IG4 IMAGE GUIDED SYSTEM

K060903 · Veran Medical Technologies, Inc. · JAK · May 11, 2006 · Radiology

Device Facts

• Record ID: K060903
• Device Name: IG4 IMAGE GUIDED SYSTEM
• Applicant: Veran Medical Technologies, Inc.
• Product Code: JAK · Radiology
• Decision Date: May 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The ig4TM Image Guided System is a stereotactic accessory for Computed Tomography (CT) Systems. The ig4 System displays an interventional instrument, such as a biopsy needle, an aspiration needle, or an ablation needle, on a computer monitor that also displays a CT-based model of the target organ(s). The ig4 System compensates for the patient's respiratory phases. The ig4 System is intended to be used in clinical interventions and for anatomical structures where computed tomography is currently used for visualizing such procedures.

Device Story

ig4 Image Guided System functions as CT accessory for interventional procedures; utilizes electromagnetic (EM) tracking to navigate instruments relative to CT-based anatomical models. System components: EM tracking accessory for rigid needles, thoracic reference marker matrix, EM field generator, computer system, software. Operation: tracks needle position in real-time; displays instrument on monitor alongside CT model; incorporates respiratory gating to compensate for patient breathing during soft tissue navigation. Used in clinical settings by physicians to guide biopsy, aspiration, or ablation needles. Output: visual guidance on computer monitor; assists clinicians in precise instrument placement; potentially improves accuracy and reduces procedure time for soft tissue interventions.

Clinical Evidence

Bench and animal testing performed to validate performance requirements. No human clinical trial data provided.

Technological Characteristics

Electromagnetic (EM) tracking system; EM field generator; thoracic reference marker matrix; software-based respiratory gating; computer-based visualization; compatible with rigid interventional needles (biopsy, aspiration, ablation).

Indications for Use

Indicated for use as a stereotactic accessory for CT systems to assist in clinical interventions and visualization of anatomical structures where CT is currently used. Supports use with biopsy, aspiration, or ablation needles. Includes respiratory gating for soft tissue navigation.

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

• UltraGuide CT-1010 (K002258)
• Medtronic Navigation GoldenEye System (K001284)

Submission Summary (Full Text)

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# SECTION 5-510(k) Summary

MAY 11 2006

# ig4TM Image Guided System

# I. Submitter Information

Veran Medical Technologies 2409 21st Avenue South Suite 205 Nashville, TN 37212 Telephone: [phone] Telefax: [phone]

Contact: Torsten M. Lyon Date Prepared: March 31, 2006

# II. Device Information

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

# III. Device Description

The ig4TM Image Guided System is an accessory for a CT System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CT-based model of the patient anatomy. Because the system is used to assist in locating 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, a matrix of thoracic reference markers, an EM field generator and tracking system, software, and a computer system.

# IV. Intended Use

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

The ig4 System is intended to be used in clinical interventions and for anatomical structures where computed tomography is currently used for visualizing such procedures.

# V. Substantial equivalence

The ig4™ Image Guided System was demonstrated to be substantially equivalent to the UltraGuide CT-1010 (K002258), the Medtronic Navigation GoldenEye

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System (K001284) and conventional soft tissue navigation with CT images. In addition, bench and animal tests demonstrated that the ig4™ Image Guided System meets the performance requirements for its intended use. Dissimilarities between the ig4™ System and the predicate devices do no affect the safety or effectiveness of this device.

:

: 上一篇:

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# MAY 11 1 2006

Mr. Torsten M. Lyon Vice President of Engineering Veran Medical Technologies. Inc. 2409 21st Avenue South Suite 205 NASHVILLE TN 37212

Re: K060903

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: March 31, 2006 Received: April 3, 2006

Dear Mr. Lyon:

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.

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**Protecting and Promoting Public Lands**

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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 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" (21 CFR 807.97). 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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# SECTION 4 - Indications for Use

Page 1 of 1

510(k) Number (if known): 长 0 6 0 9 0 3

Device Name: ig4TM Image Guided System

### Indications for Use:

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

The ig4 System is intended to be used in clinical interventions and for anatomical structures where computed tomography is currently used for visualizing such procedures.

#### 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)

(Posted November 13, 2003)

David A. Ingram

(Division Sian-Off Division of Reproductive. and Radiological Devices 510(k) Number

Page 15

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