(87 days)
No
The summary describes a software for 3D data visualization and measurement, with no mention of AI or ML capabilities. The focus is on providing a viewing and communication interface.
No This device is a software interface for visualization and communication of treatment options, performing measurements on 3D data, and assisting in the manufacturing process of medical devices; it does not directly treat or diagnose.
No
The "Intended Use / Indications for Use" states that SurgiCase Viewer is intended to "assist in visualization and communication of treatment options" and the "Device Description" clarifies that it is for "evaluating and communicating about treatment options." It explicitly states, "When used to review and validate treatment options, SurgiCase Viewer is intended to be used in conjunction with other diagnostic tools and expert clinical judgment." This indicates it is a tool to supplement, rather than independently perform, diagnostic functions.
Yes
The device description explicitly states "SurgiCase Viewer is intended to be used as a software interface" and describes its functionality solely in terms of visualizing and measuring 3D data, without mentioning any associated hardware components included with the device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- SurgiCase Viewer's Intended Use: The intended use of SurgiCase Viewer is to "assist in visualization and communication of treatment options" and to "visualize 3D data and to perform measurements on these 3D data." This is focused on processing and visualizing existing 3D data, not on analyzing biological specimens.
- Device Description: The description emphasizes visualizing and measuring 3D data, evaluating and communicating treatment options, and integrating with a Medical Device Data System. It explicitly states that the SurgiCase Viewer "does not alter the 3D data it imports and its functioning is independent of the specific medical indication or product/service it is used for." This further reinforces that it's a visualization and communication tool, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, diagnostic testing, or providing information for diagnosis based on such analysis.
In summary, SurgiCase Viewer is a software tool for visualizing and interacting with 3D medical data to aid in treatment planning and communication. It does not perform any in vitro diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
SurgiCase Viewer is intended to be used as a software interface to assist in visualization and communication of treatment options.
Product codes
LLZ
Device Description
SurgiCase Viewer provides functionality to visualize 3D data and to perform measurements on these 3D data, which should allow a clinician to evaluate and communicate about treatment options.
SurgiCase Viewer is intended for use by people active in the medical sector. When used to review and validate treatment options, SurgiCase Viewer is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
The SurgiCase Viewer can be used by a medical device/service manufacturer/provider or hospital department to visualize 3D data during the manufacturing process of the end-user who is ordering the device/service. This allows the end-user to evaluate and provide feedback on proposals or intermediate steps in the manufacturing of the device or service.
The SurgiCase Viewer is to be integrated with an online Medical Device Data System which is used to process the medical device or service and which is responsible for case management, authorization, authentication, etc.
The data visualized in the SurgiCase Viewer is controlled by the medical device manufacturer using the SurgiCase Viewer in its process. The Device manufacturer will create the 3D data to the end-user and export it to one of the dedicated formats supported by the SurgiCase Viewer. Each of these formats describe the 3D data in STL format with additional meta-data on the 3D models. The SurgiCase Viewer does not alter the 3D data it imports and its functioning is independent of the specific medical indication or product/service it is used for. It's the responsibility of the Medical device company using the SurgiCase Viewer to comply with the applicable medical device regulations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
people active in the medical sector
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 tests: The SurgiCase Viewer application has been validated for its intended use to determine substantial equivalence to the predicate device.
Summary: The characteristics that determine the functionality and performance of the SurgiCase Viewer are substantially equivalent to the devices cleared under K113599 and K132290. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized representation of a human figure in profile, repeated three times and connected to form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
Materialise NV % Oliver Clemens Regulatory Officer Technologielaan 15 Leuven, 3001 BELGIUM
Re: K170419
Trade/Device Name: SurgiCase Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 30, 2017 Received: April 3, 2017
Dear Oliver Clemens:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K170419
Device Name SurgiCase Viewer
Indications for Use (Describe)
SurgiCase Viewer is intended to be used as a software interface to assist in visualization and communication of treatment options.
| Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." |
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510(k) Summary
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92
| Company name | Materialise N.V. |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | +32 16 39 62 80 |
| Fax number | +32 16 39 66 06 |
| Principal Contact person | Oliver Clemens |
| Contact title | Regulatory Affairs Officer |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Anneleen Van Assche |
| Contact title | Software Product Manager |
| Contact e-mail address | Anneleen.VanAssche@materialise.be |
Submission date
The date of the Traditional 510(k) submission is May 11, 2017.
Submission information
| Trade Name | SurgiCase Viewer
Materialise Viewer |
|-----------------------------|----------------------------------------|
| Common Name | Image processing system |
| Classification Name | System, Image processing, Radiological |
| Classification product code | LLZ (892.2050) |
Predicate Devices
The primary predicate devices to which substantial equivalence is claimed:
| Trade or proprietary or model name | SurgiCase Connect for iPad |
|---|---|
| 510(k) number | K113599 |
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| Decision date | April 27, 2012 |
|---|---|
| Classification product code | LLZ (892.2050) |
| Manufacturer | Materialise N.V. |
The secondary predicate device:
| Trade or proprietary or model name | SurgiCase Connect |
|---|---|
| 510(k) number | K132290 |
| Decision date | April 10, 2014 |
| Classification product code | PBF (21 CFR 888.3030) |
| Manufacturer | Materialise N.V. |
The reference device:
| Trade or proprietary or model name | Materialise TKA Guide System |
|---|---|
| 510(k) number | K150928 |
| Decision date | August 10th, 2015 |
| Classification product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
Description and functioning of the device
SurgiCase Viewer provides functionality to visualize 3D data and to perform measurements on these 3D data, which should allow a clinician to evaluate and communicate about treatment options.
SurgiCase Viewer is intended for use by people active in the medical sector. When used to review and validate treatment options, SurgiCase Viewer is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
The SurgiCase Viewer can be used by a medical device/service manufacturer/provider or hospital department to visualize 3D data during the manufacturing process of the end-user who is ordering the
5
device/service. This allows the end-user to evaluate and provide feedback on proposals or intermediate steps in the manufacturing of the device or service.
The SurgiCase Viewer is to be integrated with an online Medical Device Data System which is used to process the medical device or service and which is responsible for case management, authorization, authentication, etc.
The data visualized in the SurgiCase Viewer is controlled by the medical device manufacturer using the SurgiCase Viewer in its process. The Device manufacturer will create the 3D data to the end-user and export it to one of the dedicated formats supported by the SurgiCase Viewer. Each of these formats describe the 3D data in STL format with additional meta-data on the 3D models. The SurgiCase Viewer does not alter the 3D data it imports and its functioning is independent of the specific medical indication or product/service it is used for. It's the responsibility of the Medical device company using the SurgiCase Viewer to comply with the applicable medical device regulations.
Intended Use
SurgiCase Viewer is intended to be used as a software interface to assist in visualization of treatment options.
Technological Characteristics
A detailed comparison shows the subject device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics to the primary predicate devices.
Performance Data
Non-clinical tests
The SurgiCase Viewer application has been validated for its intended use to determine substantial equivalence to the predicate device.
Summary
The characteristics that determine the functionality and performance of the SurgiCase Viewer are substantially equivalent to the devices cleared under K113599 and K132290. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicates.