(234 days)
Not Found
No
The summary describes algorithmic calculations and signal processing, but does not explicitly mention or imply the use of AI or ML techniques. The "proprietary internal database" is used for comparison, not necessarily for training an AI/ML model.
No
The device is used for diagnosis and risk assessment (computing diagnostic parameters and assessing fracture risk) rather than for treating a disease or condition.
Yes.
The device is specifically designed to compute "diagnostic parameters (BMDgs, T-score, and Z-score)" and to "assess fracture risk through the integrated FRAX® software," which are all indicators of its use in diagnosing bone health and fracture risk.
No
The device description explicitly states that the system consists of two main parts: the EchoS device with its own probe (hardware) and the EchoStudio software. The software controls the hardware and processes signals acquired by the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- EchoS Function: The EchoS device uses ultrasound applied directly to the skin to measure bone density and assess fracture risk. It does not analyze samples taken from the body.
The device is a non-invasive ultrasound bone sonometer that uses physical interaction with the body (ultrasound waves) to obtain measurements, which is characteristic of an in vivo diagnostic device, not an in vitro one.
N/A
Intended Use / Indications for Use
EchoS is a non-invasive ultrasound (US) bone sonometer. EchoS works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMD13, T-sore, and Z-sore) and to assess fracture risk through the integrated FRAX® software.
The BMDgs 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 as provided by DXA at the same anatomical location (BMDnxA), with a standard error of the estimate of 0.044 grams/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements. BMDris Index is expressed in grams/cm² and it is based on a proprietary internal database, obtained from clinical data on adult white females and males, while T- and Z-score are derived from comparison to a normative X-ray absorptiometry reference database (NHANES). BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women.
Product codes (comma separated list FDA assigned to the subject device)
MUA
Device Description
The subject device, EchoS, consists of two main parts: the equipment EchoS device with its own probe and the software EchoStudio.
The EchoS device consists of EchoS device together with its probe,
The software EchoStudio: user interface and algorithmic calculation software provided in installation disc.
The EchoS device is connected to the computer via the USB port, and it is controlled by the EchoStudio to send the transmitting parameters to the EchoS device and to acquire the ultrasound (US) signals from EchoS device in order to calculate the BMDus and the other diagnosis parameters.
The EchoS System is a PC-based device that employs an ultrasound probe to collect ultrasound (RF) signals for echographic applications. During the measurement, the ultrasound convex probe, connected by a standard connector to the EchoS device, is applied directly to the skin in correspondence of the lumbar vertebrae or proximal femur, applying a thin layer of ultrasound gel between the probe surface and the skin to facilitate acoustic coupling. The ultrasound waves emitted by the probe are reflected by the bone, and then detected by the same probe.
During the scan, the algorithm automatically detects the bone interfaces and calculates the region of interest (ROIs) for data analysis. The automatic data processing is performed through the following steps: a custom developed signal pre-processing chain performs filtering, amplification and A/D conversion operations on the RF signals that are then passed to the EchoStudio software.
EchoStudio includes RF signal analysis and spectral comparison with reference models for the calculation of diagnostic parameters (BMDus, T-score, Z-score), and generation of the final medical report. The relevant scan depth, focus position, and visualization parameter settings can be adjusted and set by the interface of the software - EchoStudio.
EchoStudio software provides BMDus (in g/cm²), T-score and Z-score. It also estimates the 10-year osteoporotic fracture risk calculated with the original FRAX® algorithm that is integrated in the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
lumbar spine or femoral neck
Indicated Patient Age Range
The BMDus Index is based on a proprietary internal database, obtained from clinical data on adult white females and males.
Women between the ages of 51 and 70 years.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Clinical data has been collected by Echolight on the intended patient population for the subject device, in order to create the proprietary internal database for the different ages and BMI.
