(14 days)
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
This premarket notification covers Broncus' LungPoint VBN System. The VBN System is a software only device, providing a navigation system to help the bronchoscopist plan and proceed to a predefined target site (also referred to as region of interest (ROI) in the tracheobronchial tree. Specifically, the VBN system provides guidance to targets preselected by the bronchoscopist in lung tissue. In doing so, the VBN can provide guidance to lymph nodes to enable tissue sampling. It can also facilitate the return to an exact location in the lungs that had previously been treated for assessment of or continued therapy, or enable marker placement.
The provided document is a 510(k) summary for the Broncus LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software. It primarily focuses on demonstrating substantial equivalence to a predicate device after software modifications, rather than presenting a detailed study with specific acceptance criteria and performance metrics for the device itself.
Therefore, much of the requested information cannot be extracted from this document because the submission does not detail a study conducted to establish acceptance criteria and prove the device meets them in the way clinical performance studies typically do for diagnostic or therapeutic devices. This 510(k) is for a software modification, and the performance data section mentions "design control process," "labeling changes, risk analysis, and design verification," rather than a clinical performance study.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The 510(k) summary refers to design verification and risk analysis as evidence of performance, but it does not specify quantitative acceptance criteria or corresponding reported device performance metrics in a clinical context.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided document. No specific test set or clinical study data is detailed for the performance validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided document. There is no mention of a test set requiring ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided document. No test set requiring ground truth adjudication is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not available in the provided document. The submission details software modifications for a navigation system, not a diagnostic AI system that would typically undergo an MRMC study to compare human reader performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not available in the provided document in the context of typical standalone performance studies for AI software. The device is described as a "Virtual Bronchoscopic Navigation (VBN) Software" that "provides guidance to targets preselected by the bronchoscopist." This implies a human-in-the-loop system where the software aids the physician, rather than acting as a standalone diagnostic algorithm. No standalone performance metrics are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available in the provided document. There is no mention of ground truth as no formal clinical performance study is detailed.
8. The sample size for the training set
This information is not available in the provided document. The document refers to software modifications and design verification, not to the training of a machine learning model, which would involve a training set.
9. How the ground truth for the training set was established
This information is not available in the provided document. As there is no mention of a training set, the method for establishing its ground truth is also not provided.
Summary of what the document does state about performance:
The document states under "8. Performance Data":
"The planned modifications were subjected to the Broncus design control process. Appropriate labeling changes, risk analysis, and design verification were performed to assure that the VBN software continues to meet its intended use."
And under "9. Safety and Effectiveness":
"Risk management is ensured via a hazard analysis and FMECA, which are used to identify potential hazards. These potential hazards are controlled via software development, verification testing and/or validation testing."
This indicates that the performance verification for this 510(k) submission was based on internal design control processes, risk analysis, and software verification/validation testing, rather than a clinical trial or performance study against predefined clinical acceptance criteria. The submission is focused on demonstrating substantial equivalence of the modified software to its predicate, particularly regarding an "enhanced graphical user interface (GUI)" and streamlined planning/procedure processes.
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K091160
Page 1 of 2
510(k) Summary
1. Date of Summary
April 14, 2009
2. 510(k) Applicant
Broncus Technologies, Inc. 1400 N. Shoreline Blvd., Bldg. A, Suite 8 Mountain View, California 94043 Phone: (650) 428-1600 FAX: (650) 428-1542
| Contact Person: | Mahtab Fatemi |
|---|---|
| Phone: | (650) 428-1600 |
| Fax: | (650) 428-1542 |
| e-mail: | mfatemi@broncus.com |
3. Device Overview
LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software Trade Name: Common Name: Picture Archiving and Communications Systems Classification Name: System, Image Processing, Radiological 21 CFR 892.2050 Product Code LLZ
4. Predicate Device
The predicate device identified for the LungPoint VBN is as follows:
| Trade Name | 510(k) Submitter | 510(k) Number |
|---|---|---|
| LungPoint™ Virtual BronchoscopicNavigation (VBN) System | BroncusTechnologies, Inc | K090095, cleared tomarket on March 13, 09 |
5. Device Description
This premarket notification covers Broncus' LungPoint VBN System. The VBN System is a software only device, providing a navigation system to help the bronchoscopist plan and proceed to a predefined target site (also referred to as region of interest (ROI) in the tracheobronchial tree. Specifically, the VBN system provides guidance to targets preselected by the bronchoscopist in lung tissue. In doing so, the VBN can provide guidance to lymph nodes to enable tissue sampling. It can also facilitate the return to an exact location in the lungs that had previously been treated for assessment of or continued therapy, or enable marker placement.
MAY - 5 2009
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The VBN software is installed on an off-the-shelf PC computer system, and is intended to be used with commercially-available flexible bronchoscopes with CT scans that are saved in DICOM format.
6. Intended Use
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
7. Comparison to Predicate Device
The LungPoint VBN software has been modified to add an enhanced graphical user interface (GUI). The planning software has been simplified to streamline the planning process. 3-D visualization, improved pathway planning with airway labeling and a summary page have also been added. The procedure software has been enhanced to simplify the user interactions and provide user-friendly virtual bronchoscopy guidance with airway labeling and obstacles visualizations. As with the planning software, a new procedure summary page has also been added.
In addition to the changes to the GUI, the software now supports saving the procedure plans on the procedure/navigation computer instead of only on removable media. The operating system has also been updated to Windows Vista Business Edition from Windows XP Professional.
The User's Manual was undated to reflect the software modifications.
The VBN software has the same intended use, technological characteristics and hardware as the predicate.
8. Performance Data
The planned modifications were subjected to the Broncus design control process. Appropriate labeling changes, risk analysis, and design verification were performed to assure that the VBN software continues to meet its intended use.
9. Safety and Effectiveness
The VBN labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the software. Risk management is ensured via a hazard analysis and FMECA, which are used to identify potential hazards. These potential hazards are controlled via software development, verification testing and/or validation testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
2009 MAY
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Broncus Technologies, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1:394 25" Street NW BUFFALO MN 55313
Re: K091160
Trade/Device Name: LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Regulatory Class: II
Product Code: LLZ
Dated: April 20, 2009 Received: April 21, 2009
Dear Mr. Job:
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 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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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): . K_09 11 60
Device Name:
LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software
Indications for Use:
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-CounterUse (21 CFR 801 Subpart C)
Page
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Carolyn Y Newland for J.m. Morris
(Division (Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).