(134 days)
Not Found
No
The description focuses on image manipulation and visualization tools, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as an image review and reporting software that assists physicians in reviewing breast ultrasound images by providing manipulation and analysis tools. It does not directly treat or diagnose a disease or condition.
No
The device is described as software that assists physicians with manipulation and analysis tools for reviewing breast ultrasound images and recording scanning paths and probe position. It does not provide a diagnosis itself.
Yes
The device is explicitly described as "standalone software device installed on a standalone windows-based computer" and its function is image review and reporting, which are software-based tasks. It processes previously recorded images and data, not live acquisition or hardware control.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to examine things outside the living body.
- Device Function: The BR-FHUS Viewer 1.0 is a software device that reviews and manipulates previously recorded ultrasound images. Ultrasound is an in vivo (within the living body) imaging modality. The software is processing and displaying images generated from a procedure performed on the patient's body.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples or performing any tests on substances taken from the body.
The device is clearly focused on the visualization and analysis of medical images obtained directly from the patient's body using ultrasound. This falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
BR-FHUS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with manipulation and analysis tools in reviewing breast ultrasound images. Images and data are previously recorded from various imaging systems and other sources such as calibrated spatial positioning devices. BR-FHUS Viewer 1.0 provides the capability to visualize two-dimensional ultrasound images along with the scanning paths and position information of probe that stored in the DICOM file in advance.
Product codes
LLZ
Device Description
BR-FHUS Viewer 1.0 is an electronic image review and reporting software program intended to operate on a windows-based computer. The device allows the review of previously recorded ultrasound examinations, which are performed using standard ultrasound systems and other sources such as calibrated spatial positioning devices, the images of which were recorded digitally.
The images are displayed on a computer monitor. The images can be reviewed individually or as a self-playing sequence. The software can adjust the speed of the playback. In addition, the device software allows the user to save the screenshots as DIOM-compatible files and generate electronic reports.
BR-FHUS Viewer 1.0 requires the following:
- ◆ Off-the-Shelf PC Computer to run BR-FHUS Viewer 1.0, which meets the following requirements
-
Minimum 500 GB Hard Drive
- A Minimum Intel Core i5 6400 processor
- Operating System: Windows A
-
Minimum 8GB RAM
-
- ◆ Computer User Interface
-
Keyboard
- A Mouse
- Display A
- Minimum display size 17"
-
- Minimum display resolution 1920*1080
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Skilled medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance, Verification and Validation testing for BR-FHUS Viewer 1.0 was performed per internal procedures to ensure that all functional requirements have been met, and that core functions execute as expected. Testing was conducted in-house by trained personnel in a simulated workenvironment using breast phantom to obtain the functional and accuracy test results.
The result of these tests demonstrate that BR-FHUS Viewer 1.0 validation is with in specification. As such. BR-FHUS Viewer 1.0 is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today.
In all instances, BR-FHUS Viewer 1.0 functioned as intended and the operation observed was as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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 and 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.
TaiHao Medical Inc. % Chiu S. Lin, Ph.D. President Lin & Associates, LLC 5614 Johnson Avenue BETHESDA MD 20817
Re: K171709
Trade/Device Name: BR-FHUS Viewer 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 31, 2017 Received: August 28, 2017
Dear Dr. Lin:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
October 20, 2017
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Robert Ochs
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 (if known) K171709
Device Name BR-FHUS Viewer 1.0
Indications for Use (Describe)
BR-FHUS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with manipulation and analysis tools in reviewing breast ultrasound images. Images and data are previously recorded from various imaging systems and other sources such as calibrated spationing devices. BR-FHUS Viewer 1.0 provides the capability to visualize two-dimensional images along with the scanning paths and position information of probe that stored in the DICOM file in advance.
| 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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3
TaiHao Medical Inc.
The Leader of Medical Software
5. 510(k) Summary of Safety and Effectiveness Information
5.1. Identification of Submitter:
Submitter: TaiHao Medical Inc.
Address: 3F .- 8, No.100, Sec. 2, Heping E. Rd., Da'an Dist., Taipei City 106, Taiwan (R.O.C.)
Phone: 886-2-2736-5679
Contact: HSIN HUNG (Simon) LAI
Title: President
886-2-2736-5679 Phone:
Email: simonlai(@taihaomed.com
Manufacturer: TaiHao Medical Inc.
US Agent and Contact: C Chiu S. Lin, Ph.D.
LIN & ASSOCIATES, LLC
Address: 5614 Johnson Avenue
Bethesda, MD 20817
Phone: (0) 301-591-3895
Email: cslin(@lin-associates.com
Date prepared: May 31, 2017
5.2. Identification of Product
Device Trade Name: BR-FHUS Viewer 1.0
Common and Usual Name: Picture Archiving and Communications System
Regulation Number: 21 CFR 892.2050
Classification Product Code: LLZ
Classification: Class II
Predicate Device: Tractus TissueMapper Reviewer Application (K123901)
4
5.3. Intended Use / Indications for Use
BR-FHUS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with manipulation and analysis tools in reviewing breast ultrasound images. Images and data are previously recorded from various imaging systems and other sources such as calibrated spatial positioning devices. BR-FHUS Viewer 1.0 provides the capability to visualize two-dimensional ultrasound images along with the scanning paths and position information of probe that stored in the DICOM file in advance.
