FibroScan® 630

K200655 · Echosens · IYO · Jul 16, 2020 · Radiology

Device Facts

• Record ID: K200655
• Device Name: FibroScan® 630
• Applicant: Echosens
• Product Code: IYO · Radiology
• Decision Date: Jul 16, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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. 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.

Device Story

FibroScan® 630 is a diagnostic ultrasound system using Vibration-Controlled Transient Elastography (VCTE™) to measure liver and spleen tissue stiffness and ultrasound attenuation (CAP). The system comprises a unit and hand-held probe containing a mechanical vibrator that induces low-amplitude elastic waves in tissue. Ultrasound tracks these waves to calculate shear wave speed and stiffness. The 'Expert' configuration adds a B-mode ultrasound module (OEM) to assist in organ localization. Used in clinical settings by healthcare providers, the device provides quantitative outputs (shear wave speed, stiffness, CAP) to aid in the diagnosis, monitoring, and management of liver disease. Benefits include non-invasive assessment of liver/spleen health, reducing the need for invasive procedures.

Clinical Evidence

Prospective, multi-center, non-randomized study of 260 patients with chronic liver disease. Evaluated 100 Hz spleen stiffness measurement (SSM) vs. 50 Hz liver measurements. Success rate for 100 Hz SSM was 92.5% vs. 76.0% for 50 Hz (p < .001). Ancillary study on 26 subjects showed good intra-class (0.94) and inter-class (0.96) reproducibility. No adverse events reported.

Technological Characteristics

Vibration-Controlled Transient Elastography (VCTE™) system. Uses piezoelectric ultrasound transducers (S+, M+, XL+ probes) and an external electromechanical vibrator. FS630E includes a convex array B-mode transducer (3.5 MHz). Complies with IEC 60601-2-37, IEC 62127, IEC 60601-1, and IEC 62304 standards. Connectivity includes system unit display of shear wave speed (m/s), stiffness (kPa), and CAP (dB/m).

Indications for Use

Indicated for non-invasive measurement of 50 Hz shear wave speed and stiffness, and 3.5 MHz CAP in the liver of adult and pediatric patients with liver disease. FibroScan® 630 Expert is additionally indicated for non-invasive measurement of 100 Hz shear wave speed and stiffness in the spleen of adult patients with liver disease.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FibroScan® Family of Products (Models: 502 Touch, 530 Compact, And 430 Mini+) (K181547)

Reference Devices

• Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (K173021)
• Telemed's MicrUs (K161968)

Submission Summary (Full Text)

{0}------------------------------------------------

July 16, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K200655

Trade/Device Name: FibroScan® 630 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: June 19, 2020 Received: June 23, 2020

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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) K200655

Device Name FibroScan® 630

#### Indications for Use (Describe)

The FibroScan® 630 is intended to provide shear wave speed measurements and estimates of tissue stiffiness 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.

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

System: FibroScan® 630

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|----|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal (liver) | Ni | P | | | | | P 1, 2, 3 |
| | Abdominal (spleen) | Ni | Ni | | | | | N4i |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | | | | | P 1, 2 |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

1. A-mode

2. Vibration Controlled Transient Elastography at 50 Hz

3. Controlled Attenuation Parameter (CAPTM) et 3.5 MHz

4. Vibration Controlled Transient Elastography at 100 Hz

^| Option available for FibroScan 630 Expert only

{4}------------------------------------------------

Transducer: FibroScan® S+ probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | P | | | | | P 1, 2 |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

1. A-mode

2. Vibration Controlled Transient Elastography at 50 Hz

{5}------------------------------------------------

Transducer: FibroScan® M+ probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | |
|-----------------------------|------------------------------------|---|----|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal (liver) | | P | | | | | P 1, 2, 3 |
| | Abdominal (spleen) | | N1 | | | | | N41 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | | | | | P 1, 2 |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

1. A-mode

2. Vibration Controlled Transient Elastography at 50 Hz

3. Controlled Attenuation Parameter (CAPTM) et 3.5 MHz

4. Vibration Controlled Transient Elastography at 100 Hz

^| Option available for FibroScan 630 Expert only

{6}------------------------------------------------

Transducer: FibroScan® XL+ probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | P | | | | | P 1, 2, 3 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

