Liver Incytes, Model 1005

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201597 Device Name Liver Incytes, Model 1005 ### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | # 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." {3}------------------------------------------------ # 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 | Colour<br>Doppler | Combined<br>(Specify) | Other1<br>(Specify) | | | General | | | | | | | (Specify) | (Specify) | | | Ophthalmic | Ophthalmic | - | - | - | - | - | - | - | | | Fetal<br>Imaging &<br>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.<br>(Non-Card.) | - | - | - | - | - | - | - | | | | Musculo-skel<br>(conventional) | - | - | - | - | - | - | - | | | | Musculo-skel<br>(superficial) | - | - | - | - | - | - | - | | | | Intra-luminal | - | - | - | - | - | - | - | | | | Other (Specify) | - | - | - | - | - | - | - | | | Cardiac | Cardiac Adult | - | - | - | - | - | - | - | | | | Cardiac Pediatric | - | - | - | - | - | - | - | | | | Trans-Esoph. (Cardiac) | - | - | - | - | - | - | - | | | | Other (Specify) | - | - | - | - | - | - | - | | | Peripheral<br>Vessel | Peripheral vessel | - | - | - | - | - | - | - | | | | Other (Specify) | - | - | - | - | - | - | - | | N = New indication for this submission 1 = Elastography mode {4}------------------------------------------------ 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 Imaging<br>System | 21 CFR §892.1560 | IYO | | Diagnostic Ultrasonic<br>Transducer | 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 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. {5}------------------------------------------------ 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-<br>1:2005/(R)2012 And<br>A1:2012 | Medical Electrical Equipment - Part 1: General Requirements For Basic<br>Safety And Essential Performance (IEC 60601-1:2005, MOD) | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-2 Edition 4.0 | Medical Electrical Equipment - Part 1-2: General Requirements For Basic<br>Safety And Essential Performance - Collateral Standard: Electromagnetic<br>Disturbances - Requirements And Tests | | IEC 60601-1-6 Edition 3.1<br>2013-10 | Medical Electrical Equipment - Part 1-6: General Requirements For Basic<br>Safety And Essential Performance - Collateral Standard: Usability | | IEC 62304:2006/A1:2015 | Medical Device Software - Software Life Cycle Processes [Including<br>Amendment 1] | {6}------------------------------------------------ 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 2.1<br>2015 | Medical Electrical Equipment - Part 2-37: Particular Requirements For<br>The Basic Safety And Essential Performance Of Ultrasonic Medical<br>Diagnostic And Monitoring Equipment | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 62359: Edition 2.1 2017-<br>09 | Ultrasonics - Field Characterization - Test Methods For The<br>Determination Of Thermal And Mechanical Indices Related To Medical<br>Diagnostic Ultrasonic Fields | | ISO 14971 Second Edition<br>2007-03-01 | Medical Devices - Application Of Risk Management To Medical Devices<br>(CL 4.2 from 60601-1) | | ISTA 3A 2008 | Packaged-Products For Parcel Delivery System Shipment 70 Kg (150 Lb)<br>Or Less | | ISO 10993-1 Fourth Edition<br>2009-10-15 | Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing<br>Within 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.