(86 days)
No
The summary describes software that uses 3D reconstruction of CT scans for navigation and guidance, but there is no mention of AI, ML, or related concepts like training or testing data sets.
No
The device is indicated for displaying images and guiding tools, not for providing therapy or treatment.
No
The "Intended Use" section explicitly states, "It does not make a diagnosis." The device's primary function is guiding endoscopic tools and enabling marker placement, not identifying medical conditions.
No
The device description explicitly mentions the "FlexNeedle is an aspiration needle" and describes its use in conjunction with the software, indicating a hardware component is part of the overall system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The LungPoint Software and FlexNeedle system is a navigational and guidance tool used during a medical procedure (bronchoscopy). It uses pre-existing imaging data (CT scans) to help a physician visualize and navigate within the patient's respiratory system and guide instruments.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It operates on imaging data.
- Intended Use: The intended use is to aid in guiding endoscopic tools and placing markers, not to perform a diagnostic test on a biological sample.
Therefore, the device falls under the category of a medical device used for procedural guidance, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
LLZ
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.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
tracheobronchial tree, pulmonary tract, lung tissue, bronchial tree
Indicated Patient Age Range
Not for pediatric use.
Intended User / Care Setting
physician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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, Radiological
21 CFR 892.2050
Product Code LLZ |
4. Predicate Device
The predicate devices identified are as follows:
| Trade Name | 510(k) Submitter | 510(k) Number |
|---|---|---|
| LungPoint Planning and Virtual | ||
| Bronchoscopic Navigation (VBN) | ||
| System | Broncus Technologies, | |
| Inc | K091160, cleared to | |
| market on May 5, 2009 | ||
| inReach System | SuperDimension | K110093, cleared to |
| market 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 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-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.