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The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The trend arrows displayed are meant for qualitative purposes only and are not intended to have any clinical significance.

The MY01 Continuous Compartmental Pressure Monitor (MY01 device) is a device for measuring real-time and continuous compartmental pressure. The measured compartmental pressures should always be used along with the current standard of care as an aid in the diagnosis of compartment syndrome. The device is supplied sterile for single patient use and intended to be used for 18 hours, it contains two major components that are referred to as the Introducer (plastic housing and 17gauge stainless-steel needle) and the Pressure Monitor. The Pressure Monitor consists of a capacitive Micro-Electro-Mechanical System (MEMS) pressure sensor, which allows for the measurement of intracompartmental pressure relative to a secondary atmospheric pressure sensor. It is embedded on a flexible PCB circuit, which extends via a lead-wire to a rigid PCB circuit within the Pressure Monitor. The Introducer allows for placement of the pressure sensor into muscle compartments. The Pressure Monitor continuously outputs pressure values on the LCD screen and can be attached on the patient's skin using the provided adhesive strip on the underside. Modification: The purpose of this submission is an enhancement of the device functionality to include wireless communication over Bluetooth Low Energy (BLE) to transmit data to a compatible mobile application for data logging and archival purposes. The MY01 mobile application does not analyze of interpret recorded pressure data. It is not intended to aid in diagnosis or monitoring. The application is not able to control any functions or configuration parameters of the MY01 device. Authenticated users of the mobile application can securely connect to a MY01 device and enable the transmission of pressure data via an encrypted BLE link. The current pressure data measurement is displayed on the application and forwarded via an encrypted network link to a cloud-based server (MY01 application server) for data logging and archival purposes.

The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The trend arrows provide a general pressure direction and are for informational purposes only. Do not rely upon the trend arrows for the diagnosis of compartment syndrome.

The MY01 Continuous Compartmental Pressure Monitor (MY01 device) is a device for measuring real-time and continuous compartmental pressured compartmental pressures should always be used along with the current standard of care as an aid in the diagnosis of compartment syndrome. The device is supplied sterile for single patient use and can be used up to a maximum of 18 hours, at which point a warning message is displayed cautioning the user. It contains two major components that are referred to as the Introducer (plastic housing and 17gauge stainless-steel needle) and the Pressure Monitor. The Pressure Monitor consists of a capacitive Micro-Electro-Mechanical System (MEMS) pressure sensor, which allows for the measurement of intracompartmental pressure relative to a secondary atmospheric pressure sensor. It is embedded on a flexible PCB circuit, which extends via a lead-wire to a rigid PCB circuit within the Pressure Monitor. The Introducer allows for placement of the pressure sensor into muscle compartments. The Pressure Monitor continuously outputs pressure values on the LCD screen and can be attached on the patient's skin using the provided adhesive strip on the underside.