(39 days)
No
The summary does not mention AI, ML, or any related terms, and the performance studies focus on standard device verification and validation, not AI/ML model performance.
No
The device is described as an imaging system for diagnostic ultrasound imaging and guidance of puncture and biopsy, indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended for "diagnostic ultrasound imaging or fluid flow analysis of the human body." The "Device Description" also mentions "diagnostic ultrasound imaging" and "guidance of puncture and biopsy."
No
The device description explicitly states that the system comprises transducers, needle guides, and a main unit, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ExactVu High Resolution Micro-Ultrasound System is an imaging system that uses ultrasound waves to create images of internal body structures. It is used for diagnostic imaging and guiding procedures like biopsies, but it does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging or fluid flow analysis of the human body" and lists anatomical sites for imaging. It does not mention analyzing biological samples.
Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified physicians, physician assistants, sonographers and ultrasound technicians in a healthcare facility for diagnostic ultrasound imaging or fluid flow analysis of the human body in B-Mode (2D), Color Flow Imaging Modes (Color Doppler and Power Doppler) and Combined (B-Mode + CFI Modes). The indications for use 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.
Product codes
IYN, IYO, ITX, OIJ
Device Description
The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System comprises of 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Small Organ, Transrectal, Abdominal
Indicated Patient Age Range
The system may be used with patients of all ages, but is not designed for pediatric or fetal use.
Intended User / Care Setting
qualified physicians, physician assistants, sonographers and ultrasound technicians in a healthcare facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance Testing:
- System Verification and Validation – Functional verification of integrated system: Test of ExactVu System and test cases developed to verify system specifications. Result: The ExactVu System meets all system specifications which is evident through the acceptance of Verification and Validation Results.
- System Verification and Validation – Testing of resolved anomalies: Testing of anomalies present in previously released versions of the device that have been resolved in the ExactVu release. Result: Previous errors were tested and verified to no longer occur.
- System Verification and Validation – User acceptance testing: Testing of ExactVu System to validate customer needs and intended use. Result: The ExactVu System meets all usability specifications which is evident through the acceptance of Verification and Validation Results.
- Human Factors Validation: Testing of critical features by intended users to determine if device is safe and effective for intended users, uses and environments per IEC 62366 and FDA Guidance: "Applying Human Factors and Usability Engineering to Medical Devices". Result: The ExactVu System compiles with IEC 62366 and FDA Guidance: "Applying Human Factors and Usability Engineering to Medical Devices."
- System Validation: Product specifications are validated by intended user in a simulated use environment to validate customer needs and intended use. Result: The ExactVu System meets all product specifications which is evident through the acceptance of Verification and Validation Results.
- Biocompatibility: Verify that all patient contacting materials are safe for contact with humans through conformance with ISO 10993. Result: All patient contact materials are biocompatible and comply with ISO 10993-1.
- Sterilization: Validation of sterilization parameters per ISO 11135 and ISO 10993-7. Result: All sterilized accessories comply with ISO 11135 and ISO 10993-7.
- Medical Electrical System Safety: External testing against the requirements of IEC 60601-1 to verify electrical and mechanical safety of the system. Result: The ExactVu System complies with IEC 60601-1.
- Electromagnetic Compatibility: External testing against the requirements of IEC 60601-1-2 to verify that the system operates within safe limits of emission and interference requirements. Result: The ExactVu System complies with IEC 60601-1-2.
- Acoustic Testing: The acoustic output was measured against requirements of IEC 60601-2-37:2015, IEC 62127-1 :2007, IEC 62359:2010 and Guidance for Industry and Food and Drug Administration Staff: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued on June 27, 2019. Result: The Acoustic Testing for the ExactVu System is performed and reported in compliance with IEC 60601-2-37:2015, IEC 62127-1 :2007, IEC 62359:2010 and Guidance for Industry and Food and Drug Administration Staff: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued on June 27, 2019.
Clinical Testing:
This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
October 1, 2019
Image /page/0/Picture/1 description: The image shows 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 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.
