electrical safety; FDA Guidance for Powered Suction Pump 510(k)s.

Although Cary differs from the predicate (LCSU 4) in operation mode, battery chemistry, runtime, positioning flexibility, and user interface, the devices share the same indications for use (upper airway fluid removal), intended patient population (adults), and core functional performance regarding vacuum levels and free air flows. Excitus demonstrated through non-clinical testing that Cary's protection devices, noise, air leakage, vacuum/flow performance, pharyngeal suction capability, and biocompatibility all meet or exceed acceptance criteria comparable to the predicate. The design differences (continuous operation, lithium-ion battery, improved ingress protection, hand-held positioning capability) do not raise new safety or effectiveness questions but rather enhance the device's practical utility while maintaining equivalent safety margins and suction performance to clear the upper airway.