(211 days)
Not Found
No
The description focuses on the VCTE™ technology, mechanical vibration, and ultrasound tracking for shear wave speed measurement and stiffness estimation. There is no mention of AI or ML in the device description, intended use, or performance studies. The software upgrade is mentioned in the context of accommodating new probes and expanded indications, not for implementing AI/ML algorithms.
No
The device aids in clinical management by providing measurements that can be used for diagnosis or monitoring, but it does not directly treat a disease or condition.
Yes
The device aids in the clinical management of patients with liver disease by providing noninvasive measurements of shear wave speed and estimates of tissue stiffness, which are used to evaluate the liver.
No
The device description explicitly states that the FibroScan® system consists of a "system unit and a hand-held probe" and describes the physical components and their function (mechanical vibrator, ultrasound). This indicates it is a hardware device with accompanying software.
No, 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. They are performed outside of the body.
- FibroScan Operation: The FibroScan system operates in vivo (within the living body). It uses a probe placed on the skin to send and receive waves through the liver tissue.
- Intended Use: The intended use clearly states it provides measurements and estimates of tissue stiffness through internal structures of the body. This is a non-invasive measurement performed directly on the patient.
Therefore, based on the provided information, the FibroScan system is a medical device used for non-invasive measurement in vivo, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The FibroScan® system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness through internal structures of the body.
FibroScan® is indicated for noninvasive measurement of shear wave speed and estimate of stiffness at 50 Hz in the liver. The shear wave speed may be used as an aid to clinical management of pediatric and adult patients with liver disease.
Product codes (comma separated list FDA assigned to the subject device)
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 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. 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 expansion of the indications for use for the FibroScan system by Echosens to pediatric patients. In order to address the smaller anatomic size of pediatric patients, a new probe (S+) was developed, and the indications for use of the previously cleared M+ probe were modified. The new probe uses the same principle of operation, intended use and methodology (i.e. application to patient, signal measurement, processing and display), design, materials, manufacturing and testing processes as the previously cleared M+ and XL+ probes. The device specifications are similar to those of the predicate device. The system's software was upgraded to accommodate these changes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Liver
Indicated Patient Age Range
Pediatric and adult patients
Intended User / Care Setting
Prescription Use Device
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)
Bench testing was performed to assure that the device meets its specifications. Measurements of the bias and precision of the device demonstrated substantial equivalence to both predicate devices.
Bias:
The bias, i.e. the difference in the mean shear wave speed measured and the nominal shear wave of the phantom, normalized by the nominal shear wave and expressed in percent was evaluated and compared to the corresponding value reported for the predicate devices. While the Aixplorer® predicate device¹ pediatric probes reported values of bias between (-7.2%) and (43.4%), and the FibroScan® predicate devices reported values of bias between (-13.9%) and (1.3%); the range of bias values measured for the candidate device were between (-13.5%) and (3.6%). Therefore, the overall range of bias values (across all values) for the Aixplorer predicate device probes are ~50% of the nominal shear wave speed, while the corresponding range for the predicate FibroScan probes and for the candidate device probe is
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2015
Echosens % Zvi Ladin Principal Boston Medtech Advisors Inc. 990 Washington Street, Suite #204 DEDHAM, MA 02026
Re: K150239
Trade/Device Name: FibroScan Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, ITX Dated: July 30, 2015 Received: August 3, 2015
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
FibroScan®
Indications for Use (Describe)
The FibroScan® system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness through internal structures of the body.
FibroScan® is indicated for noninvasive measurement of shear wave speed and estimate of stiffness at 50 Hz in the liver. The shear wave speed may be used as an aid to clinical management of pediatric and adult patients with liver disease.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 The builden time for this collection of intrion data sources, gather and maintain the data needed and complete time to review instruction. Send common 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® 502 Touch
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | P | P 1, 2 | ||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
- A-mode
4
Transducer: FibroScan® M+ probe
| **** ded Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow. | |||||
|---|---|---|---|---|---|
| -- | ------------------------------------------------------------------------------------------------- | -- | -- | -- | -- |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P 1, 2 | |||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N 1,2 | |||||||
| Fetal | Small Organ (Specify) | ||||||||
| Imaging | Neonatal Cephalic | ||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- A-mode
5
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 | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Abdominal | P | P 1, 2 | |||||
| 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) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- A-mode
6
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 | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- A-mode
7
510(K) Summary Echosens' FibroScan® System
Submitter's Name, Address, Telephone Number, Contact Persona and Date Prepared:
| Manufacturer: | Echosens
30 Place d'Italie
75013 Paris, France
Telephone: +33 1 44 82 78 55
Facsimile: +33 1 44 82 68 36 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Zvi Ladin, Ph.D.
