The FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is intended to measure liver stiffness (E) using Vibration Controlled Transient Elastography™ (VCTE™) at 50 Hz shear wave frequency and liver ultrasound attenuation coefficient (CAP™)* at 3.5 MHz. FibroScan® 630 Expert is also intended to measure spleen stiffness using VCTE™ at 100 Hz shear wave frequency.

FibroScan liver stiffness measurements (LSM) by VCTE™ may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis. FibroScan CAP™ measurements may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis.

FibroScan® is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile.

The FibroScan® device is intended for use by healthcare professionals in hospitals, clinics or any facility where healthcare is provided.

*CAP™ refers to ultrasound attenuation coefficient (originally defined as Controlled Attenuation Parameter). CAP™ on S+ probe is only available with SmartExam capability.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Echosens FibroScan® device. It details the device's indications for use and compares it to predicate devices. However, the document does not contain specific acceptance criteria or an explicit study proving the device meets acceptance criteria in the format of a clinical trial with predefined endpoints and statistical significance levels.

Instead, the submission relies on the concept of substantial equivalence to previously cleared devices (K203273 and K212035) and a comprehensive review of existing clinical literature and practice guidelines to support the expanded indications for use and labeling changes. The argument is that since the fundamental technology and hardware are the same as the cleared predicate devices, and the software updates do not impact performance, new clinical performance data in the form of a dedicated prospective study was not required.

Therefore, the requested information cannot be fully extracted in the typical format of a clinical study report. Here's what can be inferred and stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, the document does not present explicit acceptance criteria or a dedicated performance study with specific metrics in tabular format. The "performance" described is the device's consistent and robust correlation with established medical conditions, supported by existing literature.

Acceptance Criteria (Inferred from intent)	Reported Device Performance (Supported by Literature Review)
Safe and effective measurement of liver stiffness (LSM) for aiding in assessment of liver fibrosis and determining likelihood of cirrhosis.	LSM and Fibrosis/Cirrhosis: Supported by 3 longitudinal studies (290 patients) and 18 meta-analyses (369 studies, >40,000 patients) demonstrating consistent and robust correlation between LSM and fibrosis, and LSM as an indicator of cirrhosis. Strong support from professional society clinical guidelines. No adverse events related to performing FibroScan® examinations reported in pediatric studies.
Safe and effective measurement of liver ultrasound attenuation coefficient (CAP™) for aiding in assessment of hepatic steatosis.	CAP™ and Steatosis: Supported by 6 meta-analysis publications (138 studies, ~12,900 patients) demonstrating consistent and robust correlation between CAP™ and steatosis. Strong support from professional society clinical guidelines. No adverse events related to performing FibroScan® examinations reported in pediatric studies.
Safe and effective use across patient morphology (probe selection).	Probe Use and Morphology: Supported by 41 papers (~8,570 patients). Specifically: S+ probe (older than 18, 3 studies, n=250), M+ probe (younger than 14, 29 studies, n=5,950), XL+ probe (younger than 18, 9 studies, n=2,369). Studies showed no adverse events related to probe use and supported effectiveness based on LSM, CAP, or both.
Safe and effective use for clinical management, diagnosis, and monitoring in adult and pediatric patients with confirmed or suspected liver disease.	Pediatric Use: Supported by 24 papers (n=6,573) for diagnosis aid and 6 additional papers (n=293) for monitoring aid. No adverse events recorded. Suspected Liver Disease Patients: Supported by 10 studies (n=5,650 patients) assessing suspected patients using TE. Clinical guidelines also support TE use in these patients.
Safety for patients with active implants and pregnant women (removal of contraindications).	Active Implants/Pregnancy: Supported by technical considerations (acoustic/mechanical output) and 2 studies (141 patients with active implants) and 3 studies (611 pregnant women) showing effective device performance with no adverse events. A warning statement was added regarding lack of extensive studies.

