IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200

K093146 · Veran Medical Technologies, Inc. · JAK · Nov 30, 2009 · Radiology

Device Facts

• Record ID: K093146
• Device Name: IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
• Applicant: Veran Medical Technologies, Inc.
• Product Code: JAK · Radiology
• Decision Date: Nov 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4™ System compensates for the patient's respiratory phases. The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography or 3D fluoroscopic x-ray are currently used for visualizing such procedures.

Device Story

Stereotactic accessory for CT or 3D fluoroscopic x-ray systems; utilizes electromagnetic (EM) tracking to navigate instruments relative to patient anatomy models. System components: EM tracking accessory for rigid/coaxial needles, patient referencing system, EM field generator, software, computer. Input: volumetric data from CT or 3D fluoroscopic C-arm systems. Operation: tracks needle position in real-time; gates location data to patient respiratory phases to compensate for soft tissue movement. Output: visual display on monitor showing instrument position relative to target organ model. Used in clinical settings by physicians to guide interventional instruments. Benefits: improved navigation accuracy for needle placement in soft tissue structures during respiratory motion.

Clinical Evidence

No clinical data provided. Bench accuracy testing performed on a static phantom to demonstrate 3D fluoroscopic x-ray navigation accuracy.

Technological Characteristics

Electromagnetic (EM) tracking system; includes EM field generator, patient referencing system, and tracking accessories for needles. Software-based respiratory gating. Compatible with CT and 3D fluoroscopic C-arm systems. Standalone computer system for data processing and visualization.

Indications for Use

Indicated for patients undergoing clinical interventions requiring needle-based procedures (biopsy, aspiration, ablation) where CT or 3D fluoroscopic x-ray imaging is used for visualization. No specific age or gender restrictions stated.

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

• ig4™ Image Guided System (K060903)

Submission Summary (Full Text)

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1093146

NOV 30 2009

## 510(k) Summarv Veran Medical Technologies Traditional 510(k) ig4TM Image Guided System - 3D Fluoroscopic X-ray Navigation Indications for Use Expansion

## Date Prepared:

September 24, 2009

## 510(k) Applicant:

Veran Medical Technologies, Inc. 5743 West Park Avenue St. Louis, MO 63110 Telephone: [phone] [phone] Fax:

Scott Wrightstone Contact:

## Device Information:

ig4TM Image Guided System Trade Name: CT stereotactic accessory Common Name: Classification Name: Computed Tomography X-ray System Classification Code: JAK

## Equivalent Legally-Marketed Devices:

ig4TM Image Guided System (K060903)

### Device Description:

The ig4™ Image Guided System is an accessory for a CT or 3D fluoroscopic x-ray System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CTbased or 3D fluoroscopic x-ray-based model of the patient anatomy. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles or tip-tracked coaxial needle, a patient referencing system, an EM field generator and tracking system, software and a computer system.

#### Intended Use:

The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4TM System compensates for the patient's respiratory phases.

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The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography or 3D fluoroscopic x-ray are currently used for visualizing such procedures.

### Substantial Equivalence:

The ig4™ Image Guided System - 3D fluoroscopic x-ray navigation has been shown to be substantially equivalent in navigating interventional instrumentation in 3D fluoroscopic x-raybased models of the patient anatomy as the ig4™ Image Guided System (K060903) navigating instrumentation in CT-based models of the patient anatomy. This submission demonstrates that the current ig4™ Image Guided System software allows for instrument navigation with imaging systems that generate volumetric data from 3D fluoroscopic x-ray (i.e. - 3D fluoroscopic c-arm systems).

There are no required changes to the system and the software of the ig4™ Image Guided System (K060903) for instrument navigation with 3D fluoroscopic x-ray-based models of the patient anatomy.

## Performance Data:

Bench accuracy testing was completed to demonstrate 3D fluoroscopic x-ray navigation accuracy on a static phantom. As required by Veran Medical Technologies design control processes and risk analysis, all verification and validation activities have been completed by designated individuals and have demonstrated the safety and effectiveness of the device.

## Clinical Data:

Clinical tests were not required to demonstrate the safety and effectiveness of the device.

### Conclusion:

The information provided in this 510(k) notification supports that the ig4™ Image Guided System - 3D fluoroscopic x-ray navigation was shown to be substantially equivalent to the ig4™ Image Guided System (K060903) in navigating interventional instrumentation.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines. The logo is in black and white.

# 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

NOV 3 0 2009

Mr. Scott Wrightstone QA/RA Manager Veran Medical Technologies. Inc. 5743 West Park Avenue ST LOUIS MO 63110

Re: K093146

Trade/Device Name: ig4TM Image Guided System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 2, 2009 Received: October 5, 2009

Dear Mr. Wrightstone:

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 (OS) 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/CDRHQffices/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.

Sincerely yours,

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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## SECTION 4 – Indications for Use

510(k) Number: Κυ93146

Device Name: ig4™ Image Guided System

Indications for Use:

The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4™ System compensates for the patient's respiratory phases.

The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography or 3D fluoroscopic x-ray are currently used for visualizing such procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Division Sign-Off)*

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

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