(268 days)
No
The document describes software for visualizing and reporting on 3D breast ultrasound images. It mentions image processing but explicitly states "Not Found" for mentions of AI, DNN, or ML. The performance study focuses on image loading comparison, not algorithmic performance related to AI/ML.
No
The device is described as software to assist physicians in visualizing and analyzing 3-D breast ultrasound images; it does not directly treat or diagnose.
Yes
The device is described as assisting "the physician in their review and analysis of the 3-D breast ultrasound images generated by ABVS," which directly supports clinical decision-making based on medical images, a key function of diagnostic devices.
Yes
The device is explicitly described as a "standalone software device" installed on a "standalone windows-based computer" and its function is to visualize and process images generated by a separate hardware device (the ultrasound scanner). It does not include or require any specific hardware components beyond a standard computer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device, the BR-ABVS Viewer 1.0, is a software tool used to visualize and analyze medical images (ultrasound images of the breast) generated by another medical device (the ABVS scanner).
- The intended use clearly states it's for assisting physicians in reviewing and analyzing 3-D breast ultrasound images. This is a diagnostic imaging tool, not a diagnostic test performed on a biological sample.
Therefore, while it's a medical device used in the diagnostic process, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software device is indicated for use to assist the physicians in their review and analysis of the 3-D breast ultrasound images generated by ABVS. Caution: Federal law restricts this device to sale by or on the order of a physician.
Product codes
LLZ
Device Description
BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software also automatically generates reports to provide the sub-image and location information of markers annotated during the image review.
Mentions image processing
BR-ABVS Viewer 1.0 provides visualization of any orientation of 3-D image.
Image processing techniques
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
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
TaiHao Medical Inc. has conducted a performance study to validate and assess the performance of BR-ABVS Viewer 1.0 for its-intended use. An actual clinical image generated by a Siemens ACUSON S2000 Automated Breast Volume Scanner in 2014 was used to do the comparison testing between BR-ABVS Viewer 1.0 and the predicate (ABVS Workplace, K092067) in terms of substantial equivalence in 3-D image loading.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2016
TaiHao Medical, Inc. % Chiu S. Lin, Ph.D. President LIN & ASSOCIATES, LLC 9223 Cambridge Manor Court POTOMAC MD 20854
Re: K151075
Trade/Device Name: BR-ABVS Viewer 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 15, 2015 Received: December 15, 2015
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 (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.
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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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours.
Michael D'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151075
Device Name BR-ABVS Viewer 1.0
Indications for Use (Describe)
BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software device is indicated for use to assist the physicians in their review and analysis of the 3-D breast ultrasound images generated by ABVS. Caution: Federal law restricts this device to sale by or on the order of a physician.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
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5. 510(k) Summary of Safety and Effectiveness Information
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92
5.1. Identification of Submitter:
Submitter: TaiHao Medical Inc.
Address: 7F., No.410, Sec. 5, Zhongxiao E. Rd., Xinyi Dist., Taipei City 110, Taiwan (R.O.C.)
Phone: 886-2-2858-2357
Contact: HSIN HUNG (Simon) LAI
Title: President
Phone: 886-2-2858-2357
Email: simonlai@taihaomed.com
Manufacturer: TaiHao Medical Inc.
US Agent and Contact: Chiu S. Lin, Ph.D.
LIN & ASSOCIATES, LLC
Address: 9223 Cambridge Manor Court
Potomac, MD 20854 U.S.A.
Phone: (0) 301-591-3895
Email: cslin@lin-associates.com
Date prepared: April 8, 2015
5.2. Identification of Product
Device Trade Name: BR-ABVS Viewer 1.0
Common and Usual Name: Ultrasound Image Display Device
Device Classification Name: Picture Archiving and Communication System
Regulation Number: 21 CFR 892.2050
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Classification Product Code: LLZ
Classification: Class II Radiology Devices Classification Panel:
Manufacturer: TaiHao Medical Inc.
5.3. Predicate Device
This subject software medical device is substantially equivalent to the devices listed below:
Model: ABVS Workplace
Manufacturer: Siemens Medical Solutions
510(k) Number: K092067, cleared on September 18, 2009
5.4. Device Description
BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software also automatically generates reports to provide the sub-image and location information of markers annotated during the image review.
5.5. Indications for Use
BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The device is indicated for use to assist the physicians in their review and analysis of the 3-D breast ultrasound images generated by ABVS.
