MY01, Inc. · Class U · Cleared Mar 13, 2025
| K-number | K242997 |
| Device name | MY01 Continuous Compartmental Pressure Monitor |
| Applicant | MY01, Inc. |
| Product code | LXC |
| Device class | Class U |
| Decision date | Mar 13, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
The MY01 Continuous Compartmental Pressure Monitor is a single-use, sterile device that continuously measures muscle compartment pressure in real-time using a capacitive MEMS sensor. It is intended as an aid in diagnosing Compartment Syndrome (acute and chronic) in extremities. The device displays pressure readings on an LCD screen and communicates via Bluetooth to a mobile application that also calculates and displays estimated muscle perfusion pressure based on manually entered diastolic blood pressure values.
The subject device is identical to the predicate (K220952) in core hardware: same manufacturer, product code, pressure sensing technology (capacitive MEMS), pressure range (-99.9 to 99.9 mmHg), introducer design, and intended use. Key differences include: shelf life extended from 12 to 24 months (validated per ISO 11607-1:2019), IP rating reduced from IP53 to IP52, firmware updated from v1.7.0 to v1.8.0, and mobile app updated from v1.16.0 to v1.22.0 with added functionalities for perfusion pressure display and diastolic pressure management.
IEC 62304:2015 (software verification and validation), ISO 14971:2019 (risk management), ISO 11607-1:2019 (sterile package integrity and shelf life validation), IEC 60601-1 and IEC 60601-1-2 (electrical safety and EMC), and FDA guidance on cybersecurity vulnerability scanning.
The device maintains substantial equivalence because the novel functionality—continuous display of calculated perfusion pressure and extended shelf life—does not raise new safety or effectiveness questions. The perfusion pressure is a mathematical derivation (diastolic pressure minus compartment pressure) manually initiated by the clinician, not an autonomous analysis or clinical decision. Software testing confirms no adverse impact on core device function. The extended shelf life was validated through accelerated aging studies per ISO standards. Since the fundamental operating principles, pressure measurement technology, anatomical site, intended use, and patient population remain unchanged from the predicate, and the additions are clinically useful display enhancements without new hazards, substantial equivalence is supported.
View the full FDA submission: accessdata.fda.gov