(21 days)
Not Found
Yes
The document explicitly states that the software includes "optional overlay from machine learning algorithms".
No.
Explanation: The device is intended to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction to aid in clinical management of patients with liver diseases, not to treat them.
Yes
The device is intended to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction (VDFF), which are used "in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis." This indicates its role in providing objective information for diagnosis or assessment of disease.
No
The device is not a software-only medical device because it explicitly describes significant hardware components, including an "activation unit" that vibrates, an "ultrasound transducer" for scanning, and mentions "software and hardware changes were made to the device." It clearly involves physical interaction with the patient to gather data.
No.
The device measures physical parameters (stiffness and attenuation) of liver tissue using ultrasound and mechanical shear waves, not through in vitro examination of specimens derived from the human body.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis.
The device is intended to be used in a clinical setting and by trained medical professionals.
Product codes
IYO, ITX
Device Description
Velacur ONE is a portable device intended to non-invasively measure the stiffness and attenuation of the liver via measurement of liver tissue shear modulus and ultrasound attenuation. This is done by measuring the wavelength or wave speed of mechanically created shear waves within the organ of the patient. Attenuation is measured directly via the loss in power of the ultrasound beam and Velacur Determined Fat Fraction is a combination of measured ultrasound attenuation and backscatter.
The device is designed to be used at the point of care, in clinics and hospitals. The device is used by a medical profession, an employee of the clinic/hospital. The activation unit is placed under the patient, while lying supine on an exam bed. The activation unit vibrates at frequencies 40, 50, and 60 Hz causing shear waves within the liver of the patient. The ultrasound transducer is placed on the patient's skin, over the intercostal space, and is used to take volumetric scans of the liver while shear waves are occurring. The device includes two algorithms designed to help users detect good quality shear waves and identify liver tissue. From the scan data, the device calculates tissue stiffness and attenuation.
Software and hardware changes were made to the device. The intended use of the device is unchanged. The user interface was updated to a more modern platform with the same workflow and outputs. The hardware components have been consolidated, combining the functionality of the computing unit and control unit. The activation unit has been designed to include more voice coils which are distributed throughout the unit. The power output and performance of the activation unit is unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Yes (machine learning algorithms are mentioned as an optional overlay shown on the device display to indicate when the location is acceptable)
Input Imaging Modality
Pulse-echo based ultrasound
Anatomical Site
liver
Indicated Patient Age Range
Ages 2 and above for stiffness and attenuation, 18 and up for VDFF
Intended User / Care Setting
Used by a medical professional, an employee of the clinic/hospital. The device is designed to be used at the point of care, in clinics and hospitals.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Bench testing of the stiffness, attenuation and VDFF measures on reference phantoms using the same test methods and acceptance criteria as the predicate.
- Elasticity: Validated using 6 Homogeneous phantoms with different stiffness values. Average difference between the bias of Velacur ONE and the predicate was 2.45%. Velacur ONE had an average precision of 1.7% (min 0.3%, max 2.9%). Device demonstrated equivalent accuracy and precision to the predicate and met all criteria.
- Attenuation: Validated using 6 attenuation phantoms. Overall bias for Velacur ONE algorithm was 9.1% (compared to predicate's 8.0%), both less than 10% acceptance criteria. Mean precision was 0.6% for Velacur ONE.
- Velacur Determined Fat Fraction (VDFF): Compared to calculated expected VDFF for 6 phantoms. Overall bias for Velacur ONE was 8%. Overall (maximum) precision (5.4 %) was less than 10%. Pearson correlation coefficient, r, of the Velacur VDFF measurement was 0.95 (greater than 0.8).
- Human Factors testing on software and hardware: Two rounds of formative testing and a final summative test were completed. No new critical tasks or hazardous use scenarios were encountered. Minor software difficulties were easily corrected. IEC 60601-1-6 Edition 3.1 was used as the basis for evaluation. Conclusion: safe and effective for intended users, uses, and use environments.
- Shipping and packaging testing.
- Performance and human factors testing of the new activation unit design.
- Software Verification and Validation.
