(116 days)
FibroScan® is intended to provide 50Hz shear wave velocity measurements through internal structures of the body.
FibroScan® is indicated for noninvasive measurement of shear wave speed at 50 Hz in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal (Mode of Operation: N, Other*: N 1, 2)
FibroScan® uses transient elastography for the non-invasive measurement of liver shear wave speed. 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 wave and to measure its speed, which is correlated with the elasticity of the liver.
The document describes the FibroScan® System, an ultrasound device for non-invasive measurement of shear wave speed in the liver. The provided text primarily focuses on non-clinical performance data and does not contain information about clinical studies with human participants that establish acceptance criteria and device performance based on those criteria.
Here's the relevant information based on the provided text regarding the non-clinical performance:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by comparison to a predicate device.
| Performance Metric | Acceptance Criteria (Implied from Predicate Device) | Reported Device Performance (FibroScan®) |
|---|---|---|
| Bias (Difference in mean shear wave speed, normalized, in percent) | Overall range of bias values ~50% (Range: -9.4% to 43.4%) | Overall range of bias values < 20% (Range: -13.9% to 1.3%) |
| Precision (Standard deviation of individual measurements, normalized) | Range of values ~4% (Range: 0% to 3.9%) | Range of values ~3% (Range: 0% to 3.1%) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. The performance data for this device was based on tests performed on phantoms (not human subjects). The number of phantoms or measurements performed on them is not specified.
- Data provenance: Not applicable, as the tests were on phantoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for the phantom tests was based on the known elasticity of the phantoms, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Ground truth was based on known phantom properties.
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
- No MRMC comparative effectiveness study was done. The device performance (accuracy and precision) was evaluated against a predicate device using phantom data.
- The document mentions a published report by Fraquelli et al. (Gut, 2007) that documented high measurement reproducibility (intraclass correlation coefficient of 0.98 both within and between operators) in a cohort of 200 patients. This study, however, is cited as supporting the general reproducibility of the technology, not as a comparative effectiveness study involving AI or human reader improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The performance analysis described (bias and precision) is inherent to the device's measurement capabilities on phantoms and therefore represents a standalone evaluation of the device's technical performance. No human-in-the-loop performance is discussed for these specific non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance described, the ground truth was the known elasticity of phantoms.
8. The sample size for the training set
- Not applicable. The document describes a medical device (ultrasound system) that measures shear wave speed based on physical principles, not an AI/machine learning algorithm requiring a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a training set for an AI/ML algorithm.
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5 2013
APR
510 (k) SUMMARY
Echosens' FibroScan® System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared: Manufacturer: Echosens SA 30 Place d'Italie 75013 Paris - France Telephone: +33 1 44 82 78 50 Facsimile: +33 1 44 82 78 60 Contact Person: Zvi Ladin, PhD. Principal Boston MedTech Advisors, Inc. 990 Washington Street Suite #204 Dedham, MA 02026 Telephone: (781) 407 0900 x104
Email: zladin@bmtadvisors.com
(781) 407 0901
Date Prepared: February 28, 2012
Name of Device and Name/Address of Sponsor
Trade/Proprietary Name: FibroScan®
Common Name: Diagnostic Ultrasound System and Accessories
Facsimile:
Classification:
| Classification Name | Regulation | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo ImagingSystem | 21 CFR §892.1560 | IYO |
| Diagnostic Ultrasonic Transducer | 21 CFR §892.1570 | ITX |
| Manufacturing Facility: | Echosens SA |
|---|---|
| 30 Place d'Italie | |
| 75013 Paris - France | |
| Telephone: | +33 1 44 82 78 50 |
| Facsimile: | +33 1 44 82 78 60 |
| Establishment Registration Number: | N/A |
|---|---|
| Owner/operator number: | N/A |
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Predicate Device
Aixplorer®, manufactured by SuperSonic Imagine, S.A. of Aix-en-Provence, France, cleared on August 28, 2012 under 510(k) #K112255.
