(178 days)
There are no reference devices mentioned in the provided text.
Unknown
The summary mentions "proprietary algorithm" and "Echolight diagnostic algorithms" for analyzing ultrasound signals and estimating fracture risk. While these could potentially incorporate AI/ML, the summary does not explicitly state the use of AI, ML, or related terms like neural networks or deep learning. Without further information, it's not possible to definitively confirm the presence of AI/ML.
No.
The device is described as a non-invasive ultrasound (US) bone sonometer intended for diagnosis, assessment of fracture risk, and estimation of body fat percentage; it does not claim to treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device calculates "diagnostic parameters (BMDus, T-score, and Z-score)" and that its 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." The "Device Description" also states that it is "intended primarily for the diagnosis of osteoporosis."
No
The device description explicitly states that the EchoS Family consists of both equipment devices (EchoS and EchoStation) with probes and the EchoStudio software. The software analyzes signals from the hardware components.
Based on the provided information, the EchoS Family device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- EchoS Family Function: The EchoS Family is a non-invasive ultrasound device that uses ultrasound signals to assess bone mineral density and estimate fracture risk. It also has an optional module for estimating body composition parameters like body fat percentage, BMI, and BMR.
- Method of Analysis: The device analyzes ultrasound signals and images acquired directly from the patient's body (lumbar spine, femoral neck, or abdomen). It does not analyze specimens taken from the body.
Therefore, because the EchoS Family device operates by directly interacting with the patient's body using ultrasound and analyzing the resulting signals and images, it falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- 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.
- 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 vertebra/femur 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.
- 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).
Product codes
MUA, OMV
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound (US)
Anatomical Site
lumbar spine or femoral neck, lumbar spine and proximal femur, vertebra/femur neck, L1-L4
Indicated Patient Age Range
men and women between 30 and 90 years old
Intended User / Care Setting
Physician, Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Related to the first IFU claimed, two studies were conducted aimed at demonstrating that EchoS Family effectively calculates diagnostic parameters (BMDus, T-score and Z-Score) in male and female population and the age range is between 30 and 90 years old.
The first clinical trials produced a publication "Radiofrequency echographic multi spectrometry for the prediction of incident fragility fractures: A 5-year follow-up study".
The second clinical trials produced a Performance Evaluation Protocol "ECHOLIGHT: Performance Evaluation Protocol in men aged 30-90 years" and a Data Evaluation Report "ECHOLIGHT: Comparative Performance Evaluation Report Echos System Vs. DXA in a male population aged 30-90 years".
Related to the second IFU, a dedicated clinical study was conducted, aimed at demonstrating the ability of the Fragility Score (FS) parameter, calculated by an additional module of EchoStudio Software, to identify patients, men and women from 30 to 90 years old, at risk for osteoporotic fracture within 5 years.
This clinical trial is described in the documents "ECHOLIGHT: Performance Evaluation Protocol -Fragility Score Parameter" and "ECHOLIGHT: Comparative Performance Evaluation Report -Fragility Score for the assessment of fracture risk''.
Related to the third IFU, three clinical studies were conducted to:
- Evaluate the feasibility and accuracy of the investigated parameter, i.e. the body fat . percentage (BFP), calculated by an innovative ultrasound (US) approach, by assessing the correlation with the corresponding bioelectrical impedance analysis (BIA)-measured parameter, assumed as the reference. This clinical trial is described in the documents "ECHOLIGHT: Performance Evaluation Protocol - Body Fat Percentage" and "ECHOLIGHT: Comparative Performance Evaluation Report - Body Fat Percentage".
- Validate an innovative ultrasound (US) approach for body composition assessment, exploiting the signals acquired during a transabdominal echographic scan of a body volume in correspondence of lumbar vertebrae L1-L4 to determine the status of fat quantity and distribution. Specific attention will be paid to investigate the feasibility and accuracy of this novel approach, by assessing the correlation between basal metabolic rate (BMR) measured by the new US technology and by bioelectrical impedance analysis (BIA)-based technologies, assumed as the reference. This clinical trial is described in the documents "ECHOLIGHT: Performance Evaluation Protocol - Basal Metabolic Rate" and "ECHOLIGHT: Comparative Performance Evaluation Report - Basal Metabolic Rate".
- . Validate the calculation of the body mass index (BMI) provided by a novel US-based device with respect to measurements obtained by a bioelectrical impedance analysis (BIA)-based body composition monitor and to the results obtained by a pocket calculator, taken as reference. This clinical trial is described in the documents "ECHOLIGHT: Performance Evaluation Protocol - Body Mass Index" and "ECHOLIGHT: Comparative Performance Evaluation Report - Body Mass Index".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1180 Bone sonometer.
(a)
Identification. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document.
0
March 30, 2021.
