Bf-NAVI is a virtual bronchoscopic navigation (VBN) software program designed to assist a physician during a bronchoscopic examination. The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. Bf-NAVI allows the physician to view a 3D representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. Bf-NAVI is intended for use only as a guidance tool and does not make any medical diagnosis.

Device Description

The Bf-NAVI software is a self-contained Windows-based image software package. Using pulmonary CT slice data, the Bf-NAVI device helps the user in guiding endoscopic tools or catheters in the pulmonary tract. The Bf-NAVI allows the user to view computed tomography via Multi-Planar Reconstruction (MPR). The software uses the CT data to generate a 3D image of the tracheobronchial tree. The Bf-NAVI device does not interface directly with any CT or data collection equipment; the CT data is imported from files previously created on another device.

The software does not perform any function which can not be accomplished manually by a trained operator utilizing manual tracing methods; the software is designed to assist in the compilation of the data to save time and prevent errors. The Bf-NAVI software has functions for loading, analyzing, saving data profiles and will generate screen displays from the results.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Bf-NAVI device, based on the provided 510(k) summary:

The provided 510(k) summary for Bf-NAVI does not include a table of acceptance criteria or details of a specific study proving the device meets those criteria in a quantitative sense (e.g., performance metrics like sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing of its software development and functionality.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary)
Software Functionality	"All the software specifications have met the acceptance criteria of each module and interaction of processes."
Intended Use Equivalence	"The Bf-NAVI device has the same intended use and technological characteristics as the predicate devices."
Safety & Efficacy	"The safety and efficacy of the device is supported by the non-clinical testing." "The verification and validation testing of the device software of the device was found to acceptable and supports the claims of substantial equivalence."
Hazard Mitigation	"The Device Hazard analysis was completed and risk control implemented to mitigate identified hazards."

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

The document does not specify a distinct "test set" in the context of clinical or performance data for the device's diagnostic or guidance accuracy. The software was tested against its own design specifications rather than against a dataset of medical images with known ground truth for establishing diagnostic or guidance performance.

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

Not applicable. The submission does not describe a test set where experts established ground truth for medical conditions or guidance accuracy.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

6. Standalone (Algorithm Only) Performance Study

No. The document describes "non-clinical testing" as software verification and validation against its design specifications. It does not mention a standalone performance study in the sense of evaluating the algorithm's accuracy in identifying target regions or optimal routes independently against a gold standard. The device's purpose is "only as a guidance tool and does not make any medical diagnosis."

7. Type of Ground Truth Used

The "ground truth" used for Bf-NAVI's testing was its Software Design Specifications. The device's performance was evaluated against whether it performed as intended according to these internal specifications. This is distinct from medical ground truth (e.g., pathology, expert consensus on disease, or actual surgical outcomes).

8. Sample Size for the Training Set

Not applicable. This device is described as a software program that processes existing CT scan data to generate a 3D representation and assist the physician. It is not an AI/ML device that requires a "training set" in the traditional sense to learn patterns or make predictions. Its functionality is based on pre-programmed algorithms for image reconstruction and visualization.

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

Not applicable. As Bf-NAVI is not an AI/ML device requiring a training set, the concept of establishing ground truth for a training set does not apply.

Summary

{0}------------------------------------------------

K093810

Section 5 - 510(k) Summary

For

JUN 1 8 2010

Bf-NAVI

Sponsor Information 1.

KGT Inc. Tomin Shinjuku Bldg. 2-8-8, Shinjuku, Shinjuku-ku
Tokyo, 160-0022 Tokyo 160-0022 JAPAN Phone: (81) 3-3225-0744 Fax: (81) 3-3225-0950 Contact: Kouichi Mansei, Manager

2. Applicant Information

Emergo Group 1705 S. Capital of Texas Highway Suite 500 Austin, TX 78746 Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Richard Vincins, Senior Consultant QA/RA

3. Date Prepared

22 April 2010

4. Device Name

Trade/Proprietary Name: Bf-NAVI Common/Usual Name: Bf-NAVI
Common/Usual Name: Bf-NAVI, Virtual Bronchoscopy Image Editor/Viewer Classification Name: Computed tomography x-ray system Classification Regulation: 892.1750 Product Code: JAK

5. Predicate Devices

VIDA Diagnostics – VIDA Pulmonary Workstation 2 (PW2) K083227 Olympus Medical Systems Corp – VB Image Viewer Kore
Olympus Medical Systems Corp – VB Image Viewer K080581 superDimension, Inc. — Fotoms Corp — VB Image Viewer K080581
superDimension, Inc. — superDimension®/Bronchus K080271

{1}------------------------------------------------

6. Device Description

7. Intended Use

8. Technological Characteristics and Substantial Equivalence

The Bf-NAVI device shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices. The Bf-NAVI device is similar in design and function to the predicate devices for the modes of operation and use.

{2}------------------------------------------------

The Bf-NAVI software is a self-contained Windows-based image software package. The Bf-NAVI device is designed to capture pulmonary CT slice data and display results for the user in guiding endoscopic tools or catheters in the pulmonary tract. The Bf-NAVI provides computed tomography viewing via Multi-Planar Reconstruction (MPR) to generate the three-dimensional image. The Bf-NAVI device does not interface directly with any CT or data collection equipment; the software imports the data files previously generated. These devices all have the same intended use and indications for use as the Bf-NAVI device.

Non-Clinical Testing 9.

The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The Device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria of each module and interaction of processes. The Bf-NAVI device passed all testing and supports the claims of substantial equivalence and safe operation.

10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices. The safety and efficacy of the device is supported by the non-clinical testing. The verification and validation testing of the device software of the device was found to acceptable and supports the claims of substantial equivalence.

11. Conclusion

The Bf-NAVI device has the same intended use and technological characteristics as the predicate devices.

The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

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

JUL 14 2010

KGT, Inc. % Mr. Richard Vincins, CQA, RAC (US, EU) Senior Consumer QA/RA Emergo Group 1705 S. Capital of Texas Hwy., Suite 500 AUSTIN TX 78746

Re: K093810 Trade/Device Name: Bf-NAVI Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 4, 2010 Received: June 8, 2010

Dear Mr. Vincins:

This letter corrects our substantially equivalent letter of June 18, 2010.

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 (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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
it may he systicat to a litti 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

{4}------------------------------------------------

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Mark D. Thum for

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

{5}------------------------------------------------

510(k) Number (if known): K093810

Device Name: Bf-NAVI

Indications for Use:

Bf-NAVI is a virtual bronchoscopic navigation (VBN) software program designed to assist a physician during a bronchoscopic examination. The main purpose of the software us to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. Bf-NAVI allows the physician to view a 3D representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. B5-NUV is intended for use only as a guidance tool and does not make any medical diagnosis.

Prescription Use ___X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use ___________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)

Mh D O't

(Division Sign Off) (Division Significal Devicess Office of In Vitro Diagnostic Device Evaluation and Safety
Office of In Vitro Diagnostic Device Evaluation and Safety
Office of In Vitro Diagnostic Device Evaluation and Safe

510K K093810

Page 1 of 1

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.