No clinical or animal testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA 510(k) Clearance Letter - Velacur One (LI-1100)
Page 1
June 26, 2025
Sonic Incytes Medical Corp
℅ Rhona Shanker
President
Z & B Enterprises, Inc.
12154 Darnestown Road #236
GAITHERSBURG MD 20878
Re: K251728
Trade/Device Name: Velacur One (LI-1100)
Regulation Number: 21 CFR 892.1560
Regulation Name: Ultrasonic Pulsed Echo Imaging System
Regulatory Class: Class II
Product Code: IYO, ITX
Dated: June 4, 2025
Received: June 5, 2025
Dear Rhona Shanker:
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.
Page 2
K251728 - Rhona Shanker Page 2
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" (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 QS 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 (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-reporting-combination-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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K251728 - Rhona Shanker Page 3
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,
YANNA S. KANG -S
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251728
Device Name
Velacur One (LI-1100)
Indications for Use (Describe)
Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis.
The device is intended to be used in a clinical setting and by trained medical professionals.
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:
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"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."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
Velacur ONE 510(k) Summary
Model: LI-1100
Section 5 – 510(k) Summary
K251728
Sonic Incytes Velacur ONE system
I. Submitter:
Sonic Incytes
#309-1788 West 5th Avenue
Vancouver, BC V6J 1P2 Canada
Telephone: +1 604 875 4111 Extension: 54851
Contact person: Rhona Shanker
Date Prepared: 04 June 2025
II. Device
Name of Device: Velacur ONE
Model: LI-1100
Common Name: Ultrasound elastography system
| Classification Name | Regulation | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | 21 CFR §892.1560 | IYO |
| Diagnostic Ultrasonic Transducer | 21 CFR §892.1570 | ITX |
Predicate Device
Velacur (K233977) manufactured by Sonic Incytes Medical Corp., Vancouver, Canada, and cleared on September 4, 2024.
Device Description
The device that is the subject of this submission is the substantially equivalent to that cleared under K233977, Velacur.
Velacur ONE is a portable device intended to non-invasively measure the stiffness and attenuation of the liver via measurement of liver tissue shear modulus and ultrasound attenuation. This is done by measuring the wavelength or wave speed of mechanically created shear waves within the organ of the patient. Attenuation is measured directly via the loss in power of the ultrasound beam and Velacur Determined Fat Fraction is a combination of measured ultrasound attenuation and backscatter.
The device is designed to be used at the point of care, in clinics and hospitals. The device is used by a medical profession, an employee of the clinic/hospital. The activation unit is placed under the patient, while lying supine on an exam bed. The activation unit vibrates at frequencies
Page 6
Velacur ONE 510(k) Summary
Model: LI-1100
40, 50, and 60 Hz causing shear waves within the liver of the patient. The ultrasound transducer is placed on the patient's skin, over the intercostal space, and is used to take volumetric scans of the liver while shear waves are occurring. The device includes two algorithms designed to help users detect good quality shear waves and identify liver tissue. From the scan data, the device calculates tissue stiffness and attenuation.
Software and hardware changes were made to the device. The intended use of the device is unchanged. The user interface was updated to a more modern platform with the same workflow and outputs. The hardware components have been consolidated, combining the functionality of the computing unit and control unit. The activation unit has been designed to include more voice coils which are distributed throughout the unit. The power output and performance of the activation unit is unchanged.
Indication for Use
Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis.
The device is intended to be used in a clinical setting and by trained medical professionals.
Substantial Equivalence
The candidate device has the same intended use and indications for use as the predicate device in that the outputs are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases.
The technology used in the candidate and predicate device is based on ultrasound to measure elastography, attenuation (ACE) and Velacur Determined Fat Fraction (VDFF). The systems measure the same physical variables, tissue stiffness and ultrasound attenuation, and therefore the devices are substantially equivalent in their basic technology.
The hardware and software changes have been validated in the same manner as the predicate. The candidate device with the described changes does not raise any new issues of safety or effectiveness.