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

Test Set (Clinical Evidence for expanded claims): The "test set" for the expanded indications are collections of retrospective clinical literature reviews and professional guidelines.
- Liver Fibrosis/Cirrhosis: 3 longitudinal studies (290 patients), 18 meta-analyses (369 studies, >40,000 patients).
- Hepatic Steatosis: 6 meta-analysis publications (138 studies, ~12,900 patients).
- Probe Use across Morphology: 41 papers (~8,570 patients).
  - S+ probe: 3 studies (n=250)
  - M+ probe: 29 studies (n=5,950)
  - XL+ probe: 9 studies (n=2,369)
- Pediatric Use: 24 papers (n=6,573) for diagnosis, 6 additional papers (n=293) for monitoring.
- Suspected Liver Disease: 10 studies (n=5,650 patients).
- Active Implants: 2 studies (141 patients).
- Pregnant Women: 3 studies (611 pregnant women).
Data Provenance: The document does not specify the country of origin for the individual studies in the clinical literature review but indicates it's a "comprehensive clinical literature," implying international data. All studies are retrospective in the context of this submission, meaning they were published prior to this 510(k) submission.

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

The document does not specify the number of experts used to establish the ground truth for the test set in the context of this submission. The ground truth for the underlying studies in the literature review would have been established by the relevant medical professionals (e.g., pathologists for liver biopsies, radiologists, hepatologists) in those individual studies. The statement "Papers used in support of the changes were focused on studies in which FibroScan® results are compared to the ground truth of liver biopsy" indicates the ultimate gold standard used in many of these studies.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for a test set in the formal sense (e.g., 2+1, 3+1). The "adjudication" is implicitly done through the scientific peer-review process of the published literature and the consensus reflected in professional clinical guidelines that support the use of FibroScan.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as part of this 510(k) submission. The submission is based on substantial equivalence and a literature review supporting expanded indications for a device with established efficacy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The FibroScan® device, by its nature, is a diagnostic imaging tool that measures physical parameters (liver stiffness, attenuation). While it generates quantitative data (LSM, CAP values), these are intended to be used by a healthcare professional "in context with other clinical and laboratory data, as an aid in the assessment." Therefore, it inherently involves human interpretation. The question of "algorithm only" performance typically applies to AI-driven diagnostic image analysis systems providing a direct diagnosis or flagging pathologies. FibroScan provides quantitative measurements for interpretation by a human.

7. Type of Ground Truth Used

The primary ground truth for the majority of the supporting literature, especially for liver fibrosis and steatosis, is liver biopsy. The document explicitly states: "Papers used in support of the changes were focused on studies in which FibroScan® results are compared to the ground truth of liver biopsy." For other claims, the "ground truth" would be established clinical diagnoses, patient outcomes, and medical assessments based on a combination of clinical, laboratory, and other imaging data.

8. Sample Size for the Training Set

The document does not specify a "training set" sample size for this 510(k) submission. The FibroScan® device is based on physical measurement principles (VCTE™ and CAP™) rather than a machine learning algorithm that requires a separate training set in the typical sense. The underlying algorithms for shear wave speed and attenuation calculation would have been developed and validated through engineering and physical modeling, potentially with internal data, but this is not a "training set" for an AI model.

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

As there is no "training set" in the context of an AI/ML algorithm development as typically understood, this question is not directly applicable. The core technology relies on well-established physics. The calibration and validation of the device's measurements against physical phantoms or established reference standards would be part of its engineering development, rather than establishing "ground truth" for a training set of patient data.

Summary

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March 2, 2023

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Echosens % Zvi Ladin Principal Boston MedTech Advisors Inc. 990 Washington Street, Suite #204 DEDHAM MA 02026

Re: K223902

Trade/Device Name: FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: December 21, 2022 Received: December 28, 2022

Dear Zvi 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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) K223902

Device Name

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)

Indications for Use (Describe)

FibroScan® is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatic population should be interpreted while considering the clinical condition and the overall patient profile.

The FibroScan® device is intended for use by healthcare professionals in hospitals, clinics or any facility where healthcare is provided.

*CAP™ refers to ultrasound attenuation coefficient (originally defined as Controlled Attenuation Parameter). CAPTM on S+ probe is only available with SmartExam capability.

