(126 days)
The FibroScan® 630 is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. The Shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
FibroScan® 630 is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness may be used as an aid in the clinical management of pediatric patients with liver disease.
FibroScan® 630 (Expert) is also indicated for noninvasive measurement in the spleen of 100 Hz shear wave speed and estimates of stiffness that may be used as an aid to diagnosis, monitoring and clinical management of adult patients with liver disease, as part of an overall assessment of the liver.
FibroScan® system consists of a system unit and a hand-held probe. It is based on Vibration-Controlled Transient Elastography (VCTE™) technology and is designed to perform non-invasive measurements of liver/spleen shear wave speed and estimates of tissue stiffness. The probe containing a mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver/spleen. Ultrasound is used to track the shear (elastic) wave, measure its speed and provide estimated stiffness. The results are displayed on the system unit.
The focus of this submission is the new FibroScan® 630, available in two configurations: FibroScan® 630 'Prime' (FS630P) and FibroScan® 630 'Expert' (FS630E). Both FS630P and FS630E include improvements of the FibroScan appearance and user interface.
The FS630P version has the same indications as the previously cleared models and is only indicated for non-invasive measurement of 50 Hz shear wave speed in the liver and estimates of its stiffness, as well as determination of a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The FS630E includes an expansion of the intended use to include noninvasive measurement of shear wave speed at 100Hz in the spleen and estimates of its stiffness as well as an inclusion of a B-Mode ultrasound imaging system to help the user locate the liver or spleen.
Here's a breakdown of the acceptance criteria and the study details for the FibroScan® 630, based on the provided text:
Acceptance Criteria and Device Performance for FibroScan® 630
The acceptance criteria for the FibroScan® 630 are implicitly defined by its equivalence to the predicate device, FibroScan® 530 Compact, and the clinical support for its expanded indications. The reported device performance is presented as a comparison to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document explicitly states that the FibroScan® 630 is considered "equivalent" to the predicate in terms of bias and precision. Therefore, the acceptance criteria are to perform comparably to the predicate device within a specified range, or to have a similar safety and effectiveness profile. Numerical acceptance criteria are given for the liver and spleen shear wave speed and CAP bias and precision, which must fall within a range similar to or better than the predicate devices.
| Acceptance Criteria Category | Acceptance Criteria (Implicit from Predicate & Equivalence) | Reported Device Performance (FibroScan® 630) |
|---|---|---|
| Liver Shear Wave Speed Bias | Overall range of bias values ≤ 17.5% for S+ probe, <11% for M+ probe, <11% for XL+ probe (based on predicate performance) | S+: [-20.6%; -6.5%] (overall range ≤ 14.1%)M+: [-17.5%; -7.6%] (overall range ≤ 10%)XL+: [-17.5%; -7.7%] (overall range ≤ 10%) |
| Liver Shear Wave Speed Precision | Overall range of precision values < 2% for S+ probe, <1% for M+ probe, <2% for XL+ probe (based on predicate performance) | S+: [0%; 2%]M+: [0%; 2%]XL+: [0%; 1%] |
| Spleen Shear Wave Speed Bias (FS630E only, M+ probe) | Overall range of bias values similar to liver measurements (e.g., ~10%) | M+: [-24%; -17%] (overall range 7%) |
| Spleen Shear Wave Speed Precision (FS630E only, M+ probe) | Overall range of precision values similar to liver measurements (e.g., ~0-2%) | M+: [0%; 1%] |
| CAP Bias | Performance equivalent to predicate FibroScan® 530 | Equivalent to predicate FibroScan® 530 |
| CAP Precision | Performance equivalent to predicate FibroScan® 530 | Equivalent to predicate FibroScan® 530 |
| Clinical Performance (Spleen Stiffness - FS630E) | Show comparable safety and effectiveness, and improve success rate over 50Hz measurements. | 100 Hz spleen-dedicated settings showed significantly higher success rate (92.5%) compared to 50 Hz (76.0%, P <.001). No adverse events. |
| Reproducibility (Spleen Stiffness - FS630E) | Good intra-class and inter-class reproducibility (implied by "good" result) | Intra-class and inter-class reproducibility: 0.94 and 0.96, respectively. Higher in cirrhotic patients (0.96 and 0.97). |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing (Phantoms): The text mentions testing "same sample of phantoms" for direct comparison between the candidate and predicate systems. It does not provide a specific number for the sample size of phantoms, but implies a consistent set was used for comparative measurements.
