(179 days)
No
The description focuses on image processing, registration, and optical tracking for navigation, without mentioning AI or ML algorithms for image analysis, decision support, or other functions.
No
The device is used for planning, localization, and navigation during neurosurgery, which are assistive functions for the surgeon rather than directly treating a disease or condition.
No
The intended use of this device is for planning, localizing, and navigating during neurosurgery, which are functions that assist in a procedure but do not directly provide a diagnosis.
No
The device description explicitly states that the system includes hardware components such as a mobile workstation, position digitizer, optical position digitizer with cameras and laser, and dedicated instruments with LEDs. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Philips EasyGuide Neuro is an image-guided surgery system used for planning, localization, and navigation during neurosurgery. It uses pre-operative scans and a position digitizer to help the surgeon visualize anatomical structures and guide instruments in real-time.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is based on processing imaging data and tracking the position of surgical instruments relative to that data.
Therefore, the EasyGuide Neuro falls under the category of a surgical navigation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EasyGuide is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The EasyGuide facilitates image-supported decisions that may lead to more effective craniotomies, fewer unforeseen complications and shorter surgery times. As an interactive lightbox, Philips EasyGuide Neuro can facilitate image-based decision making. Anatomical structures can be visualized and surgical paths precisely determined before surgery. Decisions on the location and size of a tumor, or an arteriovenous malformation can be made with confidence. Critical areas can be identified and avoided for better access to pathology.
Product codes
90 LLZ
Device Description
The Philips EasyGuide Neuro is an image guided surgery system for use in planning, localization, and navigation of neurosurgery. The system includes a mobile workstation (based on the Easyvision workstation platform K925950), position digitizer, and dedicated instruments. The workstation is a combination of a Sun SPARC for running the EasyGuide software and a computer for processing the data from the position digitizer. The optical position digitizer uses two infrared CCD cameras mounted on a titanium alloy sub-frame and has a laser for easy positioning of the cameras. The instruments (pointers) are equipped with infrared light emitting diodes (LED). Signals from the LEDs are received by the CCD cameras. The computer processes this information and calculates the position, direction, and rotation of the pointer tip in space. The point of space is then shown on the monitor, overlaid on the image generated from the pre-operative scans.
Registration of the patient's preoperative image with the EasyGuide Neuro geometry during surgery is accomplished through the use of registration markers. These markers are placed on the patient's head before scanning. After the scanning has been completed the images are entered into the EasyGuide Neuro. The markers are left on the patient and prior to surgery, the markers on the patient can be "manually" registered with the markers on the image by placing the pointer on a marker and then selecting the corresponding marker on the image. The Philips EasyGuide Neuro is also capable of performing automatic marker registrations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeon
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)
Two plannings for neurosurgery were made:
- a planning using conventional means (2D hardcopies on the lightbox) leading to the description of an incision line. This planning was performed prior to using EasyGuide Neuro.
- a planning using EasyGuide Neuro interactively at the patient. This led to a second incision line.
Both incision lines and planned craniotomy were compared in term of size. Shape and location (centering). The system has shown to be a reliable and safe device in neuronavigation, yielding a mean RMSE = 4.1 mm. for the patient population in the study. Significantly smaller craniotomies were made when compared to conventional (hardcopy based) planning procedures. In cases where there were no significant differences between the conventional and EasyGuide planning, still major benefits were experienced ranging from avoiding vascular structures to preservation of functions, such as speech. The overall conclusion is that the results show that EasyGuide Neuro is a safe and effective device for use in cranial neurosurgery.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean RMSE = 4.1 mm.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
NOV - 8 1996
Philips Medical Systems
510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a Summary of Safety and Effectiveness.
| Device Name: | Philips EasyGuide Neuro |
|---|---|
| Classification Name: | Image Processing System |
| Class II (90 LLZ) | |
| Common/Usual Name: | Image Guided Surgery System |
| Establishment Registration No.: | 1217116 |
| Contact Person: | Peter Altman |
| Date Prepared: | May 9, 1996 |
System Description:
The Philips EasyGuide Neuro is an image guided surgery system for use in planning, localization, and navigation of neurosurgery. The system includes a mobile workstation (based on the Easyvision workstation platform K925950), position digitizer, and dedicated instruments. The workstation is a combination of a Sun SPARC for running the EasyGuide software and a computer for processing the data from the position digitizer. The optical position digitizer uses two infrared CCD cameras mounted on a titanium alloy sub-frame and has a laser for easy positioning of the cameras. The instruments (pointers) are equipped with infrared light emitting diodes (LED). Signals from the LEDs are received by the CCD cameras. The computer processes this information and calculates the position, direction, and rotation of the pointer tip in space. The point of space is then shown on the monitor, overlaid on the image generated from the pre-operative scans.
