INREACH SYSTEM, MODEL AAS00161-02

K092365 · Superdimension, Ltd. · JAK · Sep 4, 2009 · Radiology

Device Facts

• Record ID: K092365
• Device Name: INREACH SYSTEM, MODEL AAS00161-02
• Applicant: Superdimension, Ltd.
• Product Code: JAK · Radiology
• Decision Date: Sep 4, 2009
• 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 superDimension inReach System is an electromagnetic navigation bronchoscopy device. It uses pre-operative CT scan data to guide a bronchoscope and endoscopic tools to targets within or adjacent to the bronchial tree. The system provides real-time visualization of the target and bronchial tree interior. It enables placement of catheters and radiosurgical/dye markers into soft lung tissue to assist in thoracic surgery and radiosurgery. Operated by physicians in a clinical setting, the system provides visual guidance via a 3D map, real-time virtual bronchoscopy, and a locatable guide (LG) tip indicator. New software features include CT-to-Body Automatic Initial Registration (autoIR) and dynamic registration (DR) algorithms, which provide alternative navigation methods. The system displays continuous line-based guidance pathways to assist the physician in navigating to the target. The output aids the physician in precise tool placement, potentially improving the accuracy of biopsies or marker delivery in lung tissue.

Clinical Evidence

No clinical data. The device changes were validated through bench testing, design verification, and risk management analysis.

Technological Characteristics

Electromagnetic navigation bronchoscopy system. Utilizes CT scan data for 3D mapping. Features include autoIR and dynamic registration algorithms. Visualization includes real-time LG tip tracking, virtual bronchoscopy, and MIP views. Software-based guidance provides continuous pathway navigation. Hardware includes a personal/laptop computer interface. No changes to disposable components.

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

• superDimension inReach System (K081379)

Submission Summary (Full Text)

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K092365
Page 1 of 2

#### 510(k) Summary

superDimension, Ltd. Special 510(k) superDimension inReach System Addition of Software Functionality

# Date Prepared:

07/31/2009

## 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 :

superDimension inReach™ System Trade Name : Bronchoscope Common Name: Classification Name: Computed tomography x-ray system 21 CFR Part 892.1750 Product code JAK

# Equivalent Legally-Marketed Device:

superDimension inReach System, K081379

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K092365
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#### Description:

The superDimension inReach System is a device that guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan. The superDimension inReach System also allows visualization of the target and the interior of the bronchial tree; placement of catheters in the bronchial tree; and 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 software through implementation of algorithms for CT-to-Body Automatic Initial Registration (autoIR) and dynamic registration (DR) for electromagnetic navigation bronchoscopy. These new algorithms provide alternative methods for registration and navigation. Additional views are being added including a real-time Locatable Guide (LG) tip location indicator on the 3D Map, a local view showing the CT volume cut through the LG tip location, a real-time virtual bronchoscopy view synchronized with the LG position, and a Maximum Intensive Projection (MIP) view synchronized with the LG position. The software will also provide guidance on a continuous pathway (line-based guidance) when navigating inside the 3D Map.

Minor changes are being made to the Personal and Laptop Computer. No changes are being made to the disposable products. The Instructions for Use are being changed to address the changes to the software.

#### Performance Data:

The changes to the algorithms and Instructions for Use were subjected to the superDimension design control process. Risk Management was performed to analyze the potential hazards associated with the changes. Appropriate design verification and validations were performed to assure the superDimension inReach System continues to be safe and effective for its intended use.

#### Clinical Data:

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

#### Conclusion:

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

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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

SEP - 4 2009

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

Re: K092365

Trade/Device Name: superDimension® inReach™ System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 31, 2009 Received: August 5, 2009

## 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 (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

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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/CDRH/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/cdrh/mdr/ 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 vours. '

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

192245 510(k) Number (if known):

Device Name: superDimension® 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)

Hito Reum

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devic

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