(49 days)
No
The summary describes a device that uses ultrasound measurements and calculations based on physical principles (shear wave speed and attenuation) to estimate liver stiffness. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The calculations appear to be deterministic based on the physical measurements.
No.
The device is intended for diagnostic purposes, providing estimates of tissue stiffness and attenuation to assist in clinical management, rather than directly treating or preventing disease.
Yes
The device is intended to determine liver tissue stiffness and attenuation, which are then used in conjunction with other clinical indicators to assist in the clinical management of patients with liver disease. This function of measurement and providing information for clinical management aligns with the definition of a diagnostic device.
No
The device description explicitly mentions hardware components like an "activation unit" that vibrates and an "ultrasound transducer" that takes volumetric scans. This indicates it is a hardware-based device with associated software for calculations.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Liver Incytes System is a non-invasive device that uses ultrasound and mechanical vibration to measure physical properties (stiffness and attenuation) of the liver within the patient's body. It does not analyze samples taken from the patient.
- Intended Use: The intended use is to provide estimates of tissue stiffness and attenuation in vivo to assist in clinical management, not to perform diagnostic tests on biological samples.
Therefore, the Liver Incytes System falls under the category of a medical device, specifically an ultrasound-based diagnostic imaging device, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications 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 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.
Product codes
IYO, ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical profession, an employee of the clinic/hospital.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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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
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)
| 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 | Colour | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other1 | ||||||||
| (Specify) | |||||||||
| General | (Specify) | (Specify) | |||||||
| Ophthalmic | Ophthalmic | - | - | - | - | - | - | - | |
| Fetal | |||||||||
| Imaging & | |||||||||
| 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) | - | - | - | - | - | - | - | ||
| Peripheral | |||||||||
| 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
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 | ||
| System | 21 CFR §892.1560 | IYO |
| Diagnostic Ultrasonic | ||
| 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-
1:2005/(R)2012 And
A1:2012 | Medical Electrical Equipment - Part 1: General Requirements For Basic
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
Safety And Essential Performance - Collateral Standard: Electromagnetic
Disturbances - Requirements And Tests |
| IEC 60601-1-6 Edition 3.1
2013-10 | Medical Electrical Equipment - Part 1-6: General Requirements For Basic
Safety And Essential Performance - Collateral Standard: Usability |
| IEC 62304:2006/A1:2015 | Medical Device Software - Software Life Cycle Processes [Including
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
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 Second Edition
2007-03-01 | 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 Edition
2009-10-15 | Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing
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.