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

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)
CAPc applied to S+ probe
SmartDepth adjustment of measurement depth to patient anatomy
Improved probe localization step

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) with updated software (CLPC 4.1)

Intended Use: To provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (CAP) in internal structures of the body, primarily the liver (and spleen for FibroScan® 630 Expert). Used as an aid to clinical management, diagnosis, and monitoring of adult and pediatric patients with liver disease.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate devices (Echosens's FibroScan® Family of Products #K181547 and FibroScan® 630 #K200655) in terms of bias and precision for shear wave speed and CAP measurements, and improved usability (applicability, success rates, consistency, examination durations) for SmartDepth.

Acceptance Criteria (Demonstrated Equivalence to Predicate)	Reported Device Performance (FibroScan® CLPC 4.1)
Shear Wave Speed (Liver)	Bias: Ranges of bias values (0.5% – 12.6%) documented for the candidate device are substantially equivalent to the predicate device (2.6% – 8.0%). Precision: Precision values documented for the candidate are "very similar" to the predicate device. Overall Equivalence: Bias values for shear wave speed shown to be comparable (under 5% difference) between all FibroScan systems.
Standard CAP (Liver)	Static Single-Spot Measurement: - Bias: M+ probe: Predicate 17.1%, Candidate 15.3%. XL+ probe: Predicate 12.9%, Candidate 14.1%. (Similar performance) - Precision: M+ probe: Predicate 0.5%, Candidate 0.5%. XL+ probe: Predicate 1%, Candidate 0.7%. (Similar performance) Static Multiple Measurements (Rotating Turntable): - Bias: M+ probe: Predicate 0.8%, Candidate 0.8%. XL+ probe: Predicate 16.2%, Candidate 12.2%. (Similar performance) - Precision: M+ probe: Predicate 3.2%, Candidate 0.5%. XL+ probe: Predicate 2.8%, Candidate 1.7%. (Similar performance) Overall Equivalence: Bias values for standard CAP shown to be comparable (under 5% difference) between all FibroScan systems.
Continuous CAP (CAPc) (Liver)	Bias: Range and mean values of CAPc bias (6.9% - 12.2%) were substantially equivalent to standard CAP bias in the candidate device (static single spot: 14.1% - 15.3%; static multi-spot: 0.8% - 12.2%). Precision: Range and mean values of CAPc precision (0.3% - 2.1%) were equivalent to standard CAP precision in the candidate device (static single spot: 0.5% - 0.7%; static multi-spot: 0.5% - 1.7%). S+ Probe Applicability: Precision results of CAPc with the S+ probe (both S1 and S2 exam) were equivalent to precision results using M+ and XL+ probes. Correlation with M+ & XL+ (Phantoms): CAPc measurements on S+ probe highly correlated with M+ and XL+ values and within their range. Bias & Precision Equivalence: No significant bias between standard CAP and CAPc on phantoms; CAPc showed better precision (lower variability) and better robustness.
SmartDepth (Liver)	Shear Wave Speed & Stiffness (LSM): LSM with SmartDepth were substantially equivalent to LSM without SmartDepth. Improved Usability: Improved applicability, success rates, consistency, and examination durations compared to standard fixed depth.
Shear Wave Speed (Spleen, FibroScan® 630 Expert)	Bias: Comparable values (under 5% differences) to the FibroScan® 630 Expert reference device configuration system (#K200655).

2. Sample Size Used for the Test Set and Data Provenance

CAPc Validation: 195 participants (from two retrospective in-vivo studies).
SmartDepth Validation: 566 participants (from three retrospective in-vivo studies).
Provenance: All clinical validation studies were retrospective in-vivo. The document does not specify the country of origin for the clinical data.
Non-Clinical Testing: Calibrated tissue-mimicking phantoms and a heterogeneous phantom were used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document mentions "biopsy as a reference" for SmartDepth validation. For CAPc validation, "MRI-PDFF as a reference" was used. The number of experts involved in interpreting these reference standards and their specific qualifications are not provided in the text.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth from biopsy or MRI-PDFF. It simply states these were used as "references."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not specifically mentioned or described. The studies focused on comparing the device's performance (bias, precision, etc.) of the new software features against either the previous software version/predicate device or established reference standards (MRI-PDFF, biopsy). There is no information about how human readers improved with or without AI assistance, as this is a diagnostic device for physical measurements, not an image interpretation AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented (bias, precision for shear wave speed, CAP, and CAPc) reflects the standalone performance of the device's algorithms and its physical measurement capabilities, without human interpretation in the loop as the primary metric. The device measures physical parameters (shear wave speed, stiffness, attenuation) directly. The "indications for use" state these measurements "may be used as an aid to clinical management," implying a human clinician interprets the device's output.

7. The Type of Ground Truth Used

SmartDepth Validation: Biopsy
CAPc Validation: MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction)
Non-Clinical Performance: Known values in calibrated tissue-mimicking phantoms.

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set. The studies described are for validation (test sets) of the updated software features.

9. How the Ground Truth for the Training Set Was Established

As training set details are not provided, information on how its ground truth was established is also not available in this document.

Summary

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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

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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

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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 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.

*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:	Echosens6 rue Ferrus, Paris, France, 75014Telephone: +33 1 44 82 78 56Fax: +33 1 44 82 78 60
Contact Person:	Zvi Ladin, Ph.D.PrincipalBoston MedTech Advisors, Inc.990 Washington Street; Suite #204Dedham, MA 02026Telephone: (781) 407 0900 x104Fax: (781) 407 0901Email: 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:	Echosens6 rue Ferrus, Paris, France, 75014Telephone: +33 1 44 82 78 56Fax: +33 1 44 82 78 60
EstablishmentRegistration Number:	3010258456

Predicate Device

This submission claims substantial equivalence to:

1. Primary Predicate Device: Echosens's FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+), cleared on July 9, 2018 (#K181547)
1. Reference Device: Echosens's FibroScan® 630, cleared in on July 16, 2020 (#K200655)

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Device Description

. 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

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).

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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 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.

*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.

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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.

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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% 18.5<BMl≤25, 36% 25<BMl≤30, 21% 30<BMl≤35, and 15% >35. Results showed that CAPc is substantially equivalent to the performance of standard CAP. In addition, there was no significant bias between standard CAP

