VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE

K060267 · Implant Logic Systems, Ltd. · LLZ · Mar 17, 2006 · Radiology

Device Facts

• Record ID: K060267
• Device Name: VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE
• Applicant: Implant Logic Systems, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Mar 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

This device employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and pre-planning of dental implant surgery.

Device Story

Virtual Implant Placement (VIP) is a PC-based software tool for dental implant surgery pre-planning. Input consists of DICOM CT scan images from external scanners. Clinicians process images by removing non-relevant data and defining a curve to reformat axial CT data into panoramic and cross-sectional views. The software provides measurement tools (distance, angle, rectangular, elliptical) and allows placement of virtual generic or manufacturer-specific implant models to assess size and position relative to patient anatomy. Used by dentists in clinical settings to evaluate bone density and anatomy for surgical planning. Output assists clinicians in visualizing surgical sites and designing surgical appliances; does not perform automated diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

PC-based software; compatible with Windows 98, 2000, and XP. Requires minimum 256 MB RAM and 10 GB hard drive. Processes DICOM CT images. Features include image reformatting (axial to panoramic/cross-sectional), virtual implant modeling, and measurement tools. No specific hardware integration; standalone software application.

Indications for Use

Indicated for dental implant surgery planning in patients requiring visualization of jaw anatomy and bone density using DICOM CT images. Intended for use by dental clinicians.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• ImplantMaster (K042212)
• SimPlant system (K033849)

Submission Summary (Full Text)

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K060267

MAK 1 7 2006

## EXHIBIT 2 510(k) Summary Implant Logic Systems, Ltd. 76 Spruce St. Cedarhurst, NY 11516 Tel [phone] Fax [phone] www.implantlogic.com Contact: Michael Klein, DDS, President January 30, 2006

- 1. Identification of the Device: Proprietary-Trade Name: Virtual Implant Placement™ (VIP) Dental Implant Surgery Planning Software Classification Name/Product Code: Picture archiving and communications system, 90 LLZ Common/Usual Name: Picture archiving and communications system
- 2. Equivalent legally marketed devices: ImplantMaster K042212 (I-Dent Ltd.) and SimPlant system, K033849, (Materialise.)
- 3. Indications for Use (intended use): This device employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and pre-planning of dental implant surgery.
- Description of the Device: Virtual Implant Placement, or simply VIP, is a software 4. program that will allow dental implant clinicians to pre-plan their implant surgeries and/or to design surgical appliances that will be used during surgery. The program will presents the clinician with various reformatted CT images of their patient's jaw(s), allow the placement and manipulation of virtual implants, and provide measurement and other tools to assist the clinician. In typical usage a dentist evaluating a patient for dental implant surgery will often refer the patient for a CT scan to better visualize the patient's anatomy, and check the amount and density of the bone for its suitability for placing implants. The CT scan site will return the axial images from the CT scan on a CD in industry-standard DICOM format. Upon receipt of the CD, the doctor will "process" the case using VIP. Axial images are well-known to radiologists, but foreign to dentists. Processing involves the removal of unnecessary images which are outside the region of interest, and drawing a curve which will be used for the later reformatting of the data to produce images more familiar to dentists. After opening a disk of images, VIP will display the axial images and thumbnails of these, along with a scout view and a checklist of stops to follow in processing the case. After the case has been processed, the axial data will be processed to make panoramic images, which are parallel to the curve that was drawn during processing, and cross-sectional images, which are perpendicular to the panoramic image. Both types of images are normally generated by the Panorex machines dentists are familiar with. Since the primary purpose of VIP is to aid in the planning of implant surgeries, VIP will allow the surgeon to place simulated implants on the image and to gauge their size and position

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relative to the surrounding anatomy. The simulated implants will be generic models of standard dental implants, which range from cylindrical to conical. When the data becomes available from various implant manufacturers, VIP will allow the user to pick from specific, currently-manufactured implants to approximately model any of their favorite implants.

| Description | SimPlant system, K033849, (Materialise.) | ImplantMaster K042212 (I-Dent Ltd.) | Virtual Implant Placement™ (VIP) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Source | CT Scanner | DICOM CT | DICOM CT |
| Main indication | Indicated for use as a is a medical<br>front-end software that can be used<br>by medically trained people for the<br>purpose of visualizing gray value<br>images. It is indicated as a software<br>interface and image segmentation<br>system for the transfer of imaging<br>information from a medical<br>scanner such as a CT scanner or a<br>Magnetic Resonance scanner. It is<br>also indicated for use as a planning<br>and simulation software for dental<br>implant placement and surgical<br>treatment | Uses DICOM CT data<br>for visualization,<br>diagnosis and treatment<br>planning for dental<br>implant surgery. | This device employs<br>previously scanned DICOM<br>CT images in a software tool<br>which serves as an aid to<br>visualizing and pre-planning<br>of dental implant surgery. |
| Tools | Visualization, Implant placement,<br>measurement of distances, angles<br>and density | Visualization, Implant<br>placement. | Visualization,<br>Implant placement,<br>Distance measurement,<br>Angle measurement,<br>Rectangular measurement,<br>Elliptical measurement |
| Host platform | PC | PC | PC |
| Operating system | Not specified | Windows XP SP2 or<br>Win 2000 SP4 | Windows 98, 2000 and XP® |
| Host RAM | Not specified | 512 Mb | 256 MB RAM |
| Host Magnetic<br>Storage | Not specified | 1 GB | 10 GB hard drive |
| CD ROM | Yes (for installation) or download | Yes (for installation) | Yes (for installation) |
| Host Processor<br>Speed | Not specified | Intel P4 1.6 GHz<br>(recommended: 2.8<br>GHz) | Pentium III, 500 MHz |

- 5. Safety and Effectiveness, comparison to predicate devices:
- 6. Conclusion: In all important respects, the VIP is substantially equivalent to one or more predicate systems, including the one named above. This is based on testing to verify compliance with product specifications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Implant Logic Systems Ltd. % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K060267

MAR 1 7 2006

Trade/Device Name: Virtual Implant Placement™ (VIP) Dental Implant Surgery Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 30, 2006 Received: February 1, 2006

Dear Mr. Kamm:

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.

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.

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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. Brigdon

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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## Indications for Use

510(k) Number (if known):

Device Name: Virtual Implant Placement™ (VIP) Dental Implant Surgery Planning Software

Indications For Use:

This device employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and pre-planning of dental implant surgery.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Chisholm

cal Devices 510(k) Num

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