5.4. Technological Characteristics
BR-FHUS Viewer 1.0 is an electronic image review and reporting software program intended to operate on a windows-based computer. The device allows the review of previously recorded ultrasound examinations, which are performed using standard ultrasound systems and other sources such as calibrated spatial positioning devices, the images of which were recorded digitally.
The images are displayed on a computer monitor. The images can be reviewed individually or as a self-playing sequence. The software can adjust the speed of the playback. In addition, the device software allows the user to save the screenshots as DIOM-compatible files and generate electronic reports.
BR-FHUS Viewer 1.0 requires the following:
- ◆ Off-the-Shelf PC Computer to run BR-FHUS Viewer 1.0, which meets the following requirements
-
Minimum 500 GB Hard Drive
- A Minimum Intel Core i5 6400 processor
- Operating System: Windows A
-
Minimum 8GB RAM
-
- ◆ Computer User Interface
-
Keyboard
- A Mouse
- Display A
- Minimum display size 17"
-
5
- Minimum display resolution 1920*1080
5.5. Comparison with Predicate Devices
BR-FHUS Viewer 1.0 is substantially equivalent to Tractus TissueMapper Reviewer Application (K123901) with a general intended use for reviewing ultrasound images with probe's position. Minor technological characteristics differences do not raise any new questions of safety and effectiveness.
The comparison table between our device and the predicate devices is provided below:
| | BR-FHUS Viewer 1.0, k TBD | Tractus TissueMapper
Reviewer Application,
K123901 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | TaiHao Medical Inc. | Tractus Corporation |
| Device Common Name | Picture archiving and
communications system | Picture archiving and
communications system |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Regulation Name | Picture archiving and
communications system | Picture archiving and
communications system |
| Product Code | LLZ | LLZ |
| Intended Use / Indications for
Use | BR-FHUS Viewer 1.0 is
intended as a standalone
software device installed on a
standalone windows-based
computer to assist physicians
with manipulation and
analysis tools in reviewing
breast ultrasound images.
Images and data are previously
recorded from various imaging
systems and other sources
such as calibrated spatial
positioning devices. BR-
FHUS Viewer 1.0 provides the
capability to visualize two- | The Tractus TissueMapper
Reviewer Application
provides two and three
dimensional image review,
manipulation, and analysis
tools to assist users in
screening, diagnosis, planning
and performing image-guided
interventional procedures.
The supported imaging
modality is Ultrasound (US).
Images and data are received
from various imaging systems
and other sources such as
calibrated spatial positioning |
| | dimensional ultrasound images
along with the scanning paths
and position information of
probe that stored in the
DICOM file in advance. | devices. This device provides
the capability to overlay
annotations on 2D or 3D
medical image displays.
These annotations may
represent the position of
instruments including but not
limited to imaging probes or
other tracked devices. This
device is intended to assist
skilled medical professionals
in clinical screening and
interventions, for anatomical
structures where imaging is
currently used for visualizing
such structures, including
head and neck, breast,
thoracic, and abdominal
applications. |
| User Population | Skilled medical professionals | Skilled medical professionals |
| Primary Components | Software: BR-FHUS Viewer
1.0 | Software: TissueMapper
Reviewer Application |
| Accessories | Computer (PC) and storage
media (USB) | Computer (PC) and storage
media (USB) |
| Primary Application | Breast | Head and neck, breast,
thoracic, and abdominal |
| Software | Yes | Yes |
| 3-D Rendering | No | Yes |
| Reporting | Yes | Yes |
| Supported Imaging Modalities | Ultrasound | Ultrasound |
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| Software Level of Concern | Moderate level of concern | Moderate level of concern |
|---|---|---|
| Annotate position of | ||
| instruments | Yes | Yes |
| Performance Testing | Results from software | |
| verification and validation | ||
| testing performed per internal | ||
| procedures. | From the 510(k) Summary | |
| that is available on the FDA | ||
| database, it appears that no | ||
| data from performance testing | ||
| was submitted. |
5.6. Performance Data
Performance, Verification and Validation testing for BR-FHUS Viewer 1.0 was performed per internal procedures to ensure that all functional requirements have been met, and that core functions execute as expected. Testing was conducted in-house by trained personnel in a simulated workenvironment using breast phantom to obtain the functional and accuracy test results.
The result of these tests demonstrate that BR-FHUS Viewer 1.0 validation is with in specification. As such. BR-FHUS Viewer 1.0 is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today.
BR-FHUS Viewer 1.0 indications for use are drawn from the indications for use of a legally marketed predicate device: Tractus TissueMapper Image Reviewer Application. BR-FHUS Viewer 1.0 draws from features of this predicate device. As such, the features provided by BR-FHUS Viewer 1.0 do not in themselves raise new concerns of safety or effectiveness.
In all instances, BR-FHUS Viewer 1.0 functioned as intended and the operation observed was as expected.
5.7. Substantial Equivalence
The intended use, technological characteristics, and major functionality of BR-FHUS Viewer 1.0. are similar to the predicate device. Neither new safety nor new effectiveness issues are introduced during or after using this device. The performance data generated, as described, demonstrates that our device is as safe and effective, as compared to the predicate device. Therefore, we believe BR-FHUS Viewer 1.0 is substantially equivalent to the predicate device.