- Clinical Study (Spleen Stiffness):
- Sample Size: 260 patients with chronic liver disease.
- Data Provenance: Prospective, multi-center study. No specific country of origin is mentioned, but the manufacturer is based in Paris, France.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Bench Testing (Phantoms): The ground truth for shear wave speed and attenuation was established by using "calibrated phantoms with known elasticity and attenuation." This implies that the nominal values of these phantoms served as the ground truth. No human experts are involved in establishing this specific ground truth for the phantoms themselves.
- Clinical Study (Spleen Stiffness): The ground truth for the clinical study is based on indirect measures and comparisons (HVPG, other non-invasive tests, clinical diagnoses of chronic liver disease, cirrhosis status). While clinicians are involved in these assessments and patient management, the document does not specify a panel of experts used to establish a single ground truth for each patient's spleen stiffness directly for the purpose of the study. Instead, the study evaluates the device's measurements against established clinical reference points and other diagnostic tools already in use.
4. Adjudication Method for the Test Set
The document does not describe any explicit adjudication method (e.g., 2+1, 3+1) for establishing ground truth in either the bench testing or the clinical study.
- Bench Testing: Ground truth is inherent to the calibrated phantoms.
- Clinical Study: Performance is assessed by comparing device measurements against clinical markers and other diagnostic tests, not against a consensually agreed-upon "ground truth" derived from expert review of the device's output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study involving human readers with and without AI assistance was mentioned or conducted. The device performs automated measurements of shear wave speed and attenuation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, standalone performance was done for the device through the bench testing on phantoms. The bias and precision values for shear wave speed and CAP were measured directly from the device's output without human interpretation influencing the measurement itself. The clinical study also assesses the device's measurements directly as an aid to clinical management.
7. Type of Ground Truth Used
- Bench Testing: Calibrated phantoms with known elasticity and attenuation properties.
- Clinical Study (Spleen Stiffness): Indirect clinical endpoints and comparisons:
- Hepatic Venous Pressure Gradient (HVPG)
- Other Noninvasive Tests (NITs)
- Diagnosis of chronic liver disease (e.g., hepatitis C, hepatitis B, alcoholic liver disease)
- Cirrhosis status (for reproducibility study)
- Patient follow-up (implicitly, for "aid to diagnosis, monitoring and clinical management").
8. Sample Size for the Training Set
The document does not explicitly state the sample size for any training set. As this device primarily involves physical measurements (Vibration-Controlled Transient Elastography) rather than a machine learning algorithm trained on a large dataset of images or clinical outcomes, the concept of a "training set" in the context of AI development is not directly applicable or described here. The development and calibration would typically involve engineering and physics-based validations.
9. How the Ground Truth for the Training Set Was Established
Given that a "training set" in the machine learning sense is not explicitly described, the method for establishing its ground truth is also not detailed. The device's fundamental principles are based on known physics of wave propagation and tissue elasticity, and its calibration and validation would rely on known physical properties of materials (e.g., phantoms).
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July 16, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Echosens % Zvi Ladin, Ph.D. Principal Boston MedTech Advisors, Inc. 990 Washington Street, Suite #204 DEDHAM MA 02026
Re: K200655
Trade/Device Name: FibroScan® 630 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: June 19, 2020 Received: June 23, 2020
Dear Dr. Ladin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200655
Device Name FibroScan® 630
Indications for Use (Describe)
The FibroScan® 630 is intended to provide shear wave speed measurements and estimates of tissue stiffiness as well as ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body. The Shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
FibroScan® 630 is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness may be used as an aid in the clinical management of pediatric patients with liver disease.
