(139 days)
No
The description focuses on VCTE technology and ultrasound measurements, with software updates primarily related to streamlining, user interface, and specific measurement enhancements (CAPc, SmartDepth). There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision support. The performance studies focus on traditional statistical metrics like bias, precision, and success rates, not metrics typically associated with AI/ML model evaluation (e.g., AUC, sensitivity/specificity of a classification model).
No
The device measures tissue properties (shear wave speed, stiffness, and attenuation) to aid in diagnosis and monitoring, but it does not directly treat or provide therapy for liver disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device's measurements "may be used as an aid to diagnosis and monitoring of adult patients with liver disease."
No
The device description explicitly states that the FibroScan® System consists of a system unit and a hand-held probe, which are hardware components. While the submission focuses on a software update, the overall device is a system that includes hardware.
Based on the provided information, the FibroScan® Family of Products is not an In Vitro Diagnostic (IVD) device.
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, monitoring, or treatment of disease.
- FibroScan's Mechanism: The FibroScan system uses non-invasive methods (Vibration-Controlled Transient Elastography and Ultrasound) to measure shear wave speed, tissue stiffness, and ultrasound attenuation directly within the body (liver and spleen). It does not involve the collection or analysis of specimens taken from the body.
Therefore, while the FibroScan provides information that aids in the diagnosis and management of liver disease, its mechanism of action and intended use fall outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. The Shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness, and CAP* may be used as an aid in the clinical management of pediatric patients with liver disease.
FibroScan® 630 (Expert) is also indicated for noninvasive measurement in the spleen of 100 Hz shear wave speed and estimates of stiffness that may be used as an aid to diagnosis, monitoring and clinical management of adult patients with liver disease, as part of an overall assessment of the liver.
*CAP for pediatric patients with liver disease is only available with SmartExam capability on FibroScan® Models: 530 Compact, 430 Mini+, and 630
Product codes
IYO, ITX
Device Description
FibroScan® System consists of a system unit and a hand-held probe. It is based on Vibration-Controlled Transient Elastography (VCTE™) technology and is designed to perform non-invasive measurements of liver/spleen shear wave speed and estimate tissue stiffness. The probe, containing a mechanical vibrator, produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver/spleen. Ultrasound is used to track the shear (elastic) wave, measure its speed and provide estimated stiffness. The results are displayed on the system unit.
The focus of this submission is an updated version of FibroScan software (CLPC 4.1) for all previously cleared FibroScan® Family of Products. The software version CLPC 4.1 involves the following changes:
. Streamlined software platform across between all devices
Simplified user interface .
Functional enhancements: .
Continuous CAP (Controlled Attenuation Parameter) measurement (CAPc) o
CAPc applied to S+ probe o
SmartDepth adjustment of measurement depth to patient anatomy о
Improved probe localization step O
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) has the same intended use as the previously cleared FibroScan models. The submission expands the indications for use of the system to include use of the S+ probe for estimation of CAP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Liver, Spleen
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
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
The retrospective in-vivo performance of CAPc for steatosis assessment, compared with MRI-PDFF as a reference, was conducted on a total of 195 participants (from two studies). Of total participants, 58% were healthy participants, 50% males and females, age (mean +/- SD for study B085) was 56 (+/- 8). BMI distribution included 1% ≤18.5, 27% 18.535.
The retrospective in-vivo performance testing to validate LSM using SmartDepth in comparison to the standard fixed depth calculation, and in comparison to biopsy as a reference, was conducted on a total of 566 participants (from three studies). Of total participants, 32% were healthy participants, 54% males and 46% females, age (mean +/- SD) was 53 (+/- 12). BMI distribution included 4% 18.535.
Non-clinical testing was performed using phantoms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical testing with phantoms.
Sample Size: Not explicitly stated, but multiple configurations and measurements were performed.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results (Non-clinical):
- Shear wave speed bias and precision: For liver examination, the bias and precision measurements of the candidate FibroScan® system and the predicate FibroScan® system documented similar performance. Bias values for candidate were 0.5% – 12.6% (predicate: 2.6% – 8.0%). Precision values for candidate were very similar to predicate.
