Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)

K242496 · Eieling Technology (Shenzhen) Limited · IYO · Nov 19, 2024 · Radiology

Device Facts

• Record ID: K242496
• Device Name: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
• Applicant: Eieling Technology (Shenzhen) Limited
• Product Code: IYO · Radiology
• Decision Date: Nov 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended 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 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.

Device Story

Liverscan C is a portable ultrasound diagnostic system used in clinical settings by trained operators to assess liver health. It utilizes a piezoelectric ultrasound source (LS01 probe) to perform B-mode imaging and Transient Elastography (TE). The device inputs ultrasonic signals to measure shear wave speed (0.7-5.0 m/s) and tissue stiffness (1.5-75 kPa), and calculates a Mobile Attenuation Parameter (MAP) (100-400 dB/m). Outputs include median values and interquartile ranges for stiffness and attenuation, displayed on a 13-inch screen. These measurements assist clinicians in the diagnosis and monitoring of adult patients with liver disease by providing a non-invasive assessment of liver tissue properties. The device operates on a Windows 10 Embedded platform and is powered by a rechargeable Li-ion battery.

Clinical Evidence

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

Technological Characteristics

Piezoelectric ultrasound source (LS01 probe, 3.5 MHz). Imaging modes: B-mode, Transient Elastography. Dimensions: 522mm x 492mm x 265mm. Weight: 8.0kg. Power: 100-240V, 50-60Hz, rechargeable Li-ion battery (XDD-SNP5600). Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, IEC 61161, IEC 60601-1-6, IEC 62366-1, IEC 62304, ISO 10993-1.

Indications for Use

Indicated for non-invasive measurement of 50 Hz shear wave speed, tissue stiffness, and 3.5MHz ultrasound coefficient of attenuation (MAP) in the liver of adult patients with liver disease to aid in diagnosis and monitoring.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Liverscan Mobile (K233401)

Submission Summary (Full Text)

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November 19, 2024

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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 ([e-mail]) or phone [phone] 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 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.

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
- 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

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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# 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: [phone]
- Fax: [phone] >
- Contact Person (Title): like wang (General Manager) >
- > E-mail: [e-mail]
- > Date of Preparation: Aug. 22, 2024
- 2. 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: [phone]
- Fax: [phone] >
- > Contact Person (Title): Salon Chen (System engineer)
- E-mail: [e-mail] >
- Address: Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District, Dongguan City, A Guangdong Province, China

#### Device Description 6.

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.