Principal
Boston MedTech Advisors, Inc.
990 Washington Street
Suite #204
Dedham, MA 02026
Telephone: (781) 407 0900 x104
Facsimile: (781) 407 0901
Email: zladin@bmtadvisors.com |
| Date Prepared: | July 30, 2015 |
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | FibroScan® |
|---|---|
| ------------------------- | ------------ |
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
30 Place d'Italie
75013 Paris, France
Telephone: +33 1 44 82 78 55
Facsimile: +33 1 44 82 68 36 |
| ------------------------- | ---------------------------------------------------------------------------------------------------------------------- |
|---|
| Establishment | |
|---|---|
| Registration Number: | 3010258456 |
Predicate Device
This submission claims substantial equivalence to a combination of two cleared devices:
-
FibroScan® (#K123806) manufactured by the sponsor and cleared on April 5, 2013; and
-
Aixplorer® (#K132274) manufactured by Supersonic Imagine S.A. and cleared on September 24, 2013.
8
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 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. 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 expansion of the indications for use for the FibroScan system by Echosens to pediatric patients. In order to address the smaller anatomic size of pediatric patients, a new probe (S+) was developed, and the indications for use of the previously cleared M+ probe were modified. The new probe uses the same principle of operation, intended use and methodology (i.e. application to patient, signal measurement, processing and display), design, materials, manufacturing and testing processes as the previously cleared M+ and XL+ probes. The device specifications are similar to those of the predicate device. The system's software was upgraded to accommodate these changes.
Recognized Consensus Standards Used
Non-clinical testing to assure compliance with acoustic output, biocompatibility as well as thermal, electrical, 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 Edition 2.0 2007-08:Medical Electrical Equipment Part 2-37: Particular . Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment.
- NEMA UD 2-2004 (R2009): Acoustic Output Measurement Standard For Diagnostic ● Ultrasound Equipment Revision 3
- AIUM MUS: Medical Ultrasound Safety, Third Edition
- . IEC 62127-1 Edition 1.1 2013-02: Ultrasonics -- Hydrophones -- Part 1: Measurement And Characterization Of Medical Ultrasonic Fields Up To 40 Mhz
- IEC 62127-2 Edition 1.0 2007-08: Ultrasonics -- Hydrophones -- Part 2: Calibration For . Ultrasonic Fields Up To 40 Mhz [Including: Technical Corrigendum 1:2008 And Amendment 1:2013]
- . IEC 62127-03 Edition 1.1 2013-05: Ultrasonics -- Hydrophones -- Part 3: Properties Of Hydrophones For Ultrasonic Fields Up To 40 Mhz
- . IEC 61161 Edition 3.0 2013-01: Ultrasonics -- Power Measurement -- Radiation Force Balances And Performance Requirements
- . AAMI / ANSI ES60601-1:2005/(R)2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod)
- IEC 60601-1-2 Edition 3:2007-03: Medical Electrical Equipment Part 1-2: General . Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
9
- . IEC 60601-1-6 Edition 3.1 2013-10: Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usabilitv
- . IEC 62366 Edition 1.1 2014-01: Medical Devices - Application Of Usability Engineering To Medical Devices
- . IEC 62304 First Edition 2006-05: Medical Device Software - Software Life Cycle Processes
- ISO 14971 Second Edition 2007-03-01: . Medical Devices - Application Of Risk Management To Medical Devices
Performance Data
The bias and precision of the device was documented based on tests performed on phantoms with known elasticity. The bias, i.e. the difference in the mean shear wave speed measured and the nominal shear wave of the phantom, normalized by the nominal shear wave and expressed in percent was evaluated and compared to the corresponding value reported for the predicate devices. While the Aixplorer® predicate device¹ pediatric probes reported values of bias between (-7.2%) and (43.4%), and the FibroScan® predicate devices reported values of bias between (-13.9%) and (1.3%); the range of bias values measured for the candidate device were between (-13.5%) and (3.6%). Therefore, the overall range of bias values (across all values) for the Aixplorer predicate device probes are ~50% of the nominal shear wave speed, while the corresponding range for the predicate FibroScan probes and for the candidate device probe is 1 The specific values of precision and bias for the AIXPLORER system are quoted from the 510(k) Summary of #K112255 which is the predicate for #K132274 and is stated to have a substantially equivalent non-clinical performance
10
The new S+ probe and the revised software are substantially equivalent to the predicate device (FibroScan® – #K123806) manufactured by the sponsor and cleared on April 5, 2013. The proposed device uses the same technology, intended use and methodology (i.e. application to patient, signal measurement, processing and display) as the FibroScan system. It is designed to accommodate the anatomy of pediatric patients.
The expansion of the Indications for Use of the FibroScan System with the new S* probe to include pediatric patients is substantially equivalent to the diagnostic ultrasound Indications for Use of the ShearWave™ Elastography mode of the Aixplorer (#K132274) for pediatric patients. The candidate device uses the S* ultrasound transducer at a center frequency of 5 MHz, which is in the range of frequencies used by the Aixplorer predicate system for pediatic applications. The analog front end and central interface of the candidate and predicate devices have equivalent functionality.
In summary, the candidate and predicate devices are based on the same physical phenomenon. namely the effect of soft tissue elasticity on the propagation of low frequency mechanical waves in internal organs. They use ultrasound for measuring the strain field that results from the propagation of the mechanical wave, and display the shear wave speed and stiffness estimate. Therefore, the candidate and predicate devices are substantially equivalent in terms of the technology used.
Substantial Equivalence Discussion
The focus of this submission is the expansion of the indications for use for the FibroScan system by Echosens to pediatric patients. Therefore, substantial equivalence is claimed to the primary predicate device - the original FibroScan System (#K123806) in terms of the intended use, scientific principle, technological design, materials used, patient interface, data collection, processing and display. Substantial equivalence is also claimed to the secondary predicate device (AIXPLORER® #K132274), in terms of the indications for use (elastography for pediatric population), technological characteristics, signal acquisition, processing and display.
In order to address the smaller anatomic size of pediatric patients, a new probe (S+) was developed, and the indications for use of the M+ probe were modified. The center frequency of the S+ probe is well within the range of frequencies used by the predicate device (Aixplorer) for pediatric patients. The system's software was upgraded to accommodate these changes. The new probe uses the same principle of operation, design, materials, manufacturing and testing processes as the primary predicate. Therefore, the new S+ probe does not raise different questions of safety and effectiveness compared to the predicate devices.
Bench testing was performed to assure that the device meets its specifications. Measurements of the bias and precision of the device demonstrated substantial equivalence to both predicate devices.
11
A summary of the comparison between the candidate and predicate devices leading to the conclusion that the candidate device raises no new issues of safety or effectiveness is presented in the following table:
| | FibroScan® - Pediatric
Use | FibroScan® | Aixplorer® |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K150239 | K123806 | K132274 |
| Indications for Use | FibroScan® is
intended to provide
50Hz shear wave
speed
measurements and
estimates of tissue
stiffness through
internal structures of
the body.
FibroScan® is
indicated for
noninvasive
measurement of
shear wave speed
and estimate of
stiffness at 50 Hz in
the liver. The shear
wave speed may be
used as an aid to
clinical management
of pediatric and adult
patients with liver
disease.
Prescription Use
Device | FibroScan® is intended
to provide 50Hz shear
wave speed
measurements through
internal structures of
the body.
FibroScan® is indicated
for noninvasive
measurement of shear
wave speed at 50 Hz in
the liver. The shear
wave speed may be
used as an aid to
clinical management of
patients with liver
disease.
Prescription Use
Device | The SuperSonic
Imagine
AIXPLORER®)
ultrasound system is
indicated for use in the
following applications:
Abdominal, Small
Organs,
Musculoskeletal,
Superficial
Musculoskeletal,
Vascular, Peripheral
Vascular, GYN, Pelvic,
Pediatric, Urology,
Trans-rectal and Trans-
vaginal.
The system also
provides the ability to
measure anatomical
structures (Abdominal,
Small Organs,
Musculoskeletal,
Superficial
Musculoskeletal,
Peripheral Vascular,
GYN, Pelvic, Pediatric,
Urology, Transrectal
and Trans-vaginal). |
| Clinical Application | Pediatric | Abdominal | Abdominal
Pediatric
Other |
| Ultrasound Source | Piezoelectric | Piezoelectric | Piezoelectric |
| Probe Frequency | Pediatric:
5 MHz (S+ Probe) | Adults:
3.5 MHz (M+ Probe)
2.5 MHz (XL+ Probe) | Pediatric:
1 – 6 MHz (SC6-1
Probe)
4 - 15 MHz (SL15-4
Probe) |
| Elastography Mode | Vibration-Controlled
Transient™ | Vibration-Controlled
Transient™ | ShearWave
Elastography™ |
| Bias | (-13.5%) – (3.6%) | (-13.9%) – (1.3%) | (-7.2%) – (43.4%)2 |
| Precision | (0.7%) - (2.0%) | (0%) - (3.1%) | (0%) - (3.4%)3 |
3 Pediatric probes