- Standard CAP (static single-spot measurements): For liver measurements, similar performance between candidate and predicate. CAP bias for predicate: 17.1% (M+), 12.9% (XL+); for candidate: 15.3% (M+), 14.1% (XL+). CAP precision for predicate: 0.5% (M+), 1% (XL+); for candidate: 0.5% (M+), 0.7% (XL+).
- Standard CAP (static multiple measurements with rotating turntable): For liver measurements, similar performance. CAP bias for predicate: 0.8% (M+), 16.2% (XL+); for candidate: 0.8% (M+), 12.2% (XL+). CAP precision for predicate: 3.2% (M+), 2.8% (XL+); for candidate: 0.5% (M+), 1.7% (XL+).
- CAPc (dynamic testing): Range and mean values of CAPc bias were substantially equivalent to standard CAP. Range and mean values of CAPc precision values were also equivalent to standard CAP. Precision results of CAPc with S+ probe were equivalent to M+ and XL+ probes.
- Overall bias comparison: Bias values for shear wave speed and standard CAP/CAPc were comparable (under 5% difference) between all FibroScan systems in the study.
- Spleen shear wave speed bias: For FibroScan® 630 Expert, results showed comparable values (under 5% differences) compared to the reference device.
- Validation studies on phantoms: No significant bias between standard CAP and CAPc. CAPc measurements on S+ probe highly correlated with M+ and XL+ probes. No significant difference between CAPc measurements at different depths. CAPc demonstrated capability to select homogenous tissue, yielding more precise and less varied data on heterogeneous phantom.
Study Type: Clinical data (retrospective in-vivo validations)
Sample Size: 195 participants for CAPc validation; 566 participants for SmartDepth validation.
Key Results (Clinical):
- CAPc performance: CAPc is substantially equivalent to the performance of standard CAP for steatosis assessment (compared with MRI-PDFF). No significant bias between standard CAP and CAPc, but CAPc showed better precision (lower variability) and better robustness. CAPc with S+ probe is reliable.
- SmartDepth performance: LSM with SmartDepth were substantially equivalent to LSM without SmartDepth. Using SmartDepth, applicability, success rates, consistency, and examination durations showed improvement compared to standard fixed depth.
- Adverse events: No adverse events nor complications reported for all studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (bias and precision values provided instead)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
March 25, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font and enclosed in a blue square.
Echosens % Zvi Ladin, Ph.D. Principal Boston MedTech Advisors, Inc. 990 Washington Street, Suite #204 DEDHAM, MA 02026
Re: K203273
Trade/Device Name: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: March 2, 2021 Received: March 4, 2021
Dear Dr. Ladin:
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
1
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/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,
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
2
Indications for Use
510(k) Number (if known) K203273
Device Name
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)
Indications for Use (Describe)
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. The Shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness, and CAP* may be used as an aid in the clinical management of pediatric patients with liver disease.
FibroScan® 630 (Expert) is also indicated for noninvasive measurement in the spleen of 100 Hz shear wave speed and estimates of stiffness that may be used as an aid to diagnosis, monitoring and clinical management of adult patients with liver disease, as part of an overall assessment of the liver.
*CAP for pediatric patients with liver disease is only available with SmartExam capability on FibroScan® Models: 530 Compact, 430 Mini+, and 630
| 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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510(K) Summary K203273 Echosens' FibroScan® System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
| Manufacturer: | Echosens
6 rue Ferrus, Paris, France, 75014
Telephone: +33 1 44 82 78 56
Fax: +33 1 44 82 78 60 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Zvi Ladin, Ph.D.
Principal
Boston MedTech Advisors, Inc.
