MallyaD injection pen adapter (MallyaD)

The MallyaD Injection Pen Adapter is a smart sensor device that mounts on compatible Novo Nordisk PDS290 insulin pen injectors to capture and wirelessly transmit dosing information. It records the dose dialed by the user and transmits this data via Bluetooth to a mobile device app, enabling remote monitoring of insulin injection doses for diabetes patients.

The MallyaD uses the same Low Energy Bluetooth (BLE) communication technology and protocol as its predicate device to pair and transmit dosing information. It senses dose increments through rotation of the pen's dosing button during dose setting, rather than during dose administration. Both devices have non-replaceable rechargeable batteries with a 3-year lifetime and provide electronic LED feedback to users.

ISO 11608-1 (pen injector performance testing), ISO 10993-1 (biocompatibility for permanent skin contact), IEC 60601-1 (electrical safety), IEC 60601-2 (collateral safety standards), and IEC 60601-1-11 (radiocommunication requirements). Cybersecurity testing and software verification and validation followed FDA guidelines.

MallyaD is substantially equivalent to the SoloSmart predicate device because both are Class II smart sensor adapters for data capture and wireless transmission from compatible pen injectors using identical BLE technology. Although MallyaD targets a different pen platform (Novo Nordisk PDS290 vs. Sanofi SoloStar) and records dialed dose rather than delivered dose, the fundamental technological approach, intended use environment, and safety/performance profile remain identical. The minor mechanical differences in dose recording mechanism were verified through bench testing to maintain the same 99% accuracy performance, and verification testing confirmed compatibility with the intended pen platform.