(57 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 in the tracheobronchial tree. Specifically, the VBN system provides global quidance to targets preselected by the bronchoscopist in peripheral airways. In doing so, the VBN can provide local 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. 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 HRCT scans that are saved in DICOM format.
Here's a breakdown of the acceptance criteria and study information for the LungPoint™ Virtual Bronchoscopic Navigation (VBN) System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Accuracy: Distance error between virtual targets and actual targets in real bronchoscope video. | 2.17 +/- 0.84 mm (from animal study) |
| Accuracy: Mean and standard deviation of distance error (phantom study). | 2.2 +/- 2.3 mm (from phantom study) |
Note: The 510(k) summary does not explicitly state "acceptance criteria" but rather presents performance data from studies. The interpretation is that the demonstrated accuracy values were deemed acceptable by the FDA for clearance.
2. Sample Size Used for the Test Set and Data Provenance
- Animal Study: The document mentions "an animal study" in a "canine model" but does not specify the exact number of animals or trials conducted.
- Phantom Study: The document refers to "an earlier phantom study performed by Merritt et al" but does not specify the sample size (number of phantom cases/measurements).
- Data Provenance:
- Animal Study: Canine model (prospective, as it was conducted to evaluate the system).
- Phantom Study: Not explicitly stated, but phantom studies are typically controlled and designed prospectively.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided 510(k) summary does not include information on the number or qualifications of experts used to establish ground truth for either the animal or phantom studies. The ground truth for accuracy was likely established through direct measurement of physical distances, rather than expert consensus on subjective interpretations.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given the nature of measuring distance error in physical or virtual environments, it's unlikely that adjudications by multiple readers were required in the same way they would be for subjective image interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The studies focused on the standalone accuracy of the navigation system rather than its impact on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, the reported studies primarily assess the standalone performance of the LungPoint VBN system. The accuracy measurements (distance error) evaluate the system's ability to precisely align virtual targets with actual targets, which is an intrinsic performance characteristic of the algorithm/system rather than its direct impact on a human user's diagnostic ability.
7. Type of Ground Truth Used
- Animal Study: The ground truth was based on the "actual target in the real bronchoscope video" which implies physical, measurable locations marked or identified in a live setting, against which the virtual targets were compared. This would be a form of direct measurement/physical truth.
- Phantom Study: Similarly, the ground truth for the phantom study would have been based on physical precision measurements within the phantom model.
8. Sample Size for the Training Set
The 510(k) summary does not mention or specify a sample size for the training set for the VBN software. As a navigation system, its core function is to process existing HRCT scans (DICOM format) to create virtual pathways. While software development involves testing and calibration, the summary does not detail a separate "training set" in the context of machine learning model development. This submission precedes the widespread emphasis on AI/ML training data reporting in regulatory submissions.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the provided document, there is no information on how its ground truth was established. For a navigation system of this type, the "training" (if applicable in a more traditional software sense) would likely involve adherence to anatomical models and engineering specifications for calculating virtual paths and registering images.
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510(k) Summary
1. Date of Summary
December 11, 2008
510(k) Applicant 2.
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, x320 |
| Fax: | (650) 428-1542 |
| e-mail: | mfatemi@broncus.com |
3. Device Overview
| Trade Name: | LungPoint™ Virtual Bronchoscopic Navigation (VBN) System |
|---|---|
| Common Name: | Picture Archiving and Communications Systems |
| Classification Name: | System, Image Processing, Radiological21 CFR 892.2050Product Code LLZ |
4. Predicate Device
The predicate device identified for the LungPoint VBN is as follows:
| Trade Name | 510(k) Submitter | 510(k) Number |
|---|---|---|
| superDimension®/BronchusinReach™ System | superDimension, Ltd | K080271, cleared onMarch 31, 2008 |
| superDimension/Bronchus | superDimension, Ltd | K042438, cleared onNovember 8, 2004 |
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
MAR ] 3 2009
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and proceed to a predefined target site in the tracheobronchial tree. Specifically, the VBN system provides global quidance to targets preselected by the bronchoscopist in peripheral airways. In doing so, the VBN can provide local 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.
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 HRCT 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.
Comparison to Predicate Device 7.
The LungPoint VBN software is substantially equivalent to the predicate. The VBN software has the same intended use and similar technological characteristics as the predicate. The difference in technological characteristics, specifically the navigation method of the VBN software, does not raise any new questions of safety or effectiveness.
8. Performance Data
An animal study was conducted to evaluate the accuracy of the VBN system during bronchoscopic follow-up procedures in a canine model. Accuracy was assessed by determining the mean and standard deviation of the distance error between the virtual targets defined in the virtual rendering and the actual target in the real bronchoscope video. The results of the study indicate that the distance error of the VBN system is 2.17 +/- 0.84 mm.
The results of the animal study corroborated the outcome of an earlier phantom study performed by Merritt et al, which showed that the mean and standard deviation of the distance error of the VBN system is 2.2 +/- 2.3 mm.
Safety and Effectiveness 9.
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 FMEA, which are used to identify potential hazards. These potential hazards are controlled via software development, verification testing and validation testing.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAR 1 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Broncus Technologies, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
Re: K090095
Trade/Device Name: LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software Regulation Number: 21 CFR 892.2050
· Regulation Name: Picture archiving and communications systems
Regulatory Class: II
Product Code: LLZ
Dated: February 19, 2009
Received: February 20, 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.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppot/index.html.
Sincerely yours,
Janine M. Norris
Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
K 90095
Device Name:
Indications for Use:
LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tonlond 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
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-CounterUse (21 CFR 801 Subpart C)
(Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page of
Broncus Technologies, Inc.
CONFIDENTIAL
17
§ 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).