SURGPLAN AND PANPLAN

K041078 · Imaging Sciences Intl., Inc. · LLZ · Dec 23, 2004 · Radiology

Device Facts

• Record ID: K041078
• Device Name: SURGPLAN AND PANPLAN
• Applicant: Imaging Sciences Intl., Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

SurgPLAN and PanPlan are Software packages that scan film using optical scanner or Direct Digital Capture using Solid State Sensors (from Imaging Sciences International's or other manufacturer's) Tomographic, Panoramic and Cephlometric imaging machines. Additionally, the software has the ability to import DICOM images from volumetric data sets for analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.

Device Story

SurgPLAN/PanPLAN is a software package for dental implant planning and visualization. Inputs include scanned film, solid-state sensor digital captures, or imported DICOM volumetric datasets. The software processes these images to allow practitioners to perform measurements, cephalometric analysis, and surgical demonstrations for dental implants and bone grafts. Used in dental clinics by practitioners, the software facilitates communication between clinicians and patient treatment plan demonstration. Output is displayed on a workstation for clinical decision-making regarding implant placement and surgical planning. It benefits patients by providing a visual aid for treatment understanding and enables precise surgical preparation for the clinician.

Clinical Evidence

No clinical data. Bench testing and software validation were performed to ensure system performance and control potential hazards such as measurement errors.

Technological Characteristics

Software-based image processing and visualization system. Supports DICOM standard for image import. Compatible with optical scanners and solid-state digital sensors. Functions include image display, measurement tools, and surgical planning visualization. Operates on standard computing hardware.

Indications for Use

Indicated for dental practitioners to visualize, analyze, and plan dental implant procedures, bone grafts, and cephalometric assessments using imported DICOM images or scanned film/digital capture from tomographic, panoramic, and cephalometric imaging systems.

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

• SimPlant (Materialise/Columbia Scientific)
• CDRPan and CDR DICOM (Schick Technologies Inc.)

Submission Summary (Full Text)

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DEC 2 3 2004

## 510 (k) Summary

K041078 Page 1 of 2

## Submitters Information

Name: Address:

Phone Number: Fax Number:

Person To Contact:

Date Of Summary:

Trade Name Of The Device:

Common Or Usual Name:

Classification Name:

Imaging Sciences International Inc. 1910 North Penn Road Hatfield PA, 19440 215-997-5666 215-997-5665

Edward J Marandola Vice President & General Manager

November 15, 2004

SurgPLAN / PanPLAN

X-Ray Software

X-Ray, Software

Substantial Equivalence Claim: The Imaging Sciences International Inc. SurgPLAN / PanPLAN is substantially equivalent to the devices listed below:

| Device | SimPlant |
|--------------|---------------------------------------------------------------------------------------|
| Manufacturer | Materialise/Columbia Scientific<br>810-x Cromwell Park Drive<br>Glen Burnie, MD 21061 |
| Device | CDRPan and CDR DICOM |
| Manufacturer | Schick Technologies Inc.<br>31-00 47th Avenue<br>Long Island City, NY 11101 |

Description Of The Device: SurgPLAN / PanPLAN is a comprehensive software package that can scan films or certain solid state detectors, read DICOM images or DICOM volumetric data sets and display the images for the practitioner to perform analysis, measurements and surgical demonstrations for dental implants.

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Intended Use Of The Device: SurgPLAN / PanPLAN is a Software package that Intention Ose Online optical scanner or Direct Digital Capture using Solid State Scalls (sean Inni abing operation on one of the sciences International's (or other School / and stores mages pic, Panoramic and Cephlometric imaging machines. manufacturers to , software has the ability to import DICOM images from Additionally, the box reporting analysis and reporting. The software allows voluments auta between surgical demonstrations for dental implant planning, the practitioner to perform surgers and bone graft visualizations. The purpose of ecphioneerie andrysiale the doctor with a convenient method for visualization of the software to to prove modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.

Comparison with Predicate devices: SurgPLAN / PanPLAN is a software comparison with the predicated devices. SurgPLAN / PanPLAN is a software package that combines functionality from both predicated devices in one simple package that comently it allows film-based users (through flatbed scanning) to have similar functions as digital users.

Conclusions: The performance testing of the Imaging Sciences International Inc. SurgPLAN / PanPLAN would indicate that the system is substantially equivalent to both predicated devices. The potential hazards (e.g. incorrect measurements or to both preciseare controlled by the software development and validation system. mischaghould) are complies with the requirements of 21 CFR 807.87 and does not pose any new safety risks or effectiveness issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 2 3 2004

Mr. Edward J. Marandola Vice President & General Manager Imaging Sciences International, Inc. 1910 North Penn Road HATFIELD PA 19440

Re: K041078

Trade/Device Name: SurgPLANTM and PanPlan™ Regulatory Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 24, 2004

Received: November 29, 2004

Dear Mr. Marandola:

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 Scetion 510(k) I his letter will anow you to begin manteling of substantial equivalence of your device to a legally premarket nothleanon. The I DA midnig of bactuation 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 II you desire specific acvice for your de resert 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 Also, please note the regulation on your responsibilities under the Act from the 807.97). Tou may obtain other general missistance at its toll-free number (800) DWISION of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmaldsmamain.html

Sincerely yours,

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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## K041078

510(k) Number (if known): ___

SurgPLAN and PanPlan

Device Name:

Outgi D.A.V. and I line 1.

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR |
|----------------------|----|
| (Per 21 CFR 801.109) | |

David A. KaramOver-The-Counter Use_

(Optional Format 1-2-96)

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