BR-FHUS Navigation 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with tools for electromagnetic tracking of instruments in respect of breast ultrasound images generated from FDA cleared handheld ultrasound devices. The device is not intended to be used in the environment of strong magnetic or electromagnetic fields, such as in Magnetic Resonance Imaging (MRI) room. BR-FHUS Navigation 1.0 is indicated for use as an adjunct to handheld breast ultrasound to assist the physicians in their scanning process. The scanning paths are displayed on a route map and provide quality control of scanning to provide an overall observation of scanning process.

Device Description

BR-FHUS Navigation 1.0 is a standalone software device installed on a standalone windows-based computer. It requires an off-the-shelf PC computer, computer user interface (keyboard, mouse, display), off-the-shelf image capture device (PCI frame grabber card or USB frame grabber device), and an off-the-shelf 3D electromagnetic tracking system (Ascension Technologies). The system includes software for Position Sensor Monitoring, Image presentation and recording, and user interface, and hardware including a Position Sensor Clip (electromagnetic), Sensor Transmitter, and Control Computer.

AI/ML Overview

The provided text describes the BR-FHUS Navigation 1.0 device and its substantial equivalence to a predicate device, the Tractus TissueMapper Image Recording System. However, the document does not contain detailed acceptance criteria or a specific study proving the device meets quantitative acceptance criteria beyond a general statement of "in specification."

Here's a breakdown of the information that can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for performance metrics. It only generally states that "all functional requirements have been met" and "core functions execute as expected."

Reported Device Performance: The document does not provide numerical results for device performance. It only states: "The result of these tests demonstrates that BR-FHUS Navigation 1.0 validation is with in specification. As such, BR-FHUS Navigation 1.0 is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today." And "In all instances, BR-FHUS Navigation 1.0 functioned as intended and the operation observed was as expected."

Acceptance Criteria	Reported Device Performance
Not explicitly stated in quantitative terms (e.g., accuracy +/- X mm, error rate < Y%)	"BR-FHUS Navigation 1.0 validation is within specification.""All functional requirements have been met.""Core functions execute as expected.""In all instances, BR-FHUS Navigation 1.0 functioned as intended and the operation observed was as expected."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document only mentions "breast phantoms" were used.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): "Testing was conducted in-house by trained personnel in a simulated work environment using breast phantoms." This indicates a prospective in-house study. The location of "in-house" is implied to be at TaiHao Medical Inc. (Taiwan, R.O.C.) given their address in the submitter information.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It only states "trained personnel."

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The testing described focuses on the device's functional and accuracy performance using phantoms.
Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the testing described appears to be a standalone performance evaluation of the BR-FHUS Navigation 1.0 software. The device itself is described as a "standalone software device." The performance data section focuses on "functional and accuracy test results" of the software system.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the testing described with "breast phantoms" would be based on the known, measurable positions or characteristics of targets within the phantoms, which serves as a surrogate for anatomical ground truth.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document does not mention a training set, which suggests the device might not use machine learning in a way that requires a separate training set, or this information was not considered necessary for this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as no training set information is provided.

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 29, 2017

TaiHao Medical Inc. % Chiu S. Lin, Ph.D. President Lin & Associates, LLC 5614 Johnson Avenue BETHESDA MD 20817

Re: K171309

Trade/Device Name: BR-FHUS Navigation 1.0 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: September 20, 2017 Received: September 20, 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 (reporting of medical device

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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.

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/MedicalDevices/ResourcesforYou/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,

Michael D. O'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) K171309

Device Name BR-FHUS Navigation 1.0

Indications for Use (Describe)

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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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: April 20, 2017

5.2. Identification of Product

Device Trade Name: BR-FHUS Navigation 1.0

Common and Usual Name: Ultrasonic Pulsed Echo Imaging System

Regulation Number: 21 CFR 892.1560

Classification Product Code: IYO

Classification: Class II

Predicate Device: Tractus TissueMapper Image Recording System (K131489)

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5.3. Intended Use / Indications for Use

5.4. Technological Characteristics

BR-FHUS Navigation 1.0 requires the following:

◆ Off-the-shelf PC Computer to run BR-FHUS Navigation 1.0, which meets the following requirements
- Minimum 500 GB Hard Drive A
- Minimum Intel Core i5 6400 processor
- Operating System: Windows A
- A Minimum 8GB RAM
- 2 HDMI Ports
- 4 USB Ports of USB 2.0 or better
- Wired Ethernet
◆ Computer User Interface
- A Keyboard
- Mouse A
- A Display
  - . Minimum display size 17"
  - Minimum display resolution 1920*1080

