The Exact Vu micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use (clinical applications) 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.

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 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 text is a 510(k) summary for the ExactVu™ High Resolution Micro-Ultrasound System (K190995). It explicitly states that no clinical studies were required or performed to support the determination of substantial equivalence for this device and its transducers/needle guides.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, and MRMC studies for a clinical trial is not available within this document. The submission relies on non-clinical tests and a comparison to a predicate device to demonstrate substantial equivalence.

Here's a breakdown of the information that is available based on your request, highlighting the absence of clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available from a clinical study within the provided document, as no clinical studies were performed. The document focuses on regulatory compliance and technological characteristics in comparison to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as no clinical test set was used for a clinical study to demonstrate performance. The submission relies on non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as no clinical test set was used requiring expert ground truth for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as no clinical test set requiring adjudication was used.

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

An MRMC comparative effectiveness study was not performed. The document states that the ExactVu system did not require clinical studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

A standalone performance study was not performed in a clinical context. The device is an imaging system intended for use by qualified medical professionals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable as no clinical studies requiring a ground truth were performed. Safety and effectiveness were established through non-clinical compliance with standards and comparison to a predicate device.

8. The sample size for the training set

This information is not applicable as no clinical studies involving a training set for an AI/algorithm were performed or reported in this device submission.

9. How the ground truth for the training set was established

This information is not applicable as no clinical studies involving a training set were performed or reported in this device submission.

Summary from the document (Section 7, "Summary of Clinical Tests"):

"The ExactVu System, transducers and needle guides, subject of this submission, did not require clinical studies to support the determination of substantial equivalence. An analysis of clinical literature, adverse event and recall data is provided in the clinical evaluation justifies the safety and efficacy of the functionality of the ExactVu device without pre-market clinical investigation." (Page 14)

The device's substantial equivalence was supported by:

Non-clinical tests for electrical, thermal, mechanical, and EMC safety.
Evaluation of cleaning/disinfection and biocompatibility.
Compliance with recognized voluntary standards (e.g., AAMI/ANSI/ISO 10993-1, IEC 60601-1, IEC 60601-2-37, NEMA UD 2-2004).
Demonstration of a comparable quality system (ISO 13485:2016 and MDSAP).
Comparison of technological characteristics to a predicate device (ExactVu 2.0, K180636) and a reference device (Ultrasound Scanner Flex Focus 1202, K132335).

Summary

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Image /page/0/Picture/0 description: The image contains 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.

May 10, 2019

Exact Imaging, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive Suite 510k SAINT PAUL MN 55114

Re: K190995

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, IYX, OIJ Dated: April 12, 2019 Received: April 16, 2019

Dear Mr. Job:

We have reviewed vour 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

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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K190995

Device Name

ExactVuTM High Resolution Micro-Ultrasound System

Indications for Use (Describe)

• 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.

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

System	ExactVu™ High Resolution Micro-Ultrasound System
Transducer	N/A
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body as
	follows:
	Mode of Operation
Clinical Application	B (2DMode)	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal	N				N (3)		N (2)
Intra-operative
(Abdominal organs
and vascular)
Intra-operative
(Neuro.)
Laparoscopic
Pediatric
Small Organ	P						P, 1
(prostate)
Neonatal Cephalic
Adult Cephalic
Transrectal	P						P, 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

N= new indication; P= previously cleared ; E= added under this appendix

Items marked "P" were previously cleared by 510(k) number K180636.

1. Includes imaging to assist in the placement of needles for prostate biopsy procedures.
1. Includes imaging to assist in the placement of needles for kidney biopsy procedures.
1. ExactVu supports simultaneous color flow imaging with B-Mode.

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Diagnostic Ultrasound Indications for Use Form – 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 human body asfollows:
	Mode of Operation
Clinical Application	B (2DMode)	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Abdominal organsand vascular)
Intra-operative(Neuro.)
Laparoscopic
Pediatric
Small Organ(prostate)	P						P, 1
Neonatal Cephalic
Adult Cephalic
Transrectal	P						P, 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

N= new indication; P= previously cleared ; E= added under this appendix

Items marked "P" were previously cleared by 510(k) number K180636.

