The SonicEye® Dual-Array Ultrasound System is for use in B-mode (grayscale) imaging of human subjects in the following clinical applications: Fetal, Cardiac (adult and pediatric, Abdominal, Pediatric, Peripheral vessel, Musculoskeletal (conventional and superficial), Small parts (breast, thyroid, testes), Thoracic/pleural.

The device is intended for use by medical professionals to include doctors, imaging technicians, emergency medicine and military corpsmen/medics that have been trained in basic sonography techniques. The use would include medical environments such as hospitals, clinics, military field aid stations.

Device Description

The SonicEye® Dual-Array Ultrasound System is a lightweight, battery-powered unit that contains an innovative dual-array fingertip transducer which incorporates two transducer arrays, a high-frequency linear and a low-frequency phased, in a single easily-controlled fingertip design that can be worn on the fingertip or held between the thumb and forefinger like most ultrasound probes.

The transducer is hard-wired to an image processor module that is firmware controlled. The image processor controls the behavior of the device including; beamforming, image construction, and power management; and transmits acquired data via USB cable to a computer tablet, with proprietary SonicEye Application software installed. The Windows application allow the operator to view scanned images and to control the user-selectable features of the device.

The system operates in B-Mode ONLY.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SonicEye® Dual-Array Ultrasound System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly define quantitative "acceptance criteria" for the device's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity for a particular clinical task). Instead, the performance summary focuses on meeting general medical device standards and demonstrating non-inferiority to a predicate device in a specific use case.

Acceptance Criteria (Implied)	Reported Device Performance
Technological Equivalence	"Both products employ the same technological features: the use of piezo-electric transducers to project focused beams of ultrasound enerqy into the human body then process the characteristics of the returned echo to create an image of soft tissues."
Compliance with Standards	The SonicEye system meets ISO 10993-1 (Biocompatibility), IEC 60601-1 (Electrical Safety), IEC 60601-2-37 (Ultrasonic Medical Diagnostic Equipment Safety), IEC 60601-1-2 (EMC), NEMA UD 2 (Acoustic Output), and ISO 14971 (Risk Management).
Clinical Performance (eFAST)	"The study concluded that the performance of the medics did not differ between the use of the SonicEye and the GE Vscan." (Implies non-inferiority to predicate for this application by specific users)

2. Sample Size Used for the Test Set and Data Provenance

The provided text doesn't explicitly state the exact number of "live humans" or "simulation models" used in the eFAST study. It refers to "study volunteers included both men and women, ages 18-54 years" for the live human component.

Sample Size (Test Set): Not explicitly stated numbers for "live humans" and "simulation models."
Data Provenance: Prospective, randomized, crossover trial. The country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The text does not provide any information regarding the establishment of ground truth for the eFAST study. It focuses on the performance of combat medics using the devices, not on how the actual trauma findings (ground truth) were determined.

4. Adjudication Method for the Test Set

The text does not provide any information about the adjudication method used for the test set.

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

A comparative effectiveness study was done.
Effect Size: Not explicitly stated as a quantitative effect size in terms of reader improvement. The conclusion given is: "The study concluded that the performance of the medics did not differ between the use of the SonicEye and the GE Vscan." This implies no significant difference or improvement was observed between the two devices in the context of combat medic performance in eFAST. This was a comparison between two devices, not between AI assistance and no AI assistance. The SonicEye is an ultrasound system, not an AI-powered diagnostic tool as described in typical MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the context of the SonicEye device as described. The SonicEye is an ultrasound imaging system, not an AI algorithm that generates diagnoses independently. The clinical study evaluated human users (medics) operating the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The text does not provide any information about the type of ground truth used for the eFAST study (e.g., whether it was based on subsequent imaging, surgical findings,
clinical outcomes, or expert consensus on the simulation models).

8. The Sample Size for the Training Set

The text does not mention any training set or machine learning components for the SonicEye system. The device is described as firmware-controlled and operating in B-mode, implying traditional ultrasound functionality rather than an AI/ML-driven diagnostic system that requires a separate training set of labeled data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as no training set for an AI/ML component is mentioned.