1. A-mode

2. Vibration Controlled Transient Elastography at 50 Hz

3. Controlled Attenuation Parameter (CAPTM) et 3.5 MHz

{7}------------------------------------------------

Transducer: ES-C5-2R60S-3

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | Nⁱ | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

¹ Option available for FibroScan 630 Expert only

{8}------------------------------------------------

### 510(K) Summary Echosens' FibroScan® 630

Image /page/8/Picture/1 description: The image shows the text 'K200655' in a simple, sans-serif font. The text is black and appears to be on a white background. The characters are evenly spaced and clearly legible.

#### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

| Manufacturer: | Echosens<br>6 rue Ferrus, Paris, France, 75014<br>Telephone: [phone]<br>Fax: [phone] |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Zvi Ladin, Ph.D.<br>Principal<br>Boston MedTech Advisors, Inc.<br>990 Washington Street; Suite #204<br>Dedham, MA 02026<br>Telephone: [phone] x104<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 9, 2020 |

#### Name of Device and Name/Address of Sponsor

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<br>6 rue Ferrus, Paris, France, 75014<br>Telephone: [phone]<br>Fax: [phone] |
|---------------------------------------|----------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number: | 3010258456 |

#### Predicate Device

This submission claims substantial equivalence to a combination of three previously cleared devices:

- 1. Predicate device: Echosens's FibroScan® Family of Products (Models: 502 Touch, 530 Compact, And 430 Mini+) (K181547), cleared on July 9, 2018;
- 2. Reference device: Supersonic Imagine's Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (K173021), cleared on January 9, 2018; and
- 3. Reference device: Telemed's MicrUs (K161968), cleared on November 3, 2016.

{9}------------------------------------------------

### 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 estimates of 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 the new FibroScan® 630, available in two configurations: FibroScan® 630 'Prime' (FS630P) and FibroScan® 630 'Expert' (FS630E). Both FS630P and FS630E include improvements of the FibroScan appearance and user interface.

The FS630P version has the same indications as the previously cleared models and is only indicated for non-invasive measurement of 50 Hz shear wave speed in the liver and estimates of its stiffness, as well as determination of a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The FS630E includes an expansion of the intended use to include noninvasive measurement of shear wave speed at 100Hz in the spleen and estimates of its stiffness as well as an inclusion of a B-Mode ultrasound imaging system to help the user locate the liver or spleen.

### Comparison of Technological Characteristics

The FibroScan® 630 system is substantially equivalent to the FibroScan® 530 Compact system cleared by 510(k) #K181547. Both systems provide 50Hz shear wave speed measurements and estimates of tissue stiffness in the liver using the S+, M+, and XL+ transducers. Additionally, both systems encompass a Controlled Attenuation Parameter (CAP) designed to estimate the ultrasound attenuation (forward and return paths) at the frequency of 3.5 MHz.

The FibroScan® 630 modification relates to its size, weight, power, and electronics. The FS630E also includes modifications related to its software in order to accommodate the B-mode module and allow spleen stiffness measurement. The FibroScan® 630 system liver measurement is otherwise identical to the predicate FibroScan® 530 Compact system as related to the indications for use, operating principles, S+, M+, and XL+ probes, materials, examination procedure, imaging modes, imaging capabilities, information processing, performance measurements, and manufacturing process.

No new hardware elements were included in the submission apart from the addition of the localization ultrasound system, previously cleared by Telemed in 510(k) #K161968.

Similar to liver stiffness measurement (LSM), spleen stiffness measurement (SSM) using FibroScan® 630 Expert relies on VCTE™ method. As the spleen is stiffer and smaller than the liver, specific characteristics of the spleen stiffness examination were modified:

- Elastic shear wave at a controlled 100 Hz center frequency .
- Ultrasound pulse repetition frequency of 8000 Hz .
- Peak-to-peak amplitude of the vibration reduced to 1 mm-PP ●

{10}------------------------------------------------

- . Target tissue depths of 25 - 55 mm
- . Stiffness value range between 6.0 and 100.0 kPa

Unlike LSM that can be measured with S+, M+ and XL+ probes, SSM can only be measured with the FibroScan® M+ probe.

