(189 days)
Not Found
No
The document explicitly states that the software does not perform any function that cannot be accomplished manually and is designed to assist in data compilation to save time and prevent errors, rather than using AI/ML for complex analysis or decision-making. There is no mention of AI, DNN, or ML in the text.
No.
The device is described as a guidance tool that assists physicians during a bronchoscopic examination by generating a tracheobronchial tree from CT scans and helping to find an optimal bronchial route, but it does not make any medical diagnosis or provide treatment.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Bf-NAVI is intended for use only as a guidance tool and does not make any medical diagnosis."
Yes
The device is explicitly described as a "software program" and a "self-contained Windows-based image software package." It processes CT data imported from other devices and does not include or interface directly with any hardware for data collection or intervention.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Bf-NAVI's Function: Bf-NAVI processes medical images (CT scans) to create a virtual representation of the tracheobronchial tree. It is used as a guidance tool during a bronchoscopic examination, which is a procedure performed directly on the patient.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. Its input is image data, not biological samples.
- Explicit Statement: The intended use explicitly states that Bf-NAVI "does not make any medical diagnosis." While IVDs can contribute to diagnosis, their primary function is the analysis of specimens for diagnostic purposes.
Therefore, Bf-NAVI falls under the category of medical imaging software used for procedural guidance, not as an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
chest CT scan data, pulmonary CT slice data
Anatomical Site
tracheobronchial tree, bronchial tree, bronchi, pulmonary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, user, operator
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)
Non-Clinical Testing:
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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6. Device Description
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.
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.
7. Intended 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 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.
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.
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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.
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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
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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
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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
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