LUNGPOINT PROCEDURE PLANNING

K093423 · Broncus Technologies, Inc. · LLZ · Nov 17, 2009 · Radiology

Device Facts

• Record ID: K093423
• Device Name: LUNGPOINT PROCEDURE PLANNING
• Applicant: Broncus Technologies, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 17, 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 Procedure Planning Software is a standalone software application installed on an off-the-shelf PC. It processes patient CT scan images (DICOM format) to generate 3D reconstructions of the lungs and tracheobronchial tree. Physicians use the software to visualize and explore pre-selected targets within lung tissue prior to performing a procedure. The software produces a printable procedure plan, which provides a bifurcation-by-bifurcation navigation map to the target. The device is used by physicians in a clinical setting to aid in the guidance of endoscopic tools or catheters and to facilitate marker placement. It does not perform diagnostic functions and is not an endoscopic tool itself. By providing a virtual 3D roadmap, the device assists in procedure planning, potentially improving the accuracy of tool navigation and marker placement in soft lung tissue.

Clinical Evidence

No clinical data. The device relies on design controls, risk management (hazard analysis and FMECA), and software verification/validation testing to demonstrate safety and effectiveness.

Technological Characteristics

Software-only device; runs on off-the-shelf PC hardware. Inputs: DICOM-formatted CT scan images. Outputs: 3D virtual lung reconstructions and printable navigation maps. Core technology involves 3D image processing and visualization. No specific materials or energy sources; standalone software deployment.

Indications for Use

Indicated for adult patients requiring visualization of the tracheobronchial tree to assist physicians in guiding endoscopic tools or catheters and placing markers 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 Software (K091160)

Submission Summary (Full Text)

{0}------------------------------------------------

K093423
pg 1 of 2

# 510(k) Summary

## 1. Date of Summary

October 16, 2009

# 2. 510(k) Applicant

NOV 1 7 2009

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

| Contact Person: | Plamena Entcheva-Dimitrov, Ph. D. | |
|-----------------|-----------------------------------|--|
| Phone: | [phone] x 320 | |
| Fax: | [phone] | |
| e-mail: | [e-mail] | |

## 3. Device Overview

| Trade Name: | LungPoint™ Procedure Planning Software |
|----------------------|-------------------------------------------------------------------------------|
| Common Name: | Picture Archiving and Communications Systems |
| Classification Name: | System, Image Processing, Radiological<br>21 CFR 892.2050<br>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<br>Bronchoscopic Navigation<br>Software | Broncus Technologies,<br>Inc. | K091160, cleared to<br>market 5 May, 2009 |

# 5. Device Description

..

LungPoint Procedure Planning, a software only device. As with the predicate, it provides the physician with 3D reconstruction of the patient's lungs, derived from the CT images and thus provides a more realistic view of the lungs. The physician can use the 3D virtual animation and associated images to view and explore pre-selected targets in the lung tissue before conducting a procedure.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters and page numbering. The top line reads 'K093423', which could be an identification code or reference number. The second line says 'pg 2 of 2', indicating it is the second page of a two-page document. The handwriting style is cursive and slightly stylized.

Like the predicate, the software allows for printing the procedure plan as a map, which consists of a bifurcation-by-bifurcation description of the route to the selected target.

The LungPoint Procedure Planning software is installed on an off-the-shelf PC computer, and is intended to be used in conjunction with commercially-available CT scan images 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 Procedure Planning software version 2.0 has the same intended use. technological characteristics and hardware as the predicate's planning phase. Both products provide guidance to the physician and use the exact same software (including core algorithms) for planning. The key features: 3D animation and printable plan/map; are identical to those of the planning phase of the predicate device and the same software algorithms are used. The only difference is that the real-time navigation tools are removed from the Procedure Planning product.

The User Manual was updated to reflect the modifications.

# 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 Procedure Planning software continues to meet its intended use.

# 9. Safety and Effectiveness

The LungPoint Procedure Planning 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.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Broncus Technology, Inc. % Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW BUFFALO, MN 55313

NOV 1 7 2009

Re: K093423

Trade/Device Name: LungPoint Procedure Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communication Systems Regulatory Class: II Product Code: LLZ Dated: November 2, 2009 Received: November 3, 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.

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 -

Enclosure

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

Indications for Use .

510(k) Number (if known): K693423

Device Name: LungPoint™ Procedure Planning 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K093423

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of _