VB IMAGE VIEWER

K080581 · Olympus Medical Systems Corporation · JAK · Oct 16, 2008 · Radiology

Device Facts

• Record ID: K080581
• Device Name: VB IMAGE VIEWER
• Applicant: Olympus Medical Systems Corporation
• Product Code: JAK · Radiology
• Decision Date: Oct 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

VB Image Viewer is Windows-based software; extracts bronchial structures from CT data; generates 3D virtual bronchoscopy images along paths to target positions; displays images on PC monitor as reference. Used in clinical settings by physicians; provides visual guidance for endoscopic tool navigation in pulmonary tract. Does not perform diagnosis; does not physically interact with patient. Benefits include improved navigation aid for endoscopic procedures.

Clinical Evidence

No clinical data; safety and efficacy supported by clinical literature provided in the submission.

Technological Characteristics

Windows-based software application; runs on recommended PC hardware; displays 3D virtual bronchoscopy images derived from CT data. No patient-contact materials. Standalone software package (CD-ROM).

Indications for Use

Indicated for use by physicians to display virtual bronchoscopy images as an aid to guiding endoscopic tools in the pulmonary tract. Not for diagnostic use; not an endoscopic tool.

Regulatory Classification

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.

Predicate Devices

• superDimension/Bronchus (K042438)

Submission Summary (Full Text)

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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.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507<br>Establishment Registration No: 8010047 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent: | Laura Storms-Tyler<br>Vice President<br>Regulatory Affairs & Quality Assurance<br>Olympus America Inc.<br>3500 Corporate Parkway<br>PO Box 610<br>Center Valley, PA 18034-0610, USA<br>Phone: [phone]<br>FAX: [phone]<br>Email:[e-mail]<br>Establishment Registration No: 2429304 |
| ■ Manufacturer: | OLYMPUS MEDICAL SYSTEMS CORP.<br>34-3 Hirai, Hinode-machi Nishitama-gun<br>Tokyo, Japan 190-0182<br>Establishment Registration Number: 3003637092 |

### 2 Device Identification

:

| ■ | Device Trade Name: | VB Image Viewer |
|---|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| ■ | Common Name: | Virtual Bronchoscopy Image Viewer |
| ■ | Regulation Number:<br>Regulation Name: | 21 CFR 892.1750/ 21 CFR 874.4680<br>Computed tomography x-ray system<br>Bronchoscope (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

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.

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 Device<br>Virtual Bronchoscope<br>Imaging Viewer | Predicate Device<br>superDimension/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,<br>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 [phone] or [phone] 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:

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.

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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