IGI-SYSTEM

K052840 · Denx Advanced Dental Systems · HAW · Dec 16, 2005 · Neurology

Device Facts

• Record ID: K052840
• Device Name: IGI-SYSTEM
• Applicant: Denx Advanced Dental Systems
• Product Code: HAW · Neurology
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The IGI-System™, Image-Guided Implantation System, is a computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure. The device is intended for use for partially edentulous and edentulous patients who require dental implants as part of their treatment plan.

Device Story

IGI-System is a computerized navigational tool for dental implant surgery. Inputs include patient CT scans for preoperative planning and real-time tracking data from fiducial markers on the patient and surgical handpiece. The system registers the patient to the CT data and provides real-time navigation by comparing actual handpiece movement against the predefined surgical plan. Used in dental clinics by surgeons to guide instrument placement. Output is visual navigational guidance, allowing the surgeon to monitor instrument position relative to the planned site. Benefits include increased accuracy in implant placement and assistance during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computerized navigational system; utilizes CT imaging for preoperative planning; employs fiducial markers for registration; real-time tracking of patient and handpiece movement; software-based navigation.

Indications for Use

Indicated for partially edentulous and edentulous patients requiring dental implants. Used for preoperative planning and intraoperative navigational guidance of surgical instruments during dental implantation surgery.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• IGI- Image Guided Implantology System (K023424)

Submission Summary (Full Text)

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# 7.A 510(k) SUMMARY KOS2840

## (As required by Section 807.92(c))

Applicant's Name: Denx Ltd. DENX Advanced Dental Systems Ltd. Moshav Ora 106 Jerusalem 90880 ISRAEL Tel: -- 972 (2) 641-7748 Fax: - 972 (2) 642-6901

- Contact Person: Rachel Weissbrod Denx Ltd. DENX Advanced Dental Systems Ltd. Moshav Ora 106 Jerusalem 90880 ISRAEL Tel: [phone] Fax: [phone]
Email: [e-mail]

#### Date Prepared: May 2005

#### Trade Name: IGI-System™

Classification: The FDA has classified "sterotaxic Instruments" devices as class 11. pursuant to 21 C.F.R. § 882.4560 (product code HAW), and it is reviewed by the General & Plastic Surgery Advisory Committee.

Predicate Devices: IGI- Image Guided Implantology System cleared under (K)023424

Description of the Device: System enabling image guided surgery for dental implant surgery through the utilization of planning software based on patient CT, registration through the use of fiducial markers and real time navigation by tracking both patient and handpiece movement and comparing to the pre-defined surgery plan.

Indications for use: The IGI Image-Guided Implantation system, is a computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments. with regard to the pre-operative planning in dental implantation procedure.

The device is intended for use for partially edentulous and edentulous patients who require dental implants as part of their treatment plan.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is composed of three parallel lines that curve and converge. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.

DEC 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DenX Advanced Dental Systems % Patricia Murphy Kema Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914

Re: K052840

Trade/Device Name: IGI-System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 7, 2005 Received: December 8, 2005

Dear Ms. Murphy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarer a see ice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stared in the encreations of the enactment date of the Medical Device Amendments, or to commerce pror to this 2011-03-12 11:53
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been resuire approval of a premarket approval application (PMA). and Cosmetter For (110) that the device, subject to the general controls provisions of the Act. The r ou may , interest provisions of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 rr your device 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.

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 or any reathated is requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 607), adoling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2- Ms. Murphy

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your to begin finding of substantial equivalence of your device to a legally prematted 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 in you a the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational 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.

Barbara Buellm

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 7. C INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KOSQ840

Device Name: IGI Image Guided Implantion System

Indications for Use:

The IGI-System™, Image-Guided Implantation System, is a computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure.

The device is intended for use for partially edentulous and edentulous patients who require dental implants as part of their treatment plan.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Labare Buelindsen UKM

Division of General, Restorative, and Neurological Devices

510(k) Number 1053840