990 Washington Street; Suite #204
Dedham, MA 02026
Telephone: (781) 407 0900 x104
Fax: (781) 407 0901
Email: zladin@bmtadvisors.com |
| Date Prepared: | January 29, 2021 |
| Name of Device and Name/Address of Sponsor | |
| Trade/Proprietary Name: | FibroScan® Family of Products
(Models: 502 Touch, 530 Compact, 430 Mini+, and 630) |
|-------------------------|---------------------------------------------------------------------------------------|
| Common Name: | Diagnostic Ultrasound System and Accessories |
Classifications:
| Classification Name | Regulation | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | 21 CFR §892.1560 | IYO |
| Diagnostic Ultrasonic Transducer | 21 CFR §892.1570 | ITX |
| Manufacturing Facility: | Echosens
6 rue Ferrus, Paris, France, 75014
Telephone: +33 1 44 82 78 56
Fax: +33 1 44 82 78 60 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3010258456 |
Predicate Device
This submission claims substantial equivalence to:
-
- Primary Predicate Device: Echosens's FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+), cleared on July 9, 2018 (#K181547)
-
- Reference Device: Echosens's FibroScan® 630, cleared in on July 16, 2020 (#K200655)
4
Device Description
FibroScan® System consists of a system unit and a hand-held probe. It is based on Vibration-Controlled Transient Elastography (VCTE™) technology and is designed to perform non-invasive measurements of liver/spleen shear wave speed and estimate tissue stiffness. The probe, containing a mechanical vibrator, produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver/spleen. Ultrasound is used to track the shear (elastic) wave, measure its speed and provide estimated stiffness. The results are displayed on the system unit.
The focus of this submission is an updated version of FibroScan software (CLPC 4.1) for all previously cleared FibroScan® Family of Products. The software version CLPC 4.1 involves the following changes:
- . Streamlined software platform across between all devices
- Simplified user interface .
- Functional enhancements: .
- Continuous CAP (Controlled Attenuation Parameter) measurement (CAPc) o
- CAPc applied to S+ probe o
- SmartDepth adjustment of measurement depth to patient anatomy о
- Improved probe localization step O
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) has the same intended use as the previously cleared FibroScan models. The submission expands the indications for use of the system to include use of the S+ probe for estimation of CAP.
Comparison of Technological Characteristics
All systems in the FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) have the same fundamental scientific technology, basic design, operating principles, general user interface, and basic software specifications. There are no differences in the device hardware and probes compared to its predicate and reference FibroScan systems.
FibroScan® Family of Products is substantially equivalent to the FibroScan® systems cleared by 510(k) #K181547 and #K200655. Table 1 provides a detailed comparison of the candidate, predicate, and reference devices. All systems provide 50Hz shear wave speed measurements and estimates of tissue stiffness in the liver using the S+, M+, and XL+ transducers. Additionally, all systems provide CAP, designed to estimate the ultrasound attenuation at the frequency of 3.5 MHz.
The CAPc and SmartDepth options are enabled on CLPC 4.1 with the 'SmartExam' capability. The SmartDepth option automatically adapts the depth of the liver stiffness measurement (LSM), based on the anatomy of the patient. The LSM calculated with the SmartDepth capability uses the same LSM algorithm as the predicate and reference systems. The continuous CAP (CAPc) option improves the standard CAP measurements by extending the time window for data acquisition. The CAPc and SmartDepth do not impact the spleen examination (available on FibroScan® 630 Expert).
5
By allowing the system to automatically adjust to the recommended measurement depth. the FibroScan system with the SmartDepth capability is able to measure deeper and more accurate liver measurements, with the M+ and XL+ probes. Specifically, with SmartDepth, the measurement depths may be automatically adjusted to either 25-65 mm (M1) or 30-70 mm (M2) using the M+ probe, and to either 35-75 mm (XL1), 40-80 mm (XL2) or 45-85 mm (XL3) using the XL+ probe. In comparison, FibroScan without SmartDepth capability includes fixed depth measurements that correspond to the M1 and XL1 range only, for the M+ and XL+ probes, respectively.
The CAPc option was developed to improve the intra-measurements variability of the standard CAP measurements by increasing the collected data used to compute the final CAP value. Specifically, CAPc method estimates CAP based on U/S attenuation measurements captured during the imaging phase over a longer period of time. The CAPc uses the same algorithm to calculate CAP as in the standard CAP method, however, since there are more data points, CAPc is calculated as a mean value rather than the median value as in the standard CAP.
Moreover, the inclusion of the CAPc on the S+ probe allows extending the applicability of CAP for patients with anatomies consistent with the S+ probe. This submission is expanding the indications for use of the system in accordance with the new applicability of the CAP on the S+ probe. Notably, CAP examination in pediatric population was cleared using the M+ probe in the predicate devices (#K200655 and #K181547). Therefore, the candidate and reference devices are substantially equivalent.