# 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 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 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 of<br>Comparison | Proposed Device | Predicate Device | Judgment |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Company<br>Name | Eieling Technology (Shenzhen)<br>Limited | Eieling Technology Limited | / |
| Device<br>Name | Portable Liver Elastography<br>Ultrasound Diagnostic System | Portable Liver Elastography<br>Ultrasound Diagnostic System | / |
| Classificatio<br>n Product<br>Code | IYO | IYO | SE |
| Subsequent<br>Product<br>Codes | ITX | ITX | SE |
| Regulation | 21 CFR 892.1560 | 21 CFR 892.1560 | SE |
| Classificatio<br>n Name | system, imaging, pulsed echo,<br>ultrasonic | system, imaging, pulsed echo,<br>ultrasonic | SE |
| Class | 2 | 2 | SE |
| Prescription<br>or OTC | Prescription Use | Prescription Use | SE |
| Application | Abdominal | Abdominal | SE |
| Ultrasound | Piezoelectric ultrasound source | Piezoelectric ultrasound source | SE |
| Intended<br>Use | The Liverscan C is intended to provide<br>shear wave speed measurements and<br>estimates of tissue stiffness as well as<br>ultrasound coefficient of attenuation<br>(MAP: Mobile Attenuation Parameter)<br>in internal structures of the body. The<br>shear wave speed and stiffness<br>measurements may be used as an aid to<br>clinical management of adult patients<br>with liver disease.<br><br>The Liverscan C is indicated for<br>non-invasive measurement in the liver<br>of 50 Hz shear wave speed and<br>estimates of stiffness as well as<br>determining a 3.5MHz ultrasound<br>coefficient of attenuation (MAP: Mobile<br>Attenuation Parameter).<br><br>The shear wave speed and stiffness, and<br>MAP may be used as an aid to diagnosis<br>and monitoring of adult patients with<br>liver disease, as part of an overall<br>assessment of the liver. | The Liverscan Mobile is intended to provide shear wave speed<br>measurements and estimates of tissue<br>stiffness as well as ultrasound<br>coefficient of attenuation (MAP:<br>Mobile Attenuation Parameter) in<br>internal structures of the body. The<br>shear wave speed and stiffness<br>measurements may be used as an aid to<br>clinical management of adult patients<br>with liver disease.<br><br>The Liverscan Mobile is indicated for<br>non-invasive measurement in the liver<br>of 50 Hz shear wave speed and<br>estimates of stiffness as well as<br>determining a 3.5MHz ultrasound<br>coefficient of attenuation (MAP:<br>Mobile Attenuation Parameter).<br><br>The shear wave speed and stiffness, and<br>MAP may be used as an aid to<br>diagnosis and monitoring of adult<br>patients with liver disease, as part of an<br>overall assessment of the liver. | SE |
| Safety factor &<br>Performance | Proposed Device | Predicate Device | Judgment |
| Electrical<br>Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | SE |
| EMC | Compliance with IEC<br>60601-1-2 | Compliance with IEC 60601-1-2 | SE |
| Usability | Compliance with IEC<br>60601-1-6 | Compliance with IEC 60601-1-6 | SE |
| Usability<br>Engineering | 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 IEC<br>60601-2-37/ IEC 62359: 2017/<br>IEC 61161 | Compliance with IEC 60601-2-37/<br>IEC 62359: 2017/ IEC 61161 | SE |
| Imaging Modes | B-mode<br>Transient Elastography (TE) | B-mode<br>Transient Elastography (TE) | SE |
| Probes | LS01 probe (3.5 MHz) | LS01 probe (3.5 MHz) | SE |
| Depth Analysis<br>Method | 25-65 / 35-75 mm | 25-65 / 35-75 mm | SE |
| TE Mode | Shear wave speed<br>measurements and tissue<br>stiffness | Shear wave speed measurements and<br>tissue stiffness | SE |
| TE Range | Shear wave speed (0.7-5.0 m/s)<br>Stiffness (1.5-75 kPa) | Shear wave speed (0.7-5.0 m/s)<br>Stiffness (1.5-75 kPa) | SE |
| TE Display | Shear wave speed and stiffness<br>medians and IQR/median ratio | Shear wave speed and stiffness<br>medians and IQR/median ratio | SE |
| Attenuation<br>Mode | Mobile Attenuation<br>Parameter(MAP) | Mobile Attenuation Parameter(MAP) | SE |
| Safety factor &<br>Performance | Proposed Device | Predicate Device | Judgment |
| Attenuation<br>Range | MAP value (100-400 dB/m) | MAP value (100-400 dB/m) | SE |
| Attenuation<br>Display | MAP median and IQR | MAP median and IQR | SE |
| Attenuation<br>Display -<br>Probes<br>compatibility | LS01 Probe | LS01 Probe | SE |
| Size and<br>Weight | 522mm x 492mm x 265mm<br>(Lx W x H)<br>8.0kg with accessories | 525mm x 175mm x 315mm<br>(Lx W x H)<br>4.15kg with accessories | Note 1 |
| Power supply | 100-240 V ~ 50-60 Hz | 100-240 V ~ 50-60 Hz | SE |
| Core<br>Component | Elastography engine<br>Analog front end High<br>frequency (US): Transducer<br>3.5L3213A-001<br>Analog front end Low<br>frequency (servo control):<br>Transducer 3.5L3213A-001 | Elastography engine<br>Analog front end High frequency<br>(US): Transducer 3.5L3213A-001<br>Analog front end Low frequency<br>(servo control): Transducer<br>3.5L3213A-001 | SE |
| Operating<br>system | Windows 10 Embedded | Windows 10 Embedded | SE |
| Screen | Size: Minimum 13 inches or<br>above<br>Resolution: 1920 X 1080 | Size: Minimum 13 inches or above<br>Resolution: 1920 X 1080 | SE |
| Internet | / | /…