Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any AI/ML-specific features or performance metrics.

Therapeutic

No.
The intended use is for diagnostic ultrasound imaging and fluid flow analysis, not for treating a disease or condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the system is intended 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:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The ExactVu High Resolution Micro-Ultrasound System is a diagnostic imaging device that uses ultrasound to visualize internal structures of the body (specifically the prostate). It does not analyze samples taken from the body.
Intended Use: The intended use clearly states "diagnostic ultrasound imaging or fluid flow analysis of the human body," which is a form of in vivo (within the living body) diagnostic imaging.

Therefore, the device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 are: Small Organ (prostate) Transrectal. The system may be used with patients of all ages, but is not designed for pediatric or fetal use.

Product codes

IYO, ITX, 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, MRI

Anatomical Site

Small Organ (prostate), Transrectal

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)

K162972

Reference Device(s)

K170521

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

April 30, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

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

Re: K180636

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: April 23, 2018 Received: April 24, 2018

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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

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.

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,

Michael D. O'Hara For

Robert Ochs, Ph.D. 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 K180636

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 medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use are:

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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRASTAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing StIVices (301) 443-6740

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

System	ExactVu TM High Resolution Micro-Ultrasound System
Transducer	N/A
Intended Use	Diagnostic ultrasound imaging of the human body as follows:
	Mode of Operation
Clinical	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, Note 2				P, Note
1
Neonatal Cephalic
Adult Cephalic
Transrectal	P, Note 2				P, Note
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

All items marked "P" were previously cleared by 510(k) number K162972.

Additional Comments:

1. Includes imaging to assist in the placement of needles for prostate biopsy procedures.
1. Includes an option to use MRI data with micro-ultrasound images to support MRI image-guided workflows.

4

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

System	ExactVuT™ High Resolution Micro-Ultrasound System
Transducer	EV29L
Intended Use	Diagnostic ultrasound imaging of the human body as follows:
	Mode of Operation
Clinical	B (2D	M	PWD	CWD	Color	Combined	Other
Application	Mode)				Doppler	(specify)	(specify)
Ophthalmic
Fetal
Abdominal
Intra-operative
(Abdominal organs
and vascular)
Intra-operative
(Neuro.)
Laparoscopic
Pediatric
Small Organ	P, Note 2						P, Note 1
(prostate)
Neonatal Cephalic
Adult Cephalic
Transrectal	P, Note 2						P, Note 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

All items marked "P" were previously cleared by 510(k) number K162972.

Additional Comments:

Includes imaging to assist in the placement of needles for prostate biopsy procedures.
Includes an option to use MRI data with micro-ultrasound images to support MRI image-guided workflows.

5

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

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

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

All items marked "P" were previously cleared by 510(k) number K162972.

Additional Comments:

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

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

System	ExactVu™ High Resolution Micro-Ultrasound System
Transducer	EV29L
Intended Use	Diagnostic ultrasound imaging 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, Note
1
Neonatal Cephalic
Adult Cephalic
Transrectal	P				P, Note
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

All items marked "P" were previously cleared by 510(k) number K162972.

Additional Comments:

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/7/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.

Date: April 10, 2018

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:	Randy AuCoin
President and CEO
Address:	Exact Imaging, Inc.
7676 Woodbine Avenue
Markham, ON L3R 2N2, Canada
E-mail:	raucoin@exactimaging.com
Telephone:	(905) 415-0030
Facsimile:	(905) 415-0031

Establishment Registration Number:

Exact Imaging, Inc.
Registration No.	3012402886
Owner/Operator No.	100537287

Date prepared: April 5, 2018

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/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 same color in the upper right corner of the "C". Below the word "EXACT" is the word "IMAGING" 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

Table 1: ExactVu Classifications

Classification Panel

Radiology

3) Identification of the predicate or legally marketed device:

. ExactVu High Resolution Micro-Ultrasound System (K162972) (Primary Predicate)
TRINITY/3D-PROSTATE SUITE (K170521) by Koelis (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:

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 are:

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:

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Image /page/9/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. The logo is simple and modern.

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 DICOM features and support for prostate biopsy workflow that includes imported MRI data to aid in image-guided targeted biopsy.

The same prostate biopsy workflow that includes imported MRI data is also used on the reference device.

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 2.0 | Predicate Device:
ExactVu 1.0 (K162972) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Exact Imaging Inc. | Exact Imaging Inc. |
| Intended use | 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 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. |
| Indication for
use (Clinical
application) | The indications for use (clinical
applications) are:
• Small Organ (prostate)
• Transrectal

The system may be used with
patients of all ages, but is not
designed for pediatric or fetal
use. | The indications for use (clinical
applications) are:
• Small Organ (prostate)
• Transrectal

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Image /page/10/Picture/0 description: The image contains 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.