Description of the test set, sample size, data source, and annotation protocol
Clinical data has been collected by Echolight on the intended patient population for the subject device, in order to create the proprietary internal database for the different ages and BMI; and in the same time verifications on reproducibility & estimation of BMDus has been performed on EchoS with respect to the gold standard DXA.
In order to demonstrate the high correlation of the BMDus index used by the subject device to the BMD from the gold standard DXA (BMDoxA), comparative performance test of EchoS vs DXA has been performed detecting for EchoS a standard error of the estimate of 0.044 grams/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements, comparable with the standard error of 0.041 grams/cm² detected by the primary predicate device in a similar comparison test vs the same reference device.
Simulation data and ad also real data from intended patient population are used to compare results of FRAX®original algorithm with the use of inputs from both DXAmeasured femoral neck T-Score and EchoS-estimated femoral neck T-score.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The tests performed to validate the clinical performances in comparison to the reference device are listed below:
Clinical data has been collected by Echolight on the intended patient population for the subject device, in order to create the proprietary internal database for the different ages and BMI; and in the same time verifications on reproducibility & estimation of BMDus has been performed on EchoS with respect to the gold standard DXA.
In order to demonstrate the high correlation of the BMDus index used by the subject device to the BMD from the gold standard DXA (BMDoxA), comparative performance test of EchoS vs DXA has been performed detecting for EchoS a standard error of the estimate of 0.044 grams/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements, comparable with the standard error of 0.041 grams/cm² detected by the primary predicate device in a similar comparison test vs the same reference device.
Simulation data and ad also real data from intended patient population are used to compare results of FRAX®original algorithm with the use of inputs from both DXAmeasured femoral neck T-Score and EchoS-estimated femoral neck T-score.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
standard error of the estimate of 0.044 grams/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 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 letters.
October 19, 2018
Echolight S.p.a % Maurizio Pantaleoni CEO ISEMED srl Via P. Togliatti 19/X IMOLA, BO 40026 ITALY
Re: K180516
Trade/Device Name: EchoS Regulation Number: 21 CFR 892.1180 Regulation Name: Bone Sonometer Regulatory Class: Class II Product Code: MUA Dated: August 31, 2018 Received: September 21, 2018
Dear Maurizio Pantaleoni:
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/cfpmp/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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hole 2. Mild
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180516
Device Name EchoS
Indications for Use (Describe)
EchoS is a non-invasive ultrasound (US) bone sonometer. EchoS works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMD13, T-sore, and Z-sore)
and to assess fracture risk through the integrated FRAX® software.
The BMDgs 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 as provided by DXA at the same anatomical location (BMDnxA), with a standard error of the estimate of 0.044 grams/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements. BMDris Index is expressed in grams/cm² and it is based on a proprietary internal database, obtained from clinical data on adult white females and males, while T- and Z-score are derived from comparison to a normative X-ray absorptiometry reference database (NHANES). BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is being submitted as required by 21 CFR 807.92.
-
- General Information Submitter :
| Submitter : | Echolight S.p.a. |
|---|---|
| Via Raffaello Sanzio, 18, | |
| Lecce 73100 (ITALY) | |
| Tel.: +39 0832 15 92 607 | |
| Fax: +39 0832 18 36 515 | |
| E-mail: regulatory@echolight.it | |
| Consultant/ Contact: | Maurizio Pantaleoni |
| ISEMED srl | |
| Via P. Togliatti 19/X | |
| Imola, BO 40026 ITALY | |
| Mob. +39 348 4435155 | |
| Tel. +39 0542 683803 | |
| Fax +39 0542 698456 | |
| Email: regulatory@isemed.eu | |
| Summary Prepared Date: | February 15, 2018 |
-
- Names
- Device Name: EchoS
- Common Name: Bone sonometer
- Regulation Number: 21 CFR 892.1180
- . Product Code: MUA ; class II
3. Predicate Devices
The EchoS is substantially equivalent to the following predicate devices:
| Applicant | Device name | 510(k) Number |
|---|---|---|
| CyberLogic, Inc. | Ultrascan 650 | K161919 - Primary Predicate Device |
| Beam-Med Ltd. | Sunlight MiniOmni | K110646 - Secondary Predicate Device |
4. Device Description
The subject device, EchoS, consists of two main parts: the equipment EchoS device with its own probe and the software EchoStudio.