Summary

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February 25, 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 the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Sonivate Medical, Inc. % Mr. Steve Hesler Regulatory Affairs Contractor 4640 SW Macadam Avenue, Suite 200 PORTLAND OR 97239

Re: K192253

Trade/Device Name: SonicEye® Dual-Array Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: January 31, 2020 Received: February 5, 2020

Dear Mr. Hesler:

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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 medical devices and radiation-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192253

Device Name

SonicEye® Dual-Array Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)
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K192253

510(k) Submission SonicEye® Dual-Array Ultrasound System Sonivate Medical Inc

510(k) Summary (per 21 CFR 807.92)

Date prepared: January 28, 2020

SUBMITTER: Sonivate Medical Inc. 4640 SW Macadam Ave, Suite 200 Portland, OR 97239

Contact person: Steve Hesler 503 260 8221 heslers@yahoo.com

DEVICE UNDER REVIEW

SonicEye® Dual-Array Ultrasound System Proprietary name:

Common name: Diagnostic Ultrasound System

Classified name: Ultrasonic Pulsed Echo Imaging CFR 892.1560 Product code: IYO Class II

Diagnostic Ultrasound Transducer CFR 892.1570 Product code: ITX Class II

PREDICATE DEVICE

The GE Vscan with Dual Probe ultrasound system has been cleared via K140693 dated May 16, 2014.

DEVICE DESCRIPTION

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510(k) Submission SonicEye® Dual-Array Ultrasound System

easily-controlled fingertip design that can be worn on the fingertip or held between the thumb and forefinger like most ultrasound probes.

The system operates in B-Mode ONLY.

INDICATIONS FOR USE

The SonicEye® Dual-Array Ultrasound System is for use in B-mode (grayscale) imaging of human subjects in the following clinical applications: Fetal, Cardiac (adult and pediatric), Abdominal, Pediatric, Peripheral vessel, Musculoskeletal (conventional and superficial), Small parts (breast, thyroid, testes), Thoracic/pleural,

COMPARISON TO PREDICATE DEVICE

Sonivate has identified a predicate device, the GE Vscan with Dual Probe Ultrasound System as a predicate product. The GE Vscan with Dual Probe ultrasound system has been cleared via K140693 dated May 16, 2014.

Both products employ the same technological features: the use of piezo-electric transducers to project focused beams of ultrasound enerqy into the human body then process the characteristics of the returned echo to create an image of soft tissues. Both products are software-controlled medical products that conform to accepted international standards for diagnostic ultrasound device performance,

Both products are portable and battery-operated

The differences between the two devices are: the GE Vscan is capable of operating in several modes (B mode, Color Doppler, Combined modes, and Harmonic Imaging). The SonicEye supports only B mode imaging.

PERFORMANCE DATA

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The SonicEye system meets the following standards for medical devices:

Biocompatibility

. ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Electrical Safety-
IEC 60601-1: Medical Electrical Equipment PART 1: General . Requirements for Basic Safety and Essential Performance
IEC 60601-2-37: Medical electrical equipment Part 2-37: Particular . requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Electromagnetic Compatibility

IEC 60601-1-2: Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Acoustic Output Testing
NEMA UD 2: Acoustic Output Measurement Standard for Diagnostic ● Ultrasound Equipment
Risk Management
· ISO 14971: Medical devices Application of risk management to medical devices

CLINICAL STUDIES

In a prospective, randomized, crossover trial the SonicEve Dual-Plane Ultrasound System was compared with the GE Vscan Extend (an FDA-cleared diagnostic ultrasound product device that also utilizes a single transducer with two arrays) for performance of an extended focused assessment using ultrasound in trauma (eFAST) on live humans and simulation models. The subjects were combat medics with no previous ultrasound experience; study volunteers included both men and women, ages 18-54 years. Subjects were all given a standardized 60-minute lecture on eFAST. The study concluded that the performance of the medics did not differ between the use of the SonicEye and the GE Vscan.

CONCLUSIONS

Based on the similarities in technoloqy, the indications for use scanning human subjects, and the documented performance testing, the SonicEye Dual-Plane Ultrasound System is substantially equivalent to the predicate device and the benefits of use of the system on humans outweighs the risk.

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.