K Number
K060903
Device Name
IG4 IMAGE GUIDED SYSTEM
Date Cleared
2006-05-11

(38 days)

Product Code
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

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

Not Found

No
The description focuses on electromagnetic tracking and respiratory gating, with no mention of AI or ML techniques for image analysis, navigation, or other functions.

No
The device is a stereotactic accessory for CT systems that aids in visualizing interventional instruments and anatomical structures. It does not directly provide a therapeutic effect itself.

No

The device is described as an "Image Guided System" that assists in locating and navigating interventional instruments like biopsy or ablation needles. It is explicitly stated to be used in "clinical interventions" to guide procedures rather than to diagnose medical conditions through the interpretation of images or data.

No

The device description explicitly lists hardware components such as an EM tracking accessory, a matrix of thoracic reference markers, an EM field generator and tracking system, and a computer system, in addition to software.

Based on the provided information, the ig4™ Image Guided System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • ig4 System Function: The ig4 System is a stereotactic accessory for CT systems used to guide interventional instruments (needles) within the patient's body during procedures. It uses imaging and tracking technology to help the clinician visualize and navigate to a target organ or structure.
  • No Specimen Analysis: The ig4 System does not analyze any specimens taken from the patient. Its function is entirely focused on guiding instruments during in-vivo procedures.

Therefore, the ig4™ Image Guided System falls under the category of a medical device used for image-guided intervention, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for 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.

Product codes

JAK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography (CT)

Anatomical Site

soft tissue, anatomical structures where computed tomography is currently used for visualizing such procedures.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

bench and animal tests demonstrated that the ig4™ Image Guided System meets the performance requirements for its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

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

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.

0

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: (303) 594-3666 Telefax: (615) 297-0911

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

1

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

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 depiction of an eagle or bird-like figure with three wing-like shapes, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the upper portion of the logo.

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.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, and the letters "FDA" in the center. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by stars and the words "U.S. Department of Commerce".

Protecting and Promoting Public Lands

3

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
Other240-276-0100

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 (800) 638-2041 or (301) 443-6597 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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