Exact Imaging, Inc. % Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K192303
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, ITX, OIJ Dated: September 23, 2019 Received: September 24, 2019
Dear Prithul Bom:
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. 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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
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
2
Indications for Use
510(k) Number (if known)
K192303
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 physicians, physician assistants, sonographers and ultrasound techniciare facility for diagnostic ultrasound imaging or fluid flow analysis of the human body in B-Mode (2D), Color Flow Imaging Modes (Color Doppler and Power Doppler) and Combined (B-Mode + CFI Modes). The indications for use 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)
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 PRA STAFF 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."
3
Image /page/3/Picture/0 description: The image shows the logo for Exact Imaging. The word "EXACT" is in a light green color, with a plus sign in the middle of the "C". Below the word "EXACT" is the word "IMAGING" in a gray color. The logo is simple and modern.
Date: 17-July-2019
K192303 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.
| Manufacturer: | Exact Imaging, Inc. |
|---|---|
| Address: | 7676 Woodbine Avenue, Unit 15 |
| Markham, ON L3R 2N2 | |
| Canada | |
| Establishment Registration: | 3012402886 |
| Contact Name: | Ms. Sam Rajkumar, MS, RAC, RN |
| Title: | Manager, Regulatory Affairs & Quality |
| Assurance | |
| Phone Number: | +1 905 415 1654 |
| Device Proprietary Name: | ExactVu ™ High Resolution Micro- |
| Ultrasound System | |
| Device Common or Usual Name: | Diagnostic Ultrasound System with |
| Accessories | |
| Classification Panel: | Radiology |
| Product Code: | IYN, IYO, ITX, OIJ |
| Regulation Number: | 21 CFR 892.1550, 892.1560, 892.1570 |
| Regulation Class: | II |
| Regulation Description: | Ultrasonic pulsed echo imaging system, |
| Diagnostic Ultrasound Transducers, | |
| Biopsy Needle Guide, | |
| Ultrasonic pulsed doppler imaging system |
4
Image /page/4/Picture/0 description: The image shows the logo for "EXACT Imaging". The word "EXACT" is written in a light green color, with a plus sign in the same color above the "C". Below the word "EXACT", the word "IMAGING" is written in gray.
Predicate Devices:
Substantial equivalence is claimed to the following device:
| Trade name | Manufacturer | 510(k) Number | Date Cleared |
|---|---|---|---|
| ExactVu™ High | |||
| Resolution Micro- | |||
| Ultrasound System | Exact Imaging | ||
| Inc. | K190995 | May 10, 2019 |
Reference Devices:
The following reference devices have been used:
| Trade name | Manufacturer | 510(k) Number | Date Cleared |
|---|---|---|---|
| CIVCO Disposable | |||
| Template Grid | CIVCO Medical | ||
| Instruments Co., | |||
| Inc. | K131161 | September 17, | |
| 2013 | |||
| CIVCO Poly Ultrasound | |||
| Transducer Cover | CIVCO Medical | ||
| Instruments Co., | |||
| Inc. | K970513 | June 20, 1997 |
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 of 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.
Intended Use /Indications for use:
The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified physicians, physician assistants, sonographers and ultrasound technicians in a healthcare facility for diagnostic ultrasound imaging or fluid flow analysis of the human body in B-Mode (2D), Color Flow Imaging Modes (Color Doppler and Power Doppler) and Combined (B-Mode + CFI Modes). The indications for use 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.
5
Image /page/5/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.
Summary of Technological Comparisons:
The ExactVu High Resolution Micro-Ultrasound System is an enhanced implementation of the previous FDA-cleared version of ExactVu High Resolution Micro-Ultrasound System.
The primary function of both devices is for diagnostic ultrasound imaging, data processing and quidance of puncture and biopsy. The primary difference between ExactVu High Resolution Micro-Ultrasound and the predicate device is enhanced functionality through the introduction of a new accessory and minor workflow improvements.
