This instrument has been designed to display virtual bronchoscopy images to be referenced by physicians as an aid to guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.

Device Description

VB Image Viewer (Virtual Bronchoscopy Image Viewer) is the Windows software to extract the bronchus from the CT data, create 3D virtual bronchoscopy image along the route to the target position, and display the image on the PC monitor as a reference image.

AI/ML Overview

This document, K080581, for Olympus Medical Systems Corp.'s VB Image Viewer (Virtual Bronchoscopy Image Viewer), does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, the submission relies on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not specify quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific error rates) for the VB Image Viewer's performance. It primarily focuses on showing that the device is "basically identical to the predicate device in intended use" and "similar in specifications" (Section 6).

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. There is no mention of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for an independent performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. As no independent test set with expert-established ground truth is described, this information is not present.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is mentioned as there's no described test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe an MRMC study comparing human reader performance with and without AI assistance. The submission focuses on the standalone device's equivalence to a predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The "Virtual Bronchoscopy Image Viewer" is a software device intended to "extract the bronchus from the CT data, create 3D virtual bronchoscopy image along the route to the target position, and display the image on the PC monitor as a reference image." The evaluation appears to be based on the device's ability to perform these functions as intended, and its similarity to the predicate device, rather than a quantifiable standalone performance metric against human readers or a gold standard. The statement "The clinical literatures provided in this submission supports the safety and efficacy of Virtual Bronchoscopy Imaging Viewer" (Section 6) suggests reliance on existing literature for the underlying technology, but it doesn't detail a specific standalone study performed for this particular device.

7. The Type of Ground Truth Used

Not explicitly stated for this device's evaluation. For the general concept of virtual bronchoscopy, ground truth would typically refer to actual anatomical structures as seen during optical bronchoscopy or surgical dissection, or potentially high-resolution anatomical models. However, the document doesn't detail how ground truth was applied to validate this specific device. Given the reliance on predicate equivalence, the "ground truth" implicitly refers to the predicate device's accepted performance and the established understanding of CT data interpretation for virtual bronchoscopy.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the use of machine learning or AI that would require a dedicated training set in the modern sense. The device is described as "Windows software to extract the bronchus from the CT data, create 3D virtual bronchoscopy image," implying rule-based or algorithmic image processing rather than a learned model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is described.

Summary of the Study:

The submission for the VB Image Viewer is a Section 510(k) premarket notification that relies on demonstrating substantial equivalence to a legally marketed predicate device, the "superDimension/Bronchus" (K042438).

Instead of presenting an independent study with acceptance criteria, the manufacturer argues that:

The VB Image Viewer has an identical intended use to the predicate device: "to display virtual bronchoscopy images to be referenced by physicians to aid guiding endoscopic tools in the pulmonary tract."
It is similar in specifications to the predicate, with the main difference being the deletion of hardware components (Extended Working Channel, Locatable Guide, Location Board, System Controller, Monitor, Patient Contact Materials) present in the predicate, as the VB Image Viewer is a software-only product running on a recommended PC and monitor.
The manufacturer states, "The clinical literatures provided in this submission supports the safety and efficacy of Virtual Bronchoscopy Imaging Viewer." This indicates reliance on existing scientific evidence for the general concept and technology of virtual bronchoscopy, rather than a new, specific clinical trial for this particular software.

Therefore, the "study" is less about proving specific quantitative performance against acceptance criteria and more about demonstrating that the new software device functions similarly to an already cleared device for the same intended purpose, and that the differences do not raise new questions of safety or effectiveness. The FDA's letter confirms their review of the 510(k) and their determination of substantial equivalence, allowing the device to be marketed.

Summary

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Kotosstl

OCT 1 6 2008

Attachment 5

510(k) Summary

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510(k) SUMMARY

Virtual Bronchoscopy Image Viewer

General Information 1

■ Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507Establishment Registration No: 8010047
■ Official Correspondent:	Laura Storms-TylerVice PresidentRegulatory Affairs & Quality AssuranceOlympus America Inc.3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-5688FAX: 484-896-7128Email:Laura.storms-tyler@olympus.comEstablishment Registration No: 2429304
■ Manufacturer:	OLYMPUS MEDICAL SYSTEMS CORP.34-3 Hirai, Hinode-machi Nishitama-gunTokyo, Japan 190-0182Establishment Registration Number: 3003637092

2 Device Identification

■	Device Trade Name:	VB Image Viewer
■	Common Name:	Virtual Bronchoscopy Image Viewer
■	Regulation Number:Regulation Name:	21 CFR 892.1750/ 21 CFR 874.4680Computed tomography x-ray systemBronchoscope (flexible or rigid) and accessories
■	Regulatory Class:	II
■	Classification Panel:	Bronchoscope accessory
■	Product Code:	JAK

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3 Predicate Device Information

Device Name:	superDimension/Bronchus
Common Name:	Computed tomography
Manufacturer:	superDimension Ltd.
510(k) No.	K042438

4 Device Description

Refer to Software Description for the detailed functions of VB Image Viewer, and Comparison Table for the difference between VB Image Viewer and Predicate Device.

5 Indications for Use

This instrument has been designed to display virtual bronchoscopy images to be referenced by physicians to aid guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.

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Comparison of Technological Characteristics ം

The Virtual Bronchoscope Image Viewer is basically identical to the predicate device in intended use, and similar in specifications except for the deletion of Extended Working Channel/ Locatable Guide/ Location Board. Comparison between the subject and predicate devices is shown in Table 1. The clinical literatures provided in this submission supports the safety and efficacy of Virtual Bronchoscopy Imaging Viewer.

Table 1. Comparison of Specifications Subject Device: Virtual Bronchoscope Imaging Viewer Predicate Device: superDimension/Bronchus (K042438)

Specifications	Subject DeviceVirtual BronchoscopeImaging Viewer	Predicate DevicesuperDimension/Bronchus
Software	Provided	Installed
System Controller	Recommended PC	Provided
Monitor	Recommended Monitor	Provided
Extended Working Channel	None	Provided
Locatable Guide	None	Provided
Location Board	None	Provided
Standard Set	CD-ROM	Bronchoscope
Patient Contact Materials	None	Extended Working Channel,Locatable Guide

7 Conclusion

When compared to the predicate device, the Virtual Bronchoscope Image Viewer does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The text is in all caps and is smaller than the eagle symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2008

Ms. Laura Storms-Tyler Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 ČENTER VALLEY PA 18034-0610

Re: K080581

Trade/Device Name: VB Image Viewer (Virtual Bronchoscopy Image Viewer) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 27, 2008 Received: October 8, 2008

Dear Ms. Storms-Tyler:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2

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 CFR Part 807); labeling (21 CFR Part 801); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Arque M. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): None KOBOSB)

Device Name: VB Image Viewer (Virtual Bronchoscopy Image Viewer) Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devi 510(k) Number

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Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.