Recognized Consensus Standards Used
Non-clinical testing to assure compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety were performed and have been found to conform to applicable standards. The system complies with the following standards:
- . IEC 60601-2-37: Medical Electrical Equipment - Part 2-37: Particular Requirements for The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment; Edition 2.1 2015.
- NEMA UD: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment . Revision 3; 2-2004 (R2009).
- . IEC 62127-1: Ultrasonics -- Hydrophones -- Part 1: Measurement and Characterization of Medical Ultrasonic Fields Up To 40 Mhz; Edition 1.1 2013-02.
- . IEC 62127-2: Ultrasonics -- Hydrophones -- Part 2: Calibration for Ultrasonic Fields Up To 40 Mhz; Edition 1.1 2013-02.
- . IEC 62127-03:Ultrasonics -- Hydrophones -- Part 3: Properties of Hydrophones for Ultrasonic Fields Up To 40 Mhz; Edition 1.1 2013-05.
- . IEC 61161: Ultrasonics -- Power Measurement -- Radiation Force Balances and Performance Requirements; Edition 3.0 2013-01.
- . AAMI / ANSI ES60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, Mod); 2005/(R) 2012.
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- . IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests; Edition 4: 2014-02.
- . IEC 60601-1-6: Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability: Edition 3.1 2013-10
- . IEC 62366-1 Edition 1.0 2015-02: Engineering To Medical Devices.
- . IEC 62304: Medical Device Software - Software Life Cycle Processes; First Edition 2006-05, Equivalent to IEC 62304: 2006/A1:2016.
- . ISO 14971 Second: Medical Devices - Application Of Risk Management To Medical Devices: Edition 2007-03-01.
Intended Use / Indications for Use
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. The Shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness, and CAP* may be used as an aid in the clinical management of pediatric patients with liver disease.
FibroScan® 630 (Expert) is also indicated for noninvasive measurement in the spleen of 100 Hz shear wave speed and estimates of stiffness that may be used as an aid to diagnosis, monitoring and clinical management of adult patients with liver disease, as part of an overall assessment of the liver.
*CAP for pediatric patients with liver disease is only available with SmartExam capability on FibroScan® Models: 530 Compact, 430 Mini+, and 630
Performance Data
The FibroScan CLPC 4.1 effectiveness was evaluated in terms of its bias and precision in measuring liver shear wave speed (m/s), standard CAP, SmartDepth and CAPc, using the S+, M+ and XL+ probes. Direct comparison of the measurement accuracy between the proposed and cleared systems were performed on the same sample of phantoms.
The shear wave speed bias measurement and the precision measurement was evaluated and compared to the corresponding value reported for the predicate device.
7
Results show that, for liver examination, the bias and precision measurements of the candidate FibroScan® system and the predicate FibroScan® system documented similar performance. Specifically, the ranges of the bias values documented for the candidate are substantially equivalent to the ranqes of the bias values documented for the predicate device (0.5% – 12.6% for the candidate and 2.6% – 8.0% for the predicate) and the precision values documented for the candidate are very similar to the ranges of the precision values documented for the predicate device.
The range of CAP bias and precision values were also measured for the candidate and predicate FibroScan® system, using different configurations (i.e., static testing with single spot measurements, static testing with multiple spot measurements, and continuous dynamic testing with multiple spot measurements on a large surface).
Results of the standard CAP measurement with static single-spot measurements documented similar performance for the liver measurements for the candidate and predicate systems. Specifically, the range of CAP bias values for the predicate device were 17.1% for the M+ probe and 12.9% for the XL+ probe while the corresponding values for the candidate device were 15.3% and 14.1%. The range of CAP precision values for the predicate device were 0.5% for the M+ probe and 1% for the XL+ probe while the corresponding values for the candidate device were 0.5% and 0.7%.
Similarly, results of the standard CAP measurement with static multiple measurements, using a rotating turntable, documented similar performance for the liver measurements. Specifically, the range of CAP bias values for the predicate device were 0.8% for the M+ probe and 16.2% for the XL+ probe while the corresponding values for the candidate device were 0.8% and 12.2%. The range of CAP precision values for the predicate device were 3.2% for the M+ probe and 2.8% for the XL+ probe while the corresponding values for the candidate device were 0.5% and 1.7%.
