PHILIPS EASYGUIDE

K981480 · Philips Medical Systems, Inc. · HAW · Jan 28, 1999 · Neurology

Device Facts

• Record ID: K981480
• Device Name: PHILIPS EASYGUIDE
• Applicant: Philips Medical Systems, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The EasyGuide Standard Workstation is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The Easyguide Spine option expands the intended use of the EasyGuide Standard Workstation to include spinal surgical procedures. The EasyGuide Spine option is intended for planning spine surgery and for localizing and navigating during spine surgery.

Device Story

EasyGuide Spine is an add-on to the EasyGuide Standard Workstation for image-guided spinal surgery. System utilizes pre-operative imaging data to assist surgeons in planning and intraoperative navigation. Hardware includes instrument pointing, instrument learner, switchbox, tracker, flexible camera pole, and pedicle awl. Software performs 3D marker search, registration, tracking, and navigation. Used in surgical environments; instruments are autoclavable at 134° C. System provides real-time localization of surgical instruments relative to patient anatomy, aiding surgeon precision during spinal procedures like stabilization and tumor resection. Output is visualized by the surgeon to guide instrument placement, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing, hazard analysis, and compliance with recognized electrical and communication standards.

Technological Characteristics

Workstation-based image-guided navigation system. Components include tracker, camera pole, and specialized surgical instruments (e.g., pedicle awl). Connectivity via DICOM 3.0. Electrical safety per UL-2601; electromagnetic compatibility per IEC-601-1-2. Position digitizer laser complies with 21 CFR 1040.10. Instruments are autoclavable at 134° C. Software performs 3D marker search, registration, and navigation.

Indications for Use

Indicated for patients undergoing spinal surgical procedures, including stabilization techniques and tumor resection, for the purpose of pre-operative planning and intraoperative localizing and navigation.

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

• ISG Viewing Wand (K970865)
• Picker ViewPoint (K970604)
• Zeiss Surgical Microscope Navigator (SMN) (K965139)
• Sofamor Danek StealthStation (K954276)

Submission Summary (Full Text)

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# K981480

April 20, 1998

# Philips Medical Systems

# 510(K) Summary

In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a 510(K) summary of safety and effectiveness for the following device.

| CLASSIFICATION NAME: | Stereotaxic Instrument<br>(Class II; Tier 2; 84HAW, 21CFR 882.4560) |
|-------------------------|---------------------------------------------------------------------|
| COMMON/USUAL NAME: | Image Guided Surgery System |
| TRADE/PROPRIETARY NAME: | Philips EasyGuide |
| ESTABLISHMENT NO.: | 1217116 |
| CONTACT PERSON: | Peter Altman, Director of Regulatory Affairs |

## PERFORMANCE STANDARDS:

This device complies with electrical safety standard UL-2601, electromagnetic compatibility standard IEC-601-1-2 and the ACR/NEMA DICOM Version 3 digital imaging communication standard.

### SYSTEM DESCRIPTION:

The EasyGuide Spine option, which is the subject of this premarket notification, is an option for the EasyGuide Standard Workstation. The Spine option extends the functionality and application areas of the EasyGuide Standard Workstation to include pre-operative planning and intraoperative localizing and navigation during spinal surgical procedures.

The Spine option has the following features:

#### Hardware:

- . Instrument Pointing
- Instrument Learner ●
- Instrument Switchbox ●
- . Tracker
- Flexible camera pole ●
- Pedicle Awl .

Software:

- . 3D marker search
- Registration and tracking functions ●
- Planning and navigation functions .
- Instrument learning

All instruments can be used in the surgical environments used in the sterile field can be autoclaved at 134° C. All other parts are easy to clean.

> Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Tel: [phone] Fax: [phone]

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## INTENDED USE:

The EasyGuide Standard Workstation is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The Easyguide Spine option expands the intended use of the EasyGuide Standard Workstation to include spinal surgical procedures. The EasyGuide Spine option is intended for planning spine surgery and for localizing and navigating during spine surgery.

#### SUBSTANTIAL EQUIVALENCE INFORMATION:

The Philips EasyGuide Standard Workstation with the Spine option is considered substantially equivalent to the ISG Viewing Wand (K970865), the Picker ViewPoint (K970604), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K954276).

#### SAFETY INFORMATION:

The Philips EasyGuide Standard Workstation with Spine option is designed to comply with applicable requirements of Underwriters Laboratories Standard for Safety of Medical Electrical Equipment (UL-2601) and be classified by Underwriters Laboratories. Additionally, the EasyGuide Standard Workstation with Spine option is in compliance with the ACR/NEMA Digital Imaging Communication (DICOM) standard. The position digitizer laser complies with Title 21 CFR Part 1040.10.

The results of a hazard analysis. combined with the appropriate preventive measures taken indicate that the device is of minor level of concern as per the August 29, 1991 issue of the "Reviewer's Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".

Additionally, the Philips EasyGuide Standard Workstation with Spine option is designed to comply with international standard IEC-601-1-2 for electromagnetic compatibility.

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.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1999

Mr. Frank Gianelli Senior Regulatory Affairs Specialist Philips Medical Systems 710 Bridgeport Avenue Post Office Box 860 Shelton, Connecticut 06484-0917

Re: K981480

Trade Name: Spine Option for the EasyGuide Standard Workstation Regulatory Class: II Product Code: HAW Dated: November 19, 1998 Received: November 20, 1998

Dear Mr.Gianelli:

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 indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, 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 Federal 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 (QS) 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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# Page 2 - Mr. Frank Gianelli

This letter will allow you to begin marketing your device as described in your 510(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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name :

981480

Indications For Use :

The Philips EasyGuide is a viewing and navigation tool for all cranial surgical processes such as

- Tumor resection: Meningioma, Glioma, Pituitary tumor, Skull base . tumor, Metastasis
- Treatment of vascular malformations, aneurysms .
- Transnasal approaches .

The EasyGuide Standard Workstation with Spine option is intended for planning spine surgery and for localizing and navigating during spine surgery.

EasyGuide Spine is specially designed for spinal application areas such as:

- Stabilization techniques .
- . Tumor resection

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Acolle

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981480

Prescription Use
( Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)