(144 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image segmentation, simulation, and evaluation without mentioning AI/ML techniques.
No
The device is a pre-operative planning software that simulates and evaluates surgical treatment options and implant placement; it does not directly treat or diagnose a disease or condition.
No
The device is described as pre-operative software for simulating/evaluating implant placement and surgical treatment options, and for transferring/segmenting imaging information. It assists in planning but does not diagnose conditions or diseases.
Yes
The device description explicitly states that the Materialise SurgiCase system is a "software medical device" and SurgiCase Connect is a "medical device for pre-surgical simulation and evaluation of surgical treatment options." While it interacts with imaging data from hardware (CT/MRI scanners) and can lead to the manufacturing of physical guides (which are excluded from this submission), the core functionality described is entirely software-based.
Based on the provided information, the SurgiCase system and SurgiCase Connect for iPad are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that the system is for transferring imaging information, image segmentation, and pre-operative planning/simulation of surgical treatment options and implant placement. This is focused on using medical images for surgical planning, not on analyzing biological samples (like blood, urine, tissue) to diagnose or monitor a disease or condition.
- Device Description: The description reinforces the use of the software for transferring, segmenting, visualizing, and editing medical data from scanners for pre-surgical simulation and evaluation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SurgiCase system operates on medical images obtained in vivo (from within the body) and is used for planning surgical procedures.
N/A
Intended Use / Indications for Use
The 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.
SurgiCase Connect for iPad is a component of the SurgiCase system and intended to be used as a software interface to assist in pre-operative planning by simulation / evaluation of surgical treatment options.
Product codes
LLZ
Device Description
The Materialise SurgiCase system is a software medical device to transfer and to segment imaging information from a medical scanner such as a CT or MRI scanner. It allows for presurgical simulation and evaluation of implant placement and surgical treatment options.
SurgiCase Connect is a medical device for pre-surgical simulation and evaluation of surgical treatment options. This includes transferring, visualizing and editing medical data. .
Based on a pre-surgical software plan the patient specific templates - SurgiCase Guides can be manufactured to fit a specific patient. SurgiCase Guides are not a part of this premarket notification submission.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner, Magnetic Resonance Imaging scanner
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)
Non-clinical testing: The SurgiCase Connect for iPad has been validated for its intended use to determine substantial equivalence to the predicate device.
Clinical testing: Not applicable.
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
510(k) Summary
Submitter information
| Company name | Materialise N.V. |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Zip code | 3001 |
| Country | Belgium |
| Phone number | +32 16 39 62 80 |
| Fax number | +32 16 39 66 06 |
| Principal contact person | Alexandra Razzhivina |
| Contact title | Regulatory officer |
| Contact e-mail address | regulatory.affairs@materialise.be |
| Additional contact person | Mieke Janssen |
| Contact title | Director, Quality and Regulatory affairs |
| Contact e-mail address | mieke.janssen@materialise.be |
| Additional contact person | Toon Lenaerts |
| Contact title | Product Manager, SurgiCase |
| Contact e-mail address | toon.lenaerts@materialise.be |
Submission information
| Trade Name | SurgiCase, SurgiCase Connect |
|---|---|
| Common Name | Image processing system |
| Classification Name | Radiological image processing system |
| Product code | LLZ (21 CFR 892.2050) |
| Classification panel | Radiology |
| Device classification | Class II |
Device information
Description and functioning of the device
The Materialise SurgiCase system is a software medical device to transfer and to segment imaging information from a medical scanner such as a CT or MRI scanner. It allows for presurgical simulation and evaluation of implant placement and surgical treatment options.
SurgiCase Connect is a medical device for pre-surgical simulation and evaluation of surgical treatment options. This includes transferring, visualizing and editing medical data. .
Based on a pre-surgical software plan the patient specific templates - SurgiCase Guides can be manufactured to fit a specific patient. SurgiCase Guides are not a part of this premarket notification submission.
APR 2 7 2012
1
Indications for Use
The 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.
SurgiCase Connect for iPad is a component of the SurgiCase system and intended to be used as a software interface to assist in pre-operative planning by simulation / evaluation of surgical treatment options.
Predicate device
| Trade or proprietary or model name | SurgiCase |
|---|---|
| 510(k) number | K073449 |
| Decision date | 16/APR/2008 |
| Product code | LLZ |
| Manufacturer | Materialise |
Summary of technological characteristics
The SurgiCase Connect for iPad is considered to be substantially equivalent in intended use, performance characteristics, design and function to the predicate SurgiCase system.
Performance data
Non-clinical testing
The SurgiCase Connect for iPad has been validated for its intended use to determine substantial equivalence to the predicate device.
Clinical testing Not applicable.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff with a snake winding around it, symbolizing medicine and health care.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Ms. Alexandra Razzhivina Regulatory Officer Materialise NV Technologielaan 15 LEUVEN 3001 BELGIUM
APR 2 7 2012
Re: K113599
Trade/Device Name: SurgiCase system (SurgiCase, SurgiCase Connect) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 6, 2012 Received: March 8, 2012
Dear Ms. Razzhivina:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if known): K113599
Device Name: SurgiCase system (SurgiCase, SurgiCase Connect)
Indications for Use:
The 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.
SurgiCase Connect for iPad is a component of the SurgiCase system and is intended to be used as a software interface to assist in pre-operative planning by simulation of 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)
Michael D'Or
Division Sign-Off Office of In Vitro Diagnostic Device Evaluatio 510(k)
Page 1 of 1