5.6. Comparison with Predicate Devices
BR-ABVS Viewer 1.0 is substantially equivalent to ABVS Workplace with a general intended use for viewing and analyzing ultrasound image data to physicians. 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-ABVS Viewer 1.0 | ABVS Workplace | ||
|---|---|---|---|
| -- | -- | --------------------------- | ----------------------- |
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| Manufacturer | TaiHao Medical Inc. | Siemens Medical Solutions |
|---|---|---|
| 510(k) Number | K151075 | K092067 |
| 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 |
| Indications for Use | BR-ABVS Viewer 1.0 is | |
| intended as a standalone | ||
| software device installed on a | ||
| standalone windows-based | ||
| computer to assist the | ||
| physician to visualize any | ||
| orientation of three- | ||
| dimensional (3-D) breast | ||
| ultrasound images generated | ||
| by Siemens ACUSON S2000 | ||
| Automated Breast Volume | ||
| Scanner, ABVS (cleared in | ||
| K081148). The device is | ||
| indicated for use to assist the | ||
| physicians in their review and | ||
| analysis of the 3-D breast | ||
| ultrasound images generated | ||
| by ABVS. | ABVS Workplace is intended | |
| to display ultrasound images | ||
| of the breast acquired from B- | ||
| mode imaging using an | ||
| automatic or handheld | ||
| scanning linear transducer. | ||
| The images may be reviewed | ||
| and analyzed by the | ||
| physician. The ABVS | ||
| Workplace is indicated for use | ||
| as an adjunct to | ||
| mammography. The ABVS | ||
| Workplace is not intended to | ||
| be used as a replacement for | ||
| screening. | ||
| Functional Capability of | ||
| Image Processing | BR-ABVS Viewer 1.0 | |
| provides visualization of any | ||
| orientation of 3-D image. | The ABVS Workplace applies | |
| post-processing algorithms | ||
| based on the nipple location. | ||
| A reverberation removal | ||
| algorithm determines tissue | ||
| contact areas. This suppresses | ||
| reverberation artifacts from | ||
| the non-contact area. A | ||
| proprietary adaptive nipple | ||
| shadow reduction tool | ||
| analyzes the data volume and | ||
| enhances structures in the | ||
| retroareolar area to improve | ||
| visualization of this typically | ||
| challenging anatomical | ||
| region. | ||
| Software Design | Image processing techniques | Same |
| Platform | Window-based | Same |
| Operating System | Standard PC or review station | Own workstation, which |
| includes IT hardware and pre- | ||
| installed software | ||
| Clinical Application | As an adjunct to | |
| mammography screening | Same | |
| Image Type to Be Processed | ||
| by The Device | Automated breast ultrasound | |
| images generated by Siemens | ||
| ACUSON S2000 Automated | ||
| Breast Volume Scanner, | ||
| ABVS (cleared in K081148). | Same | |
| Image Format | DICOM images acquired on | |
| Siemens ACUSON S2000 | ||
| Automated Breast Volume | Same | |
| Scanner, ABVS | ||
| Automatically Generating | ||
| Report | Yes | Yes |
| Performance Testing to | ||
| Support SE Determination | Results from Software | |
| Validation Report of BR- | ||
| ABVS Viewer 1.0 | From the 510(k) Summary | |
| that is available on the FDA | ||
| database, it appears that no | ||
| data from performance testing | ||
| were submitted. |
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5.7. Performance Standards
No applicable FDA performance standards have been issued.
5.8. Software
Software development for BR-ABVS Viewer 1.0 follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards. Appropriate steps have been taken to control all identified risks for this type of image viewing and quantification device.
5.9. Summary of Performance Data to Support Substantial Equivalence
BR-ABVS Viewer 1.0 displays the 3-D image volume by axial, sagittal, and coronal plane according to the anatomical coordinate system to provide an overall observation. The actual image size is obtained by considering the spacings of three axes specified in the standard DICOM tags. TaiHao Medical Inc. has conducted a performance study to validate and assess the performance of BR-ABVS Viewer 1.0 for its-intended use. An actual clinical image generated by a Siemens ACUSON S2000 Automated Breast Volume Scanner in 2014 was used to do the comparison testing between BR-ABVS Viewer 1.0 and the predicate (ABVS Workplace, K092067) in terms of substantial equivalence in 3-D image loading.
5.10. Conclusions
The intended use, technological characteristics, and major functionality of BR-ABVS Viewer 1.0 are similar to the predicate device and no new issues of safety or effectiveness are introduced by using this device. The performance data generated, as described, demonstrates that our software device is as
8
safe and effective, as compared to the predicate. Therefore we believe BR-ABVS Viewer 1.0 is Substantially Equivalent to the predicate device.