(22 days)
Not Found
No
The summary describes a device based on Vibration-Controlled Transient Elastography (VCTE™) and Controlled Attenuation Parameter (CAP) technology, which are established ultrasound-based techniques. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The performance studies focus on accuracy and precision on phantoms, not on the performance of an algorithm trained on clinical data.
No.
The device is used for diagnostic measurements to aid in clinical management, not for direct treatment or therapy.
Yes
The device provides measurements that are intended to be used as an "aid to clinical management" of patients with liver disease, which is a diagnostic purpose. It measures tissue stiffness and attenuation, which are indicators of the state of the liver.
No
The device description explicitly mentions a "mechanical vibrator" and describes the generation and measurement of elastic waves and ultrasound, indicating the presence of hardware components beyond just software.
Based on the provided information, the FibroScan® 530 Compact 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® 530 Compact Function: The FibroScan® 530 Compact is a non-invasive device that uses ultrasound and mechanical vibration to measure shear wave speed, tissue stiffness, and ultrasound attenuation directly within the liver in vivo (within the living body). It does not analyze samples taken from the body.
Therefore, the FibroScan® 530 Compact falls under the category of a medical device used for in vivo measurement and assessment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FibroScan® 530 Compact system 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® 530 Compact is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 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 clinical management of adult patients with liver disease.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal and Pediatric.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
FibroScan® 530 Compact, based on Vibration-Controlled Transient Elastography (VCTE™) technology, is designed to perform non-invasive measurements of liver shear wave speed and estimates of tissue stiffness. A mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. The FibroScan® 530 Compact CAP (Controlled Attenuation Parameter, ranging between 100 and 400 decibels per meter (dB/m), provides an estimation of the total ultrasonic wave attenuation (forward and return paths) at 3.5 MHz, measured concomitantly with tissue stiffness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Liver, Abdominal
Indicated Patient Age Range
Adult patients with liver disease.
Pediatric patients with liver disease.
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 and CAP on calibrated phantoms with known elasticity and attenuation.
Shear wave speed bias comparison:
- Predicate FibroScan: [-11.5%; 0.7%] for M+ probe; [-13.9%; 1.3%] for XL+ probe. Overall range
§ 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 features a stylized representation of human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
Echosens % Zvi Ladin, Ph.D. Principal Boston MedTech Advisors, Inc. 990 Washington Street, Suite #204 DEDHAM MA 02026
Re: K160524
Trade/Device Name: FibroScan® 530 Compact Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: February 23, 2016 Received: February 25, 2016
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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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/Resourcesfor You/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 Oolo
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) K160524
Device Name FibroScan® 530 Compact
Indications for Use (Describe)
The FibroScan® 530 Compact system 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® 530 Compact is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The shear wave speed and stiffhess, and CAP may be used as an aid to clinical management of adult patients with liver disease.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Diagnostic Ultrasound Intended Use
System: FibroScan® 530 Compact
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 | P | P 1, 2 | ||||||
| N 3 | ||||||||
| 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 | ||||||||
| (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
-
Vibration Controlled Transient Elastography at 50 Hz
-
Controlled Attenuation Parameter at 3.5 MHz
4
Diagnostic Ultrasound Intended Use
Transducer: FibroScan® 530 Compact M+ 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 | ||||||||
| Abdominal | P | P 1, 2 | ||||||
| N 3 | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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 | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | 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
-
Vibration Controlled Transient Elastography at 50 Hz
-
Controlled Attenuation Parameter at 3.5 MHz
5
Diagnostic Ultrasound Intended Use
Transducer: FibroScan® 530 Compact 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 | ||||||||
| Abdominal | P | P 1, 2 | ||||||
| N 3 | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | 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
-
Vibration Controlled Transient Elastography at 50 Hz
-
Controlled Attenuation Parameter at 3.5 MHz
6
510(K) Summary Echosens FibroScan® 530 Compact 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: | February 23, 2016 |
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | FibroScan® 530 Compact |
|---|---|
| ------------------------- | ------------------------ |
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 FibroScan® (#K150949) manufactured by the sponsor and cleared on June 3, 2015.
7
Device Description
FibroScan® 530 Compact, based on Vibration-Controlled Transient Elastography (VCTE™) technology, is designed to perform non-invasive measurements of liver shear wave speed and estimates of tissue stiffness. A mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. The FibroScan® 530 Compact CAP (Controlled Attenuation Parameter, ranging between 100 and 400 decibels per meter (dB/m), provides an estimation of the total ultrasonic wave attenuation (forward and return paths) at 3.5 MHz, measured concomitantly with tissue stiffness.
Intended Use / Indications for Use
The FibroScan® 530 Compact system 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® 530 Compact is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 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 clinical management of adult patients with liver disease.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.
Comparison of Technological Characteristics
The FibroScan® 530 Compact system is substantially equivalent to the FibroScan® system cleared via K150949. 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, using the M+ and XL+ transducers. Additionally, both systems provide 50Hz shear wave speed measurements and estimates of tissue stiffness.
The FibroScan® 530 Compact modification relates to its smaller size and conversion to a tabletop device. The FibroScan® 530 Compact system is otherwise identical to the predicate FibroScan® systems as related to the indications for use, operating principles, M+ and XL+ probes, materials, examination procedure, imaging capabilities, information processing, performance measurements, and manufacturing process.
Consensus Standards Used
Non-clinical testing to assure compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety were performed and have been found to conform to applicable medical device safety 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.
8
- . 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
- . Ultrasonics -- Power Measurement -- Radiation IEC 61161 Edition 3.0 2013-01: 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
- . 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: Usability
- . IEC 62366 Edition 1.1 2014-01: Medical Devices - Application Of 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 accuracy and precision of the device was tested for shear wave speed and CAP on calibrated phantoms with known elasticity and attenuation.
The shear wave speed 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 device. Results show that while the predicate FibroScan shear wave speed bias results reported minimum and maximum values of [-11.5%; 0.7%] for the M+ probe and [-13.9%; 1.3%] for the XL+ probe: the range of shear wave speed bias results measured with the FibroScan 530 Compact device had minimum and maximum values of [-12.9%: -2.6%] for the M+ probe and [-14.3%; -2.3%] for the XL+ probe. Therefore, the overall range of bias values for the shear wave speed in the predicate FibroScan is