Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), Transient Elastography based device, is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP ) in internal structures of the body.

Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as Ultrasound Attenuation Parameter ( UAP ).

The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis and monitoring of patients with liver disease, as part of an overall assessment of the liver.

Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000), is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal, including location of the liver.

Device Description

The Shear Wave Quantificational Ultrasound Diagnostic System, Models: FT9000, FT100 and Mini800, iLivTouch brand, is a general purpose, mobile, software-controlled, diagnostic ultrasound system. FT9000 is equipped with two probes, a fibrosis scanning probe used in elastography mode and an imaging probe used in imaging mode. The fibrosis scanning probe is used for elasticity measurement while the imaging probe is a convex probe used for ultrasound imaging. But the model FT100 and Mini800 is equipped with only one fibrosis scanning probe.FT100 and Mini800 have the same appearance structure and hardware, but the software is different.

Under elastography mode, the system uses transient elastography to measure shear wave speed non-invasively and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator produces low-amplitude shear waves at 50 Hz that travel through the skin and intercostal space into the liver. The propagation speed of the shear wave is measured using ultrasound at 2.5 MHz.

Under imaging mode, the system acquires and displays ultrasound images in B, B/B, B/C (CFM), B/C/D (CPWD) modes. The system uses convex array probe with a frequency range of 2.1MHz to 5 MHz on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. The ultrasonic imaging also helps to find a proper location for the transient elastography examination.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Shear Wave Quantificational Ultrasound Diagnostic System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary directly compares the proposed device to predicate devices. The "acceptance criteria" are implied by the similarities to the predicate devices and the performance characteristics stated. The reported device performance is given in terms of bias and precision for shear wave speed, stiffness, and UAP measurements.

Category	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Proposed Device)
Shear Wave Speed / Stiffness Measurement
Display Range	Shear wave speed (0.8-5.0 m/s), Stiffness (2.0-75 kPa), Interquartile range (IQR) and IQR/median ratio (Predicate: FibroScan® 502 Touch)	FT9000: Shear wave speed (0.8-5.2 m/s), Stiffness (2.0-80 kPa), Interquartile range (IQR) and IQR/median ratio FT100 & Mini800: Similar to FT9000, but exact ranges not explicitly separated for TE display.
Bias	(-14.3%) - (3.6%) (Predicate: FibroScan® 502 Touch)	FT9000: (-4.7%) - (2.4%) FT100: (-2.1%) - (3.5%) Mini800: (-5.3%) - (1.2%)
Precision	(0.2%) - (1.9%) (Predicate: FibroScan® 502 Touch)	FT9000: (0.0%) - (1.6%) FT100: (0.0%) – (3.8%) Mini800: (0.0%) - (1.8%)
UAP Display Range	CAP (100-400 dB/m), Interquartile range (IQR) and IQR/median ratio (Predicate: FibroScan® 502 Touch)	UAP (90-450 dB/m), Interquartile range (IQR) and IQR/median ratio
UAP Bias	(0.0%) - (10.0%) (Predicate: FibroScan® 502 Touch)	FT9000: (-3.3%) - (2.0%) FT100: (-1.6%) – (6.5%) Mini800: (-6.9%) - (4.8%)
UAP Precision	(0.0%) - (1.0%) (Predicate: FibroScan® 502 Touch)	FT9000: (0.2%) - (1.5%) FT100: (0.3%) - (2.0%) Mini800: (0.2%) – (2.0%)

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical study is included in this submission." This means there is no test set of human data for the proposed device analyzed in this submission. The performance metrics (bias and precision) likely refer to phantom studies or bench testing rather than clinical data. The document does not provide details on the sample size for these non-clinical tests or their provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical study was included, there were no experts used to establish ground truth for a human test set. For the phantom/bench testing, the ground truth would typically be established by the known physical properties of the phantom materials and calibrated measurement equipment. No specific details about such experts or their qualifications are provided for non-clinical testing.