Results of CAPc using dynamic testing (>200 measurements) on multiple spots demonstrated the range and mean values of CAPc bias were substantially equivalent to the bias of the standard CAP in the candidate device, both as a static single spot measurement and at multiple measurements spots (range of 6.9% - 12.2% for the candidate CAPc dynamic testing vs. 0.8% - 12.2% for the candidate standard CAP static multi-spot vs. 14.1% -15.3% for the candidate standard CAP single spot). The range and mean values of CAPc precision values were also equivalent to the precision of the Standard CAP in the candidate device, both at a static single spot measurement and at multiple measurements spots (range of 0.3% - 2.1% for the candidate CAPc dynamic testing vs. 0.5% - 1.7% for the candidate standard CAP static multi-spot vs. 0.5% - 0.7% for the candidate standard CAP single spot).
The range and mean values of CAPc precision values were equivalent to the precision of the Standard CAP in the candidate device, both as a static single spot measurement and at multiple measurements spots. Moreover, the precision results of the CAPc with the S+ probe (both the S1 and S2 exam) were equivalent to the precision results when using the M+ and XL+ probes.
8
The bias values for the shear wave speed and standard CAP/CAPc were shown to be comparable (under 5% difference) between all FibroScan systems (FibroScan® 502 Touch, FibroScan® 530 Compact, FibroScan® 430 Mini+ and FibroScan® 630). Therefore, the proposed systems have substantially equivalent effectiveness in measuring shear wave speed and CAP/CAPc bias. In addition, the stiffness and CAP measurement ranges, as for the predicate devices, have been verified on applicable products of the FibroScan family, embedded with the currently submitted software version CLPC 4.1.
As the shear wave speed and stiffness for spleen is only available on FibroScan® 630 Expert and the changes introduced by CLPC 4.1 do not affect the shear wave speed and stiffness for spleen, the bias of the candidate FibroScan® 630 Expert embedded with the current software version CLPC 4.1 were compared to the FibroScan® 630 Expert reference device configuration system (#K200655). Results showed comparable values (under 5% differences). Therefore, the proposed systems have the same effectiveness in measuring spleen shear wave speed bias.
In addition, validation studies were performed on tissue-mimicking calibrated phantoms and on a heterogeneous phantom, in order to estimate the bias, precision, and reproducibility performances of the CAPc and compare its results to standard CAP. Results demonstrated that there was no significant bias between standard CAP and CAPc on phantoms, that the CAPc measurements on the S+ probe are highly correlated with the values measured by the M+ and XL+ probes and within the range of the M+ and XL+ probes, and that there is no significant difference between the CAPc measurements in different depths. Validation testing on heterogeneous phantom demonstrated the CAPc capability to select homogenous tissue, vielding more precise and less varied data.
In summary, the bias and the precision of the shear wave speed and the CAP/CAPc measured by the FibroScan® Family of Products with software version CLPC 4.1 with the SmartExam capability are within the same range as those of the predicate FibroScan® devices and, therefore, are substantially equivalent to the predicate FibroScan® devices cleared in #K200655 and #K181547.
Clinical Data
Clinical data was submitted to provide validation of the CAPc and SmartDepth capabilities with CLPC 4.1. Specifically, retrospective in-vivo validations of the CAPc in comparison to standard CAP and of LSM using SmartDepth calculation in comparison to the standard fixed depth calculation were performed on data from five studies (two used for CAPc validation and three used for SmartDepth validation). There have been no adverse events nor complications reported for all studies.
The retrospective in-vivo performance of CAPc for steatosis assessment, compared with MRI-PDFF as a reference, was conducted on a total of 195 participants (from two studies). Of total participants, 58% were healthy participants, 50% males and females, age (mean +/- SD for study B085) was 56 (+/- 8). BMI distribution included 1% ≤18.5, 27% 18.535. Results showed that CAPc is substantially equivalent to the performance of standard CAP. In addition, there was no significant bias between standard CAP
9
and CAPc but CAPc showed better precision (lower variability) and better robustness. Based on the data comparing the bias, precision and repeatability of CAPc as measured by all three probes, it is therefore concluded that the CAPc can be assessed as reliably with the S+ probe as with the other FibroScan probes.
