BR-FHUS Viewer 1.0

K171709 · Taihao Medical, Inc. · LLZ · Oct 20, 2017 · Radiology

Device Facts

• Record ID: K171709
• Device Name: BR-FHUS Viewer 1.0
• Applicant: Taihao Medical, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

BR-FHUS Viewer 1.0 is a standalone software application for Windows-based PCs used by physicians to review breast ultrasound examinations. It ingests previously recorded DICOM files containing 2D ultrasound images and spatial probe positioning data. The software allows clinicians to visualize these images alongside scanning paths, adjust playback speed, and generate electronic reports or save screenshots. It functions as a review and reporting tool for ultrasound data acquired from external imaging systems and spatial positioning devices. By providing visualization of probe paths and image sequences, it assists physicians in the review process. It does not perform 3D rendering.

Clinical Evidence

Bench testing only. Verification and validation testing were conducted in-house using a breast phantom in a simulated work environment to confirm functional requirements and accuracy. No clinical data was submitted.

Technological Characteristics

Standalone software for Windows-based PCs. Requires minimum Intel Core i5 6400, 8GB RAM, 500GB HDD, and 1920x1080 display. Operates on standard ultrasound data and spatial positioning inputs stored in DICOM format. Features include image playback, screenshot capture, and report generation. Software level of concern is moderate.

Indications for Use

Indicated for use by physicians to assist in the manipulation and analysis of previously recorded breast ultrasound images and associated probe position data.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Tractus TissueMapper Reviewer Application (K123901)

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 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

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] 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 [phone] or [phone] 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

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# 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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# 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: [phone]

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: [phone]

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)

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#### 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"

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- 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<br>Reviewer Application,<br>k123901 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | TaiHao Medical Inc. | Tractus Corporation |
| Device Common Name | Picture archiving and<br>communications system | Picture archiving and<br>communications system |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Regulation Name | Picture archiving and<br>communications system | Picture archiving and<br>communications system |
| Product Code | LLZ | LLZ |
| Intended Use / Indications for<br>Use | BR-FHUS Viewer 1.0 is<br>intended as a standalone<br>software device installed on a<br>standalone windows-based<br>computer to assist physicians<br>with manipulation and<br>analysis tools in reviewing<br>breast ultrasound images.<br>Images and data are previously<br>recorded from various imaging<br>systems and other sources<br>such as calibrated spatial<br>positioning devices. BR-<br>FHUS Viewer 1.0 provides the<br>capability to visualize two- | The Tractus TissueMapper<br>Reviewer Application<br>provides two and three<br>dimensional image review,<br>manipulation, and analysis<br>tools to assist users in<br>screening, diagnosis, planning<br>and performing image-guided<br>interventional procedures.<br>The supported imaging<br>modality is Ultrasound (US).<br>Images and data are received<br>from various imaging systems<br>and other sources such as<br>calibrated spatial positioning |
| | dimensional ultrasound images<br>along with the scanning paths<br>and position information of<br>probe that stored in the<br>DICOM file in advance. | devices. This device provides<br>the capability to overlay<br>annotations on 2D or 3D<br>medical image displays.<br>These annotations may<br>represent the position of<br>instruments including but not<br>limited to imaging probes or<br>other tracked devices. This<br>device is intended to assist<br>skilled medical professionals<br>in clinical screening and<br>interventions, for anatomical<br>structures where imaging is<br>currently used for visualizing<br>such structures, including<br>head and neck, breast,<br>thoracic, and abdominal<br>applications. |
| User Population | Skilled medical professionals | Skilled medical professionals |
| Primary Components | Software: BR-FHUS Viewer<br>1.0 | Software: TissueMapper<br>Reviewer Application |
| Accessories | Computer (PC) and storage<br>media (USB) | Computer (PC) and storage<br>media (USB) |
| Primary Application | Breast | Head and neck, breast,<br>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<br>instruments | Yes | Yes |
| Performance Testing | Results from software<br>verification and validation<br>testing performed per internal<br>procedures. | From the 510(k) Summary<br>that is available on the FDA<br>database, it appears that no<br>data from performance testing<br>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.