MallyaG Injection Pen Adapter (MallyaG)

The MallyaG Injection Pen Adapter is a smart sensor device that attaches to compatible Novo Nordisk PDS290 injection pens to capture and wirelessly transmit dosing information. It is designed for patients with growth disorders using Sogroya (somapacitan-beco) or Norditropin FlexPro pens, recording the dialed dose increment, time, and date of each injection.

The MallyaG uses the same Low Energy Bluetooth (BLE) communication technology and protocol as the predicate device to capture dose information through rotation of the pen's dosing button. Both devices calculate recorded doses based on dose increments set, differentiate between prime and dose functions, feature non-replaceable rechargeable batteries with up to 3 years of use, and provide electronic LED feedback to the user.

ISO 11608-1 for bench testing on performance; ISO 10993-1 for biocompatibility with permanent skin contact; IEC 60601-1 and collateral requirements from IEC 60601-2 and IEC 60601-1-11 for electrical safety, EMC, and radiocommunication; FDA cybersecurity guidelines for software verification and validation.

The MallyaG is substantially equivalent to the MallyaD predicate (K250555) because both devices share identical indications for use (capturing and transmitting dosing information from compatible pen injectors), use the same technological platform (BLE wireless transmission), operate on the same Novo Nordisk PDS290 pen platform, employ identical dose recording mechanisms, and demonstrate equivalent performance characteristics with 99% dose accuracy. The only difference is the compatible drug therapies (growth disorder vs. diabetes), which does not affect the device's fundamental technology, safety, or function.