- The EchoS device consists of EchoS device together with its probe,
- . The software EchoStudio: user interface and algorithmic calculation software provided in installation disc.
The EchoS device is connected to the computer via the USB port, and it is controlled by the EchoStudio to send the transmitting parameters to the EchoS device and to acquire the ultrasound
4
(US) signals from EchoS device in order to calculate the BMDus and the other diagnosis parameters.
The EchoS System is a PC-based device that employs an ultrasound probe to collect ultrasound (RF) signals for echographic applications. During the measurement, the ultrasound convex probe, connected by a standard connector to the EchoS device, is applied directly to the skin in correspondence of the lumbar vertebrae or proximal femur, applying a thin layer of ultrasound gel between the probe surface and the skin to facilitate acoustic coupling. The ultrasound waves emitted by the probe are reflected by the bone, and then detected by the same probe.
During the scan, the algorithm automatically detects the bone interfaces and calculates the region of interest (ROIs) for data analysis. The automatic data processing is performed through the following steps: a custom developed signal pre-processing chain performs filtering, amplification and A/D conversion operations on the RF signals that are then passed to the EchoStudio software.
EchoStudio includes RF signal analysis and spectral comparison with reference models for the calculation of diagnostic parameters (BMDus, T-score, Z-score), and generation of the final medical report. The relevant scan depth, focus position, and visualization parameter settings can be adjusted and set by the interface of the software - EchoStudio.
EchoStudio software provides BMDus (in g/cm²), T-score and Z-score. It also estimates the 10-year osteoporotic fracture risk calculated with the original FRAX® algorithm that is integrated in the device.
5. Indications for Use
EchoS is a non-invasive ultrasound (US) bone sonometer. EchoS works together with EchoStudio software.
EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMDus, T-score, and Z-score) and to assess fracture risk through the integrated FRAX® software.
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 as provided by DXA at the same anatomical location (BMDoxa), with a standard error of the estimate of 0.044 grams/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements. BMDus is expressed in grams/cm² and it is based on a proprietary internal database, obtained from clinical data on adult white females and males, while T- and Z-score are derived from comparison to a normative X-ray absorptiometry reference database (NHANES). BMDus Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in women.
6. Comparison of technological characteristics with the predicate devices
The EchoS is substantially equivalent to the following predicate devices:
| Applicant | Device name | 510(k) Number |
|---|---|---|
| CyberLogic, Inc. | Ultrascan 650 | K161919 - Primary Predicate Device |
| Beam-Med Ltd. | Sunlight MiniOmni | K110646 - Secondary Predicate Device |
The comparison between the EchoS and the predicate devices is summarized in the following table and discussed below.
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| | SUBJECT DEVICE | Primary Predicate Device
(PD1) | Secondary predicate
device (PD2) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PRODUCT NAME | EchoS System | Ultrascan 650
(K161919) | Sunlight MiniOmni
(K110646) |
| APPLICANT
(MANUFACTURER) | Echolight S.p.a. | CyberLogic, Inc. | BeamMed Ltd. |
| FIGURE | Image: Echos System | Image: Ultrascan 650 | Image: Sunlight MiniOmni |
| CLASSIFICATION: | Class II
Reg. Number: 892.1180
"bone sonometer"
Product Code: MUA | Class II
Reg. Number: 892.1180
"bone sonometer"
Product Code: MUA | Class II
Reg. Number: 892.1180
"bone sonometer"
Product Code: MUA |
| INDICATIONS FOR USE: | EchoS is a non-invasive ultrasound (US) bone sonometer. EchoS works together with EchoStudio software. EchoStudio analyzes the ultrasound signals in order to compute the diagnostic parameters (BMDUS, T-score, and Z-score) and to assess fracture risk through the integrated FRAX® software.
