(56 days)
The FibroScan® system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffhess as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.
FibroScan® is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The shear wave speed and stiffness, and CAP may be used as an aid to clinical management of adult patients with liver disease.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.
FibroScan®, based on Vibration-Controlled Transient Elastography (VCTE™) technology, is designed to perform non-invasive measurements of liver shear wave speed and estimates of tissue stiffness. A mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. The speed of propagation of the shear (elastic) wave is measured using ultrasounds. A new FibroScan® parameter labeled CAP (Controlled Attenuation Parameter), ranging between 100 and 400 decibels per meter (dB/m), provides an estimation of the total aforementioned ultrasonic wave attenuation (forward and return paths) at 3.5 MHz, measured concomitantly with tissue stiffness.
The provided text describes the FibroScan® system, which performs non-invasive measurements of liver shear wave speed and tissue stiffness, as well as an ultrasound coefficient of attenuation (CAP). The new submission (K150949) focuses on the addition of CAP measurements.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical thresholds, but rather as comparative performance to the predicate devices. The performance is assessed in terms of bias and precision for both shear wave measurements (from the predicate FibroScan®) and the new CAP measurements (from the candidate FibroScan®).
| Metric | Acceptance Criteria (inferred: similar or better than predicate) | FibroScan® Predicate Device Performance (Shear Wave) | Candidate Device Performance (CAP) |
|---|---|---|---|
| Bias (M+ probe) | < 13% | [-11.5%; 0.7%] (Overall range <13%) | [-4.9%; -0.4%] (Overall range <5%) |
| Bias (XL+ probe) | < 16% | [-13.9%; 1.3%] (Overall range <16%) | [-3.5%; 6.5%] (Overall range <10%) |
| Precision (M+ probe) | < 2% | [0.6%; 1.9%] (Overall range <2%) | [0%; 0.1%] (Overall range <1%) |
| Precision (XL+ probe) | < 4% | [0%; 3.1%] (Overall range <4%) | [0.4%; 1%] (Overall range <1%) |
Conclusion from table: The candidate FibroScan® device successfully meets the acceptance criteria (inferred as being similar or better than the predicate) as its bias and precision values for CAP measurements are indeed better than those reported for the shear wave measurements of the predicate FibroScan® device.
2. Sample Size Used for the Test Set and Data Provenance
The provided text only mentions "tests performed on phantoms with known attenuations" for the performance data.
- Sample Size for Test Set: Not explicitly stated. The description mentions "tests performed on phantoms," implying multiple tests but no specific number of phantoms or measurements.
- Data Provenance: The tests were performed on "phantoms," indicating a controlled laboratory setting (bench testing). There is no information provided regarding the country of origin or whether it was retrospective or prospective data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Since the test was performed on "phantoms with known attenuations," the ground truth was established by the physical properties of the phantoms themselves. Therefore, no human experts were used to establish ground truth for this specific performance evaluation.
4. Adjudication Method for the Test Set
- No adjudication method is relevant as the ground truth was based on the known, objective properties of the phantoms.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was mentioned. The study focused on the technical performance of the device on phantoms, not on human reader performance with or without AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Yes, the performance data presented is a standalone evaluation of the device as an algorithm/system measuring physical properties (shear wave speed, tissue stiffness, CAP) on phantoms. There is no mention of human interaction or interpretation being part of this specific performance evaluation.
7. Type of Ground Truth Used
- Known Attenuations of Phantoms: The ground truth for the test set was the "known attenuations" of the phantoms. This is a form of objective, engineered ground truth.
