The Liverscan C is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile 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.

The Liverscan C is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter).

The shear wave speed and stiffness, and MAP 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.

This device is designed to be used in a doctor's office to measure the stiffness and ultrasonic attenuation of the liver in patients with liver disease. It does so in a painless and completely noninvasive manner.

Device Description

The shear wave speed and stiffness, and MAP 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA, asserting that the "Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)" is substantially equivalent to a legally marketed predicate device.

Crucially, this document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, rather than presenting a clinical study of the device's performance against defined acceptance criteria for diagnostic accuracy.

Therefore, I cannot extract information related to acceptance criteria for diagnostic accuracy and a study proving the device meets those criteria, as an independent clinical study demonstrating diagnostic performance was not performed, or at least not provided in this document for the purpose of the 510(k) submission.

Specifically, section 10, "Clinical Tests Performed," explicitly states: "No clinical test data was used to support the decision of substantial equivalence."

The "acceptance criteria" discussed in the document relate to engineering and safety standards (e.g., IEC standards for electrical safety, EMC, usability, software, biocompatibility, and performance) and functional tests, which the device did meet. However, these are not diagnostic performance metrics.

For completeness, I can describe what the document does provide regarding "acceptance criteria" and "device performance" in terms of engineering and regulatory compliance:

Summary of "Acceptance Criteria" and "Device Performance" as presented in the 510(k) document (focused on substantial equivalence, not diagnostic accuracy):

The document defines "acceptance criteria" in terms of compliance with various international standards for medical devices and successful completion of bench tests. The "device performance" is reported as meeting these standards and demonstrating substantial equivalence to a predicate device.

Missing Information: Due to the nature of a 510(k) submission focused on substantial equivalence through non-clinical testing, the document does not contain any information regarding:

A table of diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a specific liver condition).
Sample size used for a clinical test set for diagnostic accuracy.
Data provenance for a clinical test set.
Number of experts used to establish ground truth for a clinical test set.
Qualifications of experts for establishing ground truth for a clinical test set.
Adjudication method for a clinical test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
Effect size of human readers improving with AI vs. without AI assistance.
Standalone (algorithm only) diagnostic performance.
Type of clinical ground truth used (e.g., pathology, outcomes data).
Sample size for a clinical training set (as no clinical AI algorithm study is detailed).
How ground truth for a clinical training set was established.

Therefore, I cannot populate the table and answer the requested questions as they pertain to clinical diagnostic performance, because the provided text explicitly states that no clinical test data was used for this 510(k) submission. The "study that proves the device meets the acceptance criteria" in this context refers to bench testing against engineering and safety standards to demonstrate substantial equivalence, not a clinical validation of diagnostic accuracy.

Summary

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November 19, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.

Eieling Technology (Shenzhen) Limited % Salon Chen System Engineer IMD Medical & Drug Technology Service Institutions Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District, Dongguan City, Guangdong Province, 523069 CHINA

Re: K242496

Trade/Device Name: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO / ITX Dated: August 22, 2024 Received: August 22, 2024

Dear Salon Chen:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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-regulatory-

assistance/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,

Marjan Nabili -S

for

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242496

Device Name

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)

Indications for Use (Describe)

The shear wave speed and stiffness, and MAP 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.

To ensure safe and effective operation, the operator shall meet the following requirements:

1. Receive training as required by local,state and national requlations, if applicable
1. Receive additional training as required by the authorized distributor or EIELING
1. Has a thorough knowledge and understanding of the material presented in this manual

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K242496

510(k) Summary

1. Submitter's Identification:

Company Name: Eieling Technology(Shenzhen) Limited
Address: RM 610, Building E, Qihang Innovation Development Park, No. 1008 Songbai Road, Yangguang Community,Xili Street Nanshan District, Shenzhen, P.R. China
Phone: +86 0755-23100816/15919830132
Fax: +852 6103 2309 >
Contact Person (Title): like wang (General Manager) >
E-mail: mzzhu@eieling.com
Date of Preparation: Aug. 22, 2024
1. Name of the Device:
Portable Liver Elastography Ultrasound Diagnostic System
Model: Liverscan C

3. Common Name and Classification:

Device Classification Name: system, imaging, pulsed echo, ultrasonic
Classification Product Code: IYO
Subsequent Product Code: ITX
Regulation Number:21 CFR 892.1560
Class:2
A Review Panel: Radiology

Predicate Device Information: 4.