FibroScan® 630 (Expert) is also indicated for noninvasive measurement in the spleen of 100 Hz shear wave speed and estimates of stiffness that may be used as an aid to diagnosis, monitoring and clinical management of adult patients with liver disease, as part of an overall assessment of the liver.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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System: FibroScan® 630
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 (liver) | Ni | P | P 1, 2, 3 | |||||
| Abdominal (spleen) | Ni | Ni | N4i | |||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& 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) | ||||||||
| 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
-
Vibration Controlled Transient Elastography at 100 Hz
| Option available for FibroScan 630 Expert only
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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
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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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal (liver) | P | P 1, 2, 3 | ||||||
| Abdominal (spleen) | N1 | N41 | ||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& 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) | ||||||||
| 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
-
Vibration Controlled Transient Elastography at 100 Hz
| Option available for FibroScan 630 Expert only
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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 | Specific | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | |||||||
| 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
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Transducer: ES-C5-2R60S-3
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Nⁱ | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| 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
¹ Option available for FibroScan 630 Expert only
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510(K) Summary Echosens' FibroScan® 630
Image /page/8/Picture/1 description: The image shows the text 'K200655' in a simple, sans-serif font. The text is black and appears to be on a white background. The characters are evenly spaced and clearly legible.
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
| Manufacturer: | Echosens6 rue Ferrus, Paris, France, 75014Telephone: +33 1 44 82 78 56Fax: +33 1 44 82 78 60 |
|---|---|
| Contact Person: | Zvi Ladin, Ph.D.PrincipalBoston MedTech Advisors, Inc.990 Washington Street; Suite #204Dedham, MA 02026Telephone: (781) 407 0900 x104Fax: (781) 407 0901Email: zladin@bmtadvisors.com |
| Date Prepared: | March 9, 2020 |
Name of Device and Name/Address of Sponsor
Common Name: Diagnostic Ultrasound System and Accessories
Classifications:
| Classification Name | Regulation | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | 21 CFR §892.1560 | IYO |
| Diagnostic Ultrasonic Transducer | 21 CFR §892.1570 | ITX |
| Manufacturing Facility: | Echosens6 rue Ferrus, Paris, France, 75014Telephone: +33 1 44 82 78 56Fax: +33 1 44 82 78 60 |
|---|---|
| EstablishmentRegistration Number: | 3010258456 |
Predicate Device
This submission claims substantial equivalence to a combination of three previously cleared devices:
-
- Predicate device: Echosens's FibroScan® Family of Products (Models: 502 Touch, 530 Compact, And 430 Mini+) (K181547), cleared on July 9, 2018;
-
- Reference device: Supersonic Imagine's Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (K173021), cleared on January 9, 2018; and
-
- Reference device: Telemed's MicrUs (K161968), cleared on November 3, 2016.
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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/spleen shear wave speed and estimates of tissue stiffness. The probe containing a mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver/spleen. Ultrasound is used to track the shear (elastic) wave, measure its speed and provide estimated stiffness. The results are displayed on the system unit.
The focus of this submission is the new FibroScan® 630, available in two configurations: FibroScan® 630 'Prime' (FS630P) and FibroScan® 630 'Expert' (FS630E). Both FS630P and FS630E include improvements of the FibroScan appearance and user interface.
The FS630P version has the same indications as the previously cleared models and is only indicated for non-invasive measurement of 50 Hz shear wave speed in the liver and estimates of its stiffness, as well as determination of a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The FS630E includes an expansion of the intended use to include noninvasive measurement of shear wave speed at 100Hz in the spleen and estimates of its stiffness as well as an inclusion of a B-Mode ultrasound imaging system to help the user locate the liver or spleen.
Comparison of Technological Characteristics
The FibroScan® 630 system is substantially equivalent to the FibroScan® 530 Compact system cleared by 510(k) #K181547. Both systems provide 50Hz shear wave speed measurements and estimates of tissue stiffness in the liver using the S+, M+, and XL+ transducers. Additionally, both systems encompass a Controlled Attenuation Parameter (CAP) designed to estimate the ultrasound attenuation (forward and return paths) at the frequency of 3.5 MHz.
The FibroScan® 630 modification relates to its size, weight, power, and electronics. The FS630E also includes modifications related to its software in order to accommodate the B-mode module and allow spleen stiffness measurement. The FibroScan® 630 system liver measurement is otherwise identical to the predicate FibroScan® 530 Compact system as related to the indications for use, operating principles, S+, M+, and XL+ probes, materials, examination procedure, imaging modes, imaging capabilities, information processing, performance measurements, and manufacturing process.
No new hardware elements were included in the submission apart from the addition of the localization ultrasound system, previously cleared by Telemed in 510(k) #K161968.
Similar to liver stiffness measurement (LSM), spleen stiffness measurement (SSM) using FibroScan® 630 Expert relies on VCTE™ method. As the spleen is stiffer and smaller than the liver, specific characteristics of the spleen stiffness examination were modified:
- Elastic shear wave at a controlled 100 Hz center frequency .
