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510(k) Data Aggregation
K Number
K202514Device Name
EchoS Family
Manufacturer
Echolight S.p.A.
Date Cleared
2021-02-25
(178 days)
Product Code
MUA, OMV
Regulation Number
892.1180Why did this record match?
Applicant Name (Manufacturer) :
Echolight S.p.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1) EchoS Family is a non-invasive ultrasound (US) bone sonometer. EchoS Family works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMDus, T-score, and Z-score). The BMDus Index is a clinical measure based on ultrasound variables of the lumbar spine or femoral neck which is highly correlated with the value of BMD of the same anatomical location as provided by DXA (BMDDXA), with a standard error of the estimate of 0.044grams/cm^2 for lumbar spine and 0.038 grams/cm^2 for femoral neck measurements.
BMDus Index is expressed in grams/cm^2 and as a T- and Z-score, derived from comparison to a normative x-ray absorptiometry reference database. BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women and men.
2) The EchoStudio software includes an optional tool called Fragility Score, which is intended to provide an assessment of 5-year fracture risk. The optional tool Fragility Score provides an estimate of 5-year probability of hip fracture and 5-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate takes into account the patient's age, sex, ethnicity, height, and the vertebraffemur neck ultrasound spectra and is computed using a proprietary algorithm. The tool has been validated for men and women between 30 and 90 years old.
The output is provided in a separate screen display and report that can be viewed or exported to an optional physician report generator tool. The results can be used by a physician, in conjunction with other clinical risk factors, as an aid in the diagnosis of osteoporosis and medical conditions leading to increased bone fragility, and ultimately in the assessment of fracture risk.
3) EchoS Family, when used with the optional Body Composition module of EchoStudio software, is indicated to estimate total body fat percentage (%BF). EchoS Family, together with Body Composition software module, is intended to be used only on generally healthy adults and is not for disease or condition. Body Composition software is indicated for the calculation of the Body Mass Index (BMI) and the Basal Metabolic Rate (BMR). Body Composition software module generates a report which displays the calculated values of Body FAT, BMR, and Body Mass Index (BMI).
Device Description
The EchoS Family is an ultrasound device intended primarily for the diagnosis of osteoporosis. EchoS, through the ultrasound scan of the lumbar or femoral site of interest, picks up the ultrasound signal (RF) and performs an estimate of the bone mineral density (BMD).
The device therefore allows not only the visualization of ultrasound images, but also the real-time sampling of the RF signal and its appropriate treatment to make it usable for diagnostic algorithms.
The EchoS Family consists in two different configurations: EchoS (portable version) and the EchoStation (cart version). Each version consists of two main parts: the equipment device (EchoS and EchoStation) with its own probe and the software EchoStudio.
EchoStudio is a biomedical software that, used in combination with EchoS Family, allows the evaluation of bone mineral density (BMD) by means of the proprietary method REMS (Radiofrequency Echographic Multi Spectrometry) densitometry.
By using EchoStudio, it is possible to assess the key diagnostic parameters directly on the anatomical sites with increased fracture risk, such as lumbar spine and proximal femur.
EchoStudio analyzes the ultrasound signals and echographic images in order to compute the diagnostic parameters (BMD, T-score, and Z-score) and to estimate the fracture risk by means of the Echolight diagnostic algorithms and non-ionizing technique.
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