(70 days)
No
The description focuses on computerized navigation, planning software based on CT data, registration using fiducial markers, and real-time tracking and comparison to a pre-defined plan. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is a navigational system intended to provide assistance in the planning and surgical phases of dental implantation surgery, not to directly treat a disease or condition.
No
The device is described as a "computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery." It provides "accurate navigational guidance of surgical instruments" and "real time navigation by tracking both patient and handpiece movement and comparing to the pre-defined surgery plan." This indicates its role in guiding surgical procedures, not in diagnosing medical conditions or diseases.
No
The device description explicitly mentions "real time navigation by tracking both patient and handpiece movement," which implies the use of hardware components (trackers) in addition to the software.
Based on the provided information, the IGI-System™ is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- IGI-System™ Function: The IGI-System™ is a surgical navigation system. It uses imaging (CT) and tracking technology to guide surgical instruments during a procedure on the patient's body. It does not analyze specimens taken from the body.
Therefore, the IGI-System™ falls under the category of a surgical guidance or navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
HAW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
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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: +972 (2) 641-7748 Fax: +972 (2) 642-6901
Email: rachelw@denx.com
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.
1
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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