- Ultrasound pulse repetition frequency of 8000 Hz .
- Peak-to-peak amplitude of the vibration reduced to 1 mm-PP ●
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- . Target tissue depths of 25 - 55 mm
- . Stiffness value range between 6.0 and 100.0 kPa
Unlike LSM that can be measured with S+, M+ and XL+ probes, SSM can only be measured with the FibroScan® M+ probe.
The technological characteristics of FibroScan® 630 Expert are substantially equivalent to those of the Aixplorer® (#K173021), which is also indicated for measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen. Both devices are based on the same physical phenomenon, namely the effect of the mechanical properties of soft tissue on the propagation of low frequency mechanical waves in internal organs. Both use ultrasound for measuring the changes in the strain field that result from the propagation of the mechanical wave and display the processed values of shear wave speed. Therefore, the candidate and the predicate and reference devices are substantially equivalent in terms of the technology used.
Recognized Consensus Standards Used
Non-clinical testing to assure compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety were performed and have been found to conform to applicable standards. The system complies with the following standards:
- IEC 60601-2-37: Medical Electrical Equipment Part 2-37: Particular Requirements For . The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment; Edition 2.1 2015.
- . NEMA UD: Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3: 2-2004 (R2009).
- IEC 62127-1: Ultrasonics -- Hydrophones -- Part 1: Measurement And Characterization ● Of Medical Ultrasonic Fields Up To 40 Mhz; Edition 1.1 2013-02.
- . IEC 62127-2: Ultrasonics -- Hydrophones -- Part 2: Calibration For Ultrasonic Fields Up To 40 Mhz; Edition 1.1 2013-02.
- IEC 62127-03: Ultrasonics -- Hydrophones -- Part 3: Properties Of Hydrophones For . Ultrasonic Fields Up To 40 Mhz; Edition 1.1 2013-05.
- . IEC 61161: Ultrasonics -- Power Measurement -- Radiation Force Balances And Performance Requirements: Edition 3.0 2013-01.
- . AAMI / ANSI ES60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod); 2005/(R) 2012.
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements For Basic . Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests; Edition 4: 2014-02.
- . IEC 60601-1-6: Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability; Edition 3.1 2013-10
- . IEC 62366-1 Edition 1.0 2015-02: Engineering To Medical Devices.
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- . IEC 62304: Medical Device Software - Software Life Cycle Processes; First Edition 2006-05, Equivalent to IEC 62304: 2006/A1:2016.
- . ISO 14971 Second: Medical Devices - Application Of Risk Management To Medical Devices: Edition 2007-03-01.
Intended Use / Indications for Use
The FibroScan® 630 is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the Shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
FibroScan® 630 is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness may be used as an aid in the clinical management of pediatric patients with liver disease.
FibroScan® 630 (Expert) is also indicated for noninvasive measurement in the spleen of 100 Hz shear wave speed and estimates of stiffness that may be used as an aid to diagnosis, monitoring and clinical management of adult patients with liver disease, as part of an overall assessment of the liver.
Performance Data
The accuracy and precision of the device was tested for shear wave speed of the liver and the spleen on calibrated phantoms with known elasticity and attenuation. In addition, to allowed direct comparison of the measurement accuracy between the proposed and cleared systems, same sample of phantoms were tested contemporaneously by the candidate and predicate FibroScan systems, using the same probes and the same phantoms.
The shear wave speed bias, i.e. the difference in the mean shear wave speed measured and the nominal shear wave speed of the phantom, normalized by the nominal shear wave speed and expressed in percent was evaluated and compared to the corresponding value reported for the predicate device.
For liver examination, results show that while the predicate FibroScan® 530 Compact shear wave speed bias results reported minimum and maximum values of [-13.9%; 3.6%] for the S+ probe, [-12.9%; -2.6%] for the M+ probe and [-14.3%; -3.4%] for the XL+ probe; the range of shear wave speed bias results measured with the candidate FibroScan device had minimum and maximum values of [-20.6%; -6.5%] for the S+ probe, [-17.5%; -7.6%] for the M+ probe and [-17.5%; -7.7%] for the XL+ probe. Therefore, the overall range of bias values for the shear wave speed in the predicate FibroScan® 530 Compact is ≤17.5%. <11% and <11% for the S+ M+ and XL+ probes
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respectively, while the corresponding values for shear wave speed in the FibroScan® 630 is ≤14.1%, <10% and <10% respectively, and can therefore be considered as equivalent to the predicate. Moreover, the bias values for the shear wave speed and CAP on the same probes, phantoms and experimental setup using the predicate and candidate devices lead to the conclusion, that the proposed system (FibroScan® 630) is as effective as its predicate (FibroScan® 530) in measuring shear wave speed and CAP bias.
