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.

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.

AI/ML Overview

The provided document describes the LungVision System, a device 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 to support catheter/device navigation during pulmonary procedures.

The 510(k) summary (pages 3-6) focuses on demonstrating substantial equivalence to a predicate device (Philips EP-Navigator K062650) rather than providing detailed acceptance criteria and a study proving the device meets those specific criteria. The document states "No clinical testing was performed." and "No animal testing was performed."

Therefore, based solely on the provided text, a comprehensive answer to your request is not possible. However, I can extract the available information regarding performance and testing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes general claims of equivalence to a predicate device. The "Performance and Specifications" section states: "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."

The "Nonclinical / Bench" section states: "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."

Without the specific "requirements specifications" or direct comparative performance data, it's impossible to generate a table of acceptance criteria and reported device performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench tests" and "testing has also been performed with pig lungs to test accuracy in deformable tissue." However, it does not specify the sample size for these tests, the data provenance (e.g., country of origin), or whether the tests were retrospective or prospective.

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)

The document does not describe the establishment of a ground truth for a test set using experts. Since no clinical or animal testing was performed to evaluate the diagnostic or navigational accuracy against defined ground truth, this information is not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical or animal studies with a test set requiring expert adjudication for ground truth were described.

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

No MRMC comparative effectiveness study was done. The document explicitly states "No clinical testing was performed."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document mentions "bench tests" and "verification testing of the requirements, testing of hazards mitigations, and performance testing of the system," as well as "testing has also been performed with pig lungs to test accuracy in deformable tissue." These appear to be standalone tests of the device's technical performance attributes. However, specific metrics of "algorithm only" performance (e.g., accuracy of segmentation or registration) are not provided, nor is the "performance" explicitly defined in terms of measurable outcomes. The application is for a navigation aid where a human is in the loop.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the "testing has also been performed with pig lungs to test accuracy in deformable tissue," the type of ground truth is not specified. Given it was in vitro testing on pig lungs, it would likely involve physical measurements or anatomical references, but this is not detailed. For other bench tests, "ground truth" would refer to the expected functional behavior or output as per the requirements specifications, rather than a clinical ground truth like pathology.

8. The sample size for the training set

The document describes the device as a "PC based software application" that utilizes algorithms to process existing 3D CT datasets and live fluoroscopic images. This suggests the system employs algorithms that might have been developed or trained. However, the document does not provide any information regarding a training set, its sample size, or how it was used in the development of the device's algorithms.

9. How the ground truth for the training set was established

Not applicable, as no information about a training set is provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, formed by three stylized human profiles facing to the right.

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)

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 AverbuchBody Vision Medical Ltd.34 Sokolov St.Ramat Hasharon IsraelTel: 646- 863-7848 (US)
Proprietary or Trade Name:	LungVision System
Common/Usual Name:	System, image processing, radiological
Classification Name:	Picture archiving and communications systemLLZ, Class II, CFR 892.2050
Predicate Device:	Philips EP-Navigator K062650

Device Description:

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	PredicateK062650 Philips EP-Navigator	Proposed DeviceLungVision	Comments
Indications for Use	EP-Navigator is intended toenable users to segmentpreviously acquired 3DCT datasets and overlay andregister these 3D segmenteddata sets with livefluoro X-ray images of thesame anatomy in order tosupport catheter/devicenavigation during specifiedprocedures.	The LungVision System isintended to enable users tosegment previously acquired3D CT datasets and overlayand register these 3Dsegmented data sets withfluoroscopic live X-ray imagesof the same anatomy in order tosupport catheter/devicenavigation during pulmonaryprocedures.	Substantiallyequivalent
Classification	Picture archiving andcommunications system21CFR 892.2050Procut Code: LLZClass II	Picture archiving andcommunications system21CFR 892.2050Procut Code: LLZClass II	Similar
Target anatomy	Heart	Lungs	Different anatomysame process
Anatomy access	Cardiac vessels	Bronchial airways	Different anatomysame process
Windows OS	Yes (Windows 7)	Yes (Windows 10)	LungVision useslatest version ofWindows OS
Medical imagingsoftware	Yes	Yes	equivalent
General Image2D/3D review	Yes	Yes	equivalent
3D rendering view	Yes	Yes	equivalent
Multi-modalitySupport	Yes	Yes	equivalent
Image registration	Yes	Yes	equivalent
Multi-planarreformatting(MPR)	Yes	Yes	equivalent
Feature	PredicateK062650 Philips EP-Navigator	Proposed DeviceLungVision	Comments
DICOM import	Yes	Yes	equivalent
Fluoroscopic video	Yes	Yes	equivalent
Standard Imageviewing tools	Yes	Yes	equivalent
Segmentation tool	Yes	Yes	equivalent
Video capture	Yes	Yes	equivalent
Live Imageoverlays	Yes	Yes	equivalent
Import prior plans	Yes	Yes	equivalent
Pointmarking/ 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.

Regulation Number and Section

§ 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).