4. Adjudication Method for the Test Set

As there was no human test set, no adjudication method was applicable or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done as "no clinical study is included in this submission." Therefore, no effect size of human readers improving with or without AI assistance is provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance metrics (bias and precision) presented in the tables are indicative of standalone performance (algorithm only) as applied to non-clinical tests (e.g., phantoms). The document states the proposed devices passed "related performance test (eg UD2 test)" and "measurement accuracy by accuracy testing and software validation." These imply standalone testing, but no specific study details are provided beyond these results.

7. The Type of Ground Truth Used

For the performance metrics listed, the ground truth was based on known physical properties of phantoms or calibrated measurement systems used in non-clinical performance and safety testing (e.g., UD2 test).

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This suggests that the device's algorithms were either established using pre-existing knowledge (e.g., physics-based models for shear wave propagation) or that any internal development/training data was not part of this 510(k) submission, which focused on demonstrating substantial equivalence through technical characteristics and non-clinical performance to existing predicate devices.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, no information on how its ground truth was established is provided.

Summary

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Image /page/0/Picture/0 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 the FDA logo, which 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.

Wuxi Hisky Medical Technologies Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd. FangShan District Beijing, Beijing 102401 CHINA

March 17, 2020

Re: K200136

Trade/Device Name: Shear Wave Quantificational Ultrasound Diagnostic System Model(s): FT9000, FT100, Mini800 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX, IYN Dated: January 17, 2020 Received: January 21, 2020

Dear Ray Wang:

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

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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 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 medical devices and radiation-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) K200136

Device Name

Shear Wave Quantificational Ultrasound Diagnostic System Model(s): FT9000, FT100, Mini800

Indications for Use (Describe)

The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis and monitoring of 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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Tab #7 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K200136

1. Date of Preparation: 03/09/2020
1. Sponsor

Wuxi Hisky Medical Technologies Co., Ltd.

Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park, 214135 Wuxi, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA

Contact Person: Jinhua Shao Position: General Manager Tel: 86-10-82151572 Fax: 86-10-82151571 Email: shaojh@fibrotouch.com

3. Submission Correspondent

Ray Wang General Manager

Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401

Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com

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Identification of Proposed Device

Trade Name: Shear Wave Quantificational Ultrasound Diagnostic System Common Name: Diagnostic Ultrasound System with Accessories Model(s): FT9000, Mini800, FT100

Regulatory Information

Classification Name: 1) Ultrasonic Pulsed Echo Imaging System; 2) Diagnostic Ultrasound Transducer; 3) Ultrasonic Pulsed Doppler Imaging System; Classification:II Product Code: IYO & ITX & IYN Regulation Number:21 CFR 892.1550 & 21 CFR 892.1560 & 21 CFR 892.1570 Review Panel: Radiology:

Indication For Use Statement:

The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis and monitoring of patients with liver disease, as part of an overall assessment of the liver.

4. Device Description

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Name	Qty.	Usage
Imaging probe	1	To determine the test zone
Fibrosis Scanning probe	1	To test the liver stiffness and UAP
Main unit	1	To calculate the liver stiffness with acquired data
Power Cord	1	To energize the main unit
Footswitch	1	To start the examination
Fuse T3.15 AH250V	2	Overcurrent protection
Protective earth wire	1	To connect the system with the ground

Table 7-1 Accessories List of FT9000

Table 7-2 Accessories List of FT100 and Mini800
-------------------------------------------------	--

Name	Qty.	Usage
Fibrosis scanning probe	1	To test the liver stiffness and UAP
Main unit	1	To calculate the liver stiffness with acquired data
Probe holder	1	To hold the probe
AC/DC adapter	1	To energize the main unit
Foot switch	1	To start the examination
Keyboard (optional)	1	For ease of operate
Mouse (optional)	1	For ease of operate

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Productmodel	TransducerModel	Type	Frequency	Application
FT9000	FT-2.5D9	Round probe	2.5MHz(deviation≤±15%)	Liver, elasticity measurement
FT9000	FT-3.5R65	convex probe	3.5MHz(nominal),2.1, 2.5, 3.1, 5.0(broadband frequency)	Abdomen, general purposePulse echo ultrasoundimaging andDoppler flow analysis
FT100	FT-2.5D9	Round probe	2.5MHz(deviation≤±15%)	Liver, elasticitymeasurement
Mini800	XW-01	Round probe	2.5MHz(deviation≤±15%)	Liver, elasticitymeasurement
Note: The XW-01 probe for Mini800 is exactly the same as the FT- 2.5D9 probe for FT9000/FT100. And
all materials and manufacturing processes to produce final finished form of XW-01 are identical to
FT-2.5D9. .

Fig 7-1 Working Frame of (Models: FT9000)

Image /page/6/Figure/3 description: The image shows a block diagram of an elastography system and an ultrasound imaging system. The elastography system includes transmitting/receiving, signal excitation device, pre-amplification, signal processing & numerical calculation, and signal processing blocks. The ultrasound imaging system includes real-time control, transmitting/receiving, signal & image processing, pre-amplification, digital beam synthesis, and high-speed A/D conversion blocks. Both systems are connected to a system control CPU and a power supply, as well as a keyboard and monitor.

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Image /page/7/Figure/1 description: This image is a block diagram of a device with several components. The main unit is connected to an AC/DC adapter, a probe holder, a fibrosis scanning probe, and a footswitch. The main unit contains a power board, a Li-ion battery, an interface board, a CPU and display, a USB port, a mini DP port, and an E ultrasonic board.

Fig 7-2 Working Frame of (Models: FT100 and Mini800)

న్. Identification of Predicate Device

Primary Predicate Device: 510(k) Number: K173595 Product Name: Shear Wave Quantificational Ultrasound Diagnostic System Manufacturer: Wuxi Hisky Medical Technologies Co., Ltd.

Secondary Predicate Device:

510(k) Number: K181547 Product Name: FibroScan® Family Of Products Model Name: FibroScan® 502 Touch Manufacturer: Echosens

The reason we selected the secondary device is that the Indication For Use of subject device covered both primary and secondary predicate device.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance;
NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3. (Radiology).
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
1. Clinical Test Conclusion

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Table 7-4 Comparison of Technology Characteristics to Primary Predicate Device

Item	Proposed Device(s)	Primary Predicate Device(K173595)	remark
Device name	Models: FT9000, FT100 and Mini800Shear Wave Quantificational Ultrasound Diagnostic System	FT9000 Shear Wave QuantificationalUltrasound Diagnostic System	/

ClassificationName	1) Ultrasonic Pulsed Echo Imaging System;	1) Ultrasonic Pulsed Echo Imaging System;
	2) Diagnostic Ultrasound Transducer;	2) Diagnostic Ultrasound Transducer;	Same
	3) Ultrasonic Pulsed Doppler Imaging System;	3) Ultrasonic Pulsed Doppler Imaging System;
Product Code	IYO	IYO
	ITX	ITX	Same
	IYN	IYN
RegulationNumber	892.1550;	892.1550;
	892.1560;	892.1560;	Same
	892.1570;	892.1570;
Intended Use	Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000,FT100 and Mini800), Transient Elastography based device, is intended to provide	Shear Wave Quantificational UltrasoundDiagnostic System, Model FT9000, is intended
	50Hz shear wave speed measurements and estimates of tissue stiffness as well as	to measure the speed of 50Hz shear wave with
	Ultrasound Attenuation Parameter (UAP) in internal structures of the body.	2.5MHz ultrasound wave in the liver. The shear
	Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000,	wave speed may be used as an aid to clinical	Analysis 1
	FT100 and Mini800), is indicated for noninvasive measurement in the liver of 50	management of patients with liver disease.
	Hz shear wave speed and estimates of stiffness as well as Ultrasound Attenuation	Shear Wave Quantificational Ultrasound
	Parameter ( UAP ).	Diagnostic System, Model FT9000, is intended
	The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis	for general purpose pulse echo ultrasound