		Predicate Device:
Feature	Subject Device: ExactVu 2.0	ExactVu 1.0 (K162972)
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	Storage
Storage Commitment	Not supported, see Table 3
"Fusion"
implementation	Prostate biopsy workflow
includes MRI data imported from
USB or DVD.
The user identifies anatomical
markers on the ultrasound
image to align the midline of the
urethra, and the software uses
the markers to compare with the
MRI data and displays a side by
side MRI/ultrasound image that
follows the rotation of the
transducer.	Not supported, see Table 3

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

| Feature | Subject Device: ExactVu 2.0 | Reference Device: TRINITY/3D-
PROSTATE SUITE (K170521) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Exact Imaging Inc. | Koelis |
| Indication for
use (Clinical
application) | The indications for use (clinical
applications) are:
Small Organ (prostate) Transrectal The system may be used with
patients of all ages, but is not
designed for pediatric or fetal
use. | TRINITY is indicated to generate
ultrasound images for structural
analysis and fluid flow analysis for:
urology gynecology vascular abdominal small organs soft tissues and musculoskeletal exams 3D-PROSTATE SUITE, embedded
on TRINITY or other KOELIS |
| Feature | Subject Device: ExactVu 2.0 | Reference Device: TRINITY/3D-
PROSTATE SUITE (K170521) |
| | | ultrasound module, is indicated to:
process, visualize and record
various 2D and 3D image
modalities (such as Ultrasound
Images, MRI) Fuse images of various
modalities Display organs and perform
measurements Manage patient data Import and export of data and
images |
| DICOM | Storage
Storage Commitment | Fully integrated with Worklist and
PACS communication |
| | ExactVu reads MRI study data in
DICOMDIR format, where MRI
markup uses DICOM GSPS
(Grayscale Softcopy
Presentation State) allowing the
ExactVu system to locate and
retrieve standard DICOM tags on
import. | Clinicians immediately receive
patient's images from PACS.
Prostate information including
contours and targets and patient
data are read via DICOM Worklist. |
| | On exports to a PACS server,
ExactVu uses both standard and
private DICOM tags to retain all
image data, needle guide
overlays, measurements,
annotations. | |
| "Fusion"
implementation | Prostate biopsy workflow
includes MRI data imported from
USB or DVD.
The user identifies anatomical | The 3D-PROSTATE SUITE is
embedded on the TRINITY system
and may also be embedded on
other Koelis systems that record
images through other modalities. |
| | markers on the ultrasound
image to align the midline of the
urethra, and the software uses
the markers to compare with the
MRI data and displays a side by
side MRI/ultrasound image that
follows the rotation of the
transducer. | MR is one of the modalities is
supported for fusion with live
ultrasound images after being
smoothly deformed to align
anatomical points. The locations of
lesions are displayed on an overlaid
3D map. |

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Image /page/11/Picture/0 description: The image contains the logo for "EXACT IMAGING". The word "EXACT" is in a light green color, and the word "IMAGING" is in gray. The plus sign is located in the upper right corner of the "C" in "EXACT".

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

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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 in the middle of the "C". Below the word "EXACT" is the word "IMAGING" written in gray. The logo is simple and modern.

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

| Reference No | Recognition
No | Title |
|--------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI/ISO
10993-1 | 2-156 | ISO 10993-1:2009, Biological evaluation of
medical devices -- Part 1: Evaluation and testing
within a risk management process |
| IEC 60601-1 | 19-4 | AAMI / ANSI ES60601-1:2005/(R) 2012 and
A1:2012, c1:2009/(R) 2012 and a2:2010/(R)
2012. Medical electrical equipment - part 1:
general requirements for basic safety and
essential performance (IEC 60601-1:2005, mod) |
| IEC 60601-1-2 | 19-1 | IEC 60601-1-2:2007, Medical electrical equipment

Part 1-2: General requirements for basic safety
and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and
tests (Edition 3) |
| IEC 60601-2-18 | 9-91 | IEC 60601-2-18: Edition 3.0 2009-08, Medical
Electrical Equipment - Part 2-18: Particular
Requirements For The Basic Safety And Essential
Performance Of Endoscopic Equipment. |
| IEC 60601-2-37 | 12-209 | IEC 60601-2-37:2007, Particular Requirements
for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring
equipment |
| NEMA UD 2-
2004 | 12-105 | Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment |
| NEMA UD 3-
2004 | | Standard for Real-Time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic |

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

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Image /page/13/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 "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.

Reference No	Recognition No	Title
		Ultrasound Equipment, American Institute of Ultrasound in Medicine

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 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 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 device.