The retrospective in-vivo performance testing to validate LSM using SmartDepth in comparison to the standard fixed depth calculation, and in comparison to biopsy as a reference, was conducted on a total of 566 participants (from three studies). Of total participants, 32% were healthy participants, 54% males and 46% females, age (mean +/- SD) was 53 (+/- 12). BMI distribution included 4% 18.535. Results showed that LSM with SmartDepth were substantially equivalent to the LSM without SmartDepth. Using SmartDepth, the applicability, success rates, consistency, and examination durations showed improvement in comparison to the standard fixed depth.
Substantial Equivalence Discussion
The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) uses the same operating principle and materials, incorporates the same basic design, emits the same energy and acquires the same information as the predicate FibroScan® device (K181547). The updated new software version CLPC 4.1, with SmartExam capability, as well as the use of the CAPc with the S+ probe, do not raise new or different questions of safety or efficacy.
The updated new software version CLPC 4.1, with SmartExam capability, was demonstrated to be substantially equivalent to its predicate device FibroScan® 530 (K181547) based on the aforementioned verification and validation studies. A comparison of the performance of the CAPc with the S+ probe with the M+ and XL+ probes demonstrated the device's safety and effectiveness in measuring CAP for pediatric patients with liver disease.
Conclusion
The conclusions drawn from the clinical and nonclinical information provided in this submission demonstrate that FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) with the updated software (CLPC 4.1) is as safe, as effective, and performs as well as or better than the legally marketed device predicate. The FibroScan® Family of Products raises no new or different issues of safety or effectiveness and is substantially equivalent to its predicate and reference devices.
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| | FibroScan® Family of Products
(Models: 502 Touch, 530 Compact,
430 Mini+, and 630) | #K200655 :
FibroScan® 630 | #K181547 :
FibroScan® Family of
Products (Models: 502 Touch,
530 Compact, And 430 Mini+) |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Echosens | Echosens | Echosens |
| 510(k) # (Clearance) | N/A | July 16, 2020 | July 8, 2018 |
| Software Version | CLPC 4.1.2 | CLPC 4.0.5 | CLPC 3.2.5 (for FibroScan® 530
and 430)
CLPC 3.2.2 (for FibroScan®
502T) |
| Indications for Use | The FibroScan® Family of Products
(Models: 502 Touch, 530 Compact,
430 Mini+, and 630) is intended to
provide shear wave speed
measurements and estimates of tissue
stiffness as well as ultrasound
coefficient of attenuation (CAP:
Controlled Attenuation Parameter) in
internal structures of the body. The
Shear wave speed and stiffness
measurements may be used as an aid
to clinical management of adult
patients with liver disease.
The FibroScan® Family of Products
(Models: 502 Touch, 530 Compact,
430 Mini+, and 630) is indicated for
non-invasive measurement in the liver
of 50 Hz shear wave speed and
estimates of stiffness as well as
determining a 3.5 MHz ultrasound
coefficient of attenuation (CAP:
Controlled Attenuation Parameter).
The shear wave speed and stiffness,
and CAP may be used as an aid to
diagnosis and monitoring of adult
patients with liver disease, as part of
an overall assessment of the liver. | The FibroScan® 630 is intended to
provide shear wave speed measurements
and estimates of
tissue stiffness as well as ultrasound
coefficient of attenuation (CAP: Controlled
Attenuation
Parameter) in internal structures of the
body. The Shear wave speed and
stiffness measurements
may be used as an aid to clinical
management of adult patients with liver
disease.
FibroScan® 630 is indicated for non-
invasive measurement in the liver of 50
Hz shear wave speed
and estimates of stiffness as well as
determining a 3.5 MHz ultrasound
coefficient of attenuation
(CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and
CAP may be used as an aid to diagnosis
and monitoring
of adult patients with liver disease, as part
of an overall assessment of the liver. | The FibroScan® Family of
Products (Models: 502 Touch,
530 Compact, and 430 Mini+) is
intended to provide 50 Hz shear
wave speed measurements and
estimates of tissue stiffness as
well as 3.5 MHz ultrasound
coefficient of attenuation (CAP:
Controlled Attenuation
Parameter) in internal structures
of the body.
