(47 days)
The Materialise SimPlant System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical image boginemation bytten or a Magnetic Resonance scanner. It is also used as a scannel such as a O P Sounterial implant placement and surgical treatment options.
The modified SimPiant System is used to transfer images from a medical scanner and to perform a segmentation of the images. It is also used to provide a means for pre-operative planning. Surgical templates may be fabricated based on the output of the pre-operative planning.
The provided text does not contain information about acceptance criteria, device performance, or any studies conducted. The document is a 510(k) premarket notification summary and an FDA clearance letter for a modified SimPlant System. It primarily discusses the device's intended use, functions, and a comparison with a predicate device to establish substantial equivalence. There is no data regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on how ground truth was established for training or testing sets.
Therefore, I cannot provide the requested table or answer the specific questions about studies and acceptance criteria based on the given information.
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2006 FEB 8
SECTION 7 SPECIAL 510(K) PREMARKET NOTIFICATION SUMMARY
| SUBMITTER'S NAME AND ADDRESS: | MATERIALISE N.V.Technologielaan 15B-3001 Leuven, Belgium |
|---|---|
| ESTABLISHMENT REGISTRATION NO: | 3003998208 |
| CONTACT PERSON: | Carl Van Lierde, Materialise N.V.Quality Manager+32 163 967 14 (tel)+32 163 966 00 (fax)carl.vanlierde@materialise.be |
| SUMMARY PREPARATION DATE: | November 22, 2005 |
SimPlant System; SimPlant - Dr James Trade name
Common Name:
Image processing system and preoperative software for simulating dental implant placement and surgical treatment options
CLASSIFICATION NAME:
System, Image Processing. This product uses images acquired from Computerized Tomography (CT) scanners.
PREDICATE DEVICE
SimPlant System (K033849)
FUNCTION
The modified SimPiant System is used to transfer images from a medical scanner and to perform a segmentation of the images. It is also used to provide a means for pre-operative planning. Surgical templates may be fabricated based on the output of the pre-operative planning.
Intended Use
The SimPlant System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment.
SimiPlant System Special 510(k) -- Premiuket Notificatio Mater: alise \ \
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TECHNOLOGICAL COMPARISON OF DEVICES
| Feature | Modified SimPlant System (Dr.James) | SimPlant System |
|---|---|---|
| Material | Software – magnetic media | Software – magnetic media |
| Design | Software for use in pre-operativeplanning. | Software for use in pre-operativeplanning |
| Function | SimPlant System is used to providea means for image segmentationand pre-operative planning.Offers extended assistance fordental implant planningSurgical templates may befabricated based on the output of thepre-operative planning | SimPlant System is used to provide ameans for image segmentation andpre-operative planning.Surgical templates may be fabricatedbased on the output of the pre-operative planning |
Conclusion
The modified SimPlant System is considered to be substantially equivalent in design, material and function to the unmodified SimPlant System. It is believed to perform as well as the predicate device for pre-operative planning and for image segmentation. Accordingly, we respectfully request the Agency to expeditiously find this special 510(k) premarket notification to be Substantially Equivalent.
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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle, with three curved lines representing its wings.
FEB 8 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Carl Van Lierde Quality Manager Materialise N.V. Technologielaan 15 Leuven 3001 BELGIUM
Re: K053592
Trade/Device Name: SimPlant System (Dr. James) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ Dated: January 26, 2006 Received: January 26, 2006
Dear Mr. Van Lierde:
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) I his letter with and w you've of substantial equivalence of your device to a legally premaince notification: "The sulassification 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 If you desire specific acriee is a 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 Also, picase note the regation of enders information on your responsibilities under the Act from the 807.77). Tou thay obtain other generational 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 yours,
Nancy C. Hogdon
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): K053592
Device Name: SimPlant System (Dr. James)
Indications For Use:
The Materialise SimPlant System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical image boginemation bytten or a Magnetic Resonance scanner. It is also used as a scannel such as a O P Sounterial implant placement and surgical treatment options.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel K. Inouye
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 5 } (Xk) Number __
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).