INREACH SYSTEM

K080271 · Superdimension, Ltd. · JAK · Mar 31, 2008 · Radiology

Device Facts

• Record ID: K080271
• Device Name: INREACH SYSTEM
• Applicant: Superdimension, Ltd.
• Product Code: JAK · Radiology
• Decision Date: Mar 31, 2008
• Decision: SESE
• Submission Type: Traditional
• 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 superDimension/Bronchus System guides bronchoscopes and bronchial tools to targets within or adjacent to the bronchial tree. The system utilizes pre-operative CT scan data to map a path to the target; it visualizes the target and the interior of the bronchial tree for the physician. The system enables the placement of radiosurgical and dye markers into soft lung tissue to assist in subsequent radiosurgery or thoracic surgery. It is operated by a physician in a clinical setting. The device does not perform automated diagnosis and is not an endoscopic tool itself; it serves as an image-guided navigation aid to improve the precision of tool placement and marker deployment, potentially benefiting patients by facilitating more accurate surgical or radiosurgical interventions.

Clinical Evidence

No new clinical testing was required for this indication expansion. The manufacturer relied on multiple published studies demonstrating the safety and effectiveness of the Bronchus system for placing radiosurgical and dye markers into soft lung tissue to guide subsequent surgical procedures.

Technological Characteristics

The system functions as an image-guided navigation platform using CT scan data. It includes hardware and software for visualizing the tracheobronchial tree and guiding tools. No changes were made to the hardware or software design compared to the predicate device.

Indications for Use

Indicated for adult patients requiring guidance of endoscopic tools or catheters in the pulmonary tract and placement of markers 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

• superDimension/Bronchus Premium 2 (K071473)

Submission Summary (Full Text)

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K080271/

510(k) Summary

superDimension, Ltd. Traditional 510(k) Indication Expansion

MAR 3 1 2008

#### Date Prepared:

01/31/2008

### 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:

superDimension/Bronchus Premium 2, K071473

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# Description:

The superDimension/Bronchus 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 superDimension/Bronchus 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:

Changes are being made to the Instructions for Use to include guidance and instruction for deploying radiosurgical and dye markers into soft lung tissue with the superDimension/Bronchus System.

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

# Performance Data:

The changes to the Instructions for Use were subjected to the superDimension design control process. A hazard analysis was performed to analyze the potential hazards associated with the changes. Appropriate design validations were performed to assure the superDimension/Bronchus continues to meet the expanded user needs and intended uses.

# Clinical Data:

Clinical tests were not required to validate the changes to the superDimension/Bronchus System. Multiple published studies have demonstrated the Bronchus is safe and effective when used to place radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery.

# Conclusion:

The superDimension/Bronchus is safe and effective for its intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

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

MAR 3 1 2008

Re: K080271

Trade/Device Name: superDimension®/Bronchus inReach™ System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 31, 2008 Received: February 1, 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, 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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. In the center of the logo are the letters "FDA" in a bold, stylized font. There are three stars below the word Centennial. The text around the circle reads "International Association of Food Industry Suppliers".

Protecting and Promoting Public Health.

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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 vours.

Nancy C. Brogdon

Nancy C. Brogdon 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 80271

Device Name: superDimension/Bronchus

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)

Aomi Whing

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