MY01 Continuous Compartmental Pressure Monitor

The MY01 Continuous Compartmental Pressure Monitor is a single-use, sterile device for real-time, continuous measurement of muscle compartment pressure to aid in diagnosing Compartment Syndrome (acute and chronic). It consists of an introducer with a 17-gauge needle and a battery-powered pressure monitor with an LCD display. The device communicates via Bluetooth with a companion mobile app that displays pressure readings and calculates muscle perfusion pressure using manually entered diastolic blood pressure.

The subject device uses the same capacitive MEMS pressure sensor technology, 17-gauge stainless-steel needle introducer, LCD display, Bluetooth Low Energy connectivity, and firmware (v1.8.0) as the predicate. Key differences include a new sensor assembly design (encapsulated within a stainless steel cap instead of epoxy) for improved manufacturability, revised packaging (single-unit dispenser instead of multi-unit), and a minor mobile app update (v1.22.1 with GUI clarifications). All other specifications including pressure range (±99.9 mmHg), sterilization method (EtO), shelf life (24 months), power source, and EMC/electrical safety standards remain identical.

Distribution simulation per ASTM D4169, accelerated aging per ASTM F1980, sterile barrier integrity validation using FDA-recognized consensus standards, mobile application verification and validation per IEC 62304, electrical safety per IEC 60601-1 and IEC 60601-1-2, and FCC compliance per Subpart 15C.

The subject device maintains identical intended use, indications for use, anatomical site, patient population, and clinical environment as the predicate. Sensor accuracy, reliability, mechanical integrity, chemical resistance, and biocompatibility were successfully evaluated. The changes to sensor assembly design, packaging, and mobile app GUI do not raise new safety or effectiveness questions and do not adversely affect device function. The evidence demonstrates the subject device is as safe and effective for its intended use and performs as well as or better than the legally marketed predicate device.