The technological characteristics of FibroScan® 630 Expert are substantially equivalent to those of the Aixplorer® (#K173021), which is also indicated for measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen. Both devices are based on the same physical phenomenon, namely the effect of the mechanical properties of soft tissue on the propagation of low frequency mechanical waves in internal organs. Both use ultrasound for measuring the changes in the strain field that result from the propagation of the mechanical wave and display the processed values of shear wave speed. Therefore, the candidate and the predicate and reference devices are substantially equivalent in terms of the technology used.

### 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.

{11}------------------------------------------------

- . 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® 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 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.

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.

#### Performance Data

The accuracy and precision of the device was tested for shear wave speed of the liver and the spleen on calibrated phantoms with known elasticity and attenuation. In addition, to allowed direct comparison of the measurement accuracy between the proposed and cleared systems, same sample of phantoms were tested contemporaneously by the candidate and predicate FibroScan systems, using the same probes and the same phantoms.

The shear wave speed bias, i.e. the difference in the mean shear wave speed measured and the nominal shear wave speed of the phantom, normalized by the nominal shear wave speed and expressed in percent was evaluated and compared to the corresponding value reported for the predicate device.

For liver examination, results show that while the predicate FibroScan® 530 Compact shear wave speed bias results reported minimum and maximum values of [-13.9%; 3.6%] for the S+ probe, [-12.9%; -2.6%] for the M+ probe and [-14.3%; -3.4%] for the XL+ probe; the range of shear wave speed bias results measured with the candidate FibroScan device had minimum and maximum values of [-20.6%; -6.5%] for the S+ probe, [-17.5%; -7.6%] for the M+ probe and [-17.5%; -7.7%] for the XL+ probe. Therefore, the overall range of bias values for the shear wave speed in the predicate FibroScan® 530 Compact is ≤17.5%. <11% and <11% for the S+ M+ and XL+ probes

{12}------------------------------------------------

respectively, while the corresponding values for shear wave speed in the FibroScan® 630 is ≤14.1%, <10% and <10% respectively, and can therefore be considered as equivalent to the predicate. Moreover, the bias values for the shear wave speed and CAP on the same probes, phantoms and experimental setup using the predicate and candidate devices lead to the conclusion, that the proposed system (FibroScan® 630) is as effective as its predicate (FibroScan® 530) in measuring shear wave speed and CAP bias.

The sheer wave speed precision measurement, i.e. the standard deviation of the independent measurements of the shear wave speed, normalized by the reference value was evaluated and compared to the corresponding value reported for the predicate device.

For liver examination, results show that while the candidate device documented the range of shear wave speed precision measured for the S+ [0%; 2%], M+ [0%; 2%] and XL+ [0%; 1%] probes. The corresponding minimum and maximum values for the predicate are [0.2%; 1.6%] for S+ probe. [0%: 0%] for the M+ probe and [0%: 1.5%] for the XL+ probe. Therefore, the overall range of precision values for the shear wave speed in the predicate FibroScan® 530 Compact is <2%, <1% and <2% for the S+ M+ and XL+ probes respectively, while the corresponding values in the FibroScan® 630 is ≤2%, ≤2% and ≤1% respectively, and can therefore be considered as equivalent to the predicate.

For spleen examination, the range of shear wave speed bias results measured by the candidate FibroScan device had minimum and maximum values of [-24%; -17%] for the M+ probe. Therefore, the overall range of bias values for the shear wave speed in the candidate FibroScan is 7% for the M+ probe. This value is similar to the range of 9.9% documented for the candidate device and 10.3% obtained in the verification of the predicate device for liver measurements. Moreover, the range of shear wave speed precision results measured with the candidate FibroScan device had minimum and maximum values of [0%; 1%] for the M+ probe. Therefore, the overall range of precision values for the shear wave speed in the candidate FibroScan is 1% for the M+ probe. This is similar to the values of 2% and 0% measured for the candidate and predicate devices for liver measurements.