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		and monitoring of patients with liver disease, as part of an overall assessment of theliver.Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000 ), isintended for general purpose pulse echo ultrasound imaging and Doppler flowanalysis of the human body. It can be used in the following applications:Abdominal, including location of the liver.	imaging and Doppler flow analysis of thehuman body. It can be used in the followingapplications: Abdominal.
Probe Types	FT9000	Fibrosis scanning probe FT-2.5D9an imaging probe FT-3.5R65		Same
	FT100	Fibrosis scanning probe FT-2.5D9	Fibrosis scanning probe FT-2.5D9an imaging probe FT-3.5R65
	Mini800	Fibrosis scanning probe XW-01		Analysis 1
Probe frequency		Fibrosis scanning probe (FT-2.5D9):2.5MHzan imaging probe FT-3.5R65: 3.5 MHzFibrosis scanning probe XW-01 Probe (2.5 MHz)	Fibrosis scanning probe (FT-2.5D9):2.5MHzan imaging probe FT-3.5R65: 3.5 MHz	Same

Modes ofOperation	M-mode		M-mode	Same
	A-mode		A-mode
Applied Standards:
Biocompatibility	ISO10993-5&ISO10993-10		ISO10993-5&ISO10993-10	Same
Electrical Safety	IEC60601-1		IEC60601-1	Same
EMC	IEC60601-1-2		IEC60601-1-2	Same
Performance	UD2		UD2	Same

Analysis 1:

The Proposed Device(s) is similar to the predicate devels sight, and only in the indications for use (adding UAP finctions) and probe models,

a、for the added UAP function, the proposed devices has passed the related performance test (eg UD2 test );

b . The Proposed Device Mini800 use the different probe frequency is same with the Predicate Devices has passed the related

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performance test and safety test (eg UD2 test ,IEC60601-1 test ,IEC60601-1-2 test) ;

So the safety and performance of the product can be ensured to be substantially equivalency with predicate device.

Table 7-5 Comparison of Technology Characteristics to Secondary Predicate Device

Item	Proposed Device(s)			Secondary Predicate Device(K181547)	remark
	FT9000	FT100	Mini800
Device name	Models: FT9000, FT100 and Mini800Shear Wave Quantificational Ultrasound Diagnostic System			FibroScan® 502 Touch(Predicate)	/
ClassificationName	1) Ultrasonic Pulsed Echo Imaging System;2) Diagnostic Ultrasound Transducer;3) Ultrasonic Pulsed Doppler Imaging System;			1) Ultrasonic Pulsed Echo Imaging System;2) Diagnostic Ultrasound Transducer;	Same
Product Code	IYOITXIYN			IYOITX	Same
RegulationNumber	892.1550;892.1560;892.1570;			892.1560;892.1570;	Same
Intended Use	Shear Wave Quantificational Ultrasound Diagnostic System(Models: FT9000, FT100 and Mini800), Transient Elastographybased device, is intended to provide 50Hz shear wave speedmeasurements and estimates of tissue stiffness as well as UltrasoundAttenuation Parameter ( UAP ) in internal structures of the body.Shear Wave Quantificational Ultrasound Diagnostic System			The FibroScan® Family of Products (Models: 502 Touch) isintended to provide 50Hz shear wave speed measurements andestimates of tissue stiffness as well as 3.5 MHz ultrasoundcoefficient of attenuation (CAP: Controlled AttenuationParameter) in internal structures of the body.FibroScan® Family of Products (Models: 502 Touch) is	Same

