(27 days)
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.
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 addition of the S+ probe to models FibroScan® 530 Compact and FibroScan® 430 Mini+. The S+ probe addresses a smaller anatomic size of pediatric patients, while using 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. In addition, the S+ probe developed for the 530 Compact and 430 Mini+ models is similar to the S+ probe cleared for the FibroScan® 502 Touch model of the FibroScan® Family of Products.
Here's a summary of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for clinical performance. Instead, it discusses the performance characteristics of the FibroScan® S+ probe (for pediatric use) and compares them to previously cleared predicate devices. The performance data presented are for bias and precision using phantoms.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (S+ probe on 530 Compact) | Reported Device Performance (S+ probe on 430 Mini+) | Reported Device Performance (S+ probe on 502 Touch - Predicate) |
|---|---|---|---|---|
| Bias (using CIRS phantoms E-1493-1 and E-1493-2) | Range of -13.5% to 3.6% (from predicate devices) | (-14.3%) - (3.6%) | (-13.7%) - (0.5%) | (-13.5%) - (3.6%) |
| Precision (using CIRS phantoms E-1493-1 and E-1493-2) | Range of 0.7% to 2.0% (from predicate devices) | (0.2%) - (1.9%) | (0.0%) - (1.6%) | (0.7%) - (2.0%) |
Note: The document explicitly states that the S+ probe underwent verification tests to ensure no new issues regarding safety and effectiveness and that software updates were verified through system tests. This implies that the performance in these verification tests (including bias and precision) met predefined standards aligned with the existing cleared devices.
2. Sample size used for the test set and the data provenance:
The document mentions that performance data for bias and precision were obtained using CIRS phantoms E-1493-1 and E-1493-2. This indicates that the "test set" for these specific performance metrics consisted of physical phantoms designed to mimic tissue properties, not human patient data.
- Sample size: Not applicable in the traditional sense for human subjects, as phantoms were used. The number of measurements taken on the phantoms is not specified.
- Data provenance: Not applicable as it involves phantom testing, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable. The "ground truth" for phantom studies is typically established by the known physical properties of the phantoms themselves, as measured by calibrated reference methods or specified by the manufacturer (CIRS).
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable, as phantom testing does not involve human interpretation or adjudication in the way clinical studies do. The measurements are objective readings from the device on the phantom.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC study: No, a multi-reader multi-case comparative effectiveness study was not explicitly mentioned or performed. This submission is for the addition of a new probe (S+ probe) to existing FibroScan models, focusing on engineering and performance characteristics using phantoms, rather than clinical efficacy studies involving human readers and AI. The device itself (FibroScan) is a measurement device, not an AI-assisted diagnostic tool that would typically involve human reader improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone performance: The performance data presented (bias and precision) is inherent to the device's measurement capabilities on phantoms and can be considered "standalone" in that it reflects the device's accuracy and reproducibility without direct human interaction influencing the measurement itself (though a human operates the device). However, it's not "algorithm only" in the sense of a standalone AI diagnostic algorithm performing a task without human intervention, but rather the performance of the integrated mechanical and ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of ground truth: The ground truth for the bias and precision data was established by the known physical properties of the CIRS phantoms E-1493-1 and E-1493-2. These phantoms are designed to have specific, measurable shear wave speed and attenuation characteristics.
8. The sample size for the training set:
- Training set sample size: Not specified. This submission focuses on the verification of a new probe with existing systems, not on the development or training of a new algorithm. The document states that the S+ probe uses the "same principle of operation, intended use and methodology...design, materials, manufacturing and testing processes as the previously cleared M+ and XL+ probes." This implies that the underlying technology and any inherent "training" (calibration, algorithm development) would have occurred for the original device and probes, not this incremental modification.
9. How the ground truth for the training set was established:
- Ground truth for training set: Not specified in this document. Given that the submission is for an incremental change (adding an S+ probe to existing models) and leverages the "same principle of operation," the ground truth establishment for any initial algorithm development or calibration would have been part of earlier submissions for the predicate devices. It can be inferred that in the context of elastography devices, ground truth for initial development would typically involve comparisons to established reference methods (e.g., biopsy for liver stiffness, or known properties of tissue-mimicking phantoms).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.
