(80 days)
The Easyvision Endo 3D Option is intended for use when visualization and assessment of anatomy from a perspective different from the original CT or MR data set's perspective may be either useful or necessary. This perspective can be external or internal; for example looking down on the cortex or looking inside the aorta. The Endo 3D option also provides visualization of structures to facilitate surgical planning.
Endo 3D w is an interactive three dimensional imaging package which provides users the ability to create a visualization from a perspective different from the perspective in which the original volume data set was acquired . The process begins by transferring an MR or CT volume data set to the Easyvision workstation. The Endoview program reformats this data set according to the user's input, creating a 3D reconstruction displaying the anatomy from the perspective selected by the user can then interactively select the trajectory through or around the structure.
The Endo 3D package combines the capabilities of two existing Easyvision functions; Trajectory MPR and 3D display. The Trajectory MPR program is intended to be used to define a path along which the simulated views will be generated. The 3D display function generates, at different locations along the defined path, a perspective three dimensional view of a region in the human body, as seen from the path. Along the path, or at any location defined in the three dimensional view, other views can be shown simulating the "fly through" or "fly around" of the anatomical object. The final result will be an interactive survey through the defined region of the patient anatomy.
Free navigation through the complex anatomy can be guided by the defined Trajectory MPR or with the aid of user defined positions. The orientation is guided by the resulting MPR along the trajectory, combined with perpendicular MPR, MIP, and/or 3D reference images. It results in an effortless journey along the selected course.
This document, K973983, is a 510(k) Summary of Safety and Effectiveness for the Philips Easy Vision Family Workstation Option Endo 3D. However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, or details of a study conducted to demonstrate the device meets any specific criteria.
The document primarily focuses on:
- Company and Device Information: Company name, address, contact, prepared date, device name (Philips Easy Vision Family Workstation Option Endo 3D), classification name (Image Processing System), common/usual name (Workstation), and predicate device (General Electric Medical Systems - Avantage Windows 3D with Navigator Option).
- Intended Use: Visualization and assessment of anatomy from a different perspective than the original CT or MR data set, for both external and internal views, and to facilitate surgical planning.
- System Description: Explains that Endo 3D is an interactive three-dimensional imaging package that creates visualizations by reformatting MR or CT volume data sets, combining Trajectory MPR and 3D display functions for "fly through" or "fly around" anatomical objects.
- FDA Communication: A letter from the FDA confirming the device's substantial equivalence to a legally marketed predicate device (dated January 8, 1998) and outlining the regulatory class, general controls provisions, and responsibilities under the Federal Food, Drug, and Cosmetic Act.
- Indications For Use: A formal statement of the intended use for the device.
Therefore, I cannot provide the requested information as it is not present in the provided text. The document is essentially a regulatory filing establishing substantial equivalence, not a performance study report.
§ 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).