8. Sample Size for the Training Set
- The document primarily describes a 510(k) submission for a device, particularly focusing on the performance validation of its new feature (CAP) using bench testing. It does not mention a "training set" in the context of machine learning or AI models. This device, based on VCTE™ technology, seems to be a measurement instrument, not a learning algorithm that requires a training set in the typical machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- As no training set is discussed or implied for a machine learning model, this question is not applicable to the information provided. The "training" for such a physical measurement device would involve its design, calibration, and manufacturing processes to ensure it accurately measures the intended physical properties.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2015
Echosens % Zvi Ladin, Ph.D. Principal Boston MedTech Advisors. Inc. 990 Washington Street, Suite #204 DEDHAM MA 02026
Re: K150949 Trade/Device Name: Fibroscan® Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: March 31, 2015 Received: April 8, 2015
Dear Dr. Ladin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name FibroScan®
Indications for Use (Describe)
The FibroScan® system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffhess as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.
FibroScan® is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffhess as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The shear wave speed and stiffness, and CAP may be used as an aid to clinical management of adult patients with liver disease.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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System: FibroScan® 502 Touch
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, 2N 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 at 3.5 MHz
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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 | P | P 1,2N 3 | ||||||
| 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 at 3.5 MHz
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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(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, 2N 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 at 3.5 MHz
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Transducer: FibroScan® S+ probe
| " tended 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 | ||||||||
| 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
{7}------------------------------------------------
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: | June 1, 2015 |
Name of Device and Name/Address of Sponsor
| Trade/Proprietary Name: | FibroScan® |
|---|---|
| ------------------------- | ------------ |
Common Name: Diagnostic Ultrasound System and Accessories
Classifications:
| Classification Name | Regulation | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | 21 CFR §892.1560 | IYO |
| Diagnostic Ultrasonic Transducer | 21 CFR §892.1570 | ITX |
| Manufacturing Facility: | Echosens30 Place d'Italie75013 Paris, FranceTelephone: +33 1 44 82 78 55Facsimile: +33 1 44 82 68 36 |
|---|---|
| ------------------------- | ---------------------------------------------------------------------------------------------------------------------- |
Establishment Registration Number: 3010258456
Predicate Device
This submission claims substantial equivalence to a combination of three cleared devices:
Primary Predicate:
-
FibroScan® (#K123806) manufactured by the sponsor and cleared on April 5, 2013; and
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Secondary Predicate:
-
SoftVue® (#K142517) manufactured by Dephinus Medical Technologies, Inc. and cleared on October 31, 2014
Device Description
FibroScan®, based on Vibration-Controlled Transient Elastography (VCTE™) technology, is designed to perform non-invasive measurements of liver shear wave speed and estimates of tissue stiffness. A mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. The speed of propagation of the shear (elastic) wave is measured using ultrasounds. A new FibroScan® parameter labeled CAP (Controlled Attenuation Parameter), ranging between 100 and 400 decibels per meter (dB/m), provides an estimation of the total aforementioned ultrasonic wave attenuation (forward and return paths) at 3.5 MHz, measured concomitantly with tissue stiffness.
Intended Use / Indications for Use
The FibroScan® system is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.
FibroScan® is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter). The shear wave speed and stiffness, and CAP may be used as an aid to clinical management of adult patients with liver disease.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.
Comparison of Technological Characteristics1
Controlled Attenuation Parameter (CAP) is designed to estimate the ultrasound attenuation (forward and return paths) at the frequency of 3.5 MHz. using the M+ and XL+ transducers. The candidate FibroScan system with the additional CAP calculations (ranging from 100 to 400 dB/m) and display feature is otherwise identical to the predicate FibroScan systems (FibroScan® -#K123806, manufactured by the sponsor), as related to the transducers used, examination procedure, technical characteristics, imaging capabilities, information processing, and performance measurements.
The soft tissue attenuation application of the candidate FibroScan system is substantially equivalent to the attenuation applications in the secondary predicate SoftVue® – #K142517.
The SoftVue system displays a colored ultrasonic image that depicts a quantitative descriptions of soft tissue in three modes: reflection, sound speed and attenuation. Operating at a similar central frequency as the candidate device, attenuation images are reconstructed based on
1 Guidelines indicate that if the Indications for Use are different from those of the predicate device, a brief explanation is required to address why the differences in the Indications do not affectiveness of the device and do not alter the intended therapeutic, diagnostic, or surgical use of the device.