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/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements. BMDUS Index is expressed in grams/cm² 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. | UltraScan 650 can be used to determine BMDUS Index in adult men and women and to assess appendicular fracture risk in postmenopausal women.
The BMD US Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the estimate of 0.041 grams/cm². BMDUS Index is expressed in grams/cm² 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 postmenopausal women. | Sunlight MiniOmni Ultrasound Bone Sonometers is a non-invasive device. The output is also expressed as a T-score and a Z-score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk. |
| PATIENT POPULATION | Women between the ages of 51 and 70 years | Assess appendicular fracture risk in postmenopausal women and for determination of BMDUS Index in adult men and women | Female 50-65 years old |
| TECHNOLOGY:
FOUNDAMENTAL TECHNOLOGIES | Ultrasound | Ultrasound | Ultrasound |
| MEASUREMENT MODE | reflection | Through-transmission | Axial Transmission |
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7. Performance Data
EchoS system has been evaluated for electrical safety, for EMC, to satisfy specific requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, including also acoustic performances; for biocompatibility and for Software. This evaluation has been executed performing non clinical performance tests in compliance to the voluntary standards and to the FDA guidance listed below:
- AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 ● (IEC 60601-1:2005, Mod) (Consolidated text) Medical Electrical Equipment - Part 1: General Requirements for Safety (Iec60601-1:2005 and A1:2012)
- . IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- . 60601-2-37 Edition 2.1:2015 Medical Electrical Equipment - Part 2-37: Particular Requirements For Basic Safety And Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment (Radiology)
- . FDA Guidance "Class II Special Controls Guidance Document: Bone Sonometers - Guidance for Industry and FDA Staff" - issued on July 17, 2008
- . FDA Guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" - issued on September 9, 2008
- . ISO 10993-1 Fourth Edition 2009-10-15 - Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
- . FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016
- IEC 62304 First edition 2006-05, Medical device software – Software life cycle processes
- "Guidance for the Content of Premarket Submissions for Software Contained in ● Medical Devices" – issued on May 11, 2005
Furthermore Echolight S.p.a. performed many clinical performance tests, in order to compare the clinical performances of the subject device to the performances of the X-Ray Densitometry that is a recognized gold standard for bone densitometry applications and it is used as reference device, as for the primary predicate device Ultrascan650.
The tests performed to validate the clinical performances in comparison to the reference device are listed below:
- . Clinical data has been collected by Echolight on the intended patient population for the subject device, in order to create the proprietary internal database for the different ages and BMI; and in the same time verifications on reproducibility & estimation of BMDus has been performed on EchoS with respect to the gold standard DXA
- . in order to demonstrate the high correlation of the BMDus index used by the subject device to the BMD from the gold standard DXA (BMDoxA), comparative performance test of EchoS vs DXA has been performed detecting for EchoS a standard error of the estimate of 0.044 grams/cm² for lumbar spine and 0.038 grams/cm² for femoral neck measurements,
9
comparable with the standard error of 0.041 grams/cm² detected by the primary predicate device in a similar comparison test vs the same reference device.
- . Simulation data and ad also real data from intended patient population are used to compare results of FRAX®original algorithm with the use of inputs from both DXAmeasured femoral neck T-Score and EchoS-estimated femoral neck T-score.
8. Conclusions
In light of the evidence discussed above, the subject device has similar indications for use, patient population, technology features and performances of the predicate devices, pointing out only few differences that have been addressed by the dedicated clinical performance tests, demonstrating that the diagnostic effectiveness and accuracy on lumbar vertebrae and femoral neck of EchoS system has a significant correlation with the reference device DXA. For all these reasons, the subject device may be found substantially equivalent to the predicate devices.