Mi~Scan®

Download Mi~Scan® Instructions For Use (IFU)

Download Declaration of Conformity (PENDING)

This product is a CE-marked medical device under EU MDR 2017/745 (PENDING), Class IIa, Notified Body IMQ 0051

Basic UDI-DI 50700007164Mi-ScanAG

INTENDED USE

The Density Measurement Tool, known as Mi~Scan®, is intended to produce a quantitative indication of breast tissue density for use on adult women with breast tissue thickness in the range of 20-196 mm. It provides healthcare or health & wellbeing trained professionals with objective data on breast tissue density, which assists them in:

• Evaluating a patient's breast cancer risk by providing objective data on breast tissue density composition.

• Determining appropriate screening and diagnostic imaging techniques and follow-up procedures based on the patient's breast tissue density.

• Developing personalized cancer care pathways based on individual breast density profiles.

The Mi~Scan® is not a standalone diagnostic device and should not be used as the sole basis for clinical decisions. The final assessment and any diagnosis should always be made by qualified healthcare professionals, taking into account the full clinical context and patient history.

Exclusions:

The Mi~Scan device has been validated only in female patients who are not pregnant and not breast feeding. Its safety and performance in male patients has not been established. Therefore, male patients are excluded from the intended patient population. Its safety and performance in pregnant or breast-feeding female patients has not been established. Therefore, pregnant or breastfeeding female patients are excluded from the intended patient population.

Contraindications to use:

It 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.

INTENDED USER/OPERATOR:

Typically, users of the Mi~Scan® Device 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.