The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body; the intended uses are:

Small Organ (prostate) Transrectal

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

Device Description

The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and quidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

AI/ML Overview

The provided FDA 510(k) summary for the ExactVu High Resolution Micro-Ultrasound System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria related to its diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards rather than clinical performance metrics.

Specifically, the "Summary of Clinical Tests" section on page 10 explicitly states: "The ExactVu System, transducers and needle guide, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done
If a standalone performance (algorithm only) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a cascading manner. The profiles are depicted in a dark color, creating a sense of depth and unity. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 2, 2016

Exact Imaging, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K162972

Trade/Device Name: ExactVu High Resolution Micro-Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX, OIJ Dated: November 29, 2016 Received: November 30, 2016

Dear Mr. Job:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael O'Hara

For

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) TBD

Device Name

ExactVuTM High Resolution Micro-Ultrasound System

Indications for Use (Describe)

Small Organ (prostate) Transrectal

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

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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing StIVices (301) 443-6740 EF

{3}------------------------------------------------

Table 1.3.1: Diagnostic Ultrasound Indications for Use Form – ExactVu™ High Resolution Micro-Ultrasound System

System:	ExactVu TM High Resolution Micro-Ultrasound System
Transducer:	NA
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	Mode of Operation
	B(2D)	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominalorgans and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid,testicles, prostate)	N						1
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N						1
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)
DERMATOLOGY

Additional Comments:

1: Includes imaging to assist in the placement of needles for prostate biopsy procedures.

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

Table 1.3.2: Diagnostic Ultrasound Indications for Use Form – EV29L™ High Resolution Transrectal Side-fire Transducer

System:	ExactVu™ High Resolution Micro-Ultrasound System
Transducer:	EV29L
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	Mode of Operation
	B(2D)	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid,testicles, prostate)	N						1
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N						1
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)DERMATOLOGY

Additional Comments:

1: Includes imaging to assist in the placement of needles for prostate biopsy procedures.

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

Table 1.3.3: Diagnostic Ultrasound Indications for Use Form – EV9C™ Transrectal End-fire Transducer

System:	ExactVu TM High Resolution Micro-Ultrasound System
Transducer:	EV9C
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	Mode of Operation
	B(2D)	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid,testicles, prostate)	N						1
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N						1
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)DERMATOLOGY

Additional Comments:

1: Includes imaging to assist in the placement of needles for prostate biopsy procedures.

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

Table 1.3.3: Diagnostic Ultrasound Indications for Use Form – Needle guide for use with EV29L™ High Resolution Transrectal Side-fire Transducer

System:	ExactVuT™ High Resolution Micro-Ultrasound System
Transducer:	EV29L
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application	Mode of Operation
	B(2D)	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid,testicles, prostate)	N						1
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N						1
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)DERMATOLOGY

Additional Comments:

1: Provides a mechanical means for performing needle / instrument guided procedures with the use of the diagnostic ultrasound transducer, EV29L

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

Image /page/7/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.

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.

1) Submitter's name, address, telephone number, contact person:

Exact Imaging, Inc. 7676 Woodbine Avenue Markham, ON L3R 2N2 Canada

Corresponding Official:	Karina TorresManager, Regulatory Affairs and Quality Assurance
E-mail:	ktorres@exactimaging.com
Telephone:	(905) 415-0030
Facsimile:	(905) 415-0031
Date prepared:	September 1st, 2016

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

ExactVu™ High Resolution Micro-Ultrasound System

Classification Names

Name	FR Number	Product Code
Ultrasonic pulsed echo imaging system	892.1560	IYO
Diagnostic Ultrasound Transducers	892.1570	ITX
Biopsy Needle Guide	892.1560	OIJ

Classification Panel

Radiology

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is written in a light green sans-serif font, with a plus sign in the middle of the "C". Below the word "EXACT" is the word "IMAGING" in a gray sans-serif font.

3) Identification of the predicate or legally marketed device:

Flex Focus 1202 Ultrasound Scanner (K081154) (Primary Predicate) ●
. FUJIFILM SonoSite Vevo MD Imaging system (K160674) (Reference Device)

4) Device Description:

5) Intended Use:

Small Organ (prostate) Transrectal

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

6) Technological Characteristics:

The ExactVu High Resolution Micro-Ultrasound System ("ExactVu") that is the subject of this submission is substantially equivalent to the predicate devices. The same fundamental scientific technology and general ultrasound principles that are used for ExactVu are also used on the predicate devices indicated. Each of ExactVu and the indicated predicates are Track 3 devices.