In summary, the bias and the precision of the shear wave speed measured by the FibroScan® 630 are within the same range than those of the predicate FibroScan® 530 Compact device. Furthermore, the direct comparison (i.e., same probes, phantoms and experimental setup) of the candidate system and its predicate lead to the conclusion that the FibroScan® 630 system was found to have a safety and effectiveness profile that is similar to the predicate FibroScan® 530 Compact device.

In addition to bench testing, clinical information was submitted to provided support for the expanded indications for use for spleen stiffness measurement.

{13}------------------------------------------------

## Clinical Data

The performance of FibroScan® 100 Hz sheer wave speed for spleen stiffness estimates was assessed in a prospective, multi-center, non-randomized study. The device was used to perform a spleen stiffness examination in each patient using the settings of the novel spleen examination (100 Hz), and the standard liver examination (50 Hz). Study objectives also included evaluating the 100 Hz SSM in comparison to hepatic venous pressure gradient (HVPG) and other noninvasive tests (NITs). The study included 260 patients with chronic liver disease (169 male; 91 female) with a median age of 59 (range 51 - 68) and a median BMI of 26 kg/m² (range 23.7 -28.6). Patients with chronic liver disease due to hepatitis virus C (155 patients), hepatitis virus B (19 patients), or alcoholic liver diseases (79 patients) were enrolled. Patients had ultrasound examination, blood examination, and esophagogastroduodenoscopy (EGD) performed within 6 months of the spleen stiffness measurement (SSM). The examination was performed with the patient lying in supine position with left arm in maximal abduction, and the probe placed in the left intercostal spaces. The median liver stiffness measurement was 46.2 kPa and the median SSM was 48 kPa. The novel 100 Hz spleen-dedicated FibroScan® settings demonstrated significantly higher success rate than the 50 Hz measurements (92.5% compared to 76.0%, P <.001). No adverse events were reported in this study.

An ancillary study to examine intra-operator and inter-operator reproducibility, including 10 cirrhotic patients, 10 non-cirrhotic patients, and 6 healthy subjects showed good intra-class and inter-class reproducibility (0.94 and 0.96, respectively). In cirrhotic patients the intra-class and inter-class coefficient correlations were higher (0.96 and 0.97, respectively) than in non-cirrhotic patients and healthy subjects, potentially due to larger spleen diameters in cirrhotic patients.

### Substantial Equivalence Discussion

The FibroScan® 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® 530 device (K181547). The differences in size, weight and internal organization of its components do not raise new or different questions of safety or efficacy. The FS630P also includes the same intended use and indications for use as the predicate device.

The addition of the spleen stiffness indication for the FS630E was demonstrated to be substantially equivalent to its predicate device FibroScan® 530 (K181547) and Aixplorer Ultimate Ultrasound Diagnostic Systems (K173021), as they both have the same intended use, indications for use, and the technological differences do not raise different issues of safety and effectiveness. A comprehensive literature review and a large clinical study demonstrated the device's safety and effectiveness in measuring spleen stiffness. Furthermore, the inclusion of a B-Mode ultrasound imaging system (OEM previously cleared by Telemed under K161968) to help the user locate the liver or spleen is operating in compliance with its intended use, indications for use and FDAcleared labeling.

In summary, the conclusions drawn from the clinical information provided in this submission demonstrate that FibroScan® 630 raises no new or different issues of safety or effectiveness and is substantially equivalent to its predicate devices.

