ExactVu High Resolution Micro-Ultrasound System

• K Number: K162972
• Device Name: ExactVu High Resolution Micro-Ultrasound System
• Manufacturer: Exact Imaging
• Date Cleared: 2016-12-02 ( 38 days)
• Product Code: IYO ITX OIJ
• Regulation Number: 892.1560

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

Device Description

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

Predicate Devices

K081154

Reference Devices

K160674

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound image processing and does not mention AI, ML, or related concepts.

Therapeutic

No
The device is described as a "diagnostic ultrasound imaging" system, and its intended uses are for "diagnostic ultrasound imaging or fluid flow analysis" and "guidance of puncture and biopsy," which are diagnostic rather than therapeutic actions.

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." The "Device Description" also reiterates this by stating it is "intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and quidance of puncture and biopsy."

SaMD (Software as a Medical Device)

No

The device description explicitly states the system is comprised of transducers, a needle guide, 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. They are performed outside of the body.
• Device Function: The ExactVu High Resolution Micro-Ultrasound System is described as a system for diagnostic ultrasound imaging and fluid flow analysis of the human body. It uses ultrasound waves to create images of internal structures.
• Method of Use: The system is used on the patient (transrectal imaging of the prostate) to visualize internal anatomy. This is an in vivo (within the living body) diagnostic method, not an in vitro method.

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

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

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 quidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

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 guide, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

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.

K081154

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.

K160674

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

§ 892.1560 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

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

December 2, 2016

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

Re: K162972

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

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Michael O'Hara

For

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

Enclosure

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Indications for Use

510(k) Number (if known) TBD

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 intended uses are:

Small Organ (prostate) Transrectal

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

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

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

Additional Comments:

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

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

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

Additional Comments:

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

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

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

Additional Comments:

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

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

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

Additional Comments:

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

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Image /page/7/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is in green, with a plus sign in the middle of the "C". Below the word "EXACT" is the word "IMAGING" in gray. The logo is simple and modern.

510(K) Summary

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

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

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

| Corresponding Official: | Karina Torres
Manager, Regulatory Affairs and Quality Assurance |
|-------------------------|--------------------------------------------------------------------|
| E-mail: | [e-mail] |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date prepared: | September 1st, 2016 |

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

Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

ExactVu™ High Resolution Micro-Ultrasound System

Classification Names

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

Classification Panel

Radiology

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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 middle of the "C". Below the word "EXACT" is the word "IMAGING" in a gray sans-serif font.

3) Identification of the predicate or legally marketed device:

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

4) Device Description:

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

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 intended uses as defined by FDA guidance documents, is:

Small Organ (prostate) Transrectal

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

6) Technological Characteristics:

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

| Feature | ExactVu | Flex Focus 1202 (Primary
Predicate) | Vevo MD (Reference
Device) |
|-------------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Exact Imaging Inc. | BK Medical | FUJIFILM SonoSite |
| Intended use
(Clinical
application) | Transrectal
Small Parts (organs) | Abdominal
Cardiac
Fetal (incl. Obstetrics)
Intraoperative
Transurethral
Neurosurgery
Pediatrics
Transrectal
Small Parts (organs)
Transvaginal
Peripheral vascular
Musculo-skeletal | Abdominal Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Musculo-skeletal (conventional)
Musculo-skeletal (superficial)
Peripheral vessel
Dermatology |

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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 above the "C". Below the word "EXACT" is the word "IMAGING" in a smaller, gray sans-serif font. The logo is simple and modern.

| Modes of Operation | B-mode (2-D Grayscale
Imaging, Transverse,
CFM and combinations | B-mode (2-D Grayscale
Imaging, M, PWD, CFM and
combinations, Tissue
Harmonic Imaging | B-mode (2D Grayscale
Imaging)
Color Doppler
Combination Modes
M-mode |
|---------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| MI Indication | Yes | Yes | Yes |
| TI Indication | Yes | Yes | Yes |
| Electrical Safety | TUV, IEC 60601-1 | UL, IEC 60601-1 | CSA IEC 60601-1 |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
| Center Frequency
Range | 3.5-29 MHz | 1.8-18 MHz | 15-49MHz |
| Transducer Types | Endocavity Linear
Endocavity Curved
Array | Endocavity Linear
Endocavity Curved Array
Endocavity Biplane
Endocavity Triplane
Linear
Curved Array | Linear Array |
| #Transmit
Channels | 128 channels | Not available | 64 digital channels |
| #Receive Channels | 128 channels | Not available | 64 digital channels |
| DICOM | Not supported | DICOM, Print, Modality
Worklist, Storage
Commitment, Modality
Performed Procedure Steps
(MPPS) | DICOM 3.0 Store
Print
Modality Worklist
Perform Procedure
Step (PPS)
Storage Commitment
NEMA PS3.15 2003 |

7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

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

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

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

Reference No	Recognition No	Title
AAMI/ANSI/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 60601-2-37	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	12-100	Standard for Real-Time Display of Thermal
and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment, American
Institute of Ultrasound in Medicine

Summary of Clinical Tests:

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

8) Conclusion:

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

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

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