ExactVu High Resolution Micro-Ultrasound System
Device Facts
| Record ID | K190995 |
|---|---|
| Device Name | ExactVu High Resolution Micro-Ultrasound System |
| Applicant | Exact Imaging, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | May 10, 2019 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The ExactVu 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 (clinical applications) are: • Small Organ • Transrectal • Abdominal The system may be used with patients of all ages, but is not designed for pediatric or fetal use. The system is contraindicated for direct cardiac application and for ophthalmic use or any application that causes the acoustic beam to pass through the eye.
Device Story
ExactVu High Resolution Micro-Ultrasound System; diagnostic ultrasound imaging and fluid flow analysis. System comprises main unit, transducers (EV9C, EV29L, EV5C), and needle guides. Operates by generating/recording ultrasound signals; processes acoustic data; displays images. Used by qualified medical professionals in clinical settings. Supports B-mode (2D grayscale), Color Doppler, and Power Doppler. Includes manual measurement tools (distance, area, volume). Facilitates needle/instrument guidance for prostate and kidney biopsies. Integrates with DICOM for data storage and MRI study review. Benefits include high-resolution imaging for diagnostic and interventional guidance.
Clinical Evidence
No clinical studies were required. Safety and efficacy were supported by an analysis of clinical literature, adverse event data, and recall data. Bench testing included electrical, thermal, mechanical, and EMC safety, as well as biocompatibility and acoustic output measurements.
Technological Characteristics
System uses ultrasonic pulsed echo/Doppler imaging. Transducers: EV9C (6.5 MHz), EV29L (22.5 MHz), EV5C (3.5 MHz). 128 transmit/receive channels. Materials: Epotek 301, PEEK LSG, Polyurethane, Rexolite, Silicon. Connectivity: DICOM Storage/Query/Retrieve SCU. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, NEMA UD 2-2004. Sterilization: Not specified (biocompatible materials).
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of small organs (prostate), transrectal, and abdominal applications in patients of all ages. Contraindicated for pediatric, fetal, ophthalmic, or direct cardiac use.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- ExactVu High Resolution Micro-Ultrasound System (K180636)
Reference Devices
- Ultrasound Scanner Flex Focus 1202 (K132335)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2019
Exact Imaging, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive Suite 510k SAINT PAUL MN 55114
Re: K190995
Trade/Device Name: ExactVu™ High Resolution Micro-Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, IYX, OIJ Dated: April 12, 2019 Received: April 16, 2019
Dear Mr. Job:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K190995
Device Name
ExactVuTM High Resolution Micro-Ultrasound System
Indications for Use (Describe)
The Exact Vu 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 (clinical applications) are:
• Small Organ
· Transrectal
· Abdominal
The system may be used with patients of all ages, but is not designed for pediatric or fetal use.
The system is contraindicated for direct cardiac application and for ophthalmic use or any application that causes the acoustic beam to pass through the eye.
| 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™ High Resolution Micro-Ultrasound System | | | | | | | | |
|----------------------|---------------------------------------------------------------------------|---|-----|-----|------------------|-----------------------|--------------------|--|--|
| Transducer | N/A | | | | | | | | |
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body as | | | | | | | | |
| | follows: | | | | | | | | |
| | Mode of Operation | | | | | | | | |
| Clinical Application | B (2D<br>Mode) | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other<br>(specify) | | |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | N | | | | N (3) | | N (2) | | |
| Intra-operative | | | | | | | | | |
| (Abdominal organs | | | | | | | | | |
| and vascular) | | | | | | | | | |
| Intra-operative | | | | | | | | | |
| (Neuro.) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ | P | | | | | | P, 1 | | |
| (prostate) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Transrectal | P | | | | | | P, 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
Items marked "P" were previously cleared by 510(k) number K180636.
- 1. Includes imaging to assist in the placement of needles for prostate biopsy procedures.
- 2. Includes imaging to assist in the placement of needles for kidney biopsy procedures.
- 3. ExactVu supports simultaneous color flow imaging with B-Mode.
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### Diagnostic Ultrasound Indications for Use Form – 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<br>follows: | | | | | | |
| | Mode of Operation | | | | | | |
| Clinical 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, 1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | P | | | | | | P, 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
Items marked "P" were previously cleared by 510(k) number K180636.