July 9th, 2018
Echosens % Zvi Ladin, Ph.D. Principal Boston MedTech Advisors Inc. 990 Washington Street, Suite #204 DEDHAM MA 02026
Re: K181547
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: June 1, 2018 Received: June 12, 2018
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 medical devices and radiation-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.
Jeff Rogers
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) K181547
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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System: FibroScan® 430 Mini+
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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P 1, 2, 3 | ||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P 1, 2 | ||||||
| FetalImaging& Other | 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) | ||||||||
| PeripheralVessel | 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 (CAPTM) at 3.5 MHz
{4}------------------------------------------------
System: FibroScan® 530 Compact
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | (Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal | |||||||
| Abdominal | P | P 1, 2, 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) | ||||||||
| PeripheralVessel | 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 (CAPTM) at 3.5 MHz
{5}------------------------------------------------
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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P 1, 2 | ||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | 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
{6}------------------------------------------------
Transducer: FibroScan® M+ probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler (Specify) | Combined (Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P 1, 2, 3 | ||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P 1, 2 | ||||||
| FetalImaging& Other | 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) | ||||||||
| PeripheralVessel | 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 (CAPTM) et 3.5 MHz
{7}------------------------------------------------
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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal | |||||||
| Abdominal | P | P 1, 2, 3 | ||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | 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 (CAPTM) et 3.5 MHz
{8}------------------------------------------------
510(K) Summary Echosens' FibroScan® System
Submitter's Name, Address, Telephone Number, Contact Persona and Date Prepared:
| Manufacturer: | Echosens30 Place d'Italie75013 Paris, FranceTelephone: +33 1 44 82 78 55Facsimile: +33 1 44 82 68 36 |
|---|---|
| Contact Person: | Zvi Ladin, Ph.D.PrincipalBoston MedTech Advisors, Inc.990 Washington StreetSuite #204Dedham, MA 02026Telephone: (781) 407 0900 x104Facsimile: (781) 407 0901Email: zladin@bmtadvisors.com |
Date Prepared: July 4, 2018
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: | Echosens30 Place d'Italie75013 Paris, FranceTelephone: +33 1 44 82 78 55Facsimile: +33 1 44 82 68 36 |
|---|---|
| EstablishmentRegistration Number: | 3010258456 |
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Predicate Device
This submission claims substantial equivalence to a combination of two previously cleared devices:
-
- Echosens's FibroScan® Family of Products (#K173034) cleared on November 14, 2017; and
-
- Echosens's FibroScan® System (#K150239) cleared on September 1, 2015.
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 addition of the S+ probe to models FibroScan® 530 Compact and FibroScan® 430 Mini+. The S+ probe addresses a smaller anatomic size of pediatric patients, while using 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. In addition, the S+ probe developed for the 530 Compact and 430 Mini+ models is similar to the S+ probe cleared for the FibroScan® 502 Touch model of the FibroScan® Family of Products.
Recognized 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 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.
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- . 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 3: 2007-03.
- 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.
- . IEC 62304: Medical Device Software - Software Life Cycle Processes: First Edition 2006-05, Equivalent to IEC 62304: 2006.
- . ISO 14971 Second: Medical Devices - Application Of Risk Management To Medical Devices; Edition 2007-03-01.
Performance Data
The S+ probe underwent verification tests with the FibroScan® 530 Compact and FibroScan® 430 Mini+ systems to ensure that there were no new issues regarding safety and effectiveness. Software updates were verified through system tests and did not raise any concerns regarding safety or effectiveness.
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 addition of the S+ probe applies to models 530 Compact and 430 Mini+ of the FibroScan® family of products. The S+ probe was previously cleared for the 502 Touch model, following the premarket notification process (#K150239). The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is otherwise identical to the predicate FibroScan® Family of Products (#K173034) 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.
