OPTICAL DIGITIZER OPTION FOR VIEW POINT

K963221 · Philips Medical Systems (Cleveland), Inc. · HAW · Jan 10, 1997 · Neurology

Device Facts

• Record ID: K963221
• Device Name: OPTICAL DIGITIZER OPTION FOR VIEW POINT
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: HAW · Neurology
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).

Device Story

ViewPoint Optical Digitizer Option is an image-assisted surgery device. It uses infrared-emitting diodes on a handheld wand to track position and orientation during intra-cranial surgery. A position sensor assembly with two optical detectors captures these infrared signals. The system integrates this tracking data with pre-acquