ExactVu High Resolution Micro-Ultrasound System
Device Facts
| Record ID | K180636 |
|---|---|
| Device Name | ExactVu High Resolution Micro-Ultrasound System |
| Applicant | Exact Imaging, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Apr 30, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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.
Device Story
The ExactVu High Resolution Micro-Ultrasound System is a diagnostic ultrasound device used by urologists and qualified medical professionals in clinical settings. It utilizes high-frequency transducers to generate ultrasound signals, which are processed by a main unit to produce real-time 2D grayscale and color Doppler images. The system supports prostate biopsy workflows by allowing the import of MRI data (via USB or DVD). Users identify anatomical markers on the ultrasound image to align the urethra, enabling the software to display a side-by-side MRI/ultrasound view that tracks transducer rotation. This fusion capability assists clinicians in targeting prostate biopsies. The device also provides manual measurement tools (distance, area, volume) and supports needle/instrument guidance for biopsy procedures. Output is displayed for the clinician to facilitate diagnostic imaging and image-guided interventions, potentially improving biopsy accuracy and patient outcomes.
Clinical Evidence
No clinical studies were required. Safety and efficacy were supported by an analysis of clinical literature, adverse event data, and recall data, alongside bench testing for electrical, thermal, mechanical, and EMC safety, biocompatibility, and acoustic output.
Technological Characteristics
System includes main unit and transducers (EV9C, EV29L). Materials are biocompatible per ISO 10993-1. Operates via ultrasonic pulsed echo imaging (128 transmit/receive channels). Connectivity includes DICOM storage/commitment. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, NEMA UD 2, and NEMA UD 3. Software supports MRI-ultrasound fusion and DICOM data handling.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the prostate (small organ) via transrectal approach. Suitable for patients of all ages; contraindicated for pediatric or fetal use.
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
- ExactVu High Resolution Micro-Ultrasound System (K162972)
Reference Devices
- TRINITY/3D-PROSTATE SUITE (K170521)
Related Devices
- K162972 — ExactVu High Resolution Micro-Ultrasound System · Exact Imaging · Dec 2, 2016
- K192303 — ExactVu High Resolution Micro-Ultrasound System · Exact Imaging, Inc. · Oct 1, 2019
- K190995 — ExactVu High Resolution Micro-Ultrasound System · Exact Imaging, Inc. · May 10, 2019
- K153166 — Fusion Bx · Focal Healtcare, Inc. · Jan 25, 2016
- K170841 — BiopSee, Mobile US · Medcom GmbH · Jul 26, 2017
Submission Summary (Full Text)
{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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRASTAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing StIVices (301) 443-6740
{3}------------------------------------------------
### 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<br>Mode) | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative<br>(Abdominal organs<br>and vascular) | | | | | | | |
| Intra-operative<br>(Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ<br>(prostate) | P, Note 2 | | | | | | P, Note<br>1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | P, Note 2 | | | | | | P, Note<br>1 |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-<br>Card.) | | | | | | | |
| Musculo-skel.<br>(Convent.) | | | | | | | |
| Musculo-skel.<br>(Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal<br>(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.
- 2. 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:
1. Includes imaging to assist in the placement of needles for prostate biopsy procedures.
2. 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<br>1 |
| (prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | P | | | | | | P, Note<br>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.
{6}------------------------------------------------
#### 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<br>Application | B (2D<br>Mode) | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative<br>(Abdominal organs<br>and vascular) | | | | | | | |
| Intra-operative<br>(Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ<br>(prostate) | P | | | | | | P, Note<br>1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | P | | | | | | P, Note<br>1 |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-<br>Card.) | | | | | | | |
| Musculo-skel.<br>(Convent.) | | | | | | | |
| Musculo-skel.<br>(Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal<br>(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.
{7}------------------------------------------------
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.<br>7676 Woodbine Avenue<br>Markham, ON L3R 2N2<br>Canada | |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Corresponding Official: | Randy AuCoin<br>President and CEO |
| Address: | Exact Imaging, Inc.<br>7676 Woodbine Avenue<br>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
{8}------------------------------------------------
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<br>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:
{9}------------------------------------------------
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:<br>ExactVu 1.0 (K162972) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Exact Imaging Inc. | Exact Imaging Inc. |
| Intended use | The ExactVu High Resolution<br>Micro-Ultrasound System is<br>intended for use by qualified<br>medical professionals for<br>diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body. | The ExactVu High Resolution Micro-<br>Ultrasound System is intended for<br>use by qualified medical<br>professionals for diagnostic<br>ultrasound imaging or fluid flow<br>analysis of the human body. |
| Indication for<br>use (Clinical<br>application) | The indications for use (clinical<br>applications) are:<br>• Small Organ (prostate)<br>• Transrectal<br><br>The system may be used with<br>patients of all ages, but is not<br>designed for pediatric or fetal<br>use. | The indications for use (clinical<br>applications) are:<br>• Small Organ (prostate)<br>• Transrectal<br><br>The system may be used with<br>patients of all ages, but is not<br>designed for pediatric or fetal use. |
| Modes of<br>Operation | B-mode (2-D Grayscale<br>Imaging, Transverse, CFM and<br>combinations | B-mode (2-D Grayscale Imaging,<br>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 |
| Center<br>Frequency<br>Range | EV9C: 6.5 MHz<br>EV29L: 22.5 MHz | EV9C: 6.5 MHz<br>EV29L: 22.5 MHz |
| Transducer<br>Types | Endocavity Linear<br>Endocavity Curved Array | Endocavity Linear<br>Endocavity Curved Array |
{10}------------------------------------------------
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<br>available on the ultrasound<br>system, including distance, area<br>approximations and volume<br>calculations. | Manual measurements are<br>available on the ultrasound system,<br>including distance, area<br>approximations and volume<br>calculations. |
| #Transmit<br>Channels | 128 channels | 128 channels |
| #Receive<br>Channels | 128 channels | 128 channels |
| DICOM | Storage<br>Storage Commitment | Not supported, see Table 3 |
| "Fusion"<br>implementation | Prostate biopsy workflow<br>includes MRI data imported from<br>USB or DVD.<br>The user identifies anatomical<br>markers on the ultrasound<br>image to align the midline of the<br>urethra, and the software uses<br>the markers to compare with the<br>MRI data and displays a side by<br>side MRI/ultrasound image that<br>follows the rotation of the<br>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-<br>PROSTATE SUITE (K170521) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Exact Imaging Inc. | Koelis |
| Indication for<br>use (Clinical<br>application) | The indications for use (clinical<br>applications) are:<br>Small Organ (prostate) Transrectal The system may be used with<br>patients of all ages, but is not<br>designed for pediatric or fetal<br>use. | TRINITY is indicated to generate<br>ultrasound images for structural<br>analysis and fluid flow analysis for:<br>urology gynecology vascular abdominal small organs soft tissues and musculoskeletal exams 3D-PROSTATE SUITE, embedded<br>on TRINITY or other KOELIS |
| Feature | Subject Device: ExactVu 2.0 | Reference Device: TRINITY/3D-<br>PROSTATE SUITE (K170521) |
| | | ultrasound module, is indicated to:<br>process, visualize and record<br>various 2D and 3D image<br>modalities (such as Ultrasound<br>Images, MRI) Fuse images of various<br>modalities Display organs and perform<br>measurements Manage patient data Import and export of data and<br>images |
| DICOM | Storage<br>Storage Commitment | Fully integrated with Worklist and<br>PACS communication |
| | ExactVu reads MRI study data in<br>DICOMDIR format, where MRI<br>markup uses DICOM GSPS<br>(Grayscale Softcopy<br>Presentation State) allowing the<br>ExactVu system to locate and<br>retrieve standard DICOM tags on<br>import. | Clinicians immediately receive<br>patient's images from PACS.<br>Prostate information including<br>contours and targets and patient<br>data are read via DICOM Worklist. |
| | On exports to a PACS server,<br>ExactVu uses both standard and<br>private DICOM tags to retain all<br>image data, needle guide<br>overlays, measurements,<br>annotations. | |
| "Fusion"<br>implementation | Prostate biopsy workflow<br>includes MRI data imported from<br>USB or DVD.<br>The user identifies anatomical | The 3D-PROSTATE SUITE is<br>embedded on the TRINITY system<br>and may also be embedded on<br>other Koelis systems that record<br>images through other modalities. |
| | markers on the ultrasound<br>image to align the midline of the<br>urethra, and the software uses<br>the markers to compare with the<br>MRI data and displays a side by<br>side MRI/ultrasound image that<br>follows the rotation of the<br>transducer. | MR is one of the modalities is<br>supported for fusion with live<br>ultrasound images after being<br>smoothly deformed to align<br>anatomical points. The locations of<br>lesions are displayed on an overlaid<br>3D map. |
{11}------------------------------------------------
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
{12}------------------------------------------------
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<br>No | Title |
|--------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI/ISO<br>10993-1 | 2-156 | ISO 10993-1:2009, Biological evaluation of<br>medical devices -- Part 1: Evaluation and testing<br>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 a2:2010/(R)<br>2012. Medical electrical equipment - part 1:<br>general requirements for basic safety and<br>essential performance (IEC 60601-1:2005, mod) |
| IEC 60601-1-2 | 19-1 | IEC 60601-1-2:2007, Medical electrical equipment<br>- Part 1-2: General requirements for basic safety<br>and essential performance - Collateral standard:<br>Electromagnetic compatibility - Requirements and<br>tests (Edition 3) |
| IEC 60601-2-18 | 9-91 | IEC 60601-2-18: Edition 3.0 2009-08, Medical<br>Electrical Equipment - Part 2-18: Particular<br>Requirements For The Basic Safety And Essential<br>Performance Of Endoscopic Equipment. |
| IEC 60601-2-37 | 12-209 | IEC 60601-2-37:2007, Particular Requirements<br>for the basic safety and essential performance of<br>ultrasonic medical diagnostic and monitoring<br>equipment |
| NEMA UD 2-<br>2004 | 12-105 | Acoustic Output Measurement Standard for<br>Diagnostic Ultrasound Equipment |
| NEMA UD 3-<br>2004 | | Standard for Real-Time Display of Thermal and<br>Mechanical Acoustic Output Indices on Diagnostic |
The ExactVu System is designed to comply with the following voluntary standards:
{13}------------------------------------------------
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
#### 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.
