LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM

K091160 · Broncus Technologies, Inc. · LLZ · May 5, 2009 · Radiology

Device Facts

• Record ID: K091160
• Device Name: LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
• Applicant: Broncus Technologies, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 5, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Device Story

LungPoint VBN is software-only navigation system; processes patient CT scans (DICOM format) to generate 3D visualizations of tracheobronchial tree. Bronchoscopist uses system to plan pathways to predefined targets (ROI) in lung tissue; provides virtual bronchoscopic guidance during procedures to assist in navigating endoscopic tools/catheters to targets (e.g., lymph nodes) or returning to previously treated sites. System installed on off-the-shelf PC; used in clinical settings by physicians. Enhancements include improved GUI, simplified planning, airway labeling, and obstacle visualization. Output aids physician navigation; does not perform diagnosis. Benefits include precise tool placement for tissue sampling or therapy.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through design control processes, risk management (hazard analysis/FMECA), and software verification/validation testing.

Technological Characteristics

Software-only device; runs on off-the-shelf PC. Inputs: DICOM CT scans. Features: 3D visualization, airway labeling, pathway planning, and virtual bronchoscopic guidance. OS: Windows Vista Business Edition. Connectivity: Supports local storage of procedure plans.

Indications for Use

Indicated for adult patients requiring guidance of endoscopic tools or catheters in the pulmonary tract and marker placement in soft lung tissue. Not for pediatric use.

Regulatory Classification

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

• LungPoint™ Virtual Bronchoscopic Navigation (VBN) System (K090095)

Submission Summary (Full Text)

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K091160
Page 1 of 2

# 510(k) Summary

## 1. Date of Summary

April 14, 2009

# 2. 510(k) Applicant

Broncus Technologies, Inc. 1400 N. Shoreline Blvd., Bldg. A, Suite 8 Mountain View, California 94043 Phone: [phone] FAX: [phone]

| Contact Person: | Mahtab Fatemi |
|-----------------|---------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| e-mail: | [e-mail] |

# 3. Device Overview

LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software Trade Name: Common Name: Picture Archiving and Communications Systems Classification Name: System, Image Processing, Radiological 21 CFR 892.2050 Product Code LLZ

## 4. Predicate Device

The predicate device identified for the LungPoint VBN is as follows:

| Trade Name | 510(k) Submitter | 510(k) Number |
|-------------------------------------------------------------|------------------------------|-----------------------------------------------|
| LungPoint™ Virtual Bronchoscopic<br>Navigation (VBN) System | Broncus<br>Technologies, Inc | K090095, cleared to<br>market on March 13, 09 |

## 5. Device Description

This premarket notification covers Broncus' LungPoint VBN System. The VBN System is a software only device, providing a navigation system to help the bronchoscopist plan and proceed to a predefined target site (also referred to as region of interest (ROI) in the tracheobronchial tree. Specifically, the VBN system provides guidance to targets preselected by the bronchoscopist in lung tissue. In doing so, the VBN can provide guidance to lymph nodes to enable tissue sampling. It can also facilitate the return to an exact location in the lungs that had previously been treated for assessment of or continued therapy, or enable marker placement.

MAY - 5 2009

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The VBN software is installed on an off-the-shelf PC computer system, and is intended to be used with commercially-available flexible bronchoscopes with CT scans that are saved in DICOM format.

## 6. Intended Use

Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

#### 7. Comparison to Predicate Device

The LungPoint VBN software has been modified to add an enhanced graphical user interface (GUI). The planning software has been simplified to streamline the planning process. 3-D visualization, improved pathway planning with airway labeling and a summary page have also been added. The procedure software has been enhanced to simplify the user interactions and provide user-friendly virtual bronchoscopy guidance with airway labeling and obstacles visualizations. As with the planning software, a new procedure summary page has also been added.

In addition to the changes to the GUI, the software now supports saving the procedure plans on the procedure/navigation computer instead of only on removable media. The operating system has also been updated to Windows Vista Business Edition from Windows XP Professional.

The User's Manual was undated to reflect the software modifications.

The VBN software has the same intended use, technological characteristics and hardware as the predicate.

#### 8. Performance Data

The planned modifications were subjected to the Broncus design control process. Appropriate labeling changes, risk analysis, and design verification were performed to assure that the VBN software continues to meet its intended use.

## 9. Safety and Effectiveness

The VBN labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the software. Risk management is ensured via a hazard analysis and FMECA, which are used to identify potential hazards. These potential hazards are controlled via software development, verification testing and/or validation testing.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

2009 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Broncus Technologies, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1:394 25" Street NW BUFFALO MN 55313

Re: K091160

Trade/Device Name: LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software Regulation Number: 21 CFR 892.2050

Regulation Name: Picture archiving and communications system

Regulatory Class: II

Product Code: LLZ

Dated: April 20, 2009 Received: April 21, 2009

# Dear Mr. Job:

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 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); 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.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Janine M. Morris 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): . K_09 11 60

Device Name:

LungPoint™ Virtual Bronchoscopic Navigation (VBN) Software

Indications for Use:

Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-CounterUse (21 CFR 801 Subpart C)

Page

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

Carolyn Y Newland for J.m. Morris

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

Concurrence of CDRH, Office of Device Evaluation (ODE)