The Table below compares relevant characteristics of the above devices.
| Proposed Device | Predicate Device K233977 | Comment | |
|---|---|---|---|
| Description | Velacur ONE – 1100 | Velacur- 1005 | |
| Company | Sonic Incytes | Sonic Incytes | Same |
Pg. 2
Page 7
Velacur ONE 510(k) Summary
Model: LI-1100
| Proposed Device | Predicate Device K233977 | Comment | |
|---|---|---|---|
| Indications of Use | Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis. The device is intended to be used in a clinical setting and by trained medical professionals. | Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis. The device is intended to be used in a clinical setting and by trained medical professionals. | Same |
| Imaging Method | Pulse-echo based ultrasound | Pulse-echo based ultrasound | Same |
| Technological Characteristics (General) | The system uses an external shear wave generator to produce shear waves at 40-70Hz within the abdominal cavity. Ultrasound imaging is used to acquire the wave field over a volume and to measure the tissue stiffness over a volume. Analysis of the ultrasound radio-frequency (RF) data is used to estimate tissue attenuation and backscatter coefficient, which are combined to measure Velacur Determined Fat Fraction (VDFF). | The system uses an external shear wave generator to produce shear waves at 40-70Hz within the abdominal cavity. Ultrasound imaging is used to acquire the wave field over a volume and to measure the tissue stiffness over a volume. Analysis of the ultrasound radio-frequency (RF) data is used to estimate tissue attenuation and backscatter coefficient, which are combined to measure Velacur Determined Fat Fraction (VDFF). | Same |
Pg. 3
Page 8
Velacur ONE 510(k) Summary
Model: LI-1100
| Proposed Device | Predicate Device K233977 | Comment | |
|---|---|---|---|
| Indications of Use | Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis. The device is intended to be used in a clinical setting and by trained medical professionals. | Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis. The device is intended to be used in a clinical setting and by trained medical professionals. | Same |
| Imaging Method | Pulse-echo based ultrasound | Pulse-echo based ultrasound | Same |
| Technological Characteristics (General) | The system uses an external shear wave generator to produce shear waves at 40-70Hz within the abdominal cavity. Ultrasound imaging is used to acquire the wave field over a volume and to measure the tissue stiffness over a volume. Analysis of the ultrasound radio-frequency (RF) data is used to estimate tissue attenuation and backscatter coefficient, which are combined to measure Velacur Determined Fat Fraction (VDFF). | The system uses an external shear wave generator to produce shear waves at 40-70Hz within the abdominal cavity. Ultrasound imaging is used to acquire the wave field over a volume and to measure the tissue stiffness over a volume. Analysis of the ultrasound radio-frequency (RF) data is used to estimate tissue attenuation and backscatter coefficient, which are combined to measure Velacur Determined Fat Fraction (VDFF). | Same |
Pg. 3
Page 9
Velacur ONE 510(k) Summary
Model: LI-1100
| Proposed Device | Predicate Device K233977 | Comment | |
|---|---|---|---|
| Shear Wave Generation | External vibration source on the skin | External vibration source on the skin | Same |
| Shear Wave Frequencies | 40 -70Hz | 40 -70Hz | Same |
| Shear Wave type | Steady state mechanical waves | Steady state mechanical waves | Same |
| Vibration signal characteristics | Steady state superimposed multi-frequency signal | Steady state superimposed multi-frequency signal | Same |
| Elasticity averaging | 3D Elasticity output computed as an average of all the shear moduli computed at each pixel in the ROI | 3D Elasticity output computed as an average of all the shear moduli computed at each pixel in the ROI | Same |
| Attenuation Measurement Algorithm | Spectral Shift Reference Phantom method | Spectral Shift Reference Phantom method | Same |
| Liver Fat fraction Estimate | Estimates liver fat using a combination of attenuation and backscatter | Estimates liver fat using a combination of attenuation and backscatter | Same |
| Liver Fat Fraction Validation | Fat fraction estimate is validated against MRI PDFF as the reference standard | Fat fraction estimate is validated against MRI PDFF as the reference standard | Same |
