Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging and data processing without mentioning AI or ML capabilities.

Therapeutic

No
The device is described as an imaging system for diagnostic use, not for treating conditions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for use by qualified medical professionals for diagnostic ultrasound imaging."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system comprises transducers, needle guides, and a main unit, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes an in-vivo (within the living body) diagnostic procedure, not an in-vitro (outside the living body) diagnostic test.
Device Description: The device description details a system that uses ultrasound transducers to generate and record signals from within the body, process the data, and display images. This is consistent with an ultrasound imaging system used for in-vivo diagnosis.
Anatomical Site: The specified anatomical sites (Small Organ, Transrectal, Abdominal) are all locations within the human body where in-vivo imaging is performed.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) outside of the body, which is a defining characteristic of IVD devices.

Therefore, the ExactVu micro-ultrasound system, as described, is a medical device used for in-vivo diagnostic imaging, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, IYX, OIJ

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Small Organ (prostate), Transrectal, Abdominal

Indicated Patient Age Range

patients of all ages, but is not designed for pediatric or fetal use.

Intended User / Care Setting

qualified medical professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180636

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K132335

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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

1

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

2

Indications for Use

510(k) Number (if known) K190995

Device Name

ExactVuTM High Resolution Micro-Ultrasound System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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 (2D
Mode)	M	PWD	CWD	Color
Doppler	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.

4

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 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 organs
and 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 as
follows:
	Mode of Operation
Clinical Application	B (2D
Mode)	M	PWD	CWD	Color
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal	N				N (2)		N (1)
Intra-operative
(Abdominal organs
and 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 organs
and 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 AuCoin
President & CEO |
|-------------------------------------|------------------------------------------------------------------------------------|
| Address: | Exact Imaging, Inc.
7676 Woodbine Avenue, Unit 1
Markham, 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 imaging
system	892.1560	IYO
Diagnostic Ultrasound Transducers	892.1570	ITX
Biopsy Needle Guide	892.1560	OIJ
Ultrasonic pulsed doppler imaging
system	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:

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.

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 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.

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. | 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 indications for use (clinical
applications) are:
• Small Organ (prostate)
• Transrectal

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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 Array
EV5C: Abdominal Curved Array	Endocavity Curved Array
Measurement	Manual measurements are
available on the ultrasound
system, including distance, area
approximations and volume
calculations.	Manual measurements are
available on the ultrasound
system, including distance, area
approximations and volume
calculations.
#Transmit
Channels	128 channels	128 channels
#Receive
Channels	128 channels	128 channels
DICOM	DICOM Storage SCU Version 3.0
DICOM Storage Commitment SCU
Version 3.0
DICOM Query Retrieve SCU
Version 3.0
ExactVu reads MRI study data in
DICOMDIR format, where MRI
markup uses DICOM GSPS
(Grayscale Softcopy Presentation
State)	DICOM Storage SCU Version 3.0
DICOM Storage Commitment SCU
Version 3.0
ExactVu reads MRI study data in
DICOMDIR format, where MRI
markup uses DICOM GSPS
(Grayscale Softcopy Presentation
State)

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

| Feature | Subject Device:
ExactVu 2.5 | Reference Device:
Ultrasound Scanner Flex Focus
1202 (K132335) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Exact Imaging Inc. | BK Medical |
| Intended Use /
Indication 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: | Ultrasound scanner and
transducers for B, Tissue and
Contrast Harmonic Imaging, M,
PWD, CWD, Color Doppler, Vector
Flow Imaging and combined mode
imaging. Signal analysis and
display. |
| Feature | Subject Device:
ExactVu 2.5 | Reference Device:
Ultrasound Scanner Flex Focus
1202 (K132335) |
| | 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. | Guidance of biopsy needles,
geometrical measurements and
calculation of parameters. An
optional 3-DI unit can reconstruct a
series of 2-DI images into a single
3-DI volume and display this on the
screen.

An optional Vector Flow Imaging
(VFI) module: Color Flow Mapping
(CFM) imaging mode with the
ability to visualize both the axial
and the transverse velocity.
|
| Abdominal
Transducer | Abdominal Curved Array
(transducer model EV-5C)
Center Frequency: 3.5 MHz
Maximum depth: 180 mm

Global Maximum Outputs/Worst
Case Settings 2D mode Ispta.3: 11.93 mW/cm2 TI Type: TIS TI Value: