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K Number
K200655
Device Name
FibroScan® 630
Manufacturer
Echosens
Date Cleared
2020-07-16

(126 days)

Product Code
IYOITX
Regulation Number
892.1560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

K181547

K173021, K161968

No
The device description focuses on the underlying VCTE™ technology and ultrasound tracking, with no mention of AI or ML algorithms for data processing, interpretation, or image analysis. The performance metrics are standard for medical devices and do not suggest AI/ML involvement.

No.
The device is strictly for diagnostic purposes, providing measurements to aid in clinical management and diagnosis, without directly treating any condition.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device's measurements "may be used as an aid to diagnosis" for adult and pediatric patients with liver disease.

No

The device description explicitly states that the FibroScan® system consists of a "system unit and a hand-held probe" and describes the probe containing a "mechanical vibrator" and using "Ultrasound" to track waves. This indicates the device includes significant hardware components beyond just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • FibroScan® 630 Function: The FibroScan® 630 is a non-invasive device that uses ultrasound and mechanical vibration to measure shear wave speed and estimate tissue stiffness and attenuation within the body (specifically the liver and spleen). It does not analyze samples taken from the body.

Therefore, the FibroScan® 630 falls under the category of medical devices used for imaging and measurement within the body, not in vitro diagnostics.

N/A

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 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.

Product codes

IYO, ITX

Device Description

FibroScan® system consists of a system unit and a hand-held probe. It is based on Vibration-Controlled Transient Elastography (VCTE™) technology and is designed to perform non-invasive measurements of liver/spleen shear wave speed and 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

internal structures of the body, liver, spleen

Indicated Patient Age Range

Adult patients, pediatric patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. To allow direct comparison of the measurement accuracy between the proposed and cleared systems, the same sample of phantoms were tested contemporaneously by the candidate and predicate FibroScan systems, using the same probes and the same phantoms.

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 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

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

0

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

System: FibroScan® 630

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

Clinical ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
OphthalmicOphthalmic
Fetal
Abdominal (liver)NiPP 1, 2, 3
Abdominal (spleen)NiNiN4i
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Fetal
Imaging
& OtherPediatricPP 1, 2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
CardiacCardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral 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 ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
OphthalmicOphthalmic
Fetal
Imaging
& OtherFetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPP 1, 2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral 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 ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
OphthalmicOphthalmic
Fetal
Abdominal (liver)PP 1, 2, 3
Abdominal (spleen)N1N41
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Fetal
Imaging
& OtherPediatricPP 1, 2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
CardiacCardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral 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 ApplicationMode of Operation
GeneralSpecificBMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
(Track 1 Only)(Tracks 1 & 3)
OphthalmicOphthalmic
Fetal
Imaging
& OtherFetal
AbdominalPP 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
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral 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 ApplicationMode of Operation
GeneralSpecificBMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
(Track 1 Only)(Tracks 1 & 3)
OphthalmicOphthalmic
Fetal
AbdominalNⁱ
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Fetal
Imaging
& OtherSmall Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
CardiacCardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral 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
6 rue Ferrus, Paris, France, 75014
Telephone: +33 1 44 82 78 56
Fax: +33 1 44 82 78 60 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Zvi Ladin, Ph.D.
Principal
Boston MedTech Advisors, Inc.
990 Washington Street; Suite #204
Dedham, MA 02026
Telephone: (781) 407 0900 x104
Fax: (781) 407 0901
Email: zladin@bmtadvisors.com |
| Date Prepared: | March 9, 2020 |

Name of Device and Name/Address of Sponsor

Common Name: Diagnostic Ultrasound System and Accessories

Classifications:

Classification NameRegulationProduct Code
Ultrasonic Pulsed Echo Imaging System21 CFR §892.1560IYO
Diagnostic Ultrasonic Transducer21 CFR §892.1570ITX

| Manufacturing Facility: | Echosens
6 rue Ferrus, Paris, France, 75014
Telephone: +33 1 44 82 78 56
Fax: +33 1 44 82 78 60 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3010258456 |

Predicate Device

This submission claims substantial equivalence to 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;
    1. Reference device: Supersonic Imagine's Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (K173021), cleared on January 9, 2018; and
    1. 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.

