The VistaScan™ USB Ultrasound Imaging System is intended for diagnostic ultrasound imaging in B mode for the following applications: Fetal/obstetric Gynecology Abdominal Pediatric Small organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Pelvic floor Neuro-muscular Peripheral vessel

Indications for use vary by probe type. The VistaScan™ USB Ultrasound Imaging System is indicated for Rx (prescription) use and intended for use by appropriately trained healthcare professionals such as physicians and ultrasound technologists. The VistaScan™ USB Ultrasound Imaging System is intended for use in healthcare facilities such as hospitals, clinics and facilities where ultrasound testing is performed.

Device Description

The VistaScan™ USB Ultrasound Imaging System is a self-contained portable single-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering B operating mode, parameter controls, and recording functions. The selection of transducers offered with the system permit a wide range of clinical applications including Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Muscular-skeletal, Urology, Gynecology, Pelvic Floor, Neuromuscular, and Peripheral Vessel.

The initial operational settings for each transducer are preprogrammed in the system. User-customized parameter settings for each transducer may be set by the operator within a specific range which is controlled by the transducer hardwareffirmware and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the Cine function.

The VistaScan™ USB Ultrasound Imaging System is a B-Mode scanner and supports a wide variety of applications. It is an ultrasound scanner providing high resolution and high penetration performance. Probes are supported in frequencies from 2.5 MHz to 10.0 MHz. The product family uses non-array, curved, and flat linear array transducers and includes two General Purpose (GP) probes and a Small Parts (SP) probe. The probes can be connected to a USB 2.0 port (micro USB and USB-C).

System Components:

Android™ based device operating VistaScan™ application .
Transducer GP-3.5 ●
Transducer GP-C01 ●
. Transducer SP-L01

AI/ML Overview

This looks like a 510(k) summary for a medical device called "VistaScan™ USB Ultrasound Imaging System." Unfortunately, this document does not contain the details necessary to answer your specific questions about acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's why and what information is missing:

No specific acceptance criteria: The document mentions "predetermined acceptance criteria" for verification testing but does not list what those criteria actually are (e.g., specific performance metrics like sensitivity, specificity, accuracy, image resolution values, etc.).
No detailed study results: It states "VistaScan™ successfully passed verification testing" and "The results support substantial equivalence," but it does not provide the actual quantitative results of these tests against the acceptance criteria.
No information on clinical validation studies: While it states "VistaScan™ USB Ultrasound Imaging System introduces no new indication for use, modes, features, or technologies relative to the predicate devices that require animal or clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices," this means they did not conduct a new clinical study. They are relying on the known safety and effectiveness of the predicate devices. Therefore, there are no details on sample size, data provenance, ground truth, expert opinions, MRMC studies, or standalone performance for this specific device's clinical performance.

Based on the provided document, I cannot create the requested table or answer most of your detailed questions regarding acceptance criteria and the study proving the device meets them because that information is not present.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway in the US that often relies on comparison to existing legally marketed devices rather than extensive de novo clinical trials for performance metrics.

Here's what I can extract from the document related to testing, but it falls short of your request:

Non-Clinical Performance Testing Mentioned:

The VistaScan™ USB Ultrasound Imaging System underwent evaluation against relevant requirements in the "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff, June 27, 2019." The areas of evaluation included:

Acoustic Output
Clinical measurement accuracy and system sensitivity
Thermal, mechanical, and electrical safety
Patient-contacting materials
Cleaning, disinfection, sterilization, and pyrogenicity
Software

Electrical Safety / Electromagnetic Compatibility:

Standards referenced: IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) and IEC/EN 60601-1-2:2014.
Conditions: Evaluation was performed for use of the transducer with a specific computer model (HP Netbook).
User Responsibility: Use of alternate USB 2.0 compatible computer hardware requires verification by the end user (as stated in the Instructions for Use).

Standards Conformity:

The device references the following FDA recognized standards:

IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) (FDA Recognition#: 19-4): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC/EN 60601-1-2:2014 4th Ed. (FDA Recognition#: 19-8): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
IEC 60601-2-37:2007 (FDA Recognition#: 12-293): Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

Regarding your specific questions, here's what the document indicates or lacks:

A table of acceptance criteria and the reported device performance: Not provided. The document states "predetermined acceptance criteria" were used and "VistaScan™ successfully passed verification testing," but does not list the criteria or the quantitative performance results.
Sample size used for the test set and the data provenance: Not provided. This document does not describe a performance study with a distinct test set of imaging data. The evaluations mentioned are primarily non-clinical engineering and safety tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No clinical ground truth establishment for a test set is described.
Adjudication method for the test set: Not applicable/Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study was not done. The document states that clinical safety/effectiveness is "well accepted for both predicate and subject devices" due to similar indications/features, implying no new clinical trials were performed for this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is an ultrasound imaging system, not an AI-driven image analysis or diagnostic algorithm in the sense of standalone performance evaluation like an AI CADe/CADx device. The "Software control" is listed as "Standalone," which refers to the software being self-contained, not a standalone AI algorithm's diagnostic performance.
The type of ground truth used: Not applicable/Not provided. Clinical ground truth (pathology, expert consensus, outcomes) is not discussed because no clinical performance study for this device's imaging capabilities is detailed. The ground truth for engineering tests would be instrument readings or established safety limits.
The sample size for the training set: Not applicable/Not provided. There is no mention of a training set as this document doesn't describe an AI/machine learning model that requires a training set for clinical diagnostic performance.
How the ground truth for the training set was established: Not applicable/Not provided.

In summary, this document is a regulatory submission demonstrating substantial equivalence based on technical specifications and non-clinical testing against recognized standards, rather than a detailed report of a clinical performance study with defined acceptance criteria and results against those criteria.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 23, 2020

Emagine Solutions Technology, LLC % Ms. Michelle Lott Senior RA & QA Consultant Lean RAQA, LLC 12602 North Summerwind Drive MARANA AZ 85658

Re: K192170

Trade/Device Name: VistaScan™ USB Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: December 18, 2019 Received: December 23, 2019

Dear Ms. Lott:

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) K192170

Device Name

VistaScan™ USB Ultrasound Imaging System

Indications for Use (Describe) The VistaScan™ USB Ultrasound Imaging System is intended for diagnostic ultrasound imaging in B mode for the following applications: Fetal/obstetric Gynecology Abdominal Pediatric Small organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Pelvic floor Neuro-muscular Peripheral vessel

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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K192170

510(k) Summary

GENERAL INFORMATION

This 510(k) Summary is submitted in accordance with 21 CFR 807, Section 807.92.

Submitted by:

Owner's Name:Address:Contact:Title:Tel:Fax:Email:	Emagine Solutions Technology, LLC9040 S. Rita Road, Suite 1270 Tucson, AZ 85747Courtney WilliamsCEO+1 (520) 485-9905Nonecourtney.williams@emaginesolutionstech.com
Contact Person:
Name:Title:Tel:Email:	Michelle LottSenior RA & QA Consultant at Lean RAQA, LLC+1 (520) 275 9838michelle@leanraqa.com
Date Prepared:	January 15, 2020
Trade Name:	VistaScan™ USB Ultrasound Imaging System
Common Name:	Diagnostic Ultrasound System and Accessories
Classification Name:Classification:	Ultrasonic pulsed echo imaging system, Diagnostic UltrasoundTransducerClass II
Product Code:	IYO, ITX
Regulation Number:	892.1560, 892.1570
Predicate Device(s):	Interson USB Ultrasound System, Interson Corporation.(K163443) (Primary Predicate device)
	Interson USB Ultrasound Probe System, Interson Corporation.(K070907)
Reference Device:	Philips Lumify(K152899)

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DEVICE DESCRIPTION:

System Components:

Android™ based device operating VistaScan™ application .
Transducer GP-3.5 ●
Transducer GP-C01 ●
. Transducer SP-L01

Supported Hardware

The VistaScan™ USB Ultrasound Imaging System has been verified and validated on the Samsung Galaxy S4 Tablet using the Android software Operating System (OS). Device safety and performance cannot be assured when using other computing hardware which utilizes the Android OS. Computing hardware other than the Samsung Galaxy S4 Tablet using the Android software Operating System (OS) is not supported and should not be used with the VistaScan USB Ultrasound Imaging System.

Automated Safety/Performance Checks

The VistaScan™ USB Ultrasound Imaging System includes several automated safety/performance checks to verify that the USB ultrasound probe is functioning properly prior to use. These automated performance checks include:

System Initialize
. Hardware Initialize
Hardware Check ●
Probe ID Code Read ●
. Setup Control

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INTENDED USE / INDICATIONS FOR USE:

The VistaScan™ USB Ultrasound Imaging device is intended for diagnostic ultrasound imaging in B mode for the following applications:

. Fetal/obstetric
Gynecology ●
Abdominal ●
Pediatric ●
Small Organ ●
Musculo-skeletal (conventional) ●
Musculo-skeletal (superficial)
Urology
Pelvic Floor ●
Neuro-muscular
. Peripheral Vessel

PRODUCT MODELS:

Model	Track	Common Applications
Transducer Model GP 3.5 MHz	1	Fetal, Abdominal, Small Organ
Transducer Model GP-C01	3	Fetal/Obstetric, Abdominal, Pelvic Floor, Urology, Musculoskeletal, Small Organs, Neuromuscular
Transducer Model SP-L01	3	Pediatric, Small Organs, Peripheral Vessel, Pelvic Floor

Table 1: Common Applications of Transducer Models

LABELING AND TECHNOLOGICAL CHARACTERISTICS COMPARISON:

Both the proposed VistaScan™ USB Ultrasound Imaging System and the predicate devices are provided nonsterile. They use similar packaging systems except for adapted product documentation (instructions for use in package labeling). The proposed VistaScan™ device has an identical intended use for B mode imaging, and similar technology characteristics to the currently marketed Interson USB Ultrasound Probe System (K070907, K163443). Technological differences are limited to the software operating system. The VistaScan™ device uses a commercially available electronic mobile device with an Android-based operating system, while the predicate Interson USB Ultrasound Probe System (K070907, K163443) device uses a proprietary Windows-based imaging system. All other technological features are substantially equivalent to the Interson USB Ultrasound Probe System (K070907, K163443). The reference device was selected as a point of comparison for the software operating system. Both the

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VistaScan™ device and the reference device, Philips Lumify (K152899), use an Android based operating system.

DeviceFeatures	Subject Device:VistaScan ™ USBUltrasoundImaging System	Primary Predicate:Interson UltrasoundSystem: K163443	Secondary Predicate:Interson UltrasoundSystem K070907	Reference Device:Philips Lumify K152899
Intended Use	Diagnostic ultrasoundimaging in B mode.	Diagnostic ultrasoundimaging in B, colorDoppler and Combined(B + Color)modes.	Diagnostic ultrasoundimaging in B mode (alltransducers), A mode(ophthalmic)	Diagnostic ultrasoundimaging in B, colorDoppler, and Combined(B + Color)modes.
Indications forUse	Indicated for diagnosticultrasound imaging inspecified applications	Indicated for diagnosticultrasound imaging andfluid flow analysis inspecified applications	Indicated for diagnosticultrasound imaging inspecified applications	Indicated for diagnosticultrasound imaging andfluid flow analysis inspecified applications
ArrayGeometry	Non-ArrayCurved and linear	Curved and linear	Non-Array	Curved and linear
Mechanics	MechanicalSolid State	Solid State	Mechanical	Solid State
Softwareplatform	Commercial off-the-shelfoperating system(Android)	Commercial off-the-shelfoperating system(Windows)	Commercial off-the-shelfoperating system(Windows)	Commercial off-the-shelf operating system(Android)
Softwarecontrol	Standalone	Standalone	Standalone	Standalone
Measurementfunction	2D measurement	2D measurement andarea measurement	2D measurement tool	2D measurement tool
Wirelessnetworking	Not supported	Not supported	Not supported	Supported
Connector	USB	USB	USB	USB

Table 2: Predicate Comparison Table

NON-CLINICAL PERFORMANCE TESTING

The VistaScan™ USB Ultrasound Imaging System was generally evaluated against relevant requirements in Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Guidance for Industry and Food and Drug Administration Staff, June 27, 2019.

Acoustic Output ●
Clinical measurement accuracy and system sensitivity
Thermal, mechanical, and electrical safety ●
Patient -contacting materials ●
Cleaning, disinfection, sterilization, and pyrogenicity
Software ●

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Verification testing was conducted against predetermined acceptance criteria and recognized standards1 to show that the subject device performs functions equivalent to the predicate device. VistaScan™ successfully passed verification testing. The results support substantial equivalence to the predicate device and demonstrate that is safe and effective for its intended use.

Electrical Safety / Electromagnetic Compatibility

Evaluation per standard IEC 60601 1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) and IEC/EN 60601-1-2:2014 was performed for use of the transducer with a specific computer model (HP Netbook). Use of alternate USB 2.0 compatible computer hardware requires verification by the end user. Further information is provided in the Instructions for Use.

Standards Conformity

The VistaScan™ USB Ultrasound Imaging System references the following FDA recognized standards:

Standard Number/FDA Recognition#	Standard Name
IEC 60601 1: 2005 + CORR. 1 (2006) +	Medical electrical equipment-Part 1: General
CORR. 2 (2007),	requirements for basic safety and essential performance
FDA Recognition#: 19-4
IEC/EN 60601-1-2:2014 4th Ed.	Medical electrical equipment -Part 1-2: General
FDA Recognition#: 19-8	requirements for basic safety and essential performance .
	Collateral Standard: Electromagnetic disturbances -
	Requirements and tests
IEC 60601-2-37:2007	Medical electrical equipment -Part 2-37: Particular
FDA Recognition#: 12-293	requirements for the basic safety and essential
	performance of ultrasonic medical diagnostic and
	monitoring equipment

ANIMAL AND CLINICAL TESTING

VistaScan™ USB Ultrasound Imaging System introduces no new indication for use, modes, features, or technologies relative to the predicate devices that require animal or clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.

CONCLUSION OF COMPARISON

The VistaScan™ USB Ultrasound Imaging System device and its predicate device are technologically The devices are identical in their use of probes, and similar in design, materials, and similar. technological characteristics. The packaging and labeling has been designed to provide sufficient information to the user to ensure the safe and effective use of the proposed device. Furthermore, the proposed device is comparable to the reference device which was cleared for the same intended use for B mode operation, the same indication for use, and utilizes the same operating platform. The proposed device does not raise substantial new questions of safety or effectiveness. Therefore, the proposed device (VistaScan™ USB Ultrasound Imaging System) is determined to be substantially equivalent to the predicate device.

1 Electrical Safety and EMC standards are applied by 'right of reference'.

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.