(86 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.
The LungPoint Software is a device that guides a bronchoscope and commercially available endoscopic tools to a prespecified target in or adjacent to the bronchial tree by providing a path, which is displayed on a 3D reconstruction of a CT scan. The Software allows visualization of the interior of the bronchial tree; placement of catheters in the bronchial tree; visualization of a prespecified target in lung tissue; and placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. The FlexNeedle is an aspiration needle. When used together with the LungPoint Software, the needle can be guided to a prespecified targeted area within the respiratory organs.
The 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.
The provided text is a 510(k) summary for the LungPoint™ Planning and Virtual Bronchoscopic Navigation (VBN) Software. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria and specific statistical results.
Therefore, many of the requested details about acceptance criteria, performance data, test set characteristics, expert qualifications, and ground truth establishment are not explicitly available in the provided text.
Here's an analysis based on the information that is present:
1. A table of acceptance criteria and the reported device performance
The document states: "No new risks were identified as the use of endoscopic tools, like the FlexNeedle, is inherent to the design and intended use of the existing LungPoint Software. Additionally, no new verification and validation testing was performed as the software was not modified in any way to allow for the use of the FlexNeedle."
This indicates that the primary "acceptance criterion" for this specific 510(k) submission was the absence of new risks or modifications to the software that would necessitate new performance testing. Therefore, there is no direct table of acceptance criteria and reported device performance for this submission. The performance of the underlying LungPoint Software would have been established in previous 510(k) clearances (K091160).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new risks identified with FlexNeedle integration. | No new risks were identified. |
| No modifications to the software requiring new verification/validation. | The software was not modified in any way. |
| Substantial equivalence to predicate devices (K091160, K110093). | Determined to be substantially equivalent. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text, as no new performance testing was conducted for this specific submission.
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 provided in the text, as no new performance testing was conducted for this specific submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text, as no new performance testing was conducted for this specific submission.
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
There is no mention of an MRMC comparative effectiveness study or AI assistance in the provided text. The device is described as "guid[ing] a bronchoscope... by providing a path, which is displayed on a 3D reconstruction of a CT scan." This suggests a visualization and navigation tool rather than an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone performance study is mentioned in the text for this submission. The device is explicitly intended to "aid the physician in guiding endoscopic tools," indicating a human-in-the-loop design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the text, as no new performance testing was conducted for this specific submission.
8. The sample size for the training set
This information is not provided in the text, as no new performance testing was conducted for this specific submission. The device is not described as being based on machine learning or requiring a "training set" in the context of this 510(k).
9. How the ground truth for the training set was established
This information is not provided in the text, as no new performance testing was conducted for this specific submission and the device's mechanism isn't described as requiring a training set in this context.
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OCT 1 2 2011
510(k) Summary
1. Date of Summary
June 30, 2011
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
| Trade Name: | LungPoint™ Planning and Virtual Bronchoscopic Navigation(VBN) Software |
|---|---|
| Common Name: | Picture Archiving and Communications Systems |
| Classification Name: | System, Image Processing, Radiological21 CFR 892.2050Product Code LLZ |
4. Predicate Device
The predicate devices identified are as follows:
| Trade Name | 510(k) Submitter | 510(k) Number |
|---|---|---|
| LungPoint Planning and VirtualBronchoscopic Navigation (VBN)System | Broncus Technologies,Inc | K091160, cleared tomarket on May 5, 2009 |
| inReach System | SuperDimension | K110093, cleared tomarket on February 11,2011, (and K071473,K092365, and K102604,by reference) |
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5. Device Description
The LungPoint Software is a device that guides a bronchoscope and commercially available endoscopic tools to a prespecified target in or adjacent to the bronchial tree by providing a path, which is displayed on a 3D reconstruction of a CT scan. The Software allows visualization of the interior of the bronchial tree; placement of catheters in the bronchial tree; visualization of a prespecified target in lung tissue; and placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. The FlexNeedle is an aspiration needle. When used together with the LungPoint Software, the needle can be guided to a prespecified targeted area within the respiratory organs.
The 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 Software with FlexNeedle has the same intended use and technological characteristics as the predicate devices.
8. Performance Data
The existing risk analysis for the LungPoint Software was reviewed to assess whether guidance of the FlexNeedle adds any new hazards. No new risks were identified as the use of endoscopic tools, like the FlexNeedle, is inherent to the design and intended use of the existing LungPoint Software. Additionally, no new verification and validation testing was performed as the software was not modified in any way to allow for the use of the FlexNeedle.
9. Safety and Effectiveness
The 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.
Broncus Technologies, Inc.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Broncus Technologies, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LL.C. 1 394 25" Street NW BUFFALO MN 55313
OCT 1 2 2011
Re: K112051
Trade/Device Name: LungPoint™ Planning and Virtual Brochoscopic Navigation (VBN) Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 3, 2011 Received: October 6. 2011
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 your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reportion of
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Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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 Parts 801 and 809), please contact the Office of in Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K112051 |
|---|---|
| Device Name: | LungPoint™ Planning and Virtual BronchoscopicNavigation (VBN) Software |
| Indications for Use: | Indicated for displaying images of the tracheobronchial treeto aid the physician in guiding endoscopic tools or cathetersin the pulmonary tract and to enable marker placementwithin soft lung tissue. It does not make a diagnosis and isnot an endoscopic tool. Not for pediatric use. |
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) K112051
Page __ of ___________________________________________________________________________________________________________________________________________________________________
Broncus Technologies, Inc.
§ 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).