(114 days)
Mimics 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 to an output file. It is also used as pre-operative software for simulating /evaluating surgical treatment options. Mimics is not intended to be used for mammography imaging.
The Materialise Mimics software 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 to an output file. It is also intended as pre-operative software for simulating / evaluating surgical treatment options. Mimics is not intended to be used for mammography imaging.
This 510(k) summary for the Mimics software does not provide any specific acceptance criteria or a study demonstrating that the device meets those criteria.
Instead, the submission focuses on establishing substantial equivalence to a previously cleared predicate device (SimPlant product from Materialise Dental, K033849). This means that the FDA determined Mimics is as safe and effective as the predicate device based on its similar design, materials, function, and indications for use.
Therefore, I cannot populate the table or answer the specific questions requested, as the information is not present in the provided document.
Here's why and what can be inferred:
- Acceptance Criteria & Reported Performance: No specific performance metrics (e.g., accuracy, precision, sensitivity, specificity for image segmentation or surgical simulation) are mentioned. The concept of "acceptance criteria" is not explicitly discussed in the context of device performance.
- Study Details: There's no description of a study conducted to prove the device meets performance criteria. The clearance is based on substantial equivalence, not a new clinical performance study.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth: None of these details are provided because a direct performance study, as typically described by these parameters, was not the basis for this 510(k) clearance.
- Training Set: There is no mention of a training set as the clearance is not based on an AI/ML model for diagnostic or predictive purposes that would typically require a training set. The device is described as an "image processing system" and "preoperative software for simulating surgical treatment options," implying functionality rather than a learned algorithm.
Conclusion based on the provided document:
The Mimics software received 510(k) clearance by demonstrating substantial equivalence to a predicate device (SimPlant System, K033849). This type of clearance typically relies on showing that the new device has similar technological characteristics and performance (or provides equivalent performance) to a device already on the market, rather than requiring new, independently established acceptance criteria and a performance study against those criteria. The provided document details the regulatory classification, indications for use, and the basis for substantial equivalence, but not a specific performance study.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS MIMICS (Materialise's Interactive Medical Image Control System)
PROPRIETARY NAME:
Mimics
APR - 2 2008
COMMON NAME:
Image processing system and preoperative software for simulating surgical treatment options
CLASSIFICATION NAME:
System, Image Processing. This product uses images acquired from Computerized 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
Summary Preparation Date: April 1, 2008
PREDICATE DEVICE
The Mimics software 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 Mimics software 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 to an output file. It is also intended as pre-operative software for simulating / evaluating
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surgical treatment options. Mimics is not intended to be used for mammography imaging.
STERILIZATION
The Mimics product is provided non-sterile.
INDICATIONS FOR USE
The Materialise Mimics software 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 to an output file. It is also intended as pre-operative software for simulating / evaluating surgical treatment options. Mimics is not intended to be used for mammography imaging.
SUBSTANTIAL EQUIVALENCE
Mimics is considered to be substantially equivalent to the SimPlant System.
CONCLUSION
Mimics is considered to be substantially equivalent in design, material and function to the SimPlant system.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR - 2 2008
Mr. Mieke Janssen Quality Engineer Materialise NV Technologielaan 15 3001 Leuven BELGIUM
Re: K073468
Trade/Device Name: Mimic Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 20, 2008 Received: March 24, 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 (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.
Image /page/2/Picture/10 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906 - 2006" are displayed. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by a circle of stars.
Protecting and Promoting Public Health
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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.
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/cdrh/industry/support/index.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
Page 2
Enclosure
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Indications for Use
510(k) Number (if known): K073468
Device Name: Mimics
Indications For Use:
Mimics 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 to an output file. It is also used as pre-operative software for simulating /evaluating surgical treatment options.
Mimics is not intended to be used for mammography imaging.
A
Prescription Use X (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)
Arznhnh
(Division Sign-Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Page 1 of
§ 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).