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  • . 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%. Indications for Use | Indications for 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 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. | The FibroScan® Family of
products (Models: 502
Touch, 530 Compact and
430 Mini+) is intended to
provide 50Hz shear wave
speed measurements and
estimates of tissue stiffness
as well as 3.5 MHz
ultrasound coefficient of
attenuation (CAP: Controlled
Attenuation Parameter) in
internal structures of the
body.
FibroScan® Family of
products (Models: 502
Touch, 530 Compact and
430 Mini+) is indicated for
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. | The SuperSonic Imagine
AIXPLORER® & AIXPLORER®
Ultimate ultrasound diagnostic
systems and transducers are
intended for general purpose puls
echo ultrasound imaging, soft
tissue elasticity imaging, doppler
fluid flow analysis of the human
body.
The SuperSonic Imagine
AIXPLORER® & AIXPLORER®
Ultimate ultrasound diagnostic
systems are indicated for use in
the following applications, for
imaging and measurement of
anatomical structures: Abdominal
Small Organs, Musculoskeletal,
Superficial Musculoskeletal,
Vascular, Peripheral Vascular,
Intraoperative, OB-GYN, Pelvic,
Pediatric, Urology, Trans-rectal,
Trans-vaginal and Neonatal/Adult
Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic
Imagine AIXPLORER® &
AIXPLORER® Ultimate ultrasound
diagnostic systems and associated
transducers are intended for:- Measurements of abdominal
anatomical structures,- Measurements of broad band
shear wave speed, and tissue
stiffness in internal structures of
the liver and the spleen,- Measurements of brightness ratio
between liver and kidney,- Visualization of abdominal
vascularization,
microvascularization and
perfusion,- Quantification of
abdominal vascularization and
perfusion.
The shear wave speed and
stiffness measurements, the
brightness ratio, the visualization
of vascularization,
microvascularization and
perfusion, the quantification of
vascularization and perfusion may
be used as an aid to clinical
management of adult patients with liver disease. | |
| Clinical
Application | Abdominal; | Abdominal; | Abdominal; |
| | FS630P: Shear wave speed,
stiffness, and coefficient of
attenuation in the liver
FS630E: Shear wave speed,
and stiffness, in the liver and
the spleen and coefficient of
attenuation in the liver | Shear wave speed, stiffness,
and coefficient of attenuation
in the liver | Shear wave speed, and tissue
stiffness in the liver and the spleen
in the liver |
| Imaging
modes | A-mode
M-mode
B-mode (FS630E only for
organ localization)
Transient Elastography / Shear
Wave | A-mode
M-mode
Transient Elastography /
Shear Wave | B-mode
ShearWave™ Elastography |
| Ultrasound
Source | Piezoelectric ultrasound source | Piezoelectric ultrasound
source | Piezoelectric ultrasound source |
| Probe | M+ VCTE probe (3.5 MHz)*
XL+ VCTE probe (2.5 MHz)
S+ VCTE probe (5.0 MHz)
ES-C5-2R60S-3 convex array
(3.5 MHz) (FS630E only)**
(single element ultrasound
transducer)
*M+ Probe is only probe used
for Spleen (FS630E only)
** OEM MicrUs EXT-1H
(#K161968) | M+ VCTE probe (3.5 MHz)
XL+ VCTE probe (2.5 MHz)
S+ VCTE probe (5.0 MHz)
(single element ultrasound
transducer) | SC6-1 (3.5 MHz)
(1 - 6 MHz curved array
transducer) |
| Elastography
mode | Vibration-controlled Transient
Elastography™ | Vibration-controlled Transient
Elastography™ | ShearWave™ Elastography |
| Source of
Mechanical
Vibration | External electromechanical
Vibrator | External electromechanical
Vibrator | Radiation force in ShearWave™
Elastography |
| Shear Wave
Speed
Determination | Post-processing | Post-processing | Post-processing |
| Elastography
Display | Liver:
Shear wave speed (0.8-5.0
m/s)
Stiffness (2.0-75 kPa)
Interquartile range (IQR) and
IQR/median ratio
Spleen: (FS630E only)
Shear wave speed (1.4-5.8
m/s)
Stiffness (6.0-100 kPa) for
spleen
Interquartile range (IQR) | Liver:
Shear wave speed (0.8-5.0
m/s)
Stiffness (2.0-75 kPa)
Interquartile range (IQR) and
IQR/median ratio | 2D color coded shear wave speed
map (elastogram) |

15

16

| Controlled
Attenuation
Parameter
(CAP) | Available for M+ and XL+
Probes only for liver | Available for M+ and XL+
Probes | N/A |
|-------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------|
| CAP Display | CAP value (100-400 dB/m) and
interquartile range (IQR) | CAP value (100-400 dB/m) and
interquartile range (IQR) | N/A |
| Bias (Liver) | S+: (-20.6%) – (-6.5%)
M+: (-17.5%) – (-7.6%)
XL+: (-17.5%) - (-7.7%) | S+: (-13.9%) – (3.6%)
M+: (-12.9%) – (-2.6%)
XL+: (-14.3%) – (3.4%) | (-9.4%) - (43.4%) |
| Bias (Spleen)
FS630E Only | M+: (-24%) - (-17%) | N/A | |
| Precision
(Liver) | S+: (0%) - (2%)
M+: (0%) - (2%)
XL+: (0%) - (1%) | S+: (0.2%) - (1.6%)
M+: (0%) - (0%)
XL+: (0%) - (1.5%) | (0%) - (3.9%) |
| Precision
(Spleen)
FS630E Only | M+: (0%) - (1%) | N/A | |

Table 1. Predicate Device Comparison for FibroScan® 630