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.

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 does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria with performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to various safety and performance standards.

However, based on the information provided, here's a breakdown of what can be inferred and constructed:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the nature of the submission (510(k) for an ultrasound system) and the provided text, the "acceptance criteria" appear to be compliance with relevant safety and performance standards, and comparison to existing legally marketed devices. As no specific performance metrics are given in the provided text, the table is structured to reflect this.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Electrical Safety	Conformance to IEC 60601-1 (general requirements for basic safety and essential performance of medical electrical equipment).	The device (ExactVu System) has been evaluated for electrical safety and found to conform to IEC 60601-1. This compliance was verified through independent evaluation.
Thermal Safety	Conformance to relevant standards for thermal safety.	The device has been evaluated for thermal safety.
Mechanical Safety	Conformance to relevant standards for mechanical safety.	The device has been evaluated for mechanical safety.
EMC Safety	Conformance to IEC 60601-1-2 (Electromagnetic compatibility).	The device has been evaluated for EMC safety and found to conform to IEC 60601-1-2 (Edition 3).
Acoustic Output	Conformance to NEMA UD 2-2004 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment) and NEMA UD 3-2004 (Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices).	Acoustic output has been evaluated, and the device found to conform to applicable mandatory medical device safety standards, including NEMA UD 2-2004 and NEMA UD 3-2004.
Biocompatibility	Conformance to AAMI/ANSI/ISO 10993-1 (Biological evaluation of medical devices).	All patient contact materials are biocompatible and either used in other legally marketed devices or meet ISO 10993-1.
Cleaning/Disinfection	Conformance to relevant standards for cleaning and disinfection.	Cleaning/disinfection has been evaluated.
Software Verification	Comprehensive software verification as part of product development.	Assurance of quality was established by employing elements of product development including System and Software Verification.
Performance Equivalence	Substantial equivalence to the predicate device (ExactVu 1.0, K162972) in terms of intended use, indications for use, modes of operation, MI/TI indications, center frequency range, transducer types, and measurements.	The subject device (ExactVu 2.0) is substantially equivalent to its predicate device (ExactVu 1.0, K162972) with the same fundamental scientific technology and general ultrasound principles, and both are Track 3 devices. Differences in DICOM and MRI fusion capabilities are noted, and compared to a reference device (TRINITY/3D-PROSTATE SUITE, K170521).
Track Device Status	Classification as a Track 3 device.	Both the subject device and the predicate device are Track 3 devices.
Quality System	Manufacturing under an ISO 13485 quality system.	The device is manufactured using the same ISO 13485 quality system as the predicate.

2. Sample size used for the test set and the data provenance:

The document explicitly states: "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."

Therefore, no specific test set or clinical study data (including sample size or data provenance) is provided for the subject device (ExactVu 2.0) in this submission. The determination of substantial equivalence relies on non-clinical tests and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

As per point 2, no specific clinical test set was used to establish ground truth because clinical studies were not required for this submission.

4. Adjudication method for the test set:

As per point 2, no specific clinical test set was used, so no adjudication method is described.

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:

No MRMC comparative effectiveness study was done, nor is there any mention of AI assistance in improving human reader performance. The submission is for an ultrasound system, not an AI-powered diagnostic tool.

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

Not applicable. This submission is for an ultrasound imaging system, which inherently involves human operation and interpretation. There is no mention of a standalone algorithm or AI performance.

7. The type of ground truth used:

Given the absence of clinical studies for this submission, the "ground truth" for demonstrating safety and effectiveness relied on:

Conformance to recognized industry standards: (e.g., IEC 60601-1, ISO 10993-1, NEMA UD 2 & 3). Third-party testing and certification against these standards serve as the "ground truth" for the device's adherence to established safety and performance benchmarks.
Substantial equivalence to a legally marketed predicate device: The predicate device (ExactVu 1.0, K162972) implicitly provides the "ground truth" of a device that has already been deemed safe and effective for its intended use. The submission argues that the new device is sufficiently similar to share this established safety and effectiveness profile.

8. The sample size for the training set:

Not applicable. There is no mention of machine learning or AI components requiring a training set in this submission.

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

Not applicable. As no training set is mentioned (see point 8).

Summary

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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.

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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

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Indications for Use

510(k) Number K180636

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)

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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 (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, Note 2						P, Note1
Neonatal Cephalic
Adult Cephalic
Transrectal	P, Note 2						P, Note1
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.

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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.