	(Models: FT9000, FT100 and Mini800), is indicated for noninvasivemeasurement in the liver of 50 Hz shear wave speed and estimatesof stiffness as well as Ultrasound Attenuation Parameter (UAP).The shear wave speed and stiffness, and UAP may be used as an aidto diagnosis and monitoring of patients with liver disease, as part ofan overall assessment of the liver.Shear Wave Quantificational Ultrasound Diagnostic System(Models: FT9000), is intended for general purpose pulse echoultrasound imaging and Doppler flow analysis of the human body. Itcan be used in the following applications: Abdominal, includinglocation of the liver.			indicated for noninvasive measurement in the liver of 50 Hzshear wave speed and estimates of stiffness as well as 3.5 MHzultrasound coefficient of attenuation (CAP: ControlledAttenuation Parameter).The shear wave speed and stiffness, and CAP may be used asan aid to diagnosis and monitoring of adult patients with liverdisease, as part of an overall assessment of the liver.Shear wave speed and stiffness may be used as an aid toclinical management of pediatric patients with liver disease.
Imaging modes		A-modeM-modeTransient Elastography /Shear Wave		A-modeM-modeTransient Elastography /Shear Wave	Same
UltrasoundSource	Piezoelectric ultrasound source			Piezoelectric ultrasound source	Same E
Probe	FT-2.5D9 Probe (2.5 MHz)FT-3.5R65(3.5 MHz)	FT-2.5D9 Probe(2.5 MHz)	XW-01 Probe(2.5 MHz)	S+ Probe (5 MHz)(single element ultrasound transducer)	Analysis 2
Elastographymode	TransientElastography			Vibration-controlled TransientElastographyTM	Same E
Source ofMechanicalVibration	External electromechanicalVibrator			External electromechanicalVibrator	Same
Shear WaveSpeed	Post-processing			Post-processing	Same
Determination
TE mode	Shear wave speed measurements and tissue stiffness			Shear wave speed measurements and tissue stiffness	Same
TE display	Shear wave speed (0.8-5.2 m/s)Stiffness (2.0-80 kPa)Interquartile range (IQR) and IQR/median ratio			Shear wave speed (0.8-5.0 m/s)Stiffness (2.0-75 kPa)Interquartile range (IQR) and IQR/median ratio	Analysis 2
Bias	(-4.7%) - (2.4%)	(-2.1%) - (3.5%)	(-5.3%) - (1.2%)	(-14.3%) - (3.6%)	Analysis 2
Precision	(0.0%) - (1.6%)	(0.0%) – (3.8%)	(0.0%) - (1.8%)	(0.2%) - (1.9%)	Analysis 2
CAP/UAPdisplay	UAP (90-450 dB/m)Interquartile range (IQR) and IQR/median ratio			CAP (100-400 dB/m)Interquartile range (IQR) and IQR/median ratio	Analysis 2
Bias	(-3.3%) - (2.0%)	(-1.6%) – (6.5%)	(-6.9%) - (4.8%)	(0.0%) - (10.0%)	Analysis 2
Precision	(0.2%) - (1.5%)	(0.3%) - (2.0%)	(0.2%) – (2.0%)	(0.0%) - (1.0%)	Analysis 2
Applied Standards:
Biocompatibility	ISO10993-5&ISO10993-10			ISO10993-5&ISO10993-10	Same
ElectricalSafety	IEC60601-1			IEC60601-1	Same
EMC	IEC60601-1-2			IEC60601-1-2	Same
Performance	IEC 60601-2-37UD2			IEC60601-2-37UD2	Same

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510(k) Summary

Analysis 2:

The Proposed Device(s) is similar to the predicate devices, the difference is very slight, and only in the probe frequency, the mode and CAPUAP display, but the proposed devices has passed the rest and safety test (eg UD2 test ,JEC6060 - 1 est , JEC6060 - 1-2 test, measurement accuracy by acunacy testing and software validation) - the safety and be ensured - so the safety and performance of the product can be ensured, so the

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proposed device is determined to be substantially equivalency with predicate device.

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Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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.