← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K163622
# Lung Vision (K163622)
_Bodyvision Medical , Ltd. · LLZ · May 11, 2017 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K163622
## Device Facts
- **Applicant:** Bodyvision Medical , Ltd.
- **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md)
- **Decision Date:** May 11, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.2050
- **Device Class:** Class 2
- **Review Panel:** Radiology
## Intended 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.
## Device Story
LungVision System assists physicians in guiding endobronchial tools during pulmonary procedures. Input: previously acquired 3D CT datasets (DICOM) and live fluoroscopic X-ray video. Operation: system segments CT data, registers it with live fluoroscopic images, and overlays planned navigation paths onto the live X-ray feed. Used in clinical settings by physicians. Output: visual overlay on external monitor (not provided) showing tool position relative to target anatomy. Benefits: improved navigation accuracy for endobronchial tools toward target areas of interest. System comprises a laptop, video capture box, isolation transformer, and software.
## Clinical Evidence
No clinical data. Bench testing only. Verification testing of requirements, hazard mitigations, and system performance conducted. Accuracy in deformable tissue tested using pig lungs. Electrical safety and EMC testing performed per ANSI AAMI ES 60601-1 and IEC 60601-1-2.
## Technological Characteristics
PC-based software platform; Windows 10 OS. Hardware includes laptop, video capture box, and IEC 60601-1 compliant isolation transformer. Connectivity: DICOM import, video capture. Image processing: segmentation, registration, and overlay of 3D CT to live fluoroscopy. No patient-contact parts; no biocompatibility required.
## Regulatory 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.
## Special Controls
*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).
## Predicate Devices
- Philips EP-Navigator ([K062650](/device/K062650.md))
## Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2017
Body Vision Medical Ltd. % Mr. Paul Dryden Consultant PROMEDIC, LLC 24301 Woodsage Drive BONITA SPRINGS FL 34134
Re: K163622
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 13, 2017 Received: April 14, 2017
Dear Mr. Dryden:
This letter corrects our substantially equivalent letter of May 11, 2017.
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 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 requirements, including, but not limited to: registration and listing (21
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jeff Balyer
For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
### K163622
### Device Name
### LungVision System
Indications for Use (Describe)
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.
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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#### 510(k) Summary April 13, 2017 Page 1 of 5
| Official Contact: | Dorian Averbuch
Body Vision Medical Ltd.
34 Sokolov St.
Ramat Hasharon Israel
Tel: 646- 863-7848 (US) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------|
| 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: | Philips EP-Navigator K062650 |
#### Device Description:
The LungVision System is designed enabling 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 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 image processing algorithms are executed on a PC based hardware platform, which 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:
- Laptop with a mouse and DVD reader ●
- . Video Capture Box
- IEC 60601-1compliant Isolation Transformer
- LungVision Board (passive device) ●
- LungVision Software ●
The laptop mouse and DVD reader are off-the-shelf information technology equipment powered from the isolation transformer. The video capture box is manufactured by BodyVision and is also powered from the isolation transformer. The system above has been evaluated to AAIM ANSI ES 60601-12005+ A1:2012 and IEC 60601-1-2: 2014. The system connects to customer supplied imaging and display devices.
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#### 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.
#### Contraindications:
None
### Device Comparison
Table 1 compares the subject device to the predicate
| Feature | Predicate
K062650 Philips EP-
Navigator | Proposed Device
LungVision | Comments |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Indications for Use | EP-Navigator is intended to
enable users to segment
previously acquired 3D
CT datasets and overlay and
register these 3D segmented
data sets with live
fluoro X-ray images of the
same anatomy in order to
support catheter/device
navigation during specified
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. | Substantially
equivalent |
| Classification | Picture archiving and
communications system
21CFR 892.2050
Procut Code: LLZ
Class II | Picture archiving and
communications system
21CFR 892.2050
Procut Code: LLZ
Class II | Similar |
| Target anatomy | Heart | Lungs | Different anatomy
same process |
| Anatomy access | Cardiac vessels | Bronchial airways | Different anatomy
same process |
| Windows OS | Yes (Windows 7) | Yes (Windows 10) | LungVision uses
latest version of
Windows OS |
| Medical imaging
software | Yes | Yes | equivalent |
| General Image
2D/3D review | Yes | Yes | equivalent |
| 3D rendering view | Yes | Yes | equivalent |
| Multi-modality
Support | Yes | Yes | equivalent |
| Image registration | Yes | Yes | equivalent |
| Multi-planar
reformatting
(MPR) | Yes | Yes | equivalent |
| Feature | Predicate
K062650 Philips EP-
Navigator | Proposed Device
LungVision | Comments |
| DICOM import | Yes | Yes | equivalent |
| Fluoroscopic video | Yes | Yes | equivalent |
| Standard Image
viewing tools | Yes | Yes | equivalent |
| Segmentation tool | Yes | Yes | equivalent |
| Video capture | Yes | Yes | equivalent |
| Live Image
overlays | Yes | Yes | equivalent |
| Import prior plans | Yes | Yes | equivalent |
| Point
marking/ tagging | Yes | Yes | equivalent |
| Navigation type | Visual | Visual | equivalent |
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### 510(k) Summary April 13, 2017 Page 3 of 5
### 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. Discussion: There are no differences.
### Design and Technology:
The LungVision utilizes the same technological characteristics as the predicate devices. Both:
- are PC based software applications that provide 2D and 3D medical image acquisition including real-. time video image acquisition arid visualization of the anatomy
- use Windows operating systems ●
- 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
Discussion: Same design and technology.
### 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.
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### 510(k) Summary April 13, 2017 Page 4 of 5
### Compliance with Standards:
LungVision includes hardware and complies with IEC 60601-1:2005 and IEC 60601-1-2:2014. The EP Navigator includes hardware and complies with IEC 60601-1:2005 and IEC 60601-1-2:2007 Discussion: The proposed device comples with the latest standards and thus can be found substantially equivalent.
#### Performance Testing:
#### Nonclinical / Bench:
We have performed bench tests and found that the Body 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.
The device was also tested to the requirements of ANSI AAMI ES 60601-1 and IEC 60601-1-2.
#### Biocompatibility:
There are no patient contact 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 LungVision System is substantially equivalent in safety and effectiveness to the predicate device.
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K163622](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K163622)
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