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acoustic wave amplitude changes. Additionally, the attenuation image measure by SoftVue is displayed only if the sound speed measurement exceeds a defined threshold. Though both devices use attenuation measurements, the SoftVue attenuation is displayed differently than the candidate FibroScan device as the attenuation measurements are not provided separately but rather fused together with the sound speed and reflection images.
Consensus Standards Used
Non-clinical testing to assure compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety were performed and have been found to conform to applicable medical device safety standards. The system complies with the following standards:
- . IEC 60601-2-37 Edition 2.0 2007-08:Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment.
- . NEMA UD 2-2004 (R2009): Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3
- . AIUM MUS: Medical Ultrasound Safety, Third Edition
- . IEC 62127-1 Edition 1.1 2013-02: Ultrasonics -- Hydrophones -- Part 1: Measurement And Characterization Of Medical Ultrasonic Fields Up To 40 Mhz
- . IEC 62127-2 Edition 1.0 2007-08: Ultrasonics -- Hydrophones -- Part 2: Calibration For Ultrasonic Fields Up To 40 Mhz [Including: Technical Corrigendum 1:2008 And Amendment 1:2013]
- . IEC 62127-03 Edition 1.1 2013-05: Ultrasonics -- Hydrophones -- Part 3: Properties Of Hydrophones For Ultrasonic Fields Up To 40 Mhz
- . IEC 61161 Edition 3.0 2013-01: 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
- Medical Devices Application Of Of Usability . IEC 62366 Edition 1.1 2014-01: Engineering To Medical Devices
- . IEC 62304 First Edition 2006-05: Medical Device Software - Software Life Cycle Processes
- ISO 14971 Second Edition 2007-03-01: Medical Devices - Application Of Risk . Management To Medical Devices
{10}------------------------------------------------
Performance Data
The accuracy and precision of the device was documented based on tests performed on phantoms with known attenuations. The bias, i.e. the difference in the mean CAP measured and the nominal CAP of the phantom, normalized by the nominal CAP and expressed as a percentage, was evaluated and compared to the corresponding value reported for the predicate devices.
While the FibroScan® predicate device reported minimum shear wave bias values of [-11.5%; 0.7%] for the M+ probe and [-13.9%; 1.3%] for the XL+ probe; the range of CAP bias values measured for the candidate device were between [-4.9%; -0.4%] for the M+ probe and [-3.5%; 6.5%] for the XL+ probe. Therefore, the overall range of bias values for the FibroScan predicate device probes are <13% and <16% for the M+ and XL+ probes respectively, while the corresponding values for the CAP bias in the candidate device is <5% and 10% respectively.
Similarly, the system's precision, i.e. the standard deviation of the independent measurements of the CAP, normalized by the reference value was calculated. The range of values reported for the Fibroscan® predicate device shear wave precision measurements is between [0.6%; 1.9%] for the M+ probe and [0%; 3.1%] for the XL+ probe, while the CAP measurement precision range for the candidate device is between [0%; 0.1%] for the M+ probe and [0.4%; 1%] for the XL+ probe. Therefore, the range of precision for the predicate device is <2% and <4% for the M+ and XL+ probes respectively, while for the candidate device it is <1% for both probes.
In summary, the FibroScan candidate device has bias and precision values that are similar or better than that of the predicate FibroScan device. Therefore, based on the bench testing documented in the submitted study reports, the FibroScan system was found to have a safety and effectiveness profile that is similar to its predicate devices.
Substantial Equivalence
The FibroScan® system and transducers, by Echosens, are similar to the predicate devices with regard to intended use, technology, and imaging capabilities. In addition, based on bench testing conducted with the FibroScan system ensures that the CAP meets specifications and should perform as intended in the specified use conditions. The accuracy and precision of the device were found to be substantially equivalent to those of the predicate device. Therefore, the device raises no new issues of safety or effectiveness.
§ 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.