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◆ Off-the-shelf Image Capture Device
- PCI frame grabber card inserted into computer card slot of computer noted above or USB frame grabber device connected to computer by cable
- Video cable from ultrasound system to image capture device
◆ Off-the-shelf 3D electromagnetic tracking system (Ascension Technologies)
- Sensor position interface electronics (trakSTAR/driveBAY) connected to computer by cable
- Sensor position transmitter (Mid-Range Transmitter) and electronics connected to trakSTAR/driveBAY by cable
- Six degrees of freedom (6DOF) sensor (Model 800) and electronics connected to trakSTAR/driveBAY by cables
- Urethane clip for affixing a 6DOF sensor to ultrasound transducer

5.5. Comparison with Predicate Devices

BR-FHUS Navigation 1.0 is substantially equivalent to Tractus TissueMapper Image Recording System (K131489) with a general intended use for recording ultrasound sequence images with probe's position. Minor technological characteristics differences do not raise any new questions of safety and effectiveness.

	BR-FHUS Navigation 1.0,k TBD	Tractus TissueMapperImage Recording System,K131489
Manufacturer	TaiHao Medical Inc.	Tractus Corporation
Regulation Number	21 CFR 892.1560	21 CFR 892.1560
Regulation Name	Ultrasonic Pulsed EchoImaging System	Ultrasonic Pulsed EchoImaging System
Product Code	IYO	IYO
Intended Use / Indications for	BR-FHUS Navigation 1.0 isintended as a standalone	The Tractus TissueMapperImage Recording System is

Use	software device installed on a	intended to provide
	standalone windows-based	physicians with tools for
	computer to assist physicians	electromagnetic racking of
	with tools for electromagnetic	instruments with respect to
	tracking of instruments in	image data.
	respect of breast ultrasound
	images generated from FDA
	cleared handheld
	ultrasound devices. The device
	is not intended to be used in
	the environment of strong
	magnetic or electromagnetic
	fields, such as in Magnetic
	Resonance Imaging (MRI)
	room. BR-FHUS Navigation
	1.0 is indicated for use as an
	adjunct to handheld breast
	ultrasound to assist the
	physicians in their scanning
	process. The scanning paths
	are displayed on a route map
	and provide quality control of
	scanning to provide an overall
	observation of scanning
	process.
User Population	Skilled medical professionals	Skilled medical professionals
Primary Components	Software: Position Sensor	Software: Position Sensor
	Monitoring, Image	Monitoring, Image
	presentation and recording,	presentation and recording,
	user interface.	user interface.
	Hardware: Position Sensor	Hardware: Position Sensor
	Clip (electromagnetic), Sensor	Clip (electromagnetic),
	Transmitter, Control	Sensor Transmitter, Control
	Computer.	Computer.
Accessories	Media storage (USB)	Media storage (USB)
Virtual Navigator Software	Yes	Yes
Primary Application	Small Parts (Breast)	Abdominal, Small Parts(Breast)
Tracking System	Electromagnetic (Ascension)	Electromagnetic (Ascension)
Software	Yes	Yes
3-D Rendering	No	Yes
Supported Imaging Modalities	Ultrasound	Ultrasound
Software Level of Concern	Moderate level of concern	Moderate level of concern
Image Archiving	Yes	Yes
Scanning Path Recording	Yes	Yes
Scanning Quality Control	Yes	No
Performance Testing	Results from softwareverification and validationtesting performed per internalprocedures.	From the 510(k) Summarythat is available on the FDAdatabase, it appears that nodata from performance testingwas submitted.

The comparison table between our device and the predicate devices is provided below:

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TaiHao Medical Inc.

The Leader of Medical Software

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5.6. Performance Data

Performance, Verification and Validation testing for BR-FHUS Navigation 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 phantoms to obtain the functional and accuracy test results.

The result of these tests demonstrates that BR-FHUS Navigation 1.0 validation is with in specification. As such, BR-FHUS Navigation 1.0 is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today.

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TaiHao Medical Inc.

The Leader of Medical Software

BR-FHUS Navigation 1.0 indications for use are drawn from the indications for use of a legally marketed predicate device: Tractus TissueMapper Image Recording System. BR-FHUS Navigation 1.0 draws from features of this predicate device. As such, the features provided by BR-FHUS Navigation 1.0 do not in themselves raise new concerns of safety or effectiveness.

In all instances, BR-FHUS Navigation 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 Navigation 1.0. is 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 Navigation 1.0 is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.