Philips Medical Systems
North America Company
710 Bridgeport Avenue
Shelton, CT 06484-4708
Tel: (203) 926-7674
Fax: (203) 929-6099
.. .
9 61 834
1
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Registration of the patient's preoperative image with the EasyGuide Neuro geometry during surgery is accomplished through the use of registration markers. These markers are placed on the patient's head before scanning. After the scanning has been completed the images are entered into the EasyGuide Neuro. The markers are left on the patient and prior to surgery, the markers on the patient can be "manually" registered with the markers on the image by placing the pointer on a marker and then selecting the corresponding marker on the image. The Philips EasyGuide Neuro is also capable of performing automatic marker registrations.
Performance Standards:
The device will comply with applicable requirements of the Underwriters Laboratories Standard for Safety, X-ray Equipment (UL 2601) and be classified by Underwriters Laboratories: Additionally, the Philips EasyGuide Neuro will comply with the ACR/NEMA DICOM digital imaging communication standard. The position digitizer laser will comply with Title 21CFR Part 1040.10.
Substantial Equivalence Information:
The Philips EasyGuide Neuro is substantially equivalent to the Zeiss MKM (K942233), the Radionics OAS (K951262), and the Elekta ISG Viewing Wand (K911783). These are all types of image guided surgery devices. The Zeiss MKM is a microscope based navigation system and the Radionics OAS and Elekta/ISG Viewing Wand are mechanical navigation systems. While the EasyGuide Neuro is an optical based navigation system, a commonality exists in that all these systems are indicated for neurosurgical procedures and achieve their intended use through the location of a point in space (in real time) that is correlated with a patient's preoperative images. This ability supports the neurosurgeon in localization, navigation, and planning.
Safety Information:
The Philips EasyGuide Neuro system is designed to comply with National and International safety standards as well as the DICOM communication standard. The EasyGuide Neuro system has been extensively investigated during clinical trials in the United States and Europe. It utilizes mature diagnostic imaging technology for the visualization and reconstruction of images, with which the industry and users have many years of experience. The interactive portion (the optical position digitizer) has been tested in both laboratory and clinical environments.
2
1 f
In order to evaluate the benefits and effectiveness of the use of the device, two plannings for neurosurgery were made:
- a planning using conventional means (2D hardcopies on the lightbox) leading . to the description of an incision line. This planning was performed prior to using EasyGuide Neuro.
- a planning using EasyGuide Neuro interactively at the patient. This led to a . second incision line.
Both incision lines and planned craniotomy were compared in term of size. Shape and location (centering).
The system has shown to be a reliable and safe device in neuronavigation, yielding a mean RMSE = 4.1 mm. for the patient population in the study. Significantly smaller craniotomies were made when compared to conventional (hardcopy based) planning procedures. In cases where there were no significant differences between the conventional and EasyGuide planning, still major benefits were experienced ranging from avoiding vascular structures to preservation of functions, such as speech. The overall conclusion is that the results show that EasyGuide Neuro is a safe and effective device for use in cranial neurosurgery.
The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of minor level of concern, as per the August 29, 1991 issue of the "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".
Intended Use:
The EasyGuide is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The EasyGuide facilitates image-supported decisions that may lead to more effective craniotomies, fewer unforeseen complications and shorter surgery times. As an interactive lightbox, Philips EasyGuide Neuro can facilitate image-based decision making. Anatomical structures can be visualized and surgical paths precisely determined before surgery. Decisions on the location and size of a tumor, or an arteriovenous malformation can be made with confidence. Critical areas can be identified and avoided for better access to pathology.
Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence.