PHILIPS EASYGUIDE NEURO

K961834 · Philips Medical Systems, Inc. · HAW · Nov 8, 1996 · Neurology

Device Facts

• Record ID: K961834
• Device Name: PHILIPS EASYGUIDE NEURO
• Applicant: Philips Medical Systems, Inc.
• Product Code: HAW · Neurology
• Decision Date: Nov 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

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.

Device Story

Image-guided surgery system for neurosurgery; utilizes mobile workstation (Sun SPARC) and optical position digitizer. Input: preoperative scan images and real-time infrared LED signals from pointer instruments. Digitizer uses two infrared CCD cameras on titanium alloy frame to track pointer tip position, direction, and rotation. System overlays pointer location onto preoperative images on monitor. Used in OR by neurosurgeons for craniotomy planning and intraoperative navigation. Benefits include smaller craniotomies, avoidance of vascular structures, and preservation of critical functions (e.g., speech). Registration achieved via markers placed on patient head, matched manually or automatically to image markers.

Clinical Evidence

Clinical trials conducted in US and Europe. Study compared conventional 2D hardcopy planning vs. EasyGuide Neuro interactive planning. Primary endpoints: incision line size, shape, and location. Results: mean RMSE = 4.1 mm; significantly smaller craniotomies achieved with EasyGuide; benefits included avoidance of vascular structures and preservation of speech function.

Technological Characteristics

Mobile workstation with Sun SPARC processor; optical position digitizer with infrared CCD cameras on titanium alloy sub-frame; infrared LED-equipped pointers. Connectivity: DICOM standard. Safety: UL 2601, 21CFR 1040.10 (laser). Software: EasyGuide software on Easyvision platform.

Indications for Use

Indicated for neurosurgical procedures requiring planning, localization, and navigation using preoperative image data.

Regulatory Classification

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.

Predicate Devices

• Zeiss MKM (K942233)
• Radionics OAS (K951262)
• Elekta/ISG Viewing Wand (K911783)

Reference Devices

• Easyvision workstation platform (K925950)

Submission Summary (Full Text)

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PHILIPS

NOV - 8 1996

K961834

# 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: [phone]
Fax: [phone]

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510(k) Summary
Philips EasyGuide Neuro
page 2

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.

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510(k) Summary
Philips EasyGuide Neuro
page 3

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.