(128 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on image segmentation and simulation, which can be achieved with traditional algorithms.
No
The device is described as pre-operative software for simulating and evaluating implant placement and surgical treatment options, not for directly treating a condition.
Partial input, not enough to provide an answer. Please provide the full text.
Yes
The device description explicitly states it is a "software interface and image segmentation system" and "pre-operative software". There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, the Materialise SurgiCase System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SurgiCase System's intended use: The intended use clearly states that the system is for:
- Transferring imaging information from medical scanners (CT, MRI).
- Pre-operative simulation and evaluation of implant placement and surgical treatment options.
- No mention of biological specimens: There is no indication that the SurgiCase System interacts with or analyzes biological specimens. Its function is based on processing medical imaging data.
Therefore, the Materialise SurgiCase System falls under the category of medical imaging software and surgical planning software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Materialise SurgiCase 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 Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options.
Product codes
LLZ
Device Description
The Materialise SurgiCase 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 Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computerized System, Image Processing. Tomography (CT) or Magnetic Resonance Imaging (MRI) scanners.
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
§ 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
APR 1 6 2008
SUMMARY OF SAFETY AND EFFECTIVENESS MATERIALISE SURGICASE SYSTEM
Proprietary Name:
SurgiCase System
COMMON NAME:
Image processing system and preoperative software for simulating implant placement and surgical treatment options
CLASSIFICATION NAME
This product uses images acquired from Computerized System, Image Processing. Tomography (CT) or Magnetic Resonance Imaging (MRI) scanners.
DEVICE CLASSIFICATION:
This device has been classified as Class II.
REGULATORY CLASS:
Class II
Product Code:
LLZ
SUBMITTER'S NAME AND ADDRESS:
MATERIALISE N.V. Technologielaan 15 B-3001 Leuven, Belgium
ESTABLISHMENT REGISTRATION NO:
3003998208
Contact Person:
Mieke Janssen, Materialise N.V. Quality Engineer
December 6, 2007 Summary Preparation Date:
PREDICATE DEVICE
The SurgiCase System is claimed to be substantially equivalent in material, design, and function to the SimPlant product from Materialise Dental which was cleared by FDA under 510(k) K033849 on May 25, 2004.
DEVICE DESCRIPTION
The Materialise SurgiCase 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 Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options.
1
STERILIZATION
The SurgiCase System is provided non-sterile.
INDICATIONS FOR USE
The Materialise SurgiCase 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 Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options.
SUBSTANTIAL EQUIVALENCE
The SurgiCase System is considered to be substantially equivalent to the SimPlant product.
CONCLUSION
The SurgiCase System is considered to be substantially equivalent in design, material and function to the SimPlant product.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2008
Mr. Mieke Janssen Quality Engineer Materialise NV Technologielaan 15 3001 Leuven BELGUM
Re: K073449
Trade/Device Name: SurgiCase Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 27, 2008 Received: February 29, 2008
Dear Mr. Janssen:
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.
3
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Buxton
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K073449
Device Name: SurgiCase
Indications For Use:
The Materialise SurgiCase 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 Imaging scanner. If is also intended as pre-operative software for simulating I evaluating implant placement and surgical treatment options.
MICKE JANSSEN
14.4.2008
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)
Aomith Wh
(Division Sign-C Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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