Pivot Insulin Delivery System

The Pivot Insulin Delivery System is a programmable insulin infusion pump designed for subcutaneous delivery of insulin at set and variable basal and bolus rates for adults 18 years and older with diabetes mellitus requiring insulin therapy. It consists of a reusable microprocessor-controlled pump, a disposable 3.0mL insulin cartridge with integrated battery, a disposable integrated infusion set with built-in cannula and adhesive pad, a reusable inserter device, and a smartphone application for configuration.

The Pivot System retains the identical motor-driven, microprocessor-controlled multi-piston delivery mechanism and operating principle as its predicate (MODD1 System K240158). The main technological differences are integration of the infusion set and adhesive pad into a single disposable component, introduction of a reusable Pivot Inserter replacing the external Orbit Inserter, a revised cartridge connection interface for direct coupling, and updated packaging. The pump, software, control logic, basal rate range (0.5-4 units/hour), bolus range (2-20 units), and suspension capability remain identical.

Not stated in this summary.

Modular Medical argues substantial equivalence based on identical indications for use, retention of the same fundamental operating principle and control logic, and comprehensive verification and validation testing demonstrating that design modifications do not raise different safety or effectiveness questions. Testing included biocompatibility, sterilization validation, insulin compatibility, delivery accuracy, occlusion detection, adhesive performance, inserter reliability, and human factors validation—all meeting predefined acceptance criteria. The modifications are limited to component integration and interface changes that do not alter the fundamental scientific technology or intended use.