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Echolight S.p.A % Giovanna De Masi Quality, Certification and Regulatory Assistant Via Raffaello Sanzio, 18 Lecce, Lecce 73100 ITALY
Re: K202514
Trade/Device Name: EchoS Family Regulation Number: 21 CFR 892.1180 Regulation Name: Bone sonometer Regulatory Class: Class II Product Code: MUA, OMV
Dear Giovanna De Masi:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 25, 2021. Specifically, FDA is updating this SE Letter as an administrative correction due to typos in the Indications for Use Statement.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Thalia Mills, OHT7: Office of In Vitro Diagnostics and Radiological Health by email (Thalia.Mills@fda.hhs.gov) or phone (301-796-6641).
Sincerely,
Michael D.'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
February 25, 2021
Image /page/1/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Echolight S.p.A. % Giovanna De Masi Quality, Certification and Regulatory Assistant Via Raffaello Sanzio, 18 Lecce, Lecce 73100 ITALY
Re: K202514
Trade/Device Name: EchoS Family Regulation Number: 21 CFR 892.1180 Regulation Name: Bone Sonometer Regulatory Class: Class II Product Code: MUA, OMV Dated: January 18, 2021 Received: January 21, 2021
Dear Giovanna De Masi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
2
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K202514
Device Name EchoS Family
Indications for Use (Describe)
- 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.
- 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.
- 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).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
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Section 5 510(k) Summary K202514
I. SUBMITTER
| Applicant Information | Echolight S.p.A. | |
|---|---|---|
| Via Raffaello Sanzio, 18 | ||
| 73100 Lecce, Italy | ||
| Contact | dott.ssa Giovanna De Masi | |
| (Quality, Certification and Regulatory Assistant) | ||
| Date Prepared | 25 august 2020 | |
| II. | ||
| DEVICE | ||
| Device Trade Name | ECHOS FAMILY | |
| Common Name | Ultrasound System | |
| Classification Name: | Bone Sonometer | |
| Regulation Number: | 21 CFR 892.1180 |
| Classification Name: | Analyzer, Body Composition, Ultrasonic |
|---|---|
| Regulation Number: | 21 CFR §870.2770 |
Product Code MUA and OMV
PREDICATE DEVICE III.
Legally Marketed Predicate Device (s)
| 510(k)
| Number | Pro Code | Trade Name | Applicant |
|---|---|---|---|
| K180516 | 21 CFR 892.1180 | EchoS | Echolight S.p.a. |
| K082317 | 21 CFR 892.1170 | FRAX® 10-Year Fracture Risk | |
| Software Option for GE Lunar | |||
| Bone Densitometers | General Electric Co. | ||
| K082147 | 21 CFR 870.2770 | BodyMetrix BX2000TM | IntelaMetrix, Incorporated |
IV. 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.
5
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.
V. Indication for Use
- 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.
- 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 5year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture).
6
This estimate takes into account the patient's age, sex, ethnicity, height, weight, and the vertebra/femur 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 printed 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.
EchoS Family, when used with the optional Body Composition module of EchoStudio 3) 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 diagnosis of 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).
VI. Comparison of technological characteristics with the predicate devices
The technological characteristics of the subject device do not raise different safety or effectiveness questions in comparison to the primary predicate EchoS K180516 because the EchoS Family includes the "EchoS" and "EchoStation" devices, respectively portable and cart version, with the relevant EchoStudio software. Compared to the primary predicate, the subject device substitutes the C3.5/60/128-Z probe with C3.5/60/128Z-3 probe. The two probes are substantially equivalent in terms of techincal specification, acoustic and thermal performances, biocompatibility, safety and EMC as reported on the attached documentation.
The "Fragility Score" software module of the subject device and the predicate K082317 are both software algorithms that require an input data set (i.e. age, sex, ethnicity, ...) and provide an output estimation of fracture probability.
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In terms of effectiveness. it is based on the acquisition of anthropometric data together with REMS data (BMD) to calculate a probability estimate of hip and major osteoporotic fractures (clinical spine, forearm, hip or shoulder fracture) and the related indication for use is the same of the IFU reported on the predicate K082317 (FRAX™) 10-Year Fracture Risk Software Option for GE Lunar).
In terms of safety, the use of the Fragility Score module does not imply different conditions of use of the device because the required input data are the same that are normally collected during an acquisition performed with the primary predicate EchoS K180516.
The subject device and the predicate K082147 are both ultrasound devices equipped with an echographic probe which communicates with a portable or desktop computer through a USB interface. Both devices have a software module that, acquiring signals by an ultrasound device and patient anthroprometric data, provide as output the following body parameters: total body fat percentage (Body FAT), Body Mass Index (BMI) and the Basal Metabolic Rate (BMR). In terms of effectiveness, the "Body Composition" optional module is indicated to estimate the
total body fat percentage (%BF) like the analogous function performed by the predicate K082147 "BodyMetrix BX2000TM" with the related software BodyView. In addition, it is indicated, as the BodyView software, for the calculation of the Body Mass Index (BMI) and the Basal Metabolic Rate (BMR).
