The Liver Incytes System is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz) and coefficient of attenuation. The device is indicated to non-invasively determine liver tissue stiffness and attenuation. These are meant to be used in conjunction with other clinical indicators in order to assist in clinical management of patients with liver disease.

Device Description

Liver Incytes is a non-invasive ultrasound based device for measuring tissues stiffness and ultrasound attenuation in patients with chronic liver disease. The device uses ultrasound measurements of shear wave speed in the tissues to estimate stiffness. The attenuation is measured through the ultrasound signal itself.

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 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. From the scan data, the device calculates tissue stiffness and attenuation.

AI/ML Overview

The provided text describes the regulatory clearance of the Sonic Incytes Liver Incytes, Model 1005 device. However, it does not contain specific details about a clinical study involving human patients to prove the device meets acceptance criteria for accuracy and performance for tissue stiffness and attenuation measurements.

The document primarily focuses on:

Regulatory Clearance: FDA 510(k) clearance process.
Device Description: What the Liver Incytes system is, how it works, and its intended use.
Predicate Device: Comparison to the EchoSens FibroScan® for substantial equivalence.
Non-Clinical Testing: Mentions electrical safety, electromagnetic interference, ultrasound, and phantom testing for accuracy and precision. It also mentions a "small cohort of healthy volunteers" for a usability study related to BMI, not for clinical performance against a ground truth.
Standards Compliance: Lists various recognized consensus standards the device complies with.

Therefore, based only on the provided text, I cannot answer the questions directly related to a clinical study proving detailed performance against acceptance criteria in human subjects. The text explicitly states that only "non-clinical testing" was performed, which included phantom testing and a usability study on healthy volunteers.

Below, I will indicate where the information would typically be found in a complete study report and what is missing from this document.

Based on the provided text, the specific details for a clinical study with acceptance criteria and performance data are NOT available. The document focuses on non-clinical testing and substantial equivalence to a predicate device.

However, I can extract what is mentioned regarding testing and what would be required for the requested information:

Missing Information/Gaps from the Provided Text:

Clinical Study for Performance: The text explicitly mentions "non-clinical testing" and a "usability study" on healthy volunteers. It does not describe a clinical performance study using patient data with established liver disease to validate the accuracy of tissue stiffness and attenuation measurements against a clinical ground truth.
Specific Acceptance Criteria (for clinical performance): While general statements about accuracy and precision are made for phantom testing, no quantitative acceptance criteria for clinical performance (e.g., minimum sensitivity/specificity for liver fibrosis staging) are provided.
Device Performance (Clinical): No specific metrics (e.g., AUC, sensitivity, specificity, accuracy, error margins) for how the device performed on human liver tissue stiffness and attenuation measurements are reported.
Test Set Details: No information regarding a clinical test set (sample size, data provenance, ground truth establishment, adjudication) is provided.
Training Set Details: No information regarding a training set for an AI/algorithm (if applicable, though this device seems to be a physical measurement system rather than a deep learning AI) is provided.
MRMC Study: No mention of a multi-reader, multi-case study.
Standalone Performance: No specific standalone performance metrics for the device on clinical data.

What is available in the provided document:

1. A table of acceptance criteria and the reported device performance (for non-clinical/phantom testing):

Acceptance Criteria: Not explicitly stated as quantitative thresholds for clinical performance. For non-clinical tests, it states "The accuracy and precision of the device was tested and documented based on tests performed on phantoms with known elasticity and attenuation." This implies the acceptance criteria were that the device measurements on phantoms should align with the known values, but specific quantitative criteria are not given.
Reported Device Performance: "The accuracy and precision of the device were found to be substantially equivalent to those of the predicate device and reference device (MRI Elastography)." No numerical performance metrics (e.g., mean absolute error, correlation coefficient, limits of agreement) are provided for either phantom or human studies. The human study mentioned was a "usability study" on healthy volunteers, not a performance study for liver stiffness/attenuation.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size:
- For phantom testing: Not specified, but likely refers to a set of phantoms.
- For human usability study: "a small cohort of healthy volunteers." The exact number is not provided, but it's explicitly for "usability" and "Body Mass Index from 25 to 43 kg/m2," not for clinical performance demonstration.
Data Provenance: Not explicitly stated for any clinical performance data, as none are presented. The submitter is based in Vancouver, BC, Canada, but the location of any hypothetical clinical data collection is not mentioned. The usability study was on "healthy volunteers."
Retrospective or Prospective: Not indicated, as no clinical performance study data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided because no clinical performance test set with expert-established ground truth is described. For phantom testing, the ground truth is the "known elasticity and attenuation" of the phantoms.