| Output/Visualization | Image with measurement of 3D tissue stiffness, ultrasound attenuation and Velacur determined fat fraction (VDFF) | Image with measurement of 3D tissue stiffness, ultrasound attenuation and Velacur determined fat fraction (VDFF) | Same |
| Patient Population | Ages 2 and above for stiffness and attenuation, 18 and up for VDFF | Ages 2 and above for stiffness and attenuation, 18 and up for VDFF | Same |
| User certification | Medical professional trained for using Velacur ONE | Medical professional trained for using Velacur | Same |
| Required User interactions | User holds the probe against the skin, and software (shown on the laptop display) including the optional overlay from machine learning algorithms is shown on the device display to indicate when the location is acceptable. | User holds the probe against the skin, and software (shown on the laptop display) including the optional overlay from machine learning algorithms is shown on the device display to indicate when the location is acceptable. | Same |
Pg. 4
Page 10
Velacur ONE 510(k) Summary
Model: LI-1100
| Proposed Device | Predicate Device K233977 | Comment | |
|---|---|---|---|
| User moves the probe in sweep motion. | User moves the probe in sweep motion. | ||
| Patient interaction | Patient lays supine, holds breath during image acquisition. Scan is performed intercostally. | Patient lays supine, holds breath during image acquisition. Scan is performed intercostally. | Same |
| Use Environment | Clinic and Hospital | Clinic and Hospital | Same |
| Time for acquisition | 5-10 minutes | 5-10 minutes | Same |
| Types of images displayed | Ultrasound B-Mode image | Ultrasound B-Mode image | Same |
| Other displayed information to the user, e.g., information displayed to indicate the measurement will be valid | Yes, overall quality of image and tracking. Warning message if quality is too low. Ultrasound B-Mode image with overlays to indicate where the liver and acceptable shear waves are located | Yes, overall quality of image and tracking. Warning message if quality is too low. Ultrasound B-Mode image with overlays to indicate where the liver and acceptable shear waves are located | Same |
| Information displayed to indicate that the location is acceptable for imaging | Yes | Yes | Same |
| Cybersecurity | Evaluated using OWASP IoT best practices, NIST SP 800-53, ISO/IEC 27002, ISO/IEC 80001-1, FDA guidelines; OSSTMM-based network testing; testing per IEC 81001-5-1:2021 and EMA 726/2004. Testing included functional, boundary, and stress testing. Determined to have adequate security controls. | Evaluated using the same methodologies: OWASP IoT best practices, NIST SP 800-53, ISO/IEC 27002, ISO/IEC 80001-1, FDA and PHAC guidelines; network infrastructure testing per OSSTMM; IEC 81001-5-1:2021 and EMA 726/2004 compliant. Testing included penetration, vulnerability, stress, boundary, and functional assessments. Concluded to have added security controls | Equivalent: same security testing standards and methodology used. Proposed device demonstrated robust cybersecurity protection. |
Pg. 5
Page 11
Velacur ONE 510(k) Summary
Model: LI-1100
Performance Data
The following testing was performed:
- Bench testing of the stiffness, attenuation and VDFF measures on reference phantoms using the same test methods and acceptance criteria as the predicate
- Human Factors testing on software and hardware
- Shipping and packaging testing
- Performance and human factors testing of the new activation unit design
- Software Verification and Validation
No clinical or animal testing was performed.
Bench Testing Validation for Elasticity, Attenuation and VDFF Algorithms
Bench testing validation for the algorithms is summarized below:
| Proposed Device | Predicate Device K233977 | Comment | |
|---|---|---|---|
| Number of Components | 3 | 4 | Mobile computing unit has been integrated into the control unit to create a single Core unit |
| Power requirements | 110V (wall power) | 110V (wall power) | Same |
| Battery | Internal (non-removable) battery to provide back-up power and allow device to function as designed for approximately 20 minutes. | Relied on laptop battery for back-up power for computing unit | Internal battery is part of the new Core Unit design with improved functionality. Battery is IEC 62133-2:2017 certified |
| EMC compliance | IEC 60601-1-2:2020 Edition 4.1 | IEC 60601-1-2:2020 Edition 4.1 | Same |
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Page 12
Velacur ONE 510(k) Summary
Model: LI-1100
Elasticity
The elasticity was validated using 6 Homogeneous phantoms with different stiffness values.
