(80 days)
Not Found
No
The description focuses on interactive 3D reconstruction and navigation based on user input and existing imaging techniques (Trajectory MPR, 3D display). There is no mention of AI, ML, or any learning algorithms used for image processing, analysis, or decision-making.
No.
The device is used for visualization and assessment of anatomy, and surgical planning. It does not provide any therapy or treatment.
No.
The device is described as an interactive three-dimensional imaging package intended for visualization and assessment of anatomy, and for surgical planning. It processes existing CT or MR data but does not perform diagnosis itself.
No
The device description explicitly states it is an "interactive three dimensional imaging package" that runs on an "Easyvision workstation." This implies the device includes both software and dedicated hardware (the workstation) for processing and displaying the images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Easyvision Endo 3D Option processes existing medical images (CT and MR scans) to create different visualizations and aid in surgical planning. It does not analyze biological samples.
- Intended Use: The intended use clearly states its purpose is for visualization and assessment of anatomy from different perspectives and to facilitate surgical planning, all based on existing imaging data.
- Device Description: The description details image processing and 3D reconstruction from CT and MR data, not the analysis of biological specimens.
Therefore, the Easyvision Endo 3D Option falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes
90 LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR
Anatomical Site
human body
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
General Electric Medical Systems - Avantage Windows 3D with Navigator Option
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 of Safety and Effectiveness JAN - 8 1998
11 11 11
| Company Name: | Philips Medical Systems North America Company |
|---|---|
| Address: | 710 Bridgeport Avenue |
| Shelton, CT 06484 | |
| Contact Person | Peter Altman |
| Telephone Number: | 203-926-7031 |
| Prepared (date): | July 11, 1997 |
| Device Name: | Philips Easy Vision Family Workstation Option |
| Endo 3D | |
| Classification Name: | Image Processing System |
| (90 LLZ) | |
| Common/Usual Name: | Workstation |
| Predicate Devices: | General Electric Medical Systems - Avantage Windows 3D with |
| Navigator Option |
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1
Intended Use:
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.
System Description.
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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 1998
Peter Altman Director of Regulatory Affairs Philips Medical Systems, Inc. North America Company 710 Bridgeport Avenue Shelton, CT 06484-0917
Re:
K973983 Endo 3D Option for Easyvision Workstation Dated: October 17, 1997 Received: October 20, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 LLZ
Dear Mr. Altman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the includes for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 Ecleral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your 110(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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.goveedrh/dsmamain.html": ............................................................................................
Sincerely yours,
William Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): _
Unknown
Philips EasyVision Workstation Endo 3D Option Device Name :
Indications For Use :
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chirlane McCray
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic
510(k) Number K973983
OR
Prescription Use ( Per 21 CFR 801.109
Over-The-Counter Use
(Optional Format 1-2-96)