LymphScanner Receives 510(k) Clearance by FDA
LymphScanner received 510(k) clearance by FDA (U.S. Food and Drug Administration) in May 2022. Now, Delfin Technologies Ltd has a total of three medical devices cleared by FDA. MoistureMeterD Compact was also cleared along with LymphScanner in May 2022, both joining the company of multiprobe MoistureMeterD which was cleared by FDA in 2015. All these units are also medical devices within EU with a medical device classification 2a.
Intended Medical Use
LymphScanner is a non-invasive hand-held device intended to measure localized percentage water content (PWC) in lymphedema of human skin after surgery for breast cancer or gynecological cancers. Applicability ranges from undetectable preclinical lymphedema to advanced lymphedema. The device integrating the main unit and the easily cleaned measurement probe can be used to aid in forming a clinical judgement of skin edema at any soft tissue site of the body by a health care professional. The measurement results are displayed in seconds after applying the measurement probe on the skin surface. There are no restrictions to the number of repeated measurements that can be performed for the same subject.
LymphScanner is intended to be operated by healthcare professionals in professional health care facilities.
LymphScanner consists of an electronic control unit and an integrated probe to measure the tissue dielectric constant (TDC) of the measurement site. The device generates a high-frequency electromagnetic (EM) wave and sends it into the coaxial probe and the skin down to 2.5 mm’s depth, when the probe is placed on the skin. The reflected EM wave is registered. This wave contains information of the water content of the measured tissue.
LymphScanner measures TDC, which is a dimensionless physical quantity. It is known that tissue water has a high dielectric constant value and fat and tissue macromolecules, especially proteins, have a very low dielectric constant. LymphScanner automatically converts the measured TDC value into percentage water content (PWC) of the measurement site and displays the PWC. A higher PWC indicates higher water content.
PWC value is an accurate objective indicator of tissue water when following a subject’s tissue water changes on a single site over time or detecting site-to-site differences.
Medical Device Status
LymphScanner: Medical product Class IIa (EU), FDA clearance 510(k) (K220557)
MoistureMeterD Compact: Medical product Class IIa (EU), FDA clearance 510(k) (K220557)
Multiprobe MoistureMeterD: Medical product Class IIa (EU), FDA clearance 510(k) (K143310)
Delfin Technologies Ltd