GO-PEN®

GO-PEN® is a reusable insulin pen for self-injection of NovoLog® (insulin aspart U-100) from 10 mL vials. The user fills a disposable sterile 1.3 mL reservoir with insulin, mounts it on the durable pen unit, dials doses from 1–60 Units in 1-Unit increments, and injects using standard single-use hypodermic needles with luer locks. The filled reservoir can be used for up to 3 days at room temperature.

Both GO-PEN® and predicate HumaPen Savvio are reusable, mechanical pen-injectors delivering U-100 rapid-acting insulin with two-way dose dialing and 60-Unit maximum doses. Key differences: GO-PEN® uses a user-fillable 1.3 mL reservoir from vials (vs. predicate's 3 mL pre-filled cartridges), has a shorter durable-pen life span (2–3 years vs. 6 years), implements an Insufficient Remaining Dose feature via dose-dial display method rather than prevention, and includes a luer-lock interface. Both meet similar dose-accuracy and mechanical specifications.

ISO 11608-1:2022 (needle-based injection systems requirements and test methods); ISO 10993-1:2018 (biocompatibility evaluation); ISO 80369-7 and 80369-20 (luer connector dimensions and performance); FDA guidance on Technical Considerations for Pen, Jet, and Related Injectors. Testing included dose accuracy, injection force, environmental preconditioning, fluid leakage, usability, and drug compatibility.

Both devices deliver U-100 rapid-acting insulin via reusable mechanical pen-injectors with identical dose-dialing ranges and increments, satisfying the same intended purpose. Although GO-PEN® requires user-filling from vials and includes a luer interface (features absent in the predicate), these differences do not raise distinct safety or effectiveness questions because: (1) the devices operate identically post-filling; (2) usability testing confirmed reservoir-filling tasks do not adversely impact device performance; (3) both comply with current ISO 11608-1 standards and achieve equivalent dose-accuracy requirements; and (4) the Insufficient Remaining Dose feature, though implemented differently, satisfies the same functional requirement under ISO 11608-1. The different insulin brand (NovoLog vs. Humalog) is clinically and functionally irrelevant, both being rapid-acting insulin.