(118 days)
No
The summary describes image processing algorithms for segmentation, registration, and overlay, but does not mention AI, ML, or related terms. The performance studies focus on bench testing and equivalence to a predicate device, without mentioning training or test sets typically associated with AI/ML development.
No
The device is used for navigation support during pulmonary procedures, meaning it assists in guiding other devices or tools, rather than directly treating a condition itself.
No
The device is described as supporting catheter/device navigation and assisting in guiding endobronchial tools. It is explicitly stated that the "Tablet is for planning but is not for diagnostic purposes." Therefore, its primary function is not to diagnose a disease or condition.
No
The device description explicitly states that the Lung Vision system includes a "main unit and a tablet" which are hardware components, in addition to the software.
Based on the provided information, the LungVision System is not an In Vitro Diagnostic (IVD) device.
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.
- LungVision System's Function: The LungVision System's intended use and description clearly state that it is used to process and overlay medical images (CT and fluoroscopy) to assist in catheter/device navigation during pulmonary procedures. It is a tool for guiding interventions within the body, not for analyzing biological specimens.
- No Specimen Analysis: There is no mention of the system collecting, preparing, or analyzing any biological specimens from the patient. Its inputs are imaging data.
Therefore, the LungVision System falls under the category of a medical device used for image processing and navigation during procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
Product codes
LLZ
Device Description
The Lung Vision System (K163622) is designed to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
The Lung Vision System is designed to assist the physician in guiding endobronchial tools towards the target area of interest inside the patient lungs. Prior to the endoscopic procedure the system allows planning the target location and the path to the target area on the CT scan. During the endoscopic procedure the system overlays planned data over fluoroscopic images to support endobronchial tool navigation towards the area of interest. The system does not include the Fluoroscope, Bronchoscope or the external monitor. Lung Vision system includes a main unit and a tablet vs. the previous PC based hardware platform. Image processing algorithms are executed on the main unit and the tablet is used as a primary method of interacting with the system. The Tablet is for planning but is not for diagnostic purposes. Both can perform the following functions: segment previously acquired DICOM 3D CT image data, . register DICOM 3D CT image data with live fluoroscopic X-ray image . overlay the segmented 3D CT dataset over a live fluoroscopic X-ray image of the same anatomy, obtained on a Fluoroscopic system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D CT datasets, live X-ray images, fluoroscopic X-ray image, fluoroscopic images, real-time video image
Anatomical Site
lungs, Bronchial airways
Indicated Patient Age Range
Not Found
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
Nonclinical / Bench: We have performed bench tests and found that the Lung Vision met all requirements specifications and was found to be equivalent in comparison to the predicate. Testing includes verification testing of the requirements, testing of hazards mitigations) and performance testing of the system. Testing has also been performed with pig lungs to test accuracy in deformable tissue.
Biocompatibility: There are no patient contacting parts of the LungVision System
Animal: No animal testing was performed
Clinical: No clinical testing was performed
Key Metrics
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).
0
| | 510(k) Summary
April 18, 2019 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Dorian Averbuch
Body Vision Medical Ltd.
34 Sokolov St.
Ramat Hasharon Israel
Tel: 646- 863-7848 (US) |
| Submission Correspondent: | Paul Dryden
ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg, FL 33704 |
| Proprietary or Trade Name: | LungVision System |
| Common/Usual Name: | System, image processing, radiological |
| Classification Name: | Picture archiving and communications system
LLZ, Class II, CFR 892.2050 |
| Predicate Device: | BodyVision – LungVision – K163622 |
| Reference Device: | Covidien - superDimension™ Navigation System V7.2
K173244 |
Device Modification
-
- Virtual Bronchoscopy
- a. A standard technology in the field of pulmonology. This is a visualization technique showing the same information already available in the CT scan.
-
- Software upgrades
- a. C-Arm based Tomography - visual aid. Collecting a number of successive images produced by a standard C-Arm which are digitally "stacked" together to form an additional alternative visualization of imaging information sourcing from standard C-Arm.
- b. Multi view Setup - an algorithm improvement. Same airway based registration algorithm, extended to multiple C-Arm angles. previous was limited to one angle (AP, LAO, RAO or other C-Arm position)
-
- Real time compensation
- Predicate displays a static target overlay on the fluoroscopic image, whereas the proposed a. modification performs small adjustments related to the tool movement on the fluoroscopic screen to the target overlay.
-
- 3D Guidance
- Predicate calculates the tool position with respect to pre-operative CT. The proposed a. modification provides 3D visualization for those calculations in addition to the existing screen.
-
- Use of a Tablet in addition to PC
- The Tablet image displayed is not for diagnostic purposes. a.
None of these modifications changes the indications for use, environment of use or patient population.
Description:
The Lung Vision System (K163622) is designed to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
1
510(k) Summary April 18, 2019
The Lung Vision System is designed to assist the physician in guiding endobronchial tools towards the target area of interest inside the patient lungs. Prior to the endoscopic procedure the system allows planning the target location and the path to the target area on the CT scan. During the endoscopic procedure the system overlays planned data over fluoroscopic images to support endobronchial tool navigation towards the area of interest. The system does not include the Fluoroscope, Bronchoscope or the external monitor. Lung Vision system includes a main unit and a tablet vs. the previous PC based hardware platform. Image processing algorithms are executed on the main unit and the tablet is used as a primary method of interacting with the system. The Tablet is for planning but is not for diagnostic purposes. Both can perform the following
- functions: segment previously acquired DICOM 3D CT image data, .
- . register DICOM 3D CT image data with live fluoroscopic X-ray image
- . overlay the segmented 3D CT dataset over a live fluoroscopic X-ray image of the same anatomy, obtained on a Fluoroscopic system.