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

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

System	ExactVu™ High Resolution Micro-Ultrasound System
Transducer	EV9C
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body as
	follows:
	Mode of Operation
Clinical Application	B (2D	M	PWD	CWD	Color	Combined	Other
	Mode)				Doppler	(specify)	(specify)
Ophthalmic
Fetal
Abdominal
Intra-operative
(Abdominal organs
and vascular)
Intra-operative
(Neuro.)
Laparoscopic
Pediatric
Small Organ	P						P, 1
(prostate)
Neonatal Cephalic
Adult Cephalic
Transrectal	P						P, 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

N= new indication; P= previously cleared ; E= added under this appendix

ltems marked "P" were previously cleared by 510(k) number K180636.

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

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Diagnostic Ultrasound Indications for Use Form – EV5C™ Abdominal Transducer

System	ExactVu™ High Resolution Micro-Ultrasound System
Transducer	EV5C
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body asfollows:
	Mode of Operation
Clinical Application	B (2DMode)	M	PWD	CWD	ColorDoppler	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal	N				N (2)		N (1)
Intra-operative(Abdominal organsand vascular)
Intra-operative(Neuro.)
Laparoscopic
Pediatric
Small Organ(prostate)
Neonatal Cephalic
Adult Cephalic
Transrectal
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
System	ExactVu™ High Resolution Micro-Ultrasound System
Transducer	EV29L
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	B (2D Mode)	M	PWD	CWD	Color Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Abdominal organsand vascular)
	Intra-operative(Neuro.)
Laparoscopic
Pediatric
Small Organ(prostate)	P						P, 1
	Neonatal Cephalic
Adult Cephalic
Transrectal	P						P, 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

N= new indication; P= previously cleared ; E= added under this appendix

1. Includes imaging to assist in the placement of needles for kidney biopsy procedures.
1. ExactVu supports simultaneous color flow imaging with B-Mode.

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

N= new indication; P= previously cleared ; E= added under this appendix

Items marked "P" were previously cleared by 510(k) number K180636.

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

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Image /page/8/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.

Date: May 3, 2019

510(k) Summary

K190995

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, Unit 15 Markham, ON L3R 2N2 Canada

Corresponding Official:	Randy AuCoinPresident & CEO
Address:	Exact Imaging, Inc.7676 Woodbine Avenue, Unit 1Markham, ON L3R 2N2, Canada
E-mail:Telephone:Facsimile:	raucoin@exactimaging.com(905) 415-0030(905) 415-0031

Establishment Registration Number:

Exact Imaging, Inc.
Registration No.	3012402886
Owner/Operator No.	10053728

May 3, 2019 Date prepared:

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

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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 in the same color above the "C". Below the word "EXACT", the word "IMAGING" is written in a gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.

Classification Names

Name	CFR Number	Product Code
Ultrasonic pulsed echo imagingsystem	892.1560	IYO
Diagnostic Ultrasound Transducers	892.1570	ITX
Biopsy Needle Guide	892.1560	OIJ
Ultrasonic pulsed doppler imagingsystem	892.1550	IYN

Table 1: ExactVu Classifications

Classification Panel

Radiology

3) Identification of the predicate or legally marketed device:

ExactVu High Resolution Micro-Ultrasound System (K180636) (Primary Predicate)
Ultrasound Scanner Flex Focus 1202 by BK Medical (K132335) (Reference ● Device) (used as a Reference Device to support differences in technological characteristics)

4) Device Description:

5) Intended Use /Indications for use:

The ExactVu micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use (clinical applications) are:

Small Organ
Transrectal
Abdominal

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

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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 upper right corner of the "C". Below the word "EXACT" is the word "IMAGING" in gray. The logo is simple and modern.

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.

6) Technological Characteristics:

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

Primary differences between the subject and predicate device are support for an abdominal transducer, the addition of color flow imaging modes and the addition of a DICOM service class.

Comparisons of relevant significant features are presented in two tables below: Table 2 for a comparison between the Subject Device and the Predicate Device and Table 3 for a comparison between the Subject Device and the Reference Device.