Therefore, the Indication for Use of the subject device is the same as that of the predicate K082147 "BodyMetrix BX2000TM".
In terms of safety, the use of the Body Composition module does not imply different conditions of use of the device because the required input data are the same that are normally collected during an acquisition performed with the primary predicate EchoS K180516.
Based on the provided information, the subject device does not raise different safety or effectiveness questions to the listed predicate devices in terms of intended use, typical clinical use, operational characteristics, and fundamental technological characteristics.
VII. Performance Data
The part in contact with patient of EchoS Family has been tested and is in compliance with:
Biocompatibility (according to ISO 10993)
The battery of testing included the following tests:
8
- Cvtotoxicitv
- -Sensitization
- Irritation/Intracutaneous -
Electrical Safety, Electromagnetic Compatibility EMC (according to EN 60601-1 and EN 60601-1-2)
The battery of testing included the following tests:
- Electrical Safety Test:(see attachment 15 A) -
- Electromagnetic Compatibility: Test Report (see attachment 15 B) -
Software Validation (According to ISO 62304)
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could not directly result in serious injury or death to the patient or operator.
The documentation of Software Validation can be found in the annexes of Section 14
Usability (According to IEC 62366-1:2015)
The usability of the product was conducted in accordance with IEC 62366-1:2015 and concerns various aspects of the device use.
The documentation can be found in the annexes of Section 16:
- -Usability File (see Attachment 16 A)
ANIMAL STUDIES
none
PERFORMANCE TESTING - CLINICAL
Echolight, during the EchoS Family project development, carried out clinical investigations to demonstrate the safety and efficacy of the device.
Related to the first IFU claimed, two studies were conducted aimed at demonstrating that EchoS Family effectively calculates diagnostic parameters (BMDus, T-score and Z-Score) in male and female population and the age range is between 30 and 90 years old.
The first clinical trials produced a publication "Radiofrequency echographic multi spectrometry for the prediction of incident fragility fractures: A 5-year follow-up study".
9
The second clinical trials produced a Performance Evaluation Protocol "ECHOLIGHT: Performance Evaluation Protocol in men aged 30-90 years" and a Data Evaluation Report "ECHOLIGHT: Comparative Performance Evaluation Report Echos System Vs. DXA in a male population aged 30-90 years".
Related to the second IFU, a dedicated clinical study was conducted, aimed at demonstrating the ability of the Fragility Score (FS) parameter, calculated by an additional module of EchoStudio Software, to identify patients, men and women from 30 to 90 years old, at risk for osteoporotic fracture within 5 years.
This clinical trial is described in the documents "ECHOLIGHT: Performance Evaluation Protocol -Fragility Score Parameter" and "ECHOLIGHT: Comparative Performance Evaluation Report -Fragility Score for the assessment of fracture risk''.
Related to the third IFU, three clinical studies were conducted to:
- Evaluate the feasibility and accuracy of the investigated parameter, i.e. the body fat . percentage (BFP), calculated by an innovative ultrasound (US) approach, by assessing the correlation with the corresponding bioelectrical impedance analysis (BIA)-measured parameter, assumed as the reference. This clinical trial is described in the documents "ECHOLIGHT: Performance Evaluation Protocol - Body Fat Percentage" and "ECHOLIGHT: Comparative Performance Evaluation Report - Body Fat Percentage".
- Validate an innovative ultrasound (US) approach for body composition assessment, exploiting the signals acquired during a transabdominal echographic scan of a body volume in correspondence of lumbar vertebrae L1-L4 to determine the status of fat quantity and distribution. Specific attention will be paid to investigate the feasibility and accuracy of this novel approach, by assessing the correlation between basal metabolic rate (BMR) measured by the new US technology and by bioelectrical impedance analysis (BIA)-based technologies, assumed as the reference. This clinical trial is described in the documents "ECHOLIGHT: Performance Evaluation Protocol - Basal Metabolic Rate" and "ECHOLIGHT: Comparative Performance Evaluation Report - Basal Metabolic Rate".
- . Validate the calculation of the body mass index (BMI) provided by a novel US-based device with respect to measurements obtained by a bioelectrical impedance analysis (BIA)-based body composition monitor and to the results obtained by a pocket calculator, taken as reference. This clinical trial is described in the documents "ECHOLIGHT: Performance
10
Evaluation Protocol - Body Mass Index" and "ECHOLIGHT: Comparative Performance Evaluation Report - Body Mass Index".
VIII. Conclusions
Echolight S.p.A. has determined, by using comparisons and tests, that Echos Family is substantially equivalent to the listed predicate devices in terms of intended use, typical clinical use, operational characteristics, and fundamental technological characteristics. Any differences are considered minor and do not raise new issues of the safety and effectiveness of the Echos Family device when compared to the predicate devices.