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 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:	February 23, 2023
Name of Device and Name/Address of Sponsor

Trade/Proprietary Name: FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, 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 the following predicate and reference devices:

1. Primary Predicate Device: Echosens's FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630), cleared on March 25, 2021 (#K203273)
1. Reference Device: Echosens's FibroScan® 230, cleared in on July 30, 2021 (#K212035)

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Device Description

The focus of this submission is the clearance of the FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) with a streamlined IFU and updated labelling materials. FibroScan® has the same intended use as the predicate and reference FibroScan systems. However, this submission is expanding the indications for use of the system, to be used with other clinical and laboratory data, as an aid in determining the likelihood of cirrhosis, in the assessment of liver fibrosis and in the assessment of hepatic steatosis. Additionally, the IFU is expanding its indications to patients with confirmed or suspected liver disease. The contraindications of the system for patients with pregnancy and/or active implants were removed. Instead, a warning statement was included in the device labeling regarding the lack of extensive studies of such populations and the resulting possible impact on patient risk and measurement reliability. These changes, among others, are based on comprehensive clinical literature and practice guideline support.

Although there have been no significant changes to the software, this clearance includes an updated version of the FibroScan® software for all models.

Comparison of Technological Characteristics

All systems in the FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, 230, 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) #K203273 and #K212035. 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 3.5MHz.

The technological characteristics of the FibroScan® Family of Products in this submission are substantially equivalent to the predicate and reference devices.

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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.
. 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: Edition 1.1 2015-. 06 CONSOLIDATED VERSION.
ISO 14971 Second: Medical Devices Application of Risk Management To Medical . Devices: Third Edition 2019-12.

Intended Use / Indications for Use

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taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis.

The FibroScan® device is intended for use by healthcare professionals in hospitals, clinics or any facility where healthcare is provided.

*CAP™ refers to ultrasound attenuation coefficient (originally defined as Controlled Attenuation Parameter). CAP™ on S+ probe is only available with SmartExam capability.

Performance Data

No new hardware elements were included in the submission, and the new software version does not impact device performance. Therefore, no new performance data were required in support of the submission. The changes in the indications for use and labeling included in this submission are supported by a comprehensive clinical literature of approximately 100 published clinical literature articles and 20 supporting published professional guidelines. Papers used in support of the changes were focused on studies in which FibroScan® results are compared to the ground truth of liver biopsy.

The use of probes based on patient morphology rather than age is supported by 41 papers with ~8.570 patients. Of the 41 studies, the safe and effective use of the S+ probe on patients older than 18 was evaluated in 3 studies (n = 250 patients including healthy controls, patients with liver disease, and patients with cystic fibrosis); the safe and effective use of the M+ probe on patients younger than 14 was evaluated in 29 studies (n = 5,950 patients including healthy controls, Nonalcoholic fatty liver disease (NAFLD), Non-alcoholic steatohepatitis (NASH), with fibrosis and/or steatosis, cystic fibrosis, obese without liver disease, chronic liver disease, intestinal failure, Hepatitis C, and liver transplant patients); and the safe and effective use of the XL+ Probe on patients younger than 18 was evaluated in = 2,369 patients including healthy controls, NAFLD, with fibrosis, Hepatitis C, and NASH). Use of probes on patients outside their indicated age limits, as documented in the numerous clinical publications, showed no adverse events related to probe use, supporting the safety of such use, as well as supported the effectiveness based on LSM, CAP, or both.

The use of FibroScan® as an aid to diagnosis and monitoring of pediatric patients is supported by 24 papers (n = 6,573) supporting the effectiveness of FibroScan® as an aid to diagnosis in pediatric population, and six additional papers (n = 293) supporting FibroScan® as an aid to monitoring in pediatric population. No adverse events related to performing FibroScan® examinations were recorded.

The effectiveness of the FibroScan® system in patients suspected of liver disease is supported by ten studies (n= 5,650 patients) assessing suspected patients (following their initial screening) using transient elastography (TE) as part of an overall assessment of the liver. The use of TE in

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patients suspected of liver disease is also supported by clinical quidelines. Similarly, the revision of the labeling for FibroScan® output interpretation by physicians "with appropriate training" is intended to reflect the current recommendations from clinical quidelines on the use of FibroScan® as an essential component of clinical care, following initial screening of suspected liver disease patients in a primary care clinical environment, followed by further assessment by physicians experienced in the management of liver diseases as necessary.

The added clinical claims in the IFU include the aid in assessment of liver fibrosis and hepatic steatosis, when taken in context with other clinical and laboratory data. Additionally, the claims include the aid in determining the likelihood of cirrhosis. The addition of the clinical claims to the IFU is supported by peer reviewed literature demonstrating the consistent and robust correlation between LSM and fibrosis and LSM as an indicator of cirrhosis (3 longitudinal studies (290 patients) and 18 meta-analyses totaling 369 studies (>40,000 patients)) as well as between CAP™ and steatosis (6 meta-analysis publications, tallying 138 studies with ~12,900 patients). The clinical utility is also strongly supported by professional society clinical guidelines.