The sheer wave speed precision measurement, i.e. the standard deviation of the independent measurements of the shear wave speed, normalized by the reference value was evaluated and compared to the corresponding value reported for the predicate device.
For liver examination, results show that while the candidate device documented the range of shear wave speed precision measured for the S+ [0%; 2%], M+ [0%; 2%] and XL+ [0%; 1%] probes. The corresponding minimum and maximum values for the predicate are [0.2%; 1.6%] for S+ probe. [0%: 0%] for the M+ probe and [0%: 1.5%] for the XL+ probe. Therefore, the overall range of precision values for the shear wave speed in the predicate FibroScan® 530 Compact is <2%, <1% and <2% for the S+ M+ and XL+ probes respectively, while the corresponding values in the FibroScan® 630 is ≤2%, ≤2% and ≤1% respectively, and can therefore be considered as equivalent to the predicate.
For spleen examination, the range of shear wave speed bias results measured by the candidate FibroScan device had minimum and maximum values of [-24%; -17%] for the M+ probe. Therefore, the overall range of bias values for the shear wave speed in the candidate FibroScan is 7% for the M+ probe. This value is similar to the range of 9.9% documented for the candidate device and 10.3% obtained in the verification of the predicate device for liver measurements. Moreover, the range of shear wave speed precision results measured with the candidate FibroScan device had minimum and maximum values of [0%; 1%] for the M+ probe. Therefore, the overall range of precision values for the shear wave speed in the candidate FibroScan is 1% for the M+ probe. This is similar to the values of 2% and 0% measured for the candidate and predicate devices for liver measurements.
In summary, the bias and the precision of the shear wave speed measured by the FibroScan® 630 are within the same range than those of the predicate FibroScan® 530 Compact device. Furthermore, the direct comparison (i.e., same probes, phantoms and experimental setup) of the candidate system and its predicate lead to the conclusion that the FibroScan® 630 system was found to have a safety and effectiveness profile that is similar to the predicate FibroScan® 530 Compact device.
In addition to bench testing, clinical information was submitted to provided support for the expanded indications for use for spleen stiffness measurement.
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Clinical Data
The performance of FibroScan® 100 Hz sheer wave speed for spleen stiffness estimates was assessed in a prospective, multi-center, non-randomized study. The device was used to perform a spleen stiffness examination in each patient using the settings of the novel spleen examination (100 Hz), and the standard liver examination (50 Hz). Study objectives also included evaluating the 100 Hz SSM in comparison to hepatic venous pressure gradient (HVPG) and other noninvasive tests (NITs). The study included 260 patients with chronic liver disease (169 male; 91 female) with a median age of 59 (range 51 - 68) and a median BMI of 26 kg/m² (range 23.7 -28.6). Patients with chronic liver disease due to hepatitis virus C (155 patients), hepatitis virus B (19 patients), or alcoholic liver diseases (79 patients) were enrolled. Patients had ultrasound examination, blood examination, and esophagogastroduodenoscopy (EGD) performed within 6 months of the spleen stiffness measurement (SSM). The examination was performed with the patient lying in supine position with left arm in maximal abduction, and the probe placed in the left intercostal spaces. The median liver stiffness measurement was 46.2 kPa and the median SSM was 48 kPa. The novel 100 Hz spleen-dedicated FibroScan® settings demonstrated significantly higher success rate than the 50 Hz measurements (92.5% compared to 76.0%, P <.001). No adverse events were reported in this study.
An ancillary study to examine intra-operator and inter-operator reproducibility, including 10 cirrhotic patients, 10 non-cirrhotic patients, and 6 healthy subjects showed good intra-class and inter-class reproducibility (0.94 and 0.96, respectively). In cirrhotic patients the intra-class and inter-class coefficient correlations were higher (0.96 and 0.97, respectively) than in non-cirrhotic patients and healthy subjects, potentially due to larger spleen diameters in cirrhotic patients.
