(47 days)
No
The summary describes a device based on Vibration-Controlled Transient Elastography (VCTE™) and ultrasound to measure shear wave speed and attenuation. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used for diagnostic purposes (aid to diagnosis and monitoring) and measurement, not for treatment or therapy.
Yes
The device provides measurements that "may be used as an aid to diagnosis and monitoring of adult 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 is based on "Vibration-Controlled Transient Elastography (VCTE™) technology," which involves a "mechanical vibrator" and "Ultrasound." This indicates the presence of 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's mechanism: The description clearly states that FibroScan uses non-invasive methods (Vibration-Controlled Transient Elastography and ultrasound) to measure shear wave speed and estimate tissue stiffness in internal structures of the body, specifically the liver. It does not involve analyzing samples taken from the body.
Therefore, FibroScan falls under the category of a medical device that performs measurements in vivo (within the living body), rather than an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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 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 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 to clinical management of pediatric patients with liver disease.
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 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 revision of the indications for use (IFU) for the FibroScan system by Echosens. The phrase "…an aid to clinical management…" is replaced by the phrase "…an aid to diagnosis and monitoring…"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
liver, internal structures of the body
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)
No new hardware or software elements were included in the submission. Therefore, no new performance data were required in support of the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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November 14, 2017
Echosens % Zvi Ladin, Ph.D. Principal Boston MedTech Advisors Inc. 990 Washington Street, Suite #204 DEDHAM MA 02026
Re: K173034
Trade/Device Name: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: September 21, 2017 Received: September 28, 2017
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 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);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173034
Device Name
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
Indications for Use (Describe)
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 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 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 to clinical management of pediatric 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) |
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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: | November 9, 2017 |
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | FibroScan® Family of Products
(Models: 502 Touch, 530 Compact, and 430 Mini+) |
|-------------------------|----------------------------------------------------------------------------------|
| 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 previously cleared FibroScan® 530 Compact System (#K160524)
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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 revision of the indications for use (IFU) for the FibroScan system by Echosens. The phrase "…an aid to clinical management…" is replaced by the phrase "…an aid to diagnosis and monitoring…"
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 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
- . 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 -- 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
- 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
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- ISO 14971 Second Edition 2007-03-01: . Management To Medical Devices
Medical Devices - Application Of Risk
Performance Data
No new hardware or software elements were included in the submission. Therefore, no new performance data were required in support of the submission.
Intended Use / Indications for Use
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 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 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 to clinical management of pediatric patients with liver disease.
Comparison of Technological Characteristics
The revision of the indications for use applies to all members of the FibroScan® family, including the 502 Touch, 530 Compact and 430 Mini+. All products listed in this submission were previously cleared following the premarket notification process.
Substantial Equivalence Discussion
The revised indications for use provide clarity on the clinical utilization of the FibroScan® system. lts perfect safety record and broad clinical use as an aid to the diagnosis and monitoring of adult patients with liver disease support the revision of its indications for use.
This submission did not involve changes in the hardware or software of the system, leading to the conclusion that the candidate device raises no new or different issues of safety or effectiveness.