FibroScan® Family of Products
(Models: 502 Touch, 530
Compact, and 430 Mini+) is
indicated for noninvasive
measurement in the liver of 50
Hz shear wave speed and
estimates of stiffness as well as
determining a 3.5 MHz
ultrasound coefficient of
attenuation (CAP: Controlled
Attenuation Parameter).
The shear wave speed and
stiffness, and CAP may be used
as an aid to diagnosis and
monitoring of adult patients with |
| | Shear wave speed and stiffness, and
CAP* may be used as an aid in the
clinical management of pediatric
patients with liver disease.
FibroScan® 630 (Expert) is also
indicated for noninvasive measurement
in the spleen of 100 Hz shear wave
speed and estimates of stiffness that
may be used as an aid to diagnosis,
monitoring and clinical management of
adult patients with liver disease, as
part of an overall assessment of the
liver.
*CAP for pediatric patients with liver
disease is only available with
SmartExam capability on
FibroScan® Models: 530 Compact,
430 Mini+, and 630 | Shear wave speed and stiffness may be
used as an aid in the clinical management
of pediatric
patients with liver disease.
FibroScan® 630 (Expert) is also indicated
for noninvasive measurement in the
spleen of 100 Hz
shear wave speed and estimates of
stiffness that may be used as an aid to
diagnosis, monitoring
and clinical management of adult patients
with liver disease, as part of an overall
assessment of the liver. | liver disease, as part of an
overall assessment of the liver.
Shear wave speed and stiffness
may be used as an aid to clinical
management of pediatric
patients with liver disease. |
| Application | Abdominal | Abdominal | Abdominal |
| Imaging Modes | A-mode / M-mode
Transient Elastography/ Shear Wave /
(CAP™) | A-mode / M-mode
Transient Elastography/ Shear Wave /
(CAP™) | A-mode / M-mode
Transient Elastography/ Shear
Wave / (CAP™) |
| Ultrasound | Piezoelectric ultrasound source | Piezoelectric ultrasound source | Piezoelectric ultrasound source |
| Probes | M+-probe (3.5 MHz)
XL+ probe (2.5 MHz)
S+ probe (5 MHz)
(single element ultrasound transducer) | M+-probe (3.5 MHz)
XL+ probe (2.5 MHz)
S+ probe (5 MHz)
(single element ultrasound transducer) | M+-probe (3.5 MHz)
XL+ probe (2.5 MHz)
S+ probe (5 MHz)
(single element ultrasound
transducer) |
| Depth Analysis
Method | Fixed Depth:
S1 exam : 15-40 mm
S2 exam : 20-50 mm
M exam: 25-65 mm
XL exam: 35-75 mm
With SmartDepth (Adaptative
Depth):
M exam: 25-65 mm / 30-70 mm | Fixed Depth:
S1 exam : 15-40 mm
S2 exam : 20-50 mm
M exam: 25-65 mm
XL exam: 35-75 mm | Fixed Depth:
S1 exam : 15-40 mm
S2 exam : 20-50 mm
M exam: 25-65 mm
XL exam: 35-75 mm |
| | XL exam: 35-75 mm/ 40-80 mm/ 45-85 mm | | |
| B-Mode Ultrasound
Localization Probe | ES-C5-2R60S-3 (for FibroScan® 630 Expert) | ES-C5-2R60S-3 (for FibroScan® 630 Expert) | N/A |
| VCTE™ Mode | Shear wave speed measurements and
tissue stiffness | Shear wave speed measurements and
tissue stiffness | Shear wave speed
measurements and tissue
stiffness |
| VCTE™ Range
(Liver) | Shear wave speed (0.8-5.0 m/s)
Stiffness (2.0-75 kPa) | Shear wave speed (0.8-5.0 m/s)
Stiffness (2.0-75 kPa) | Shear wave speed (0.8-5.0 m/s)
Stiffness (2.0-75 kPa) |
| VCTE™ Range
(Spleen) | For FibroScan® 630 Expert :
Shear wave speed (1.4-5.8 m/s)
Stiffness (6.0-100 kPa) | For FibroScan® 630 Expert :
Shear wave speed (1.4-5.8 m/s)
Stiffness (6.0-100 kPa) | N/A |