Substantial Equivalence Discussion
The FibroScan® 630 uses the same operating principle and materials, incorporates the same basic design, emits the same energy and acquires the same information as the predicate FibroScan® 530 device (K181547). The differences in size, weight and internal organization of its components do not raise new or different questions of safety or efficacy. The FS630P also includes the same intended use and indications for use as the predicate device.
The addition of the spleen stiffness indication for the FS630E was demonstrated to be substantially equivalent to its predicate device FibroScan® 530 (K181547) and Aixplorer Ultimate Ultrasound Diagnostic Systems (K173021), as they both have the same intended use, indications for use, and the technological differences do not raise different issues of safety and effectiveness. A comprehensive literature review and a large clinical study demonstrated the device's safety and effectiveness in measuring spleen stiffness. Furthermore, the inclusion of a B-Mode ultrasound imaging system (OEM previously cleared by Telemed under K161968) to help the user locate the liver or spleen is operating in compliance with its intended use, indications for use and FDAcleared labeling.
In summary, the conclusions drawn from the clinical information provided in this submission demonstrate that FibroScan® 630 raises no new or different issues of safety or effectiveness and is substantially equivalent to its predicate devices.
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| FibroScan® 630(TBD; Submission Device) | FibroScan® 530 Compact#K181547 (July 9, 2018) | Aixplorer®#K173021 (January 9, 2018) | |
|---|---|---|---|
| Echosens | Echosens | SuperSonic Imagine, S.A. | |
| Indications for Use | Indications for Use | Indications for Use | |
| The FibroScan® 630 isintended to provide shear wavespeed measurements andestimates of tissue stiffness aswell as ultrasound coefficient ofattenuation (CAP: ControlledAttenuation Parameter) ininternal structures of the body.The Shear wave speed andstiffness measurements maybe used as an aid to clinicalmanagement of adult patientswith liver disease.FibroScan® 630 is indicated fornon-invasive measurement inthe liver of 50 Hz shear wavespeed and estimates ofstiffness as well as determininga 3.5 MHz ultrasoundcoefficient of attenuation (CAP:Controlled AttenuationParameter).The shear wave speed andstiffness, and CAP may beused as an aid to diagnosisand monitoring of adult patients withliver disease, as part of anoverall assessment of the liver.Shear wave speed andstiffness may be used as an aidin the clinical management ofpediatric patients with liverdisease.FibroScan® 630 (Expert) isalso indicated for noninvasivemeasurement in the spleen of100 Hz shear wave speed andestimates of stiffness that maybe used as an aid to diagnosis,monitoring and clinicalmanagement of adult patientswith liver disease, as part of anoverall assessment of the liver. | The FibroScan® Family ofproducts (Models: 502Touch, 530 Compact and430 Mini+) is intended toprovide 50Hz shear wavespeed measurements andestimates of tissue stiffnessas well as 3.5 MHzultrasound coefficient ofattenuation (CAP: ControlledAttenuation Parameter) ininternal structures of thebody.FibroScan® Family ofproducts (Models: 502Touch, 530 Compact and430 Mini+) is indicated fornon-invasive measurement inthe liver of 50 Hz shear wavespeed and estimates ofstiffness as well asdetermining a 3.5 MHzultrasound coefficient ofattenuation (CAP: ControlledAttenuation Parameter).The shear wave speed andstiffness, and CAP may beused as an aid to diagnosisand monitoring of adultpatients with liver disease, aspart of an overall assessmentof the liver.Shear wave speed andstiffness may be used as anaid in the clinicalmanagement of pediatricpatients with liver disease. | The SuperSonic ImagineAIXPLORER® & AIXPLORER®Ultimate ultrasound diagnosticsystems and transducers areintended for general purpose pulsecho ultrasound imaging, softtissue