SmartPilot YpsoMate NS-A2.25

The SmartPilot YpsoMate NS-A2.25 is a reusable, battery-operated device designed to work with compatible disposable autoinjectors for Secukinumab (Cosentyx). It captures and records injection data including date, time, and injection outcome, provides visual and audible feedback to guide users through injection, and transfers data to a paired mobile application. The device does not interfere with the autoinjector's function and does not contact the drug itself.

Key differences from the predicate (Mallya Injection Pen Adapter) include: use of an inductive sensor to detect spring position rather than rotational dose detection; inability to capture dialed dose information since the compatible autoinjectors have fixed 2.25 mL doses; compatibility with disposable autoinjectors rather than reusable pens; prescription-only use rather than over-the-counter; addition of NFC wireless capability alongside Bluetooth; non-rechargeable battery versus rechargeable; enhanced software documentation per IEC 62304 and cybersecurity testing; and optional mobile app versus mandatory app.

ISO 10993 (biocompatibility), ISO 11608-1 and ISO 11608-5 (compatibility/dose accuracy), IEC 60601-1 and IEC 60601-1-11 (electrical safety and EMC), IEC 62304 (software life cycle), IEC 62133-2 (battery safety), FCC 47 CFR Parts 15B, 15.225, and 15.247 (wireless), IEEE ANSI USEMCSC C63.27 and AIM 7351731 (wireless coexistence), ASTM D4169 (transportation), ASTM F1981 (accelerated aging), and IEC 60601-1-6 (usability).

Although the subject device uses different sensor technology (inductive versus rotational), does not capture dosing information, and includes NFC connectivity, these differences do not raise new safety or effectiveness concerns because: (1) the device does not drive the injection process and therefore cannot alter injection safety; (2) detection accuracy is evaluated under the same risk framework regardless of sensing method; (3) wireless connectivity is evaluated per the same safety standards as the predicate; and (4) the fixed-dose compatible autoinjectors eliminate the variable-dose risk that exists with the predicate's reusable pens, making the binary determination of injection completion comparable in risk to dose volume reporting.