The overall bias to the CIRS values was used as a comparison point for both systems to determine the substantial equivalence of Velacur ONE to the predicate. The average difference between the bias of Velacur ONE and the predicate was 2.45%.
The precision of the predicate ranged from 1.1% to 2.6% with an average of 2.1%. In comparison, Velacur ONE had an average precision of 1.7% with a min and max of 0.3% and 2.9% respectively.
The device demonstrated equivalent accuracy and precision to the predicate and met all criteria necessary to support clinical suitability.
The results of the Bland-Altman plots show excellent correlation between the measurements and that no value falls outside the 1.96*STD lines.
The results of the two systems both passed the defined acceptance criteria when being compared to each other and are considered substantially equivalent.
Attenuation
The attenuation algorithm was validated using 6 attenuation phantoms that span the expected range of attenuation values in human liver.
The overall bias was the basis on which the two algorithms are compared to the expected values. The overall bias for the Velacur ONE algorithm was 9.1% compared to the Velacur overall bias of 8.0%. Both have an overall bias less than the 10% acceptance criteria.
The mean precision value across all the phantoms was 0.9% for Velacur and 0.6% for Velacur ONE. The maximum precision for Velacur ONE was less than 10%.
Velacur Determined Fat Fraction algorithm (VDFF)
Velacur Determined Fat Fraction (VDFF) was compared to the calculated expected VDFF based on the labeled backscatter and attenuation for 6 different phantoms, with a variety of backscatter coefficients at 3MHz from 7.01e-3 cm-1sr-1 to 4.24e-4 cm-1sr-1.
The overall bias for Velacur ONE was 8%, compared to the predicate bias of 9% in the phantoms, or were clinically meaningful cutoff value for any steatosis of 5%. The overall (maximum) precision (5.4 %) was less than 10%. The Velacur ONE passes this performance test in all measured phantoms.
The Pearson correlation coefficient, r, of the Velacur VDFF measurement when compared to the expected VDFF value was 0.95. The Pearson correlation coefficient is greater than 0.8 and so the Velacur VDFF measurement passes this performance test.
Pg. 7
Page 13
Velacur ONE 510(k) Summary
Model: LI-1100
Human Factors testing on software and hardware
Human Factors testing completed on the new software and hardware form factor included two rounds of formative testing (using a hardware mock up and then just the interface) and a final summative test.
No new critical tasks or hazardous use scenarios were encountered. Minor software difficulties were encountered, but all were easily corrected. Descriptions of these software features have been added to the training of operators to ensure no errors or difficulties will be encountered.
IEC 60601-1-6 Edition 3.1 was used as the basis for this evaluation. The risk-based assessment of modifications made and preliminary formative testing rounds and summative testing of Velacur ONE support the conclusion that Velacur ONE is safe and effective for the intended users, uses, and use environments.
Recognized Consensus Standards Used
The system complies with the same standards as the predicate, the standards are:
IEC 60601-1-2 Edition 4.1 2020-09: Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
IEC 60601-1 Edition 3.2 2020-08: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-6 Edition 3.2 2020-07: Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
IEC 62304 Edition 1.1 2015-06: Medical Device Software - Software Life Cycle Processes
IEC 60601-2-37 Edition 2.1 2015: Medical Electrical Equipment - Part 2-37: Particular Requirements for The Basic Safety and Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment
IEC 62359: Edition 2.1 2017-09: Ultrasonics - Field Characterization - Test Methods for The Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields
ISO 14971 Third Edition 2019-12: Medical Devices - Application of Risk Management to Medical Devices
ISO 10993-1 fifth edition 2018-08: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process
IEC 62133-2 Edition 1.0 2017-02: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems
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Velacur ONE 510(k) Summary
Model: LI-1100
Conclusion
The conclusion drawn from the testing described above demonstrate that the Velacur ONE is substantially equivalent to the predicate device with respect to safety, effectiveness and performance.
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