MODIFICATION TO INREACH SYSTEM

K081379 · Superdimension, Ltd. · JAK · Jun 11, 2008 · Radiology

Device Facts

• Record ID: K081379
• Device Name: MODIFICATION TO INREACH SYSTEM
• Applicant: Superdimension, Ltd.
• Product Code: JAK · Radiology
• Decision Date: Jun 11, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

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

The inReach System guides bronchoscopes and bronchial tools to targets in or near the bronchial tree using CT scan data. It visualizes the target and the interior of the bronchial tree to assist physicians during procedures. The system enables the placement of radiosurgical and dye markers into soft lung tissue to facilitate subsequent thoracic surgery or radiosurgery. Operated by physicians in a clinical setting, the system transforms CT inputs into a 3D bronchial tree map and navigation guidance. The updated software version 5.0 adds 3D-pathway planning, verification, and an enhanced graphical user interface. The output is displayed to the physician to aid in navigation and tool placement; it does not provide a diagnosis.

Clinical Evidence

No clinical data was required to validate the software modifications. Evidence consists of bench testing, design validation, and risk analysis.

Technological Characteristics

Software-based navigation system for bronchoscopy. Features 3D bronchial tree map generation, 3D-pathway planning, and GUI enhancements. Operates on CT scan data. No changes to hardware or fundamental technological characteristics.

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 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

• inReach System (K080271)

Submission Summary (Full Text)

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K6r13779

# 510(k) Summary

superDimension, Ltd. Special 510(k) Changes to inReach System Software Version 5.0

JUN 1 1 2008

# Date Prepared:

05/15/2008

#### 510(k) Applicant:

superDimension, Ltd. 8 Hamenofim St., P.O. Box 2045 Herzliya 46120 Israel Ph: [phone] Fax: [phone]

### 510(k) Application Correspondent:

Jonathan Kovach Vice President, Quality and Regulatory Affairs superDimension, Inc. 161 Cheshire Lane, Suite 100 Minneapolis, MN 55441 Phone: [phone] Cell : 763-360-4984 763-210-4098 Fax : Email : jkovach(@superdimension.com

#### Name of Device :

| Trade Name : | - superDimension®/Bronchus<br>- inReach™ System |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Bronchoscope |
| Classification Name: | Computed tomography x-ray system<br>21 CFR Part 892.1750<br>Product code JAK |

# Equivalent Legally-Marketed Device:

inReach System, K080271

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# Description:

The inReach System is a device that guides a bronchoscope and bronchial tool to a target in or adjacent to the bronchial tree on a path indicated by CT scan, and visualizes the target and the interior of the tree. The inReach System also enables the placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.

# 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.

# Summary of Characteristics Compared to Predicate Device:

The planning software has been modified to add the generation and visualization of a three-dimensional (3D) bronchial tree map, an enhanced graphical user interface (GUI), improved 3D-pathway planning and verification, the addition of the product brand name (inReach™), and a splash screen.

The procedure software has been modified to include the 3D-Map view of the bronchial tree, GUI enhancements, increased navigation ability with navigation guidance enhancements, a backup/cleanup utility, the addition of the product brand name (inReach™), and a splash screen.

Modifications are being made to the Instructions for Use (inReach User Manual) to reflect the aforementioned software modifications.

No changes are being made to the hardware or intended use, or technological characteristics of the current marketed device.

# Performance Data:

The planned modifications were subjected to the superDimension design control process. Appropriate labeling changes, risk analysis, software and design validations were performed to assure the inReach System continues to meet the its intended use.

# Clinical Data:

Clinical tests were not required to validate the changes to the inReach System.

# Conclusion:

The inReach System is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 11 2008

SuperDimension, Ltd. % Mr. Jonathan Kovach Vice President, Quality and Regulatory Affairs SuperDimension, Inc. 161 Cheshire Lane, Suite 100 MINNEAPOLIS MN 55441

Re: K081379

Trade/Device Name: inReach System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 15, 2008 Received: May 16, 2008

#### Dear Mr. Kovach:

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. Iisting 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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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 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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# Indications for Use

510(k) Number (if known): _ K 08 / 3 7 9

Device Name: inReach System

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-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arni Khang

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Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081379