elasticity imaging, dopplerfluid flow analysis of the humanbody.The SuperSonic ImagineAIXPLORER® & AIXPLORER®Ultimate ultrasound diagnosticsystems are indicated for use inthe following applications, forimaging and measurement ofanatomical structures: AbdominalSmall Organs, Musculoskeletal,Superficial Musculoskeletal,Vascular, Peripheral Vascular,Intraoperative, OB-GYN, Pelvic,Pediatric, Urology, Trans-rectal,Trans-vaginal and Neonatal/AdultCephalic, Non-invasive Cardiac.In addition, the SuperSonicImagine AIXPLORER® &AIXPLORER® Ultimate ultrasounddiagnostic systems and associatedtransducers are intended for:- Measurements of abdominalanatomical structures,- Measurements of broad bandshear wave speed, and tissuestiffness in internal structures ofthe liver and the spleen,- Measurements of brightness ratiobetween liver and kidney,- Visualization of abdominalvascularization,microvascularization andperfusion,- Quantification ofabdominal vascularization andperfusion.The shear wave speed andstiffness measurements, thebrightness ratio, the visualizationof vascularization,microvascularization andperfusion, the quantification ofvascularization and perfusion maybe used as an aid to clinicalmanagement of adult patients with liver disease. | |
| ClinicalApplication | Abdominal; | Abdominal; | Abdominal; |
| FS630P: Shear wave speed,stiffness, and coefficient ofattenuation in the liverFS630E: Shear wave speed,and stiffness, in the liver andthe spleen and coefficient ofattenuation in the liver | Shear wave speed, stiffness,and coefficient of attenuationin the liver | Shear wave speed, and tissuestiffness in the liver and the spleenin the liver | |
| Imagingmodes | A-modeM-modeB-mode (FS630E only fororgan localization)Transient Elastography / ShearWave | A-modeM-modeTransient Elastography /Shear Wave | B-modeShearWave™ Elastography |
| UltrasoundSource | Piezoelectric ultrasound source | Piezoelectric ultrasoundsource | Piezoelectric ultrasound source |
| Probe | M+ VCTE probe (3.5 MHz)XL+ VCTE probe (2.5 MHz)S+ VCTE probe (5.0 MHz)ES-C5-2R60S-3 convex array(3.5 MHz) (FS630E only)**(single element ultrasoundtransducer)M+ Probe is only probe usedfor Spleen (FS630E only) OEM MicrUs EXT-1H(#K161968) | M+ VCTE probe (3.5 MHz)XL+ VCTE probe (2.5 MHz)S+ VCTE probe (5.0 MHz)(single element ultrasoundtransducer) | SC6-1 (3.5 MHz)(1 - 6 MHz curved arraytransducer) |
| Elastographymode | Vibration-controlled TransientElastography™ | Vibration-controlled TransientElastography™ | ShearWave™ Elastography |
| Source ofMechanicalVibration | External electromechanicalVibrator | External electromechanicalVibrator | Radiation force in ShearWave™Elastography |
| Shear WaveSpeedDetermination | Post-processing | Post-processing | Post-processing |
| ElastographyDisplay | Liver:Shear wave speed (0.8-5.0m/s)Stiffness (2.0-75 kPa)Interquartile range (IQR) andIQR/median ratioSpleen: (FS630E only)Shear wave speed (1.4-5.8m/s)Stiffness (6.0-100 kPa) forspleenInterquartile range (IQR) | Liver:Shear wave speed (0.8-5.0m/s)Stiffness (2.0-75 kPa)Interquartile range (IQR) andIQR/median ratio | 2D color coded shear wave speedmap (elastogram) |
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| ControlledAttenuationParameter(CAP) | Available for M+ and XL+Probes only for liver | Available for M+ and XL+Probes | N/A |
|---|---|---|---|
| CAP Display | CAP value (100-400 dB/m) andinterquartile range (IQR) | CAP value (100-400 dB/m) andinterquartile range (IQR) | N/A |
| Bias (Liver) | S+: (-20.6%) – (-6.5%)M+: (-17.5%) – (-7.6%)XL+: (-17.5%) - (-7.7%) | S+: (-13.9%) – (3.6%)M+: (-12.9%) – (-2.6%)XL+: (-14.3%) – (3.4%) | (-9.4%) - (43.4%) |
| Bias (Spleen)FS630E Only | M+: (-24%) - (-17%) | N/A | |
| Precision(Liver) | S+: (0%) - (2%)M+: (0%) - (2%)XL+: (0%) - (1%) | S+: (0.2%) - (1.6%)M+: (0%) - (0%)XL+: (0%) - (1.5%) | (0%) - (3.9%) |
| Precision(Spleen)FS630E Only | M+: (0%) - (1%) | N/A |
Table 1. Predicate Device Comparison for FibroScan® 630
§ 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.