ExactVu High Resolution Micro-Ultrasound System
Device Facts
| Record ID | K162972 |
|---|---|
| Device Name | ExactVu High Resolution Micro-Ultrasound System |
| Applicant | Exact Imaging |
| Product Code | IYO · Radiology |
| Decision Date | Dec 2, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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.
Device Story
ExactVu High Resolution Micro-Ultrasound System provides high-resolution diagnostic ultrasound imaging and fluid flow analysis for prostate examinations. System comprises a main unit and transducers (EV29L, EV9C) that generate/record ultrasound signals; includes needle guide for biopsy assistance. Operated by qualified medical professionals in clinical settings. Device processes acoustic data to display real-time images, aiding clinicians in visualizing prostate anatomy and guiding needle/instrument placement during biopsy procedures. Benefits include enhanced visualization for diagnostic accuracy and procedural guidance.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical, thermal, mechanical, and EMC safety, biocompatibility, and acoustic output measurements. Device conforms to applicable mandatory medical device safety standards.
Technological Characteristics
Ultrasonic pulsed echo imaging system; 128 transmit/receive channels; center frequency range 3.5-29 MHz. Transducer types: Endocavity Linear and Curved Array. Materials are biocompatible per ISO 10993-1. Safety compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3. Track 3 device.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the prostate via transrectal approach. Intended for use by qualified medical professionals on patients of all ages; not for pediatric or fetal use. Includes imaging to assist in needle placement for prostate biopsy.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Flex Focus 1202 Ultrasound Scanner (K081154)
Reference Devices
- FUJIFILM SonoSite Vevo MD Imaging system (K160674)
Submission Summary (Full Text)
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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B<br>(2D) | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>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<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B<br>(2D) | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal | | | | | | | |
| organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>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.)<br>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<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B<br>(2D) | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal | | | | | | | |
| organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>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.)<br>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<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B<br>(2D) | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal | | | | | | | |
| organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (breast, thyroid,<br>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.)<br>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<br>Manager, Regulatory Affairs and Quality Assurance |
|-------------------------|--------------------------------------------------------------------|
| E-mail: | ktorres@exactimaging.com |
| Telephone: | (905) 415-0030 |
| Facsimile: | (905) 415-0031 |
| 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<br>Predicate) | Vevo MD (Reference<br>Device) |
|-------------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Exact Imaging Inc. | BK Medical | FUJIFILM SonoSite |
| Intended use<br>(Clinical<br>application) | Transrectal<br>Small Parts (organs) | Abdominal<br>Cardiac<br>Fetal (incl. Obstetrics)<br>Intraoperative<br>Transurethral<br>Neurosurgery<br>Pediatrics<br>Transrectal<br>Small Parts (organs)<br>Transvaginal<br>Peripheral vascular<br>Musculo-skeletal | Abdominal Pediatric<br>Small Organ (breast, thyroid, testicles, prostate)<br>Musculo-skeletal (conventional)<br>Musculo-skeletal (superficial)<br>Peripheral vessel<br>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<br>Imaging, Transverse,<br>CFM and combinations | B-mode (2-D Grayscale<br>Imaging, M, PWD, CFM and<br>combinations, Tissue<br>Harmonic Imaging | B-mode (2D Grayscale<br>Imaging)<br>Color Doppler<br>Combination Modes<br>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<br>Range | 3.5-29 MHz | 1.8-18 MHz | 15-49MHz |
| Transducer Types | Endocavity Linear<br>Endocavity Curved<br>Array | Endocavity Linear<br>Endocavity Curved Array<br>Endocavity Biplane<br>Endocavity Triplane<br>Linear<br>Curved Array | Linear Array |
| #Transmit<br>Channels | 128 channels | Not available | 64 digital channels |
| #Receive Channels | 128 channels | Not available | 64 digital channels |
| DICOM | Not supported | DICOM, Print, Modality<br>Worklist, Storage<br>Commitment, Modality<br>Performed Procedure Steps<br>(MPPS) | DICOM 3.0 Store<br>Print<br>Modality Worklist<br>Perform Procedure<br>Step (PPS)<br>Storage Commitment<br>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<br>10993-1 | 2-156 | ISO 10993-1:2009, Biological evaluation of<br>medical devices -- Part 1: Evaluation and<br>testing within a risk management process |
| IEC 60601-1 | 19-4 | AAMI / ANSI ES60601-1:2005/(R) 2012 and<br>A1:2012,, c1:2009/(r)2012 and<br>a2:2010/(r)2012. Medical electrical<br>equipment - part 1: general requirements for<br>basic safety and essential performance (iec<br>60601-1:2005, mod) |
| IEC 60601-1-2 | 19-1 | IEC 60601-1-2:2007, Medical electrical<br>equipment - Part 1-2: General requirements<br>for basic safety and essential performance -<br>Collateral standard: Electromagnetic<br>compatibility - Requirements and tests<br>(Edition 3) |
| IEC 60601-2-37 | 9-91 | IEC 60601-2-18: Edition 3.0 2009-08,<br>Medical Electrical Equipment - Part 2-18:<br>Particular Requirements For The Basic<br>Safety And Essential Performance Of<br>Endoscopic Equipment. |
| IEC 60601-2-37 | 12-209 | IEC 60601-2-37:2007, Particular<br>Requirements for the basic safety and<br>essential performance of ultrasonic medical<br>diagnostic and monitoring equipment |
| NEMA UD 2-2004 | 12-105 | Acoustic Output Measurement Standard for<br>Diagnostic Ultrasound Equipment |
| NEMA UD 3-2004 | 12-100 | Standard for Real-Time Display of Thermal<br>and Mechanical Acoustic Output Indices on<br>Diagnostic Ultrasound Equipment, American<br>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.