4. Adjudication method for the test set:

Not applicable/Not provided as no clinical test set requiring human adjudication is detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, not mentioned. This document does not describe an AI-assisted interpretation system or a comparative effectiveness study involving human readers. The device measures physical properties (shear wave speed and attenuation).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The device itself provides the measurements. The performance "was tested and documented based on tests performed on phantoms." This would be a standalone performance, but the metrics are not provided in the document. No specific "algorithm only" performance for diagnosis from images is described; rather, the device directly outputs physical measurements.

7. The type of ground truth used:

For non-clinical testing: "phantoms with known elasticity and attenuation."
For a clinical performance study (which is not detailed here), common ground truths for liver stiffness could include liver biopsy (histopathology) or MRI Elastography (as referenced for substantial equivalence).

8. The sample size for the training set:

Not applicable/Not provided. This document does not describe a machine learning algorithm that requires a training set for diagnostic tasks. The device measures physical properties.

9. How the ground truth for the training set was established:

Not applicable/Not provided. As above, no machine learning training set is mentioned.

In summary, the provided FDA clearance letter and summary primarily address regulatory compliance and non-clinical testing for equivalence. It does not delve into the detailed results of a clinical performance study to establish specific acceptance criteria and device performance on human subjects for its intended diagnostic use.

Summary

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July 31, 2020

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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health and Human Services emblem. To the right of the symbol is a blue square containing the acronym "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Sonic Incytes % Rhona Shanker President Z & B Enterprises, Inc. 12154 Darnestown Road, #236 GAITHERSBURG MD 20878

Re: K201597

Trade/Device Name: Liver Incytes, Model 1005 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: June 10, 2020 Received: June 12, 2020

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 (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 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

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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 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-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) K201597

Device Name Liver Incytes, Model 1005

Indications for Use (Describe)

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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Diagnostic Ultrasound Intended Use

System: Liver Incytes, Model 1005

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

Clinical Application			Mode of Operation
	Specific	B	M	PWD	CWD	ColourDoppler	Combined(Specify)	Other1(Specify)
General							(Specify)	(Specify)
Ophthalmic	Ophthalmic	-	-	-	-	-	-	-
FetalImaging &Other	Fetal	-	-	-	-	-	-	-
	Abdominal	N	-	-	-	-	-	N
	Intra-operative (Specify)	-	-	-	-	-	-	-
	Intra-operative(Neuro)	-	-	-	-	-	-	-
	Laparoscopic	-	-	-	-	-	-	-
	Pediatric	-	-	-	-	-	-	-
	Small Organ (Specify)	-	-	-	-	-	-	-
	Neonatal Cephalic	-	-	-	-	-	-	-
	Adult Cephalic	-	-	-	-	-	-	-
	Trans-rectal	-	-	-	-	-	-	-
	Trans-vaginal	-	-	-	-	-	-	-
	Trans-urethral	-	-	-	-	-	-	-
	Trans-esoph.(Non-Card.)	-	-	-	-	-	-	-
	Musculo-skel(conventional)	-	-	-	-	-	-	-
	Musculo-skel(superficial)	-	-	-	-	-	-	-
	Intra-luminal	-	-	-	-	-	-	-
	Other (Specify)	-	-	-	-	-	-	-
Cardiac	Cardiac Adult	-	-	-	-	-	-	-
	Cardiac Pediatric	-	-	-	-	-	-	-
	Trans-Esoph. (Cardiac)	-	-	-	-	-	-	-
	Other (Specify)	-	-	-	-	-	-	-
PeripheralVessel	Peripheral vessel	-	-	-	-	-	-	-
	Other (Specify)	-	-	-	-	-	-	-

N = New indication for this submission

1 = Elastography mode

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Liver Incytes Version : LI-1005 /Dx1

Image /page/4/Picture/1 description: The image shows the logo for Sonic Incytes. The logo consists of the company name in a sans-serif font, with the word "Sonic" in black and "Incyte" in black. Above the company name is a blue horizontal line, and above that is a series of blue and black vertical lines that resemble sound waves.

