(144 days)
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.
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.
The provided text is a 510(k) summary from Materialise N.V. regarding their SurgiCase system, specifically focusing on the new component, SurgiCase Connect for iPad. The core of the submission is to demonstrate substantial equivalence to a predicate device (SurgiCase K073449).
The document explicitly states:
- Clinical testing: Not applicable.
This means that a clinical study with acceptance criteria and reported device performance, as typically understood in a clinical trial context, was not performed for this submission. The device is being cleared based on its substantial equivalence to a predicate device through non-clinical testing.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and the study proving the device meets them, because such a study (clinical or performance study with defined acceptance criteria and results) is not described in this 510(k) summary.
The submission focuses entirely on demonstrating substantial equivalence through non-clinical testing, primarily asserting that the new component (SurgiCase Connect for iPad) has equivalent intended use, performance characteristics, design, and function to the predicate SurgiCase system.
§ 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).