Intended Use / Indications for Use
FibroScan® is intended to provide 50Hz shear wave velocity measurements through internal structures of the body.
FibroScan® is indicated for noninvasive measurement of shear wave speed at 50 Hz in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease.
Technological Characteristics
FibroScan® uses transient elastography for the non-invasive measurement of liver shear wave speed. 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 wave and to measure its speed, which is correlated with the elasticity of the liver.
Performance Data
Non-clinical testing to assure compliance with electrical safety, electromagnetic interference , standards and ultrasound standards was performed. The accuracy and precision of the device was documented based on tests performed on phantoms with known elasticity. The bias, i.e. the difference in the mean shear wave speed measured and the nominal shear wave of the phantom, normalized by the nominal shear wave and expressed in percent was evaluated and compared to the corresponding value reported for the predicate device. While the predicate device reported values of bias between (-9.4%) and (43.4%), the range of bias values measured for the candidate device were between (-13.9%) and (1.3%). Therefore, the overall range of bias values for the predicate device are ~50% of the nominal shear wave speed, the corresponding range for the candidate device is < 20%. Hence, the candidate device has a bias value that is similar or better than that of the predicate device.
Similarly, the system's precision, i.e. the standard deviation of the individual measurements of shear-wave speed, normalized by the reference value was calculated. The range of values reported for the predicate device were between (0%) and (3.9%), while the corresponding range for the candidate device was between (0%) and (3.1%). Therefore, the precision of both systems is similar - range of precision values of ~4% for the predicate device and ~3% for the candidate device.
Published reports documented a high level of measurement reproducibility. For example, in a cohort of 200 patients with chronic liver disease of various etiologies Fraquelli et al. reported (Gut, 2007. 56(7):968-73) intraclass correlation coefficient of 0.98 both within and between operators, demonstrating a high level of inter- and intra-operator agreement.
Substantial Equivalence
The technology used in the candidate and predicate devices is based on elastography. The systems display the same physical variable (shear wave speed), and therefore the devices are substantially equivalent in their basic technology and its implementation. 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.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes emanating from its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2013
ECHOSENS C/O ZVI LADIN, PHD BOSTON MEDTECH ADVISORS, INC. 990 WASHINGTON STREET, SUITE 204 DEDHAM MA 02026
Re: K123806
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 7, 2013 Received: March 13, 2013
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.
This determination of substantial equivalence applies to the following transducers intended for use with the FibroScan, as described in your premarket notification:
Transducer Model Number
M XL*
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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
If you have any questions regarding the content of this letter, please contact Brendan O'Leary at (301) 796-6898.
Sincerely yours,
Smh)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K123806 Device Name: FibroScan® Indications for Use: The FibroScan® system is intended to provide 50Hz shear wave speed measurements through internal structures of the body.
FibroScan® is indicated for noninvasive measurement of shear wave speed at 50 Hz in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Image /page/4/Picture/8 description: The image shows a logo with stylized text and a triangular shape on the right side. The text is illegible due to the image quality, but it appears to be a combination of cursive and block letters. The triangular shape is outlined and contains some internal details, possibly representing a mountain or a stylized letter.
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K123806 510(k)
Page 1 of 4
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Indications for Use
Diagnostic Ultrasound Intended Use
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 | Specific | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal | |||||||
| Abdominal | N | N 1, 2 | ||||||
| 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
{6}------------------------------------------------
Indications for Use
Diagnostic Ultrasound Intended Use
Transducer: FibroScan® M+ probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other*(Specify) | ||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | N | N 1, 2 | ||||||
| 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 | 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
{7}------------------------------------------------
Indications for Use
Diagnostic Ultrasound Intended Use
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 | N | N 1, 2 | ||||||
| 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 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 1.
-
- Vibration Controlled Transient Elastography at 50 Hz
:Smh
==/2
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K123806
Page 4 of 4
§ 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.