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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, Note1
(prostate)
Neonatal Cephalic
Adult Cephalic
Transrectal	P						P, Note1
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
ClinicalApplication	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, Note1
Neonatal Cephalic
Adult Cephalic
Transrectal	P						P, Note1
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 AvenueMarkham, ON L3R 2N2Canada
Corresponding Official:	Randy AuCoinPresident and CEO
Address:	Exact Imaging, Inc.7676 Woodbine AvenueMarkham, 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 imagingsystem	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:

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:

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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 ResolutionMicro-Ultrasound System isintended for use by qualifiedmedical professionals fordiagnostic ultrasound imaging orfluid flow analysis of the humanbody.	The ExactVu High Resolution Micro-Ultrasound System is intended foruse by qualified medicalprofessionals for diagnosticultrasound imaging or fluid flowanalysis of the human body.
Indication foruse (Clinicalapplication)	The indications for use (clinicalapplications) are:• Small Organ (prostate)• TransrectalThe system may be used withpatients of all ages, but is notdesigned for pediatric or fetaluse.	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 GrayscaleImaging, Transverse, CFM andcombinations	B-mode (2-D Grayscale Imaging,Transverse, CFM and combinations
MI Indication	Yes	Yes
TI Indication	Yes	Yes
Electrical Safety	TUV, IEC 60601-1	TUV, IEC 60601-1
510(k) Track	Track 3	Track 3
CenterFrequencyRange	EV9C: 6.5 MHzEV29L: 22.5 MHz	EV9C: 6.5 MHzEV29L: 22.5 MHz
TransducerTypes	Endocavity LinearEndocavity Curved Array	Endocavity LinearEndocavity Curved Array

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		Predicate Device:
Feature	Subject Device: ExactVu 2.0	ExactVu 1.0 (K162972)
Measurement	Manual measurements areavailable on the ultrasoundsystem, including distance, areaapproximations and volumecalculations.	Manual measurements areavailable on the ultrasound system,including distance, areaapproximations and volumecalculations.
#TransmitChannels	128 channels	128 channels
#ReceiveChannels	128 channels	128 channels
DICOM	StorageStorage Commitment	Not supported, see Table 3
"Fusion"implementation	Prostate biopsy workflowincludes MRI data imported fromUSB or DVD.The user identifies anatomicalmarkers on the ultrasoundimage to align the midline of theurethra, and the software usesthe markers to compare with theMRI data and displays a side byside MRI/ultrasound image thatfollows the rotation of thetransducer.	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 foruse (Clinicalapplication)	The indications for use (clinicalapplications) are:Small Organ (prostate) Transrectal The system may be used withpatients of all ages, but is notdesigned for pediatric or fetaluse.	TRINITY is indicated to generateultrasound images for structuralanalysis and fluid flow analysis for:urology gynecology vascular abdominal small organs soft tissues and musculoskeletal exams 3D-PROSTATE SUITE, embeddedon 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 recordvarious 2D and 3D imagemodalities (such as UltrasoundImages, MRI) Fuse images of variousmodalities Display organs and performmeasurements Manage patient data Import and export of data andimages
DICOM	StorageStorage Commitment	Fully integrated with Worklist andPACS communication
	ExactVu reads MRI study data inDICOMDIR format, where MRImarkup uses DICOM GSPS(Grayscale SoftcopyPresentation State) allowing theExactVu system to locate andretrieve standard DICOM tags onimport.	Clinicians immediately receivepatient's images from PACS.Prostate information includingcontours and targets and patientdata are read via DICOM Worklist.
	On exports to a PACS server,ExactVu uses both standard andprivate DICOM tags to retain allimage data, needle guideoverlays, measurements,annotations.
"Fusion"implementation	Prostate biopsy workflowincludes MRI data imported fromUSB or DVD.The user identifies anatomical	The 3D-PROSTATE SUITE isembedded on the TRINITY systemand may also be embedded onother Koelis systems that recordimages through other modalities.
	markers on the ultrasoundimage to align the midline of theurethra, and the software usesthe markers to compare with theMRI data and displays a side byside MRI/ultrasound image thatfollows the rotation of thetransducer.	MR is one of the modalities issupported for fusion with liveultrasound images after beingsmoothly deformed to alignanatomical points. The locations oflesions are displayed on an overlaid3D 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	RecognitionNo	Title
AAMI/ANSI/ISO10993-1	2-156	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 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safetyand essential performance - Collateral standard:Electromagnetic compatibility - Requirements andtests (Edition 3)
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 60601-2-37:2007, 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
NEMA UD 3-2004		Standard for Real-Time Display of Thermal andMechanical 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.

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.