Mi~Scan®+

Download Mi~Scan®+ Instructions For Use (IFU)

Download Declaration of Conformity

This product is a CE-marked medical device under EU MDR 2017/745, Class I

Basic UDI-DI 50700007164Mi-ScanPLUSZ7

INTENDED PURPOSE

The Mi~Scan®+ Web Portal is intended to be used as part of a system with the Mi~Scan® device, by healthcare professionals or health & wellbeing / women’s health professionals, to provide optional supplemental density data insights based on Mi~Scan® measurement data of adult Women, with breast tissue thickness in the range of 20-196 mm.

These optional additional insights include the ability to report:

• A breast cancer statistical risk prediction percentage score (branded Mi~Score®) which is calculated from a 3rd party licensed,pre-validated, statistical algorithm. This calculation is based on both health questionnaire data provided/entered by the woman alongside their Mi~Scan® measured breast density.

• A graphical visualisation of estimated fibroglandular tissue distribution within the breast based on measurement data from the Mi~Scan® device

• A percentage-based density measurement from the Mi~Scan® device

• A longitudinal (density history) graph illustrating the measured breast densities over time.

The additional density data insights and breast cancer risk (Mi~Score®) report offered by Mi~Scan®+, based on Mi~Scan® measurements, supports adult women and healthcare professionals in shared decision-making regarding potential breast health strategies. It is intended as an adjunct to established clinical practices such as regular breast self-examination and participation in breast cancer screening programmes.

The report generated by the Mi~Scan®+ Web Portal, including the Mi~Score® risk result, is for informational purposes only. They do not constitute a diagnosis, nor are they intended to replace clinical judgment. The outputs must not be used as the sole basis for any medical decision. All decisions regarding clinical care should be made by a qualified healthcare professional in accordance with applicable clinical guidelines.

Exclusions:

The Mi~Scan® device safety and performance in male patients has not been established. Therefore, male patients are excluded from the intended patient population of Mi~Scan®+.

The Mi~Scan® device safety and performance in pregnant or breast-feeding female patients has not been established. Therefore, pregnant or breast-feeding female patients are excluded from the intended patient population of Mi~Scan®+.

Contraindications to use of Mi~Scan® and therefore Mi~Scan®+ are

The Mi~Scan® device (and therefore Mi~Scan®+) is not intended to be used for people who have;

• Presence of non-removable conductive body modifications on the breast (e.g., nipple piercings).

• Broken skin or open wounds on the breast area to be scanned.

• Presence of breast implants.

• Presence of electronic medical implants (e.g., pacemakers).

• Patients who have undergone a breast biopsy within the past 5 days.

The risk assessment (Mi~Score®) is not intended for people who have previously been diagnosed with breast cancer.

INTENDED USER/OPERATOR:

Typically, users of the Mi~Scan® Device (and therefore Mi~Scan®+) will be either clinically trained (for example Radiographers or Radiologists) or non-clinically trained operators (for example healthcare assistants or wellbeing specialist).

To perform a scan with the Mi~Scan® Device you need to have successfully completed operator training provided by Micrima (or an authorised representative) as a minimum. There is no other clinical training or experience required to be able to scan a patient.

Other experience required to perform a scan includes;

• the ability to work with women in roles requiring a degree of intimacy.

• basic IT knowledge to start application, login and enter patient details onto the PC.

• Sufficient physical dexterity to be able to position the antennas on the breast and press the measurement button.