(166 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image processing and simulation, not AI/ML capabilities.
No
The device is a software for simulating and evaluating dental implant placement and surgical treatment options, not directly providing therapy itself.
No
The device is a medical front-end software for processing imaging information and simulating/evaluating dental implant placement and surgical treatment. It is not described as providing a diagnosis.
Yes
The device description explicitly states it is a "software interface and image segmentation system" and a "software for simulating / evaluating dental implant placement and surgical treatment options," with no mention of accompanying hardware components being part of the submitted device.
Based on the provided information, the SimPlant system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- SimPlant's Intended Use: The SimPlant system is described as a software interface and image segmentation system that transfers imaging information from medical scanners (CT, MRI) and is used for simulating/evaluating dental implant placement and surgical treatment options.
- No mention of biological samples: The description focuses entirely on processing medical images and planning surgical procedures. There is no indication that it analyzes biological samples.
Therefore, the SimPlant system falls under the category of medical device software used for surgical planning and simulation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Materialise SimPlant System is intended for use as a software interface and the Materialise offinitiation system for the transfer of imaging information from a medical image segmentation of over a Magnetic Resonance scanner. It is also intended scanner odon as a c rovare for simulating / evaluating dental implant placement and surgical treatment options.
The SimPlant system is indicated for use as a is a medical front-end software that can be used The SimPlant system is Indicated for use as a 15 a modion frages. It is indication a software interface and image segmentation system for the transfer of imaging information a soltware interface and inlage segments or a Magnetic Resonace scamer. It is also from a medical scanner such as a CT seamer or a magical implant placement and surgical treatment.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Materialise SimPlant System is intended for use as a software interface and The Materialise offinitiation system for the transfer of imaging information from a medical image segmentation of over a Magnetic Resonance scanner. It is also intended scanner odon as a c rovare for simulating / evaluating dental implant placement and surgical treatment options.
Mentions image processing
Image processing system and preoperative software for simulating /evaluating dental implant placement and surgical treatment options
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
images acquired from Computerized System, Image Processing. Tomography (CT) scanners.
medical image segmentation of over a Magnetic Resonance scanner.
medical scanner such as a CT seamer or a Magnetic Resonace scamer.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
MAY 2 5 2004
SUMMARY OF SAFETY AND EFFECTIVENESS MATERIALISE SIMPLANT SYSTEM
Ko 33849
PROPRIETARY NAME
SimPlant System
COMMON NAME:
Image processing system and preoperative software for simulating /evaluating dental implant placement and surgical treatment options
CLASSIFICATION NAME:
This product uses images acquired from Computerized System, Image Processing. Tomography (CT) scanners.
DEVICE Classification
This device has been classified as Class II.
REGULATORY CLASS:
Class II
Product Code
LLZ
MATERIALISE N.V. SUBMITTER'S NAME AND ADDRESS: Technologielaan 15 B-3001 LEUVEN, BELGIUM Applied for ESTABLISHMENT REGISTRATION NO: Carl Van Lierde, Materialise N.V. Contact Person: Quality Manager
November 28, 2003 SUMMARY PREPARATION DATE:
Predicate Device
The SimPlant System is claimed to be substantially equivalent in material, design, and function to the SIM/Plant product which was acquired by Materialise from Columbia Scientific, Inc. and cleared by FDA under 510(k) K924810 on January 15, 1993.
The SimPlant System is claimed to be substantially equivalent in material, design, and function to the CT-Modeller product from Materialise which was cleared by FDA under 510(k) K970617 on April 21, 1997
1
DEVICE DESCRIPTION
The Materialise SimPlant System is intended for use as a software interface and The Materialise offinitiation system for the transfer of imaging information from a medical image segmentation of over a Magnetic Resonance scanner. It is also intended scanner odon as a c rovare for simulating / evaluating dental implant placement and surgical treatment options.
STERILIZATION
The SimPlant System is provided non-sterile.
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 sogmentation on a Magnetic Resonance scanner. It is also intended scanner suomas a of 50amfor en a ulating / evaluating dental implant placement and surgical treatment options.
SUBSTANTIAL EQUIVALENCE
The SimPlant System is considered to be substantially equivalent to the SIM/Plant product and to the CT-Modeller System.
CONCLUSION
The SimPlant System is considered to be substantially equivalent in design, material and function to the SIM/Plant product and the Ct-Modeller System
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2004
Mr. Carl Van Lierde Quality Manager Materialise N.V. Technologielaan 15 3001 Leuven BELGIUM
Re: K033849
Trade/Device Name: SimPlant System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: April 6, 2004 Received: April 8, 2004
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 (PMA), 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
3
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 premainted 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 11 you t the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. lxxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.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
4
Indications for Use
510(k) Number (if known): _K033849
Device Name: SimPlant System________________________________________________________________________________________________________________________________________________
Indications for Use:
The SimPlant system is indicated for use as a is a medical front-end software that can be used The SimPlant system is Indicated for use as a 15 a modion frages. It is indication a software interface and image segmentation system for the transfer of imaging information a soltware interface and inlage segments or a Magnetic Resonace scamer. It is also from a medical scanner such as a CT seamer or a magical implant placement and surgical treatment.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
(Division Sign Division of Reproductive, and Radiological Device 510(k) Number