Feature	Subject Device: ExactVu 2.5	Predicate Device:ExactVu 2.0 (K180636)
Manufacturer	Exact Imaging Inc.	Exact Imaging Inc.
Intended use /Indications forUse	The ExactVu micro-ultrasoundsystem is intended for use byqualified medical professionals fordiagnostic ultrasound imaging orfluid flow analysis of the humanbody. The indications for use(clinical applications) are:• Small Organ• Transrectal• AbdominalThe system may be used withpatients of all ages, but is notdesigned for pediatric or fetal use.The system is contraindicated fordirect cardiac application and forophthalmic use or any applicationthat causes the acoustic beam topass through the eye.	The ExactVu High ResolutionMicro-Ultrasound System isintended for use by qualifiedmedical professionals fordiagnostic ultrasound imaging orfluid flow analysis of the humanbody.The indications for use (clinicalapplications) are:• Small Organ (prostate)• TransrectalThe system may be used withpatients of all ages, but is notdesigned for pediatric or fetal use.
Modes ofOperation	B-mode (2-D Grayscale Imaging,Transverse, CFM andcombinations - Color Doppler andPower Doppler Mode)	B-mode (2-D Grayscale Imaging,Transverse, CFM and combinations
MI Indication	Yes	Yes
TI Indication	Yes	Yes

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Image /page/11/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" in gray. The logo is simple and modern.

		Predicate Device:
Feature	Subject Device: ExactVu 2.5	ExactVu 2.0 (K180636)
Electrical Safety	TUV, IEC 60601-1	TUV, IEC 60601-1
510(k) Track	Track 3	Track 3
Center	EV9C: 6.5 MHz	EV9C: 6.5 MHz
Frequency	EV29L: 22.5 MHz	EV29L: 22.5 MHz
Range	EV5C: 3.5 MHz	EV5C: 3.5 MHz
Transducer	Endocavity Linear	Endocavity Linear
Types	Endocavity Curved ArrayEV5C: Abdominal Curved Array	Endocavity Curved Array
Measurement	Manual measurements areavailable on the ultrasoundsystem, including distance, areaapproximations and volumecalculations.	Manual measurements areavailable on the ultrasoundsystem, including distance, areaapproximations and volumecalculations.
#TransmitChannels	128 channels	128 channels
#ReceiveChannels	128 channels	128 channels
DICOM	DICOM Storage SCU Version 3.0DICOM Storage Commitment SCUVersion 3.0DICOM Query Retrieve SCUVersion 3.0ExactVu reads MRI study data inDICOMDIR format, where MRImarkup uses DICOM GSPS(Grayscale Softcopy PresentationState)	DICOM Storage SCU Version 3.0DICOM Storage Commitment SCUVersion 3.0ExactVu reads MRI study data inDICOMDIR format, where MRImarkup uses DICOM GSPS(Grayscale Softcopy PresentationState)

Table 2: Technological Characteristics Comparison Between Subject Device and
Predicate Device

Feature	Subject Device:ExactVu 2.5	Reference Device:Ultrasound Scanner Flex Focus1202 (K132335)
Manufacturer	Exact Imaging Inc.	BK Medical
Intended Use /Indication forUse	The ExactVu micro-ultrasoundsystem is intended for use byqualified medical professionalsfor diagnostic ultrasoundimaging or fluid flow analysis ofthe human body. Theindications for use (clinicalapplications) are:	Ultrasound scanner andtransducers for B, Tissue andContrast Harmonic Imaging, M,PWD, CWD, Color Doppler, VectorFlow Imaging and combined modeimaging. Signal analysis anddisplay.
Feature	Subject Device:ExactVu 2.5	Reference Device:Ultrasound Scanner Flex Focus1202 (K132335)
	Small Organ Transrectal AbdominalThe system may be used withpatients of all ages, but is notdesigned for pediatric or fetaluse.The system is contraindicatedfor direct cardiac application andfor ophthalmic use or anyapplication that causes theacoustic beam to pass throughthe eye.	Guidance of biopsy needles,geometrical measurements andcalculation of parameters. Anoptional 3-DI unit can reconstruct aseries of 2-DI images into a single3-DI volume and display this on thescreen.An optional Vector Flow Imaging(VFI) module: Color Flow Mapping(CFM) imaging mode with theability to visualize both the axialand the transverse velocity.
AbdominalTransducer	Abdominal Curved Array(transducer model EV-5C)Center Frequency: 3.5 MHzMaximum depth: 180 mmGlobal Maximum Outputs/WorstCase Settings 2D mode Ispta.3: 11.93 mW/cm2 TI Type: TIS TI Value: <1.0 MI: 1.04 Ipa.3@MI_Max:117.8 W/cm2 CFI mode Ispta.3: 42.84 mW/cm2 TI Type: TIS TI Value: 1.00	Abdominal Curved Array(transducer model 8823)Center Frequency: 1.8-6 MHzMaximum depth: 171-260mmdepending on settingsGlobal Maximum Outputs/WorstCase Settings Ispta.3: 720 mW/cm2 TI Type: TIC TI Value: 6.0 MI: 1.9 Ipa.3@MI_Max: 367 W/cm2Patient contact material: notavailable
	Subject Device:	Reference Device:Ultrasound Scanner Flex Focus
Feature	ExactVu 2.5	1202 (K132335)
	Ipa.3@MI_Max:79.29 W/cm2 Patient contact material: Epotek301, PEEK LSG, Polyurethane,Rexolite, Silicon
Modes ofOperation	Color flow imaging maps fluidflow velocities over the 2Dimage using color. ExactVuprovides two color flow imagingmodes ("CFI Modes"): Color Doppler Mode Power Doppler Mode	Color mode (CFM, color flowmapping, color Doppler)ultrasound displays color-codedreal-time information aboutdirection and velocity of flow inthe tissues. Power mode displays color-coded information about theamount of flow but not thedirection.
DICOM	DICOM Storage SCU Version 3.0DICOM Storage CommitmentSCU Version 3.0DICOM Query Retrieve SCUVersion 3.0ExactVu reads MRI study data inDICOMDIR format, where MRImarkup uses DICOM GSPS(Grayscale SoftcopyPresentation State)	DICOM, Print, Modality Worklist,Storage Commitment, ModalityPerformed Procedure Steps (MPPS)

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Image /page/12/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", the word "IMAGING" is written in gray.

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Image /page/13/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is written in green, with a plus sign in the same color above the "C". Below the word "EXACT", the word "IMAGING" is written in gray. The logo is simple and modern, and the colors are clean and professional.

Table 3: Technological Characteristics Comparison Between Subject Device and Reference Device

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, Risk Mitigation, Clinical Evaluation.

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Image /page/14/Picture/0 description: The image shows the logo for "EXACT Imaging". The word "EXACT" is in a light green color, with a plus sign above the "C". Below "EXACT" is the word "IMAGING" in a gray color. The logo is simple and modern.

All patient contact materials are biocompatible and are materials that are already used in other legally marketed devices or meet 10993-1.

Reference No	RecognitionNo	Title
AAMI/ANSI/ISO10993-1	2-220	ISO 10993-1:2009, Biological evaluation ofmedical devices -- Part 1: Evaluation and testingwithin a risk management process
IEC 60601-1	19-4	AAMI / ANSI ES60601-1:2005/(R) 2012 andA1:2012, c1:2009/(R) 2012 and a2:2010/(R)2012. Medical electrical equipment - part 1:general requirements for basic safety andessential performance (IEC 60601-1:2005, mod)
IEC 60601-1-2	19-1	IEC 60601-1-2:2014, Medical electricalequipment - Part 1-2: General requirements forbasic safety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements and tests (Edition3)
IEC 60601-2-18	9-91	IEC 60601-2-18: Edition 3.0 2009-08, MedicalElectrical Equipment - Part 2-18: ParticularRequirements For The Basic Safety And EssentialPerformance Of Endoscopic Equipment.
IEC 60601-2-37	12-209	IEC 60601-2-37:2015, Particular Requirementsfor the basic safety and essential performance ofultrasonic medical diagnostic and monitoringequipment
NEMA UD 2-2004	12-105	Acoustic Output Measurement Standard forDiagnostic Ultrasound Equipment

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

Table 4: Standards with which ExactVu Complies

Summary of Clinical Tests:

The ExactVu System, transducers and needle quides, subject of this submission, did not require clinical studies to support the determination of substantial equivalence. An analysis of clinical literature, adverse event and recall data is provided in the clinical evaluation justifies the safety and efficacy of the functionality of the ExactVu device without pre-market clinical investigation.

8) Conclusion:

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The ExactVu device and predicate device conform to applicable

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Image /page/15/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" in gray. The logo is simple and modern.

electrical medical device safety standards with compliance verified through independent evaluation and meet FDA requirements for Track 3 devices, have biosafety equivalence and are manufactured using a comparable quality system that has been updated to meet ISO 13485:2016 and the requirements for MDSAP. Exact Imaging, Inc. believes that the ExactVu system is substantially equivalent with regard to safety and effectiveness to the predicate device.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.