510(k) Number: K233401
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Sponsor:Eieling Technology (Shenzhen) Limited
Classification Product Code: IYO

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Subsequent Product Code: ITX
Regulation Number:21 CFR 892.1560
Class:2
A Review Panel: Radiology
Trade/Proprietary Name: Liverscan Mobile
A Common Name: Portable Liver Elastography Ultrasound Diagnostic System
Application Correspondent న్.
Company Name: IMD Medical & Drug technology service institutions A
Phone: +86-18613190779
Fax: +86-755-62809168 >
Contact Person (Title): Salon Chen (System engineer)
E-mail: 33999439@qq.com >
Address: Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District, Dongguan City, A Guangdong Province, China

Device Description 6.

The shear wave speed and stiffness, and MAP 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.

7. Indications for Use

The Liverscan C is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter) in

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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.

The shear wave speed and stiffness, and MAP 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.

This device is designed to be used in a doctor's office to measure the stiffness and ultrasonic attenuation of the liver in patients with liver disease.It does so in a painless and completely non-invasive manner.

To ensure safe and effective operation,the operator shall meet the following requirements:

1 ) Receive training as required by local,state and national regulations,if applicable
2 ) Receive additional training as required by the authorized distributor or EIELING
3 ) Has a thorough knowledge and understanding of the material presented in this manual

8. Comparison to the predicate device

Table 1 General Comparison

Elements ofComparison	Proposed Device	Predicate Device	Judgment
CompanyName	Eieling Technology (Shenzhen)Limited	Eieling Technology Limited	/
DeviceName	Portable Liver ElastographyUltrasound Diagnostic System	Portable Liver ElastographyUltrasound Diagnostic System	/
Classification ProductCode	IYO	IYO	SE
SubsequentProductCodes	ITX	ITX	SE
Regulation	21 CFR 892.1560	21 CFR 892.1560	SE
Classification Name	system, imaging, pulsed echo,ultrasonic	system, imaging, pulsed echo,ultrasonic	SE
Class	2	2	SE
Prescriptionor OTC	Prescription Use	Prescription Use	SE
Application	Abdominal	Abdominal	SE
Ultrasound	Piezoelectric ultrasound source	Piezoelectric ultrasound source	SE
IntendedUse	The Liverscan C is intended to provideshear wave speed measurements andestimates of tissue stiffness as well asultrasound coefficient of attenuation(MAP: Mobile Attenuation Parameter)in internal structures of the body. Theshear wave speed and stiffnessmeasurements may be used as an aid toclinical management of adult patientswith liver disease.The Liverscan C is indicated fornon-invasive measurement in the liverof 50 Hz shear wave speed andestimates of stiffness as well asdetermining a 3.5MHz ultrasoundcoefficient of attenuation (MAP: MobileAttenuation Parameter).The shear wave speed and stiffness, andMAP may be used as an aid to diagnosisand monitoring of adult patients withliver disease, as part of an overallassessment of the liver.	The Liverscan Mobile is intended to provide shear wave speedmeasurements and estimates of tissuestiffness as well as ultrasoundcoefficient of attenuation (MAP:Mobile Attenuation Parameter) ininternal structures of the body. Theshear wave speed and stiffnessmeasurements may be used as an aid toclinical management of adult patientswith liver disease.The Liverscan Mobile is indicated fornon-invasive measurement in the liverof 50 Hz shear wave speed andestimates of stiffness as well asdetermining a 3.5MHz ultrasoundcoefficient of attenuation (MAP:Mobile Attenuation Parameter).The shear wave speed and stiffness, andMAP may be used as an aid todiagnosis and monitoring of adultpatients with liver disease, as part of anoverall assessment of the liver.	SE
Safety factor &Performance	Proposed Device	Predicate Device	Judgment
ElectricalSafety	Compliance with IEC 60601-1	Compliance with IEC 60601-1	SE
EMC	Compliance with IEC60601-1-2	Compliance with IEC 60601-1-2	SE
Usability	Compliance with IEC60601-1-6	Compliance with IEC 60601-1-6	SE
UsabilityEngineering	Compliance with IEC 62366-1	Compliance with IEC 62366-1	SE
Software	Compliance with IEC 62304	Compliance with IEC 62304	SE
Biocompatiblity	Compliance with ISO 10993-1	Compliance with ISO 10993-1	SE
Performance	Compliance with IEC60601-2-37/ IEC 62359: 2017/IEC 61161	Compliance with IEC 60601-2-37/IEC 62359: 2017/ IEC 61161	SE
Imaging Modes	B-modeTransient Elastography (TE)	B-modeTransient Elastography (TE)	SE
Probes	LS01 probe (3.5 MHz)	LS01 probe (3.5 MHz)	SE
Depth AnalysisMethod	25-65 / 35-75 mm	25-65 / 35-75 mm	SE
TE Mode	Shear wave speedmeasurements and tissuestiffness	Shear wave speed measurements andtissue stiffness	SE
TE Range	Shear wave speed (0.7-5.0 m/s)Stiffness (1.5-75 kPa)	Shear wave speed (0.7-5.0 m/s)Stiffness (1.5-75 kPa)	SE
TE Display	Shear wave speed and stiffnessmedians and IQR/median ratio	Shear wave speed and stiffnessmedians and IQR/median ratio	SE
AttenuationMode	Mobile AttenuationParameter(MAP)	Mobile Attenuation Parameter(MAP)	SE
Safety factor &Performance	Proposed Device	Predicate Device	Judgment
AttenuationRange	MAP value (100-400 dB/m)	MAP value (100-400 dB/m)	SE
AttenuationDisplay	MAP median and IQR	MAP median and IQR	SE
AttenuationDisplay -Probescompatibility	LS01 Probe	LS01 Probe	SE
Size andWeight	522mm x 492mm x 265mm(Lx W x H)8.0kg with accessories	525mm x 175mm x 315mm(Lx W x H)4.15kg with accessories	Note 1
Power supply	100-240 V ~ 50-60 Hz	100-240 V ~ 50-60 Hz	SE
CoreComponent	Elastography engineAnalog front end Highfrequency (US): Transducer3.5L3213A-001Analog front end Lowfrequency (servo control):Transducer 3.5L3213A-001	Elastography engineAnalog front end High frequency(US): Transducer 3.5L3213A-001Analog front end Low frequency(servo control): Transducer3.5L3213A-001	SE
Operatingsystem	Windows 10 Embedded	Windows 10 Embedded	SE
Screen	Size: Minimum 13 inches oraboveResolution: 1920 X 1080	Size: Minimum 13 inches or aboveResolution: 1920 X 1080	SE
Internet	/	/	SE
Safety factor &Performance	Proposed Device	Predicate Device	Judgment
Battery	Rechargeable Li-ion battery pack (Model:XDD-SNP5600)	Rechargeable Li-ion battery pack (Model:18650)	Note 2
Accessories	N/A	N/A	N/A