510(k) Summary

Section 5-1

510(k) Summary

Sonic Incytes Liver Incytes system

K201597

l. Submitter:

Sonic Incytes 560-828 West 10th Avenue Vancouver, BC V5Z 1M9 Canada Telephone: +1 604 875 4111 Extension: 54851

Contact person: Rhona Shanker Date Prepared: 5 June 2020

II. Device
Name of Device: Liver Incytes, Model 1005

Common Name: Ultrasound elastography system

Classification Name	Regulation	Product Code
Ultrasonic Pulsed Echo ImagingSystem	21 CFR §892.1560	IYO
Diagnostic UltrasonicTransducer	21 CFR §892.1570	ITX

Predicate Device

Predicate Device: EchoSens FibroScan® (K160524) manufactured by EchoSens, Paris, France, and cleared on March 18, 2016.

Reference device: Magnetic Resonance Elastography (K140666) is used as the reference device for some performance testing.

Device Description

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Image /page/5/Picture/1 description: The image shows the logo for Sonic Incytes. The logo consists of the word "Sonic" in bold, followed by "Incyte" in bold. Above the words is a blue line, and above that is a series of blue and black vertical lines that resemble a sound wave. The logo is simple and modern, and the use of blue and black gives it a professional look.

Intended Use/ Indication for Use

The Liver Incytes System is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz) and coefficient of attenuation. The device is indicated to noninvasively determine liver tissue stiffness and attenuation. These are meant to be used in conjunction with other clinical indicators in order to assist in clinical management of patients with liver disease.

Substantial Equivalence

The candidate device has an equivalent intended use and indications for use as the predicate device. Further, it has the same operating principle.

The technology used in the candidate, predicate device and reference device is based on ultrasound to measure elastography and attenuation. The systems measure the same physical variables, tissue stiffness and ultrasound attenuation, and therefore the devices are substantially equivalent in their basic technology. The accuracy and precision of the device were found to be substantially equivalent to those of the predicate device and reference device (MRI Elastography). The new device does not raise any new issues of safety or effectiveness.

Performance Data

The following non-clinical testing was performed and submitted:

Electrical safety, electromagnetic interference and ultrasound
The accuracy and precision of the device was tested and documented based on tests performed on phantoms with known elasticity and attenuation.
. The proposed device was tested in a small cohort of healthy volunteers with several novice users. This usability study showed that the device could be used successfully on volunteers with Body Mass Index from 25 to 43 kg/m2, representing the intended patient population. The users who participated in this study were representative of the intended use population.

Recognized Consensus Standards Used

Non-clinical testing to assure compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety were performed and the device was found to conform to applicable medical device safety standards. The system complies with the following standards:

ANSI AAMI 60601-1:2005/(R)2012 AndA1:2012	Medical Electrical Equipment - Part 1: General Requirements For BasicSafety And Essential Performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 4.0	Medical Electrical Equipment - Part 1-2: General Requirements For BasicSafety And Essential Performance - Collateral Standard: ElectromagneticDisturbances - Requirements And Tests
IEC 60601-1-6 Edition 3.12013-10	Medical Electrical Equipment - Part 1-6: General Requirements For BasicSafety And Essential Performance - Collateral Standard: Usability
IEC 62304:2006/A1:2015	Medical Device Software - Software Life Cycle Processes [IncludingAmendment 1]

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Liver Incytes Version : LI-1005 /Dx1

Image /page/6/Picture/1 description: The image shows the logo for Sonic Incytes. The logo consists of the company name in a bold, sans-serif font, with the word "Sonic" in black and "Incyte" in black. Above the company name is a blue horizontal line, and above that is a series of blue vertical lines of varying heights, resembling a sound wave.

IEC 60601-2-37 Edition 2.12015	Medical Electrical Equipment - Part 2-37: Particular Requirements ForThe Basic Safety And Essential Performance Of Ultrasonic MedicalDiagnostic And Monitoring Equipment
IEC 62359: Edition 2.1 2017-09	Ultrasonics - Field Characterization - Test Methods For TheDetermination Of Thermal And Mechanical Indices Related To MedicalDiagnostic Ultrasonic Fields
ISO 14971 Second Edition2007-03-01	Medical Devices - Application Of Risk Management To Medical Devices(CL 4.2 from 60601-1)
ISTA 3A 2008	Packaged-Products For Parcel Delivery System Shipment 70 Kg (150 Lb)Or Less
ISO 10993-1 Fourth Edition2009-10-15	Biological Evaluation Of Medical Devices - Part 1: Evaluation And TestingWithin A Risk Management Process

The conclusions drawn from the testing described above demonstrate that the device is substantially equivalent to the predicate device with respect to safety, efficacy and performance.

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.