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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% 18.5<BM≤25, 21% 25<BM≤30, 27% 30<BMl≤35, and 48% >35. 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 ofProducts (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® 530and 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 toprovide shear wave speedmeasurements and estimates of tissuestiffness as well as ultrasoundcoefficient of attenuation (CAP:Controlled Attenuation Parameter) ininternal structures of the body. TheShear wave speed and stiffnessmeasurements may be used as an aidto clinical management of adultpatients with liver disease.The FibroScan® Family of Products(Models: 502 Touch, 530 Compact,430 Mini+, and 630) is indicated fornon-invasive measurement in the liverof 50 Hz shear wave speed andestimates of stiffness as well asdetermining a 3.5 MHz ultrasoundcoefficient of attenuation (CAP:Controlled Attenuation Parameter).The shear wave speed and stiffness,and CAP may be used as an aid todiagnosis and monitoring of adultpatients with liver disease, as part ofan overall assessment of the liver.	The FibroScan® 630 is intended toprovide shear wave speed measurementsand estimates oftissue stiffness as well as ultrasoundcoefficient of attenuation (CAP: ControlledAttenuationParameter) in internal structures of thebody. The Shear wave speed andstiffness measurementsmay be used as an aid to clinicalmanagement of adult patients with liverdisease.FibroScan® 630 is indicated for non-invasive measurement in the liver of 50Hz shear wave speedand estimates of stiffness as well asdetermining a 3.5 MHz ultrasoundcoefficient of attenuation(CAP: Controlled Attenuation Parameter).The shear wave speed and stiffness, andCAP may be used as an aid to diagnosisand monitoringof adult patients with liver disease, as partof an overall assessment of the liver.	The FibroScan® Family ofProducts (Models: 502 Touch,530 Compact, and 430 Mini+) isintended to provide 50 Hz shearwave speed measurements andestimates of tissue stiffness aswell as 3.5 MHz ultrasoundcoefficient of attenuation (CAP:Controlled AttenuationParameter) in internal structuresof the body.FibroScan® Family of Products(Models: 502 Touch, 530Compact, and 430 Mini+) isindicated for noninvasivemeasurement in the liver of 50Hz shear wave speed andestimates of stiffness as well asdetermining a 3.5 MHzultrasound coefficient ofattenuation (CAP: ControlledAttenuation Parameter).The shear wave speed andstiffness, and CAP may be usedas an aid to diagnosis andmonitoring of adult patients with
	Shear wave speed and stiffness, andCAP* may be used as an aid in theclinical management of pediatricpatients with liver disease.FibroScan® 630 (Expert) is alsoindicated for noninvasive measurementin the spleen of 100 Hz shear wavespeed and estimates of stiffness thatmay be used as an aid to diagnosis,monitoring and clinical management ofadult patients with liver disease, aspart of an overall assessment of theliver.*CAP for pediatric patients with liverdisease is only available withSmartExam capability onFibroScan® Models: 530 Compact,430 Mini+, and 630	Shear wave speed and stiffness may beused as an aid in the clinical managementof pediatricpatients with liver disease.FibroScan® 630 (Expert) is also indicatedfor noninvasive measurement in thespleen of 100 Hzshear wave speed and estimates ofstiffness that may be used as an aid todiagnosis, monitoringand clinical management of adult patientswith liver disease, as part of an overallassessment of the liver.	liver disease, as part of anoverall assessment of the liver.Shear wave speed and stiffnessmay be used as an aid to clinicalmanagement of pediatricpatients with liver disease.
Application	Abdominal	Abdominal	Abdominal
Imaging Modes	A-mode / M-modeTransient Elastography/ Shear Wave /(CAP™)	A-mode / M-modeTransient Elastography/ Shear Wave /(CAP™)	A-mode / M-modeTransient Elastography/ ShearWave / (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 ultrasoundtransducer)
Depth AnalysisMethod	Fixed Depth:S1 exam : 15-40 mmS2 exam : 20-50 mmM exam: 25-65 mmXL exam: 35-75 mmWith SmartDepth (AdaptativeDepth):M exam: 25-65 mm / 30-70 mm	Fixed Depth:S1 exam : 15-40 mmS2 exam : 20-50 mmM exam: 25-65 mmXL exam: 35-75 mm	Fixed Depth:S1 exam : 15-40 mmS2 exam : 20-50 mmM exam: 25-65 mmXL exam: 35-75 mm
	XL exam: 35-75 mm/ 40-80 mm/ 45-85 mm
B-Mode UltrasoundLocalization 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 andtissue stiffness	Shear wave speed measurements andtissue stiffness	Shear wave speedmeasurements and tissuestiffness
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 stiffnessmedians and Interquartile range (IQR)and IQR/median ratio	Shear wave speed and stiffness mediansand Interquartile range (IQR) andIQR/median ratio	Shear wave speed and stiffnessmedians and Interquartile range(IQR) and IQR/median ratio
VCTE™ Display(Spleen)	For FibroScan® 630 :Shear wave speed and stiffnessmedians and Interquartile range (IQR)	Shear wave speed and stiffness mediansand Interquartile range (IQR)	N/A
Mode of U/S signalsacquisition	First generation CAP:Elastography modeSecond 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 interquartilerange (IQR)
Attenuation Display- Probescompatibility	First generation CAP:M+ ProbeXL ProbeSecond generation CAP:M+ ProbeXL+ ProbeS+ Probe (model 10 only)	First generation CAP:M+ ProbeXL Probe	First generation CAP:M+ ProbeXL Probe
Size and Weight	FibroScan® 502T :1350 mm x 680 mmx 610 mm (H x W x D)	1365mm x 642mm x 584mm(H x W x D)	FibroScan® 502T :1350 mm x680 mm x 610 mm (H x W x D)
	41kg with accessoriesFibroScan® 530 : 460 mm x 360 mm x250 mm (H x W x D)10kg with accessoriesFibroScan® 430 : 275mm x 400mm x95mm (H x W x D)6kg with accessoriesFibroScan® 630 : 1365mm x 642mm x584mm (H x W x D)46kg with accessories	46kg with accessories	41kg with accessoriesFibroScan® 530 : 460 mm x 360mm x 250 mm (H x W x D)10kg with accessoriesFibroScan® 430 : 275mm x400mm 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
Elastographyengine	FibriScan 502T :Analog front end High frequency (US):PV2 ; Analog front end Low frequency(servo control): PV2FibroScan® 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):PV3Analog front end Low frequency (servocontrol): PV3	FibriScan 502T :Analog front end High frequency(US): PV2 ; Analog front endLow frequency (servo control):PV2FibroScan® 530, and 430:Analog front end High frequency(US): PV3 ; Analog front endLow frequency (servo control):PV3
Operating system	Windows Embedded	Windows Embedded	Windows Embedded
Screen	Color LCD touch screenFibroScan® 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 screenFibroScan® 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/AFibroScan® 530 and 430 : ARTSEnergy (ref. 4 INR19/66-2) Partnumber 806957 / M300002	N/A	FibroScan® 502T: N/AFibroScan® 530 and 430 : ARTSEnergy (ref. 4 INR19/66-2) Partnumber 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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Regulation Number and Section

§ 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.