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Substantial Equivalence Discussion
The modified FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) has the same intended use and indications for use, uses the same operating principle and materials, incorporates the same basic design, emits the same energy and acquires the same information as the predicate device (#K173034). In addition, the S+ probe has the same operating principle and materials, incorporates the same basic design, emits the same energy and acquires the same information as the S+ probe cleared in the predicate device (#K150239).
The S+ probe underwent hardware and software verification tests with the FibroScan® 530 Compact and FibroScan® 430 Mini+ systems to ensure that the candidate device raises no new or different issues of safety and effectiveness.
In summary, the FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is substantially equivalent to the predicate devices.
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| FibroScan® 530 Compact(Submission Device Model) | FibroScan® 430 Mini+(Submission Device Model) | FibroScan® 502 Touch(Predicate) | |
|---|---|---|---|
| 510(k) # (ClearanceDate) | TBDClearances:K173034 (November 14,2017)K160524 (March 18, 2016) | TBDClearances:K173034 (November 14,2017)K172142 (September 13,2017) | Clearances:K173034 (November 14,2017)K150239 (September 1,2015)K150949 (June 3, 2015)K123806 (April 5, 2013) |
| Manufacturer | Echosens | Echosens | Echosens |
| Indications for Use | The FibroScan® Family of products (Models: 502 Touch, 530 Compact and 430 Mini+) isintended to provide 50Hz shear wave speed measurements and estimates of tissuestiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: ControlledAttenuation Parameter) in internal structures of the body.FibroScan® Family of products (Models: 502 Touch, 530 Compact and 430 Mini+) isindicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimatesof 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 beused as an aid to diagnosis and monitoring of adult patients with liver disease, as part of anoverall assessment of the liver.Shear wave speed and stiffness may be used as an aid in the clinical management ofpediatric patients with liver disease. | ||
| Clinical Application | Pediatric | Pediatric | Pediatric |
| Imaging modes | A-mode | A-mode | A-mode |
| M-mode | M-mode | M-mode | |
| Transient Elastography /Shear Wave | Transient Elastography /Shear Wave | Transient Elastography /Shear Wave | |
| Ultrasound Source | Piezoelectric ultrasoundsource | Piezoelectric ultrasoundsource | Piezoelectric ultrasoundsource |
| Probe | S+ Probe (5 MHz) | S+ Probe (5 MHz) | S+ Probe (5 MHz) |
| (single element ultrasoundtransducer) | (single element ultrasoundtransducer) | (single element ultrasoundtransducer) | |
| Elastography mode | Vibration-controlled TransientElastography™ | Vibration-controlled TransientElastography™ | Vibration-controlledTransient Elastography™ |
| Source ofMechanicalVibration | External electromechanicalVibrator | External electromechanicalVibrator | Externalelectromechanical Vibrator |
| Shear Wave SpeedDetermination | Post-processing | Post-processing | Post-processing |
| VCTE mode | Shear wave speedmeasurements and tissuestiffness | Shear wave speedmeasurements and tissuestiffness | Shear wave speedmeasurements and tissuestiffness |
| VCTE display | Shear wave speed (0.8-5.0m/s)Stiffness (2.0-75 kPa)Interquartile range (IQR) andIQR/median ratio | Shear wave speed (0.8-5.0m/s)Stiffness (2.0-75 kPa)Interquartile range (IQR) andIQR/median ratio | Shear wave speed (0.8-5.0 m/s)Stiffness (2.0-75 kPa)Interquartile range (IQR)and IQR/median ratio |
| ControlledAttenuationParameter (CAP) | Not available for S+ Probe | Not available for S+ Probe | Not available for S+ Probe |
| Bias1 | (-14.3%) - (3.6%) | (-13.7%) - (0.5%) | (-13.5%) - (3.6%) |
| Precision1 | (0.2%) - (1.9%) | (0.0%) - (1.6%) | (0.7%) - (2.0%) |
{13}------------------------------------------------
Table 1. Predicate Device Comparison for FibroScan® S+ Probe
1 Values obtained with CIRS phantoms E-1493-1 and E-1493-2.
§ 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.