| VCTE™ Display
(Liver) | Shear wave speed and stiffness
medians and Interquartile range (IQR)
and IQR/median ratio | Shear wave speed and stiffness medians
and Interquartile range (IQR) and
IQR/median ratio | Shear wave speed and stiffness
medians and Interquartile range
(IQR) and IQR/median ratio |
| VCTE™ Display
(Spleen) | For FibroScan® 630 :
Shear wave speed and stiffness
medians and Interquartile range (IQR) | Shear wave speed and stiffness medians
and Interquartile range (IQR) | N/A |
| Mode of U/S signals
acquisition | First generation CAP:
Elastography mode
Second generation CAP:
Imaging mode | First generation CAP:
Elastography mode | First generation CAP:
Elastography mode |
| Attenuation Range | CAP value (100-400 dB/m) | CAP value (100-400 dB/m) | CAP value (100-400 dB/m) |
| Attenuation Display | First generation CAP:
CAP median and interquartile range
(IQR)
Second generation CAP:
CAP mean and standard deviation | First generation CAP:
CAP median and interquartile range (IQR) | First generation CAP:
CAP median and interquartile
range (IQR) |
| Attenuation Display
- Probes
compatibility | First generation CAP:
M+ Probe
XL Probe
Second generation CAP:
M+ Probe
XL+ Probe
S+ Probe (model 10 only) | First generation CAP:
M+ Probe
XL Probe | First generation CAP:
M+ Probe
XL Probe |
| Size and Weight | FibroScan® 502T :1350 mm x 680 mm
x 610 mm (H x W x D) | 1365mm x 642mm x 584mm
(H x W x D) | FibroScan® 502T :1350 mm x
680 mm x 610 mm (H x W x D) |
| | 41kg with accessories
FibroScan® 530 : 460 mm x 360 mm x
250 mm (H x W x D)
10kg with accessories
FibroScan® 430 : 275mm x 400mm x
95mm (H x W x D)
6kg with accessories
FibroScan® 630 : 1365mm x 642mm x
584mm (H x W x D)
46kg with accessories | 46kg with accessories | 41kg with accessories
FibroScan® 530 : 460 mm x 360
mm x 250 mm (H x W x D)
10kg with accessories
FibroScan® 430 : 275mm x
400mm x 95mm (H x W x D)
6kg with accessories |
| Power supply | 100-240 V ~ 50-60 Hz | 100-240 V ~ 50-60 Hz | 100-240 V ~ 50-60 Hz |
| Elastography
engine | FibriScan 502T :
Analog front end High frequency (US):
PV2 ; Analog front end Low frequency
(servo control): PV2
FibroScan® 530, 430 and 630 :
Analog front end High frequency (US):
PV3 ; Analog front end Low frequency
(servo control): PV3 | Analog front end High frequency (US):
PV3
Analog front end Low frequency (servo
control): PV3 | FibriScan 502T :
Analog front end High frequency
(US): PV2 ; Analog front end
Low frequency (servo control):
PV2
FibroScan® 530, and 430:
Analog front end High frequency
(US): PV3 ; Analog front end
Low frequency (servo control):
PV3 |
| Operating system | Windows Embedded | Windows Embedded | Windows Embedded |
| Screen | Color LCD touch screen
FibroScan® 502T: 19-inch.
FibroScan® 530: 15-inch.
FibroScan® 430: 12.1-inch.
FibroScan® 630: 19-inch. | Color LCD touch screen: 19-inch. | Color LCD touch screen
FibroScan® 502T: 19-inch.
FibroScan® 530: 15-inch.
FibroScan® 430: 12.1-inch. |
| Wi-Fi Option | N/A | N/A | N/A |
| Battery | FibroScan® 502T and 630 : N/A
FibroScan® 530 and 430 : ARTS
Energy (ref. 4 INR19/66-2) Part
number 806957 / M300002 | N/A | FibroScan® 502T: N/A
FibroScan® 530 and 430 : ARTS
Energy (ref. 4 INR19/66-2) Part
number 806957 / M300002 |
Table 1. Predicate Device Comparison for FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)
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