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Table 2 Safety factor & Performance Comparison

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As shown in the above comparison Table, Portable Liver Elastography Ultrasound Diagnostic System in similarity to the predicate device. Accordingly, we are substantially equivalent to the predicate device Liverscan Mobile (K233401).

Design and Technology - The basic design and technology of providing Portable Liver

Elastography Ultrasound Diagnostic System is the same or similar.

Performance and Specifications - The subject device has similar Portable Liver Elastography

Ultrasound Diagnostic System and specifications to the

predicate device.

Indications - The indications include in. the predicate device scope.

Review of Differences:

Note 1:

Differences in weight and size between the predicate device and the proposed device do not affect the safety and effectiveness of the product.

Note 2:

The built-in lithium battery model is not the same, in line with IEC62133

Bench 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:

1) Electrical safety

IEC6060-1:2005+A1:2012+A2:2020 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.

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2) Electromagnetic compatibility(EMC)

IEC 60601-1-2:2014 /AMD1:2020 Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests.

3) Basic Safety And Essential Performance

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.

IEC 62359: 2017 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic field

IEC 61161: Ultrasonics -- Power Measurement -- Radiation Force Balances and Performance Requirements; Edition 3.0 2013-01.

IEC 60601-1-6 :2010+A1:2013+A2:2020 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability. IEC 62366-1 Edition 1.0 2015-02: Medical Devices - Application of Usability Engineering To Medical Devices.

4) Software Verification and Validating Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

9. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The proposed device is the same as the predicate device but the two devices are different. A series of safety and performance tests were conducted on the subject device: Software Validation

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Electromagnetic compatibility and electrical safety

Function test

All the test results demonstrate the Liverscan C meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.

10. Clinical Tests Performed

No clinical test data was used to support the decision of substantial equivalence.

11. Conclusion

The subject devices have all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject devices.

Thus, the subject devices are substantially equivalent to the predicate devices.

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.