The removal of the contraindication of the device for active implants and for pregnant women is supported by technical considerations addressing the acoustic and mechanical output of the electrodynamic actuator and ultrasound probe. In addition, removal of contraindications for active implants is supported by 2 studies with 141 patients and removal of contraindications for pregnant women is supported by 3 studies with 611 pregnant women. These studies showed the device performs effectively on these patient populations, with no adverse events. Moreover, a warning statement was included in the device labeling regarding the lack of extensive studies of such populations and the resulting possible impact on patient risk and measurement reliability.

The clinical literature review demonstrates that the FibroScan® Family of Products with updated labelling and indications for use are safe, effective, and substantially equivalent to the predicate and reference FibroScan® devices.

Substantial Equivalence Discussion

The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) uses the same operating principle and materials, incorporates the same basic design, emits the same energy, acquires the same information, and has the same intended use as the predicate and reference FibroScan® devices (#K203273 and #K212035). The updated indications for use and labeling, do not raise new or different questions of safety or efficacy. The updated software version was verified and validated.

In summary, the conclusions drawn from the clinical review provided in this submission demonstrate that FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) raises no new or different issues of safety or effectiveness and is substantially equivalent to its primary predicate device.

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Table 1. Predicate and Reference Device Comparison for FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+ 230 and 630)

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Size and Weight	FibroScan® 502 Touch: 1350 mm x 680mm x 610 mm (H x W x D)41kg with accessoriesFibroScan® 530 Compact: 460 mm x 360mm x 250 mm (H x W x D)10kg with accessoriesFibroScan® 430 Mini+: 275mm x 400mm x95mm (H x W x D)6kg with accessoriesFibroScan® 630: 1365mm x 642mm x584mm (H x W x D)46kg with accessoriesFibroScan® 230: 265.5mm x 157mm x200mm (H x W x D)4.4kg with accessories	FibroScan® 502 Touch:1350 mmx 680 mm x 610 mm (H x W x D)41kg with accessoriesFibroScan® 530 Compact: 460mm x 360 mm x 250 mm (H x W xD)10kg with accessoriesFibroScan® 430 Mini+: 275mm x400mm x 95mm (H x W x D)6kg with accessoriesFibroScan® 630: 1365mm x642mm x 584mm (H x W x D)46kg with accessories	FibroScan® 230: 265.5mm x157mm x 200mm(H x W x D)4.4kg with accessories
Power supply	100-240 V ~ 50-60 Hz	100-240 V ~ 50-60 Hz	100-240 V ~ 50-60 Hz
Elastography engine	FibroScan 502 Touch:Analog front end High frequency (US): PV2;Analog front end Low frequency (servocontrol): PV2FibroScan® 530 Compact, 430 Mini+, 630,and 230:Analog front end High frequency (US): PV3;Analog front end Low frequency (servocontrol): PV3	FibroScan 502 Touch:Analog front end High frequency(US): PV2; Analog front end Lowfrequency (servo control): PV2FibroScan® 530 Compact, 430Mini+, and 630:Analog front end High frequency(US): PV3; Analog front end Lowfrequency (servo control): PV3	FibroScan® 230:Analog front end High frequency(US): PV3Analog front end Low frequency(servo control): PV3
Operating system	Windows Embedded	Windows Embedded	Windows Embedded
Screen	Color LCD touch screenFibroScan® 502 Touch: 19 inches.FibroScan® 530 Compact: 15 inches.FibroScan® 430 Mini+: 12.1 inches.FibroScan® 630: 19 inches.FibroScan® 230: User's computer (Screenresolution req: 1024 x 768)	Color LCD touch screenFibroScan® 502 Touch: 19inches.FibroScan® 530 Compact: 15inches.FibroScan® 430 Mini+: 12.1inches.FibroScan® 630: 19 inches.	User's computer (Screenresolution req: 1024 x 768)

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.