System Components Overview
The following is a list of the LungVision System's main components: LungVision Main Unit LungVision Tablet LungVision Router LungVision Board (passive device) LungVision Software
Tablet is off-the-shelf information technology equipment powered from the medical grade power supply. The system has been evaluated to AAIM ANSI ES 60601-1 2005+ A1:2012 and IEC 60601-1-2: 2014.
Indications for Use:
The Lung Vision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
Contraindications:
None
Device Comparison
Table 1 compares the subject device to the predicate
| Feature | Proposed Device
LungVision | Primary Predicate
K163622
Body Vision-LungVision |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The LungVision System is intended to
enable users to segment previously
acquired 3D CT datasets and overlay and
register these 3D segmented data sets
with fluoroscopic live X-ray images of
the same anatomy in order to support
catheter/device navigation during
pulmonary procedures. | The LungVision System is intended to
enable users to segment previously
acquired 3D CT datasets and overlay and
register these 3D segmented data sets
with fluoroscopic live X-ray images of
the same anatomy in order to support
catheter/device navigation during
pulmonary procedures. |
| Classification | Picture archiving and communications
system
21CFR 892.2050 | Picture archiving and communications
system
21CFR 892.2050 |
| Feature | April 18, 2019
Proposed Device
LungVision | Primary Predicate
K163622
Body Vision-LungVision |
| | Product Code: LLZ | Product Code: LLZ |
| Target anatomy | Lungs | Lungs |
| Anatomy access | Bronchial airways | Bronchial airways |
| Windows OS | Windows 10 | Windows 10 |
| Medical imaging
software | Yes | Yes |
| General Image 2D/3D
review | Yes | Yes |
| 3D rendering view | Yes | Yes |
| Multi-modality
Support | Yes | Yes |
| Image registration | Yes | Yes |
| Multi-planar
reformatting (MPR) | Yes | Yes |
| DICOM import | Yes | Yes |
| Fluoroscopic video | Yes | Yes |
| Standard Image
viewing tools | Yes | Yes |
| Segmentation tool | Yes | Yes |
| Video capture | Yes | Yes |
| Live Image overlays | Yes | Yes |
| Import prior plans | Yes | Yes |
| Point
marking/ tagging | Yes | Yes |
| Navigation type | Visual | Visual |
| Modifications | | |
| Virtual bronchoscopy | Yes | No
Reference Covidien -
superDimension™ Navigation
System V7.2 - K173244 |
| C-Arm based | Yes | No |
| Tomography | | |
| Multi-view set-up | Yes | No |
| Real-time | Yes - software upgrade | No |
| compensation | | |
2
0(k) Summar 000 0010
Substantial Equivalence Discussion
We will discuss the table above.
Indications for Use / Patient Population / Environment of Use: As in comparison of Indications For Use above, we can conclude that the indications for use for the LungVision and the predicate are substantially equivalent.
Discussion: The differences in proposed indications for use are minor. The minor differences do not raise new risk or safety concerns, and the subject device can be found substantially equivalent.
Prescriptive: Both the LungVision and predicate are prescription devices.
3
510(k) Summary April 18, 2019
Discussion: There are no differences.
Design and Technology: The LungVision utilizes the same technological characteristics as the predicate and reference devices. Both include:
- . software applications that provide 2D and 3D medical image acquisition including real-time video image acquisition and visualization of the anatomy
- . allow co-registration of real-time images to previously created 3D image sets based on previously collected DICOM CT images
- . include image enhancements such as contrast and brightness, zoom and pan capabilities
- addition of a Tablet to the PC but not to be used for diagnostic purposes ●
For the Virtual Bronchoscopy feature the reference device - Covidien - superDimension™ Navigation System V7.2 - K173244 has the same feature and intended use.
Discussion: The software modifications including virtual bronchoscopy, C-arm based Tomography, 3D Guidance, and Real-time compensation are similar to the reference device.
Performance and Specifications:
The performance and specifications demonstrate that the Lung Vision and predicate devices perform the same functions using the same technologies thus can be found substantially equivalent. Discussion: There are no differences, thus the subject device can be found substantially equivalent.
Compliance with Standards:
LungVision includes hardware and complies with ANSI/AAMI/ES 60601-1:2005(2012) and IEC 60601-1-2:2014.
Discussion: The proposed device complies with the latest standards and thus can be found substantially equivalent.
Performance Testing:
Nonclinical / Bench: We have performed bench tests and found that the Lung Vision met all requirements specifications and was found to be equivalent in comparison to the predicate. Testing includes verification testing of the requirements, testing of hazards mitigations) and performance testing of the system.
Testing has also been performed with pig lungs to test accuracy in deformable tissue.
Biocompatibility: There are no patient contacting parts of the LungVision System
Animal: No animal testing was performed
Clinical: No clinical testing was performed
Substantial Equivalence Conclusion
Based upon the foregoing performance testing and comparison to the legally marketed predicate devices for indications for use, technology, and performance we believe we have demonstrated that the Lung Vision System is substantially equivalent in safety and effectiveness to the predicate device.
4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement on last page. |
| ------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number ( if known ) | K183593 |
|---|---|
| Device Name | LungVision System |
| Indications for Use ( Describe ) | The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures. |
| Type of Use ( Select one or both, as applicable ) | |
| XX Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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April 18, 2019
Body Vision Medical Ltd. % Mr. Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr., NE ST. PETERSBURG FL 33704
Re: K183593
Trade/Device Name: LungVision System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 1, 2019 Received: April 2, 2019
Dear Mr. Dryden:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 comply with all the Act's
6
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure