Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that uses transient elastography and ultrasound to measure shear wave speed. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The performance studies focus on traditional metrics like bias and precision using phantoms.

Therapeutic

No.
The device measures shear wave speed as an aid to clinical management, which is a diagnostic function, not a therapeutic one.

Diagnostic

Yes

The device is intended to provide measurements (shear wave speed) that may be used as an "aid to clinical management of patients with liver disease," which clearly indicates a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states that it uses a mechanical vibrator and ultrasound to measure shear wave speed, indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the FibroScan® device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
FibroScan® Mechanism: The description clearly states that FibroScan® uses transient elastography and ultrasound to measure shear wave speed through internal structures of the body, specifically the liver. This is a non-invasive method that does not involve analyzing samples taken from the body.
Intended Use: The intended use is for "noninvasive measurement of shear wave speed at 50 Hz in the liver" and as an "aid to clinical management of patients with liver disease." This aligns with an in-vivo diagnostic or monitoring device, not an in-vitro one.

Therefore, FibroScan® is an in-vivo diagnostic device, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

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.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, A-mode, Vibration Controlled Transient Elastography at 50 Hz

Product codes

IYO, ITX

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Liver, Abdominal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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

Regulation Number and Section

§ 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.

Summary

0

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 Imaging
System	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

1

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 K123806 510(k)

Page 1 of 4

5

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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal
Imaging
& 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)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

1. A-mode
1. 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 | (Specify) |
|-----------------------------|-------------- | General
(Track 1 Only) | Specific
(Tracks 1 & 3) | B Doppler | Combined
(Specify) | |
| Ophthalmic | Ophthalmic | | Fetal | | Abdominal | | Intra-operative (Specify) | | Intra-operative (Neuro) | | Laparoscopic | | Pediatric | Fetal
Imaging
& Other | Small Organ (Specify) | | Neonatal Cephalic | | Adult Cephalic | | Trans-rectal | | Trans-vaginal | | Trans-urethral | | Trans-esoph. (non-Card.) | | Musculo-skele (Conventional) | | | | | | | Musculo-skele (Superficial) | | | | | | | Intravascular | | Other (Specify) | Cardiac | Cardiac Adult | | Cardiac Pediatric | | Intravascular (Cardiac) | | Trans-esoph. (Cardiac) | | Intra-cardiac | | Other (Specify) | Peripheral
Vessel | Peripheral vessel | | Other (Specify) | Mode of Operation | | | | | | Other*
----------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| M | PWD | CWD | Color
| | | | | | | |
| | | | | | | |
| | N | | | | | N 1, 2 |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
tal
| | |
tal
| | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |

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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& 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)

Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

A-mode 1.
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