Main advantages compared to the predicate device are:
- Minor workflow improvements: bugs fixed and EV29L angle reset. .
- Additional support for Transperineal Biopsies. ●
There are no known disadvantages.
ExactVu High Resolution Micro-Ultrasound System remains substantially unchanged from the predicate with respect to its intended use and performance claims.
Nonclinical Performance Testing
Verification and validation testing have been conducted on the ExactVu High Resolution Micro-Ultrasound system to ensure the safety and effectiveness of the device to perform in accordance to its intended use. The following table provides a summary of the testing performed on the ExactVu High Resolution Micro-Ultrasound.
| Type | Activity | Description of Activity | Documentation
Results |
|---------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System
Verification
and
Validation | Functional
verification of
integrated
system | Test of ExactVu System
and test cases developed
to verify system
specifications. | The ExactVu System
meets all system
specifications which is
evident through the
acceptance of
Verification and
Validation Results. |
| System
Verification
and
Validation | Testing of
resolved
anomalies | Testing of anomalies
present in previously
released versions of the
device that have been
resolved in the ExactVu
release. | Previous errors were
tested and verified to
no longer occur. |
| System
Verification
and
Validation | User acceptance
testing | Testing of ExactVu
System to validate | The ExactVu System
meets all usability |
| Type | Activity | Description of Activity | Documentation
Results |
| | | customer needs and
intended use. | specifications which is
evident through the
acceptance of
Verification and
Validation Results. |
| | Human Factors
Validation | Testing of critical features
by intended users to
determine if device is
safe and effective for
intended users, uses and
environments per IEC
62366 and FDA
Guidance: "Applying
Human Factors and
Usability Engineering to
Medical Devices". | The ExactVu System
compiles with IEC
62366 and FDA
Guidance: "Applying
Human Factors and
Usability Engineering
to Medical Devices." |
| | System
Validation | Product specifications are
validated by intended
user in a simulated use
environment to validate
customer needs and
intended use. | The ExactVu System
meets all product
specifications which is
evident through the
acceptance of
Verification and
Validation Results. |
| | Biocompatibility | Verify that all patient
contacting materials are
safe for contact with
humans through
conformance with ISO
10993. | All patient contact
materials are
biocompatible and
comply with ISO
10993-1. |
| | Sterilization | Validation of sterilization
parameters per ISO
11135 and ISO 10993-7. | All sterilized
accessories comply
with ISO 11135 and
ISO 10993-7. |
| | Medical
Electrical System
Safety | External testing against
the requirements of IEC
60601-1 to verify
electrical and mechanical
safety of the system | The ExactVu System
complies with IEC
60601-1. |
| Type | Activity | Description of Activity | Documentation
Results |
| | Electromagnetic
Compatibility | External testing against
the requirements of IEC
60601-1-2 to verify that
the system operates
within safe limits of
emission and interference
requirements. | The ExactVu System
complies with IEC
60601-1-2. |
| | Acoustic Testing | The acoustic output
was measured against
requirements of IEC
60601-2-37:2015, IEC
62127-1 :2007, IEC
62359:2010 and
Guidance for Industry
and Food and Drug
Administration Staff:
Marketing Clearance of
Diagnostic Ultrasound
Systems and
Transducers issued on
June 27, 2019. | The Acoustic Testing
for the ExactVu
System is performed
and reported in
compliance with IEC
60601-2-37:2015, IEC
62127-1 :2007, IEC
62359:2010 and
Guidance for Industry
and Food and Drug
Administration Staff:
Marketing Clearance of
Diagnostic Ultrasound
Systems and
Transducers issued on
June 27, 2019. |
6
Image /page/6/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.
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 above the "C". Below the word "EXACT" is the word "IMAGING" written in gray. The logo is simple and modern.
Clinical Testing
This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing.
Conclusion
ExactVu High Resolution Micro-Ultrasound has been shown through comparison and performance testing to be substantially equivalent to the identified predicate device. Any technological differences do not raise new questions of safety and effectiveness.