The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified physicians, physician assistants, sonographers and ultrasound technicians in a healthcare facility for diagnostic ultrasound imaging or fluid flow analysis of the human body in B-Mode (2D), Color Flow Imaging Modes (Color Doppler and Power Doppler) and Combined (B-Mode + CFI Modes). The indications for use are:

Small Organ
Transrectal ●
Abdominal ●

Device Description

The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System comprises of transducers responsible for ultrasound signal generation and recording, needle guides and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

AI/ML Overview

The provided document describes the FDA 510(k) summary for the ExactVu™ High Resolution Micro-Ultrasound System (K192303). It outlines the device, its intended use, comparison to a predicate device, and non-clinical performance testing.

However, the document explicitly states:
"This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing."

This means that the provided text does not contain any information about a clinical study involving the device's performance against acceptance criteria in a real-world setting with human subjects, AI assistance, or expert readers. The document focuses solely on non-clinical performance testing (e.g., functional verification, human factors, biocompatibility, electrical safety, acoustic testing) to establish substantial equivalence to a previously cleared predicate device.

Therefore, I cannot provide answers to the requested points that pertain to clinical study data, such as:

A table of acceptance criteria and reported device performance from a clinical study.
Sample size used for a test set (clinical).
Number of experts and qualifications for ground truth establishment.
Adjudication method for a clinical test set.
MRMC comparative effectiveness study results.
Standalone (algorithm only) performance.
Type of ground truth used (clinical).
Sample size for the training set (clinical).
How ground truth for the training set was established (clinical).

Based on the provided text, the device's acceptance was based on non-clinical performance testing demonstrating substantial equivalence to a predicate device, not on a clinical study with a test set, expert readers, or AI performance metrics.

Summary

{0}------------------------------------------------

October 1, 2019

Image /page/0/Picture/1 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 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.

Exact Imaging, Inc. % Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114

Re: K192303

Trade/Device Name: ExactVu™ High Resolution Micro-Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OIJ Dated: September 23, 2019 Received: September 24, 2019

Dear Prithul Bom:

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)

K192303

Device Name

ExactVuTM High Resolution Micro-Ultrasound System

Indications for Use (Describe)

The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified physicians, physician assistants, sonographers and ultrasound techniciare facility for diagnostic ultrasound imaging or fluid flow analysis of the human body in B-Mode (2D), Color Flow Imaging Modes (Color Doppler and Power Doppler) and Combined (B-Mode + CFI Modes). The indications for use are:

Small Organ
Transrectal
Abdominal

The system may be used with patients of all ages, but is not designed for pediatric or fetal use.

The system is contraindicated for direct cardiac application and for ophthalmic use or any application that causes the acoustic beam to pass through the eye.

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)

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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is in a light green color, with a plus sign in the middle of the "C". Below the word "EXACT" is the word "IMAGING" in a gray color. The logo is simple and modern.

Date: 17-July-2019

K192303 510(k) Summary

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

Manufacturer:	Exact Imaging, Inc.
Address:	7676 Woodbine Avenue, Unit 15Markham, ON L3R 2N2Canada
Establishment Registration:	3012402886
Contact Name:	Ms. Sam Rajkumar, MS, RAC, RN
Title:	Manager, Regulatory Affairs & QualityAssurance
Phone Number:	+1 905 415 1654
Device Proprietary Name:	ExactVu ™ High Resolution Micro-Ultrasound System
Device Common or Usual Name:	Diagnostic Ultrasound System withAccessories
Classification Panel:	Radiology
Product Code:	IYN, IYO, ITX, OIJ
Regulation Number:	21 CFR 892.1550, 892.1560, 892.1570
Regulation Class:	II
Regulation Description:	Ultrasonic pulsed echo imaging system,Diagnostic Ultrasound Transducers,Biopsy Needle Guide,Ultrasonic pulsed doppler imaging system

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for "EXACT Imaging". The word "EXACT" is written in a light green color, with a plus sign in the same color above the "C". Below the word "EXACT", the word "IMAGING" is written in gray.

Predicate Devices:

Substantial equivalence is claimed to the following device:

Trade name	Manufacturer	510(k) Number	Date Cleared
ExactVu™ HighResolution Micro-Ultrasound System	Exact ImagingInc.	K190995	May 10, 2019

Reference Devices:

The following reference devices have been used:

Trade name	Manufacturer	510(k) Number	Date Cleared
CIVCO DisposableTemplate Grid	CIVCO MedicalInstruments Co.,Inc.	K131161	September 17,2013
CIVCO Poly UltrasoundTransducer Cover	CIVCO MedicalInstruments Co.,Inc.	K970513	June 20, 1997

Device Description:

Intended Use /Indications for use:

Small Organ
Transrectal ●
Abdominal ●

The system may be used with patients of all ages, but is not designed for pediatric or fetal use.