- 1. Includes imaging to assist in the placement of needles for prostate biopsy procedures.
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## Diagnostic Ultrasound Indications for Use Form – EV9C™ Transrectal End-fire Transducer
| System | ExactVu™ High Resolution Micro-Ultrasound System | | | | | | | | |
|----------------------|---------------------------------------------------------------------------|---|-----|-----|---------|-----------|-----------|--|--|
| Transducer | EV9C | | | | | | | | |
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body as | | | | | | | | |
| | follows: | | | | | | | | |
| | Mode of Operation | | | | | | | | |
| Clinical Application | B (2D | M | PWD | CWD | Color | Combined | Other | | |
| | Mode) | | | | Doppler | (specify) | (specify) | | |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative | | | | | | | | | |
| (Abdominal organs | | | | | | | | | |
| and vascular) | | | | | | | | | |
| Intra-operative | | | | | | | | | |
| (Neuro.) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ | P | | | | | | P, 1 | | |
| (prostate) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Transrectal | P | | | | | | P, 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
ltems marked "P" were previously cleared by 510(k) number K180636.
- 1. Includes imaging to assist in the placement of needles for prostate biopsy procedures.
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## Diagnostic Ultrasound Indications for Use Form – EV5C™ Abdominal Transducer
| System | ExactVu™ High Resolution Micro-Ultrasound System | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|-----------------------|--------------------|
| Transducer | EV5C | | | | | | |
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body as<br>follows: | | | | | | |
| | Mode of Operation | | | | | | |
| Clinical Application | B (2D<br>Mode) | M | PWD | CWD | Color<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | N | | | | N (2) | | N (1) |
| Intra-operative<br>(Abdominal organs<br>and vascular) | | | | | | | |
| Intra-operative<br>(Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ<br>(prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | | | | | | | |
| 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 | | | | | | | |
| System | ExactVu™ High Resolution Micro-Ultrasound System | | | | | | |
| Transducer | EV29L | | | | | | |
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | |
| | Mode of Operation | | | | | | |
| Clinical Application | B (2D Mode) | M | PWD | CWD | Color Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative<br>(Abdominal organs<br>and vascular) | | | | | | | |
| | Intra-operative<br>(Neuro.) | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ<br>(prostate) | P | | | | | | P, 1 |
| | Neonatal Cephalic | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | P | | | | | | P, 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
- 1. Includes imaging to assist in the placement of needles for kidney biopsy procedures.
- 2. ExactVu supports simultaneous color flow imaging with B-Mode.
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#### Diagnostic Ultrasound Indications for Use Form – Needle guide for use with EV29L™ High Resolution Transrectal Side-fire Transducer
N= new indication; P= previously cleared ; E= added under this appendix
Items marked "P" were previously cleared by 510(k) number K180636.
- 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/8/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is written in green, with a plus sign above the "C". Below the word "EXACT" is the word "IMAGING" written in gray. The logo is simple and modern.
Date: May 3, 2019
# 510(k) Summary
K190995
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, Unit 15 Markham, ON L3R 2N2 Canada
| Corresponding Official: | Randy AuCoin<br>President & CEO |
|-------------------------------------|------------------------------------------------------------------------------------|
| Address: | Exact Imaging, Inc.<br>7676 Woodbine Avenue, Unit 1<br>Markham, ON L3R 2N2, Canada |
| E-mail:<br>Telephone:<br>Facsimile: | raucoin@exactimaging.com<br>(905) 415-0030<br>(905) 415-0031 |
## Establishment Registration Number:
| Exact Imaging, Inc. | |
|---------------------|------------|
| Registration No. | 3012402886 |
| Owner/Operator No. | 10053728 |
May 3, 2019 Date prepared:
# 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/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 in the same color above the "C". Below the word "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.
### 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 |
| Ultrasonic pulsed doppler imaging<br>system | 892.1550 | IYN |
Table 1: ExactVu Classifications
## Classification Panel
Radiology
# 3) Identification of the predicate or legally marketed device:
- ExactVu High Resolution Micro-Ultrasound System (K180636) (Primary Predicate)
- Ultrasound Scanner Flex Focus 1202 by BK Medical (K132335) (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 /Indications for use:
The ExactVu 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 (clinical applications) are:
- Small Organ
- Transrectal
- Abdominal
The system may be used with patients of all ages, but is not designed for pediatric or fetal use.
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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 upper right corner of the "C". Below the word "EXACT" is the word "IMAGING" in gray. The logo is simple and modern.
The system is contraindicated for direct cardiac application and for ophthalmic use or any application that causes the acoustic beam to pass through the eye.
## 6) Technological Characteristics:
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 an abdominal transducer, the addition of color flow imaging modes and the addition of a DICOM service class.
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 2.5 | Predicate Device:<br>ExactVu 2.0 (K180636) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Exact Imaging Inc. | Exact Imaging Inc. |
| Intended use /<br>Indications for<br>Use | The ExactVu micro-ultrasound<br>system is intended for use by<br>qualified medical professionals for<br>diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body. The indications for use<br>(clinical applications) are:<br>• Small Organ<br>• Transrectal<br>• Abdominal<br><br>The system may be used with<br>patients of all ages, but is not<br>designed for pediatric or fetal use.<br><br>The system is contraindicated for<br>direct cardiac application and for<br>ophthalmic use or any application<br>that causes the acoustic beam to<br>pass through the eye. | 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.<br><br>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 Imaging,<br>Transverse, CFM and<br>combinations - Color Doppler and<br>Power Doppler Mode) | B-mode (2-D Grayscale Imaging,<br>Transverse, CFM and combinations |
| MI Indication | Yes | Yes |
| TI Indication | Yes | Yes |
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Image /page/11/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" in gray. The logo is simple and modern.
| | | Predicate Device: |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Subject Device: ExactVu 2.5 | ExactVu 2.0 (K180636) |
| Electrical Safety | TUV, IEC 60601-1 | TUV, IEC 60601-1 |
| 510(k) Track | Track 3 | Track 3 |
| Center | EV9C: 6.5 MHz | EV9C: 6.5 MHz |
| Frequency | EV29L: 22.5 MHz | EV29L: 22.5 MHz |
| Range | EV5C: 3.5 MHz | EV5C: 3.5 MHz |
| Transducer | Endocavity Linear | Endocavity Linear |
| Types | Endocavity Curved Array<br>EV5C: Abdominal Curved Array | Endocavity Curved Array |
| 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<br>system, including distance, area<br>approximations and volume<br>calculations. |
| #Transmit<br>Channels | 128 channels | 128 channels |
| #Receive<br>Channels | 128 channels | 128 channels |
| DICOM | DICOM Storage SCU Version 3.0<br>DICOM Storage Commitment SCU<br>Version 3.0<br>DICOM Query Retrieve SCU<br>Version 3.0<br>ExactVu reads MRI study data in<br>DICOMDIR format, where MRI<br>markup uses DICOM GSPS<br>(Grayscale Softcopy Presentation<br>State) | DICOM Storage SCU Version 3.0<br>DICOM Storage Commitment SCU<br>Version 3.0<br>ExactVu reads MRI study data in<br>DICOMDIR format, where MRI<br>markup uses DICOM GSPS<br>(Grayscale Softcopy Presentation<br>State) |
Table 2: Technological Characteristics Comparison Between Subject Device and
Predicate Device
| Feature | Subject Device:<br>ExactVu 2.5 | Reference Device:<br>Ultrasound Scanner Flex Focus<br>1202 (K132335) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Exact Imaging Inc. | BK Medical |
| Intended Use /<br>Indication for<br>Use | The ExactVu micro-ultrasound<br>system is intended for use by<br>qualified medical professionals<br>for diagnostic ultrasound<br>imaging or fluid flow analysis of<br>the human body. The<br>indications for use (clinical<br>applications) are: | Ultrasound scanner and<br>transducers for B, Tissue and<br>Contrast Harmonic Imaging, M,<br>PWD, CWD, Color Doppler, Vector<br>Flow Imaging and combined mode<br>imaging. Signal analysis and<br>display. |
| Feature | Subject Device:<br>ExactVu 2.5 | Reference Device:<br>Ultrasound Scanner Flex Focus<br>1202 (K132335) |