Mini+, 230, and 630)
	Subject Device:	Primary Predicate Device:	Reference Device:
	FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)	FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, 630)	FibroScan® 230
510(k) # (Clearance)	K223902	K203273	K212035
Manufacturer	Echosens	Echosens	Echosens
Indications for Use	The FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is intended to measure liver stiffness (E) using Vibration Controlled Transient Elastography™ (VCTE™) at 50 Hz shear wave frequency and liver ultrasound attenuation coefficient (CAP™)* at 3.5 MHz. FibroScan® 630 Expert is also intended to measure spleen stiffness using VCTE™ at 100 Hz shear wave frequency.FibroScan liver stiffness measurements (LSM) by VCTE™ may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis. FibroScan CAP™ measurements may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis.FibroScan® is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile.	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® 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® 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
	The FibroScan® device is intended for useby healthcare professionals in hospitals,clinics or any facility where healthcare isprovided.* CAP TM refers to ultrasound attenuationcoefficient (originally defined as ControlledAttenuation Parameter). CAPT™ on S+probe is only available with SmartExamcapability.	Shear wave speed and stiffness,and CAP* may be used as an aidin the clinical management ofpediatric patients with liverdisease.FibroScan® 630 (Expert) is alsoindicated for noninvasivemeasurement in the spleen of 100Hz shear wave speed andestimates of stiffness that may beused as an aid to diagnosis,monitoring and clinicalmanagement of adult patients withliver disease, as part of an overallassessment of the liver.*CAP for pediatric patients withliver disease is only available withSmartExam capability onFibroScan® Models: 530Compact, 430 Mini+, and 630	pediatric patients with liverdisease.
Application	Abdominal	Abdominal	Abdominal
Imaging Modes	A-mode / M-modeTransient Elastography/ Shear Wave /(CAP TM)	A-mode / M-modeTransient Elastography/ ShearWave / (CAP TM)	A-mode / M-modeTransient Elastography/ ShearWave / (CAP TM)
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 ultrasoundtransducer)	M+-probe (3.5 MHz)XL+ probe (2.5 MHz)S+ probe (5 MHz)(single element ultrasoundtransducer)
Fixed Depth Method	S1 exam : 15-40 mmS2 exam : 20-50 mmM exam: 25-65 mmXL exam: 35-75 mm	S1 exam : 15-40 mmS2 exam : 20-50 mmM exam: 25-65 mmXL exam: 35-75 mm	S1 exam : 15-40 mmS2 exam : 20-50 mm
Adaptive DepthMethod(SmartDepth)	M exam: 25-65 mm / 30-70 mmXL exam: 35-75 mm/ 40-80 mm/ 45-85 mm	M exam: 25-65 mm / 30-70 mmXL exam: 35-75 mm/ 40-80 mm/45-85 mm	M exam: 25-65 / 30-70 mmXL exam: 35-75 mm/ 40-80 mm/45-85 mm
B-Mode UltrasoundLocalization Probe	For FibroScan® 630 Expert:ES-C5-2R60S-3	For FibroScan® 630 Expert:ES-C5-2R60S-3	N/A
VCTE™ Mode	Shear wave speed measurements andtissue stiffness	Shear wave speed measurementsand tissue stiffness	Shear wave speed measurementsand 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 mediansand Interquartile range (IQR) andIQR/median ratio	Shear wave speed and stiffnessmedians and Interquartile range(IQR) and IQR/median ratio	Shear wave speed and stiffnessmedians and IQR/median ratio
VCTE™ Display(Spleen)	For FibroScan® 630 Expert:Shear wave speed and stiffness mediansand Interquartile range (IQR)	For FibroScan® 630 Expert:Shear wave speed and stiffnessmedians and Interquartile range(IQR)	N/A
Mode of U/S signalsacquisition	First generation CAP:Elastography mode	First generation CAP:Elastography mode	First generation CAP:Elastography mode
	Second generation CAP:Imaging mode	Second generation CAP:Imaging mode	Second generation CAP:Imaging 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)	First generation CAP:CAP median and interquartilerange (IQR)	CAP mean and standard deviation
	Second generation CAP and FibroScan®230:CAP mean and standard deviation	Second generation CAP:CAP mean and standard deviation
Attenuation Display- Probescompatibility	S+ Probe (second generation, model 10)M+ ProbeXL+ Probe	S+ Probe (second generation,model 10)M+ ProbeXL + Probe	S+ ProbeM+ ProbeXL Probe