DIRECTPATH

K121449 · Cybernet Systems Co., Ltd. · LLZ · Jul 10, 2012 · Radiology

Device Facts

• Record ID: K121449
• Device Name: DIRECTPATH
• Applicant: Cybernet Systems Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jul 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

DirectPath is a virtual bronchoscopic navigation software program designed to assist the physician during bronchoscopic examination. The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. The DirectPath software allows the physician to view a three-dimensional representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. DirectPath is intended for use only as a guidance tool and does not make any medical diagnosis.

Device Story

DirectPath is a Windows-based software for virtual bronchoscopic navigation. It processes pulmonary CT slice data (imported via external storage like CD/DVD/USB) to generate 3D representations of the tracheobronchial tree. The software uses Multi-Planar Reconstruction (MPR) to create virtual images of the internal bronchial surface. Used by physicians during bronchoscopic procedures to guide endoscopic tools or catheters toward target regions (e.g., suspicious tumors). The device acts as a guidance tool; it does not perform automated diagnosis. By visualizing the bronchial path, it assists the physician in navigating the pulmonary tract, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical verification and validation testing, including software design specification testing and hazard analysis.

Technological Characteristics

Windows-based software; utilizes Multi-Planar Reconstruction (MPR) for 3D image generation from CT datasets. Standalone software; no direct interface with CT hardware; data imported via external media. Verification and validation performed per FDA software guidelines.

Indications for Use

Indicated for use by physicians to assist in bronchoscopic examinations by generating a 3D tracheobronchial tree from chest CT data to identify optimal bronchial routes to target regions. Not for medical diagnosis.

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

• Bf-NAVI (K093810)
• VIDA Pulmonary Workstation 2 (PW2) (K083227)

Submission Summary (Full Text)

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Cybernet Systems Co., Ltd. Traditional 510(k) Premarket Submission Direct Path

JUL 1 0 2012

# Section 5 - 510(k) Summary for DirectPath

# 1. Sponsor Information

Cybernet Systems Co., Ltd. FUJISOFT Bldg. 3 Kanda-neribeicho, Chiyoda-ku, Tokyo 101-0022 JAPAN Phone: [phone] Fax: [phone] Contact: Yuuki Murata

### 2. Applicant Information

Emergo Group 611 West 5th Street 3d Floor Austin, TX 78701 Phone: [phone] Fax: [phone]

Email: [e-mail] Contact: Diane Sudduth, Senior Consultant QA/RA

#### 3. Date Prepared

April 17, 2012

#### · 4. Device Name

Trade/Proprietary Name:DirectPath Common/Usual Name: DirectPath, Virtual Bronchoscopic Navigator Classification Name: Computed tomography x-ray system Classification Regulation: 892.1750 Product Code: JAK

### 5. Predicate Devices

KGT Inc. -- Bf-NAVI K093810

VIDAS Diagnostics - VIDA Pulmonary Workstation 2 (PW2) K083227

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Cybernet Systems Co., Ltd. Traditional 510(k) Premarket Submission Direct Path

#### 6. Device Description

The DirectPath is a virtual bronchoscopic navigation software program designed to assist the physician during a bronchoscopic examination. The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. The DirectPath software allows the physician to view a three-dimensional representation of the bronchial tree that displays virtual images of the inside surface of the bronchi, DirectPath is intended for use only as a guidance tool and does not make any medical diagnosis.

DirectPath is a Windows-based image software package. It is designed to capture pulmonary CT slice data and display results to assist the user in guiding endoscopic tools or catheters in the pulmonary tract. The software utilizes data from a CT scan to generate a three-dimensional image of the bronchus. DirectPath provides computed tomography viewing via Multi-Planar Reconstruction (MPR) to generate the three-dimensional image. DirectPath does not interface directly with any CT or data collection equipment; CT datasets are delivered via external storage devices (basically CD, DVD and USB Flash memory).

#### 7. Intended Use

DirectPath is a virtual bronchoscopic navigation software program designed to assist the physician during bronchoscopic examination. The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. The DirectPath software allows the physician to view a three-dimensional representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. DirectPath is intended for use only as a guidance tool and does not make any medical diagnosis.

#### 8. Technological Characteristics and Substantial Equivalence

DirectPath shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate device.

DirectPath is a Windows-based image software package. It is designed to load pulmonary CT slice data and create Multi-Planar Reconstruction (MPR) images to identify a target on a suspicious tumor area. DirectPath can display the pathway to and virtual bronchoscopic images of the target. The predicate device is similar in

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Cybernet Systems Co., Ltd. Traditional 510(k) Premarket Submission Direct Path

design and function to DirectPath for the modes of operation and use and has the same intended use and indications for use as DirectPath.

### 9. Safety and Effectiveness

The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The Device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results indicate that all the software specifications have met the acceptance criteria of each module and interaction of processes. The DirectPath device passed all testing and supports the claims of substantial equivalence and safe operation.

There was no clinical testing required to support the medical device as the indications for use are equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing. The verification and validation testing of the device was found to be acceptable and supports the claims of substantial equivalence.

#### 10. Conclusion

By definition, a new device is substantially equivalent to a predicate device when the new device has the same intended use as the previously cleared predicate device and either (i) the same technological characteristics as the predicate, or (ii) if the new device has different technological characteristics, then those differences raise no new issues regarding the safety or effectiveness of the new device.

DirectPath device has the same or similar intended use and technological characteristics as the predicate device. The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators.

In conclusion, the submitter believes that the DirectPath device, as designed and manufactured, is substantially equivalent to the referenced predicate device and does not introduce any new issues of safety or effectiveness.

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# 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

JUL 1 0 2012

Cybernet System Co., Ltd. % Ms. Diane Sudduth Senior RA/QA Consultant Emergo 611 West 5th Street AUSTIN TX 78701

Re: K121449

Trade/Device Name: DirectPath Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 17, 2012 Received: May 15, 2012

Dear Ms. Sudduth:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Cybemet Traditional 510(k) Premarket Submission Direct Path

# Section 4- Indications for Use Statement

510(k) Number (if known): Not Assigned

Device Name: DirectPath

## Indications for use:

DirectPath is a virtual bronchoscopic navigation software program designed to assist the physician during bronchoscopic examination. The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. The DirectPath software allows the physician to view a three-dimensional representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. DirectPath is intended for use only as a guidance tool and does not make any medical diagnosis.

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

Over-The-Counter Use . (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Physician Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121449

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