Feature	ExactVu	Flex Focus 1202 (PrimaryPredicate)	Vevo MD (ReferenceDevice)
Manufacturer	Exact Imaging Inc.	BK Medical	FUJIFILM SonoSite
Intended use(Clinicalapplication)	TransrectalSmall Parts (organs)	AbdominalCardiacFetal (incl. Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMusculo-skeletal	Abdominal PediatricSmall Organ (breast, thyroid, testicles, prostate)Musculo-skeletal (conventional)Musculo-skeletal (superficial)Peripheral vesselDermatology

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is written in a light green sans-serif font, with a plus sign above the "C". Below the word "EXACT" is the word "IMAGING" in a smaller, gray sans-serif font. The logo is simple and modern.

Modes of Operation	B-mode (2-D GrayscaleImaging, Transverse,CFM and combinations	B-mode (2-D GrayscaleImaging, M, PWD, CFM andcombinations, TissueHarmonic Imaging	B-mode (2D GrayscaleImaging)Color DopplerCombination ModesM-mode
MI Indication	Yes	Yes	Yes
TI Indication	Yes	Yes	Yes
Electrical Safety	TUV, IEC 60601-1	UL, IEC 60601-1	CSA IEC 60601-1
510(k) Track	Track 3	Track 3	Track 3
Center FrequencyRange	3.5-29 MHz	1.8-18 MHz	15-49MHz
Transducer Types	Endocavity LinearEndocavity CurvedArray	Endocavity LinearEndocavity Curved ArrayEndocavity BiplaneEndocavity TriplaneLinearCurved Array	Linear Array
#TransmitChannels	128 channels	Not available	64 digital channels
#Receive Channels	128 channels	Not available	64 digital channels
DICOM	Not supported	DICOM, Print, ModalityWorklist, StorageCommitment, ModalityPerformed Procedure Steps(MPPS)	DICOM 3.0 StorePrintModality WorklistPerform ProcedureStep (PPS)Storage CommitmentNEMA PS3.15 2003

7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The ExactVu System has been evaluated for electrical, thermal, mechanical and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Evaluation. All patient contact materials are biocompatible and are materials that are already used in other legally marketed devices or meet 10993-1.

The ExactVu System is designed to comply with the following voluntary standards:

{10}------------------------------------------------

Image /page/10/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 "O". Below the word "EXACT" is the word "IMAGING" written in gray. The logo is simple and modern.

Reference No	Recognition No	Title
AAMI/ANSI/ISO10993-1	2-156	ISO 10993-1:2009, Biological evaluation ofmedical devices -- Part 1: Evaluation andtesting within a risk management process
IEC 60601-1	19-4	AAMI / ANSI ES60601-1:2005/(R) 2012 andA1:2012,, c1:2009/(r)2012 anda2:2010/(r)2012. Medical electricalequipment - part 1: general requirements forbasic safety and essential performance (iec60601-1:2005, mod)
IEC 60601-1-2	19-1	IEC 60601-1-2:2007, Medical electricalequipment - Part 1-2: General requirementsfor basic safety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements and tests(Edition 3)
IEC 60601-2-37	9-91	IEC 60601-2-18: Edition 3.0 2009-08,Medical Electrical Equipment - Part 2-18:Particular Requirements For The BasicSafety And Essential Performance OfEndoscopic Equipment.
IEC 60601-2-37	12-209	IEC 60601-2-37:2007, ParticularRequirements for the basic safety andessential performance of ultrasonic medicaldiagnostic and monitoring equipment
NEMA UD 2-2004	12-105	Acoustic Output Measurement Standard forDiagnostic Ultrasound Equipment
NEMA UD 3-2004	12-100	Standard for Real-Time Display of Thermaland Mechanical Acoustic Output Indices onDiagnostic Ultrasound Equipment, AmericanInstitute of Ultrasound in Medicine

Summary of Clinical Tests:

The ExactVu System, transducers and needle guide, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

8) Conclusion:

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The ExactVu device and predicate devices conform to applicable electromedical device safety standards with compliance verified through independent evaluation and meet FDA requirements for Track 3 devices, have biosafety equivalence and

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for "EXACT IMAGING". The word "EXACT" is in green, and the word "IMAGING" is in gray. There is a plus sign above the "C" in "EXACT".

are manufactured using the same ISO 13485 quality system. Exact Imaging, Inc. believes that the ExactVu system is substantially equivalent with regard to safety and effectiveness to the predicate devices.

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.