| | Small Organ Transrectal Abdominal<br>The system may be used with<br>patients of all ages, but is not<br>designed for pediatric or fetal<br>use.<br><br>The system is contraindicated<br>for direct cardiac application and<br>for ophthalmic use or any<br>application that causes the<br>acoustic beam to pass through<br>the eye. | Guidance of biopsy needles,<br>geometrical measurements and<br>calculation of parameters. An<br>optional 3-DI unit can reconstruct a<br>series of 2-DI images into a single<br>3-DI volume and display this on the<br>screen.<br><br>An optional Vector Flow Imaging<br>(VFI) module: Color Flow Mapping<br>(CFM) imaging mode with the<br>ability to visualize both the axial<br>and the transverse velocity.<br> |
| Abdominal<br>Transducer | Abdominal Curved Array<br>(transducer model EV-5C)<br>Center Frequency: 3.5 MHz<br>Maximum depth: 180 mm<br><br>Global Maximum Outputs/Worst<br>Case Settings 2D mode Ispta.3: 11.93 mW/cm2 TI Type: TIS TI Value: <1.0 MI: 1.04 Ipa.3@MI_Max:<br>117.8 W/cm2 CFI mode Ispta.3: 42.84 mW/cm2 TI Type: TIS TI Value: 1.00 | Abdominal Curved Array<br>(transducer model 8823)<br>Center Frequency: 1.8-6 MHz<br>Maximum depth: 171-260mm<br>depending on settings<br><br>Global Maximum Outputs/Worst<br>Case Settings Ispta.3: 720 mW/cm2 TI Type: TIC TI Value: 6.0 MI: 1.9 Ipa.3@MI_Max: 367 W/cm2<br>Patient contact material: not<br>available |
| | Subject Device:<br> | Reference Device:<br>Ultrasound Scanner Flex Focus |
| Feature | ExactVu 2.5 | 1202 (K132335) |
| | Ipa.3@MI_Max:<br>79.29 W/cm2 Patient contact material: Epotek<br>301, PEEK LSG, Polyurethane,<br>Rexolite, Silicon | |
| Modes of<br>Operation | Color flow imaging maps fluid<br>flow velocities over the 2D<br>image using color. ExactVu<br>provides two color flow imaging<br>modes ("CFI Modes"): Color Doppler Mode Power Doppler Mode | Color mode (CFM, color flow<br>mapping, color Doppler)<br>ultrasound displays color-coded<br>real-time information about<br>direction and velocity of flow in<br>the tissues. Power mode displays color-<br>coded information about the<br>amount of flow but not the<br>direction. |
| DICOM | DICOM Storage SCU Version 3.0<br>DICOM Storage Commitment<br>SCU Version 3.0<br>DICOM Query Retrieve SCU<br>Version 3.0<br>ExactVu reads MRI study data in<br>DICOMDIR format, where MRI<br>markup uses DICOM GSPS<br>(Grayscale Softcopy<br>Presentation State) | DICOM, Print, Modality Worklist,<br>Storage Commitment, Modality<br>Performed Procedure Steps (MPPS) |
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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 above the "C". Below the word "EXACT", the word "IMAGING" is written in gray.
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Image /page/13/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is written in green, with a plus sign in the same color above the "C". Below the word "EXACT", the word "IMAGING" is written in gray. The logo is simple and modern, and the colors are clean and professional.
Table 3: Technological Characteristics Comparison Between Subject Device and Reference Device
# 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.
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Image /page/14/Picture/0 description: The image shows the logo for "EXACT Imaging". The word "EXACT" is in a light green color, with a plus sign above the "C". Below "EXACT" is the word "IMAGING" in a gray color. The logo is simple and modern.
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 | 2-220 | 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 60601-1-2:2014, Medical electrical<br>equipment - Part 1-2: General requirements for<br>basic safety and essential performance -<br>Collateral standard: Electromagnetic<br>compatibility - Requirements and tests (Edition<br>3) |
| IEC 60601-2-<br>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-<br>37 | 12-209 | IEC 60601-2-37:2015, 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 |
The ExactVu System is designed to comply with the following voluntary standards:
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
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Image /page/15/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" in gray. The logo is simple and modern.
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 a comparable quality system that has been updated to meet ISO 13485:2016 and the requirements for MDSAP. Exact Imaging, Inc. believes that the ExactVu system is substantially equivalent with regard to safety and effectiveness to the predicate device.