The system is contraindicated for direct cardiac application and for ophthalmic use or any application that causes the acoustic beam to pass through the eye.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is in green, with a plus sign in the middle of the "C". Below the word "EXACT" is the word "IMAGING" in gray. The logo is simple and modern.

Summary of Technological Comparisons:

The ExactVu High Resolution Micro-Ultrasound System is an enhanced implementation of the previous FDA-cleared version of ExactVu High Resolution Micro-Ultrasound System.

The primary function of both devices is for diagnostic ultrasound imaging, data processing and quidance of puncture and biopsy. The primary difference between ExactVu High Resolution Micro-Ultrasound and the predicate device is enhanced functionality through the introduction of a new accessory and minor workflow improvements.

Main advantages compared to the predicate device are:

Minor workflow improvements: bugs fixed and EV29L angle reset. .
Additional support for Transperineal Biopsies. ●

There are no known disadvantages.

ExactVu High Resolution Micro-Ultrasound System remains substantially unchanged from the predicate with respect to its intended use and performance claims.

Nonclinical Performance Testing

Verification and validation testing have been conducted on the ExactVu High Resolution Micro-Ultrasound system to ensure the safety and effectiveness of the device to perform in accordance to its intended use. The following table provides a summary of the testing performed on the ExactVu High Resolution Micro-Ultrasound.

Type	Activity	Description of Activity	DocumentationResults
SystemVerificationandValidation	Functionalverification ofintegratedsystem	Test of ExactVu Systemand test cases developedto verify systemspecifications.	The ExactVu Systemmeets all systemspecifications which isevident through theacceptance ofVerification andValidation Results.
SystemVerificationandValidation	Testing ofresolvedanomalies	Testing of anomaliespresent in previouslyreleased versions of thedevice that have beenresolved in the ExactVurelease.	Previous errors weretested and verified tono longer occur.
SystemVerificationandValidation	User acceptancetesting	Testing of ExactVuSystem to validate	The ExactVu Systemmeets all usability
Type	Activity	Description of Activity	DocumentationResults
		customer needs andintended use.	specifications which isevident through theacceptance ofVerification andValidation Results.
	Human FactorsValidation	Testing of critical featuresby intended users todetermine if device issafe and effective forintended users, uses andenvironments per IEC62366 and FDAGuidance: "ApplyingHuman Factors andUsability Engineering toMedical Devices".	The ExactVu Systemcompiles with IEC62366 and FDAGuidance: "ApplyingHuman Factors andUsability Engineeringto Medical Devices."
	SystemValidation	Product specifications arevalidated by intendeduser in a simulated useenvironment to validatecustomer needs andintended use.	The ExactVu Systemmeets all productspecifications which isevident through theacceptance ofVerification andValidation Results.
	Biocompatibility	Verify that all patientcontacting materials aresafe for contact withhumans throughconformance with ISO10993.	All patient contactmaterials arebiocompatible andcomply with ISO10993-1.
	Sterilization	Validation of sterilizationparameters per ISO11135 and ISO 10993-7.	All sterilizedaccessories complywith ISO 11135 andISO 10993-7.
	MedicalElectrical SystemSafety	External testing againstthe requirements of IEC60601-1 to verifyelectrical and mechanicalsafety of the system	The ExactVu Systemcomplies with IEC60601-1.
Type	Activity	Description of Activity	DocumentationResults
	ElectromagneticCompatibility	External testing againstthe requirements of IEC60601-1-2 to verify thatthe system operateswithin safe limits ofemission and interferencerequirements.	The ExactVu Systemcomplies with IEC60601-1-2.
	Acoustic Testing	The acoustic outputwas measured againstrequirements of IEC60601-2-37:2015, IEC62127-1 :2007, IEC62359:2010 andGuidance for Industryand Food and DrugAdministration Staff:Marketing Clearance ofDiagnostic UltrasoundSystems andTransducers issued onJune 27, 2019.	The Acoustic Testingfor the ExactVuSystem is performedand reported incompliance with IEC60601-2-37:2015, IEC62127-1 :2007, IEC62359:2010 andGuidance for Industryand Food and DrugAdministration Staff:Marketing Clearance ofDiagnostic UltrasoundSystems andTransducers issued onJune 27, 2019.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is written in green, with a plus sign in the middle of the "C". Below the word "EXACT" is the word "IMAGING" written in gray.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is written in green, with a plus sign above the "C". Below the word "EXACT" is the word "IMAGING" written in gray. The logo is simple and modern.

Clinical Testing

This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing.

Conclusion

ExactVu High Resolution Micro-Ultrasound has been shown through comparison and performance testing to be substantially equivalent to the identified predicate device. Any technological differences do not raise new questions of safety and effectiveness.

Regulation Number and Section

N/A