{14}------------------------------------------------

| FibroScan® 630<br>(TBD; Submission Device) | FibroScan® 530 Compact<br>#K181547 (July 9, 2018) | Aixplorer®<br>#K173021 (January 9, 2018) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Echosens | Echosens | SuperSonic Imagine, S.A. | |
| <b>Indications for Use</b> | <b>Indications for Use</b> | <b>Indications for Use</b> | |
| The FibroScan® 630 is<br>intended to provide shear wave<br>speed measurements and<br>estimates of tissue stiffness as<br>well as ultrasound coefficient of<br>attenuation (CAP: Controlled<br>Attenuation Parameter) in<br>internal structures of the body.<br>The Shear wave speed and<br>stiffness measurements may<br>be used as an aid to clinical<br>management of adult patients<br>with liver disease.<br>FibroScan® 630 is indicated for<br>non-invasive measurement in<br>the liver of 50 Hz shear wave<br>speed and estimates of<br>stiffness as well as determining<br>a 3.5 MHz ultrasound<br>coefficient of attenuation (CAP:<br>Controlled Attenuation<br>Parameter).<br>The shear wave speed and<br>stiffness, and CAP may be<br>used as an aid to diagnosis<br>and monitoring of adult patients with<br>liver disease, as part of an<br>overall assessment of the liver.<br>Shear wave speed and<br>stiffness may be used as an aid<br>in the clinical management of<br>pediatric patients with liver<br>disease.<br>FibroScan® 630 (Expert) is<br>also indicated for noninvasive<br>measurement in the spleen of<br>100 Hz shear wave speed and<br>estimates of stiffness that may<br>be used as an aid to diagnosis,<br>monitoring and clinical<br>management of adult patients<br>with liver disease, as part of an<br>overall assessment of the liver. | The FibroScan® Family of<br>products (Models: 502<br>Touch, 530 Compact and<br>430 Mini+) is intended to<br>provide 50Hz shear wave<br>speed measurements and<br>estimates of tissue stiffness<br>as well as 3.5 MHz<br>ultrasound coefficient of<br>attenuation (CAP: Controlled<br>Attenuation Parameter) in<br>internal structures of the<br>body.<br>FibroScan® Family of<br>products (Models: 502<br>Touch, 530 Compact and<br>430 Mini+) is indicated for<br>non-invasive measurement in<br>the liver of 50 Hz shear wave<br>speed and estimates of<br>stiffness as well as<br>determining a 3.5 MHz<br>ultrasound coefficient of<br>attenuation (CAP: Controlled<br>Attenuation Parameter).<br>The shear wave speed and<br>stiffness, and CAP may be<br>used as an aid to diagnosis<br>and monitoring of adult<br>patients with liver disease, as<br>part of an overall assessment<br>of the liver.<br>Shear wave speed and<br>stiffness may be used as an<br>aid in the clinical<br>management of pediatric<br>patients with liver disease. | The SuperSonic Imagine<br>AIXPLORER® & AIXPLORER®<br>Ultimate ultrasound diagnostic<br>systems and transducers are<br>intended for general purpose puls<br>echo ultrasound imaging, soft<br>tissue elasticity imaging, doppler<br>fluid flow analysis of the human<br>body.<br>The SuperSonic Imagine<br>AIXPLORER® & AIXPLORER®<br>Ultimate ultrasound diagnostic<br>systems are indicated for use in<br>the following applications, for<br>imaging and measurement of<br>anatomical structures: Abdominal<br>Small Organs, Musculoskeletal,<br>Superficial Musculoskeletal,<br>Vascular, Peripheral Vascular,<br>Intraoperative, OB-GYN, Pelvic,<br>Pediatric, Urology, Trans-rectal,<br>Trans-vaginal and Neonatal/Adult<br>Cephalic, Non-invasive Cardiac.<br>In addition, the SuperSonic<br>Imagine AIXPLORER® &<br>AIXPLORER® Ultimate ultrasound<br>diagnostic systems and associated<br>transducers are intended for:- Measurements of abdominal<br>anatomical structures,- Measurements of broad band<br>shear wave speed, and tissue<br>stiffness in internal structures of<br>the liver and the spleen,- Measurements of brightness ratio<br>between liver and kidney,- Visualization of abdominal<br>vascularization,<br>microvascularization and<br>perfusion,- Quantification of<br>abdominal vascularization and<br>perfusion.<br>The shear wave speed and<br>stiffness measurements, the<br>brightness ratio, the visualization<br>of vascularization,<br>microvascularization and<br>perfusion, the quantification of<br>vascularization and perfusion may<br>be used as an aid to clinical<br>management of adult patients with liver disease. | |
| Clinical<br>Application | Abdominal; | Abdominal; | Abdominal; |
| | FS630P: Shear wave speed,<br>stiffness, and coefficient of<br>attenuation in the liver<br>FS630E: Shear wave speed,<br>and stiffness, in the liver and<br>the spleen and coefficient of<br>attenuation in the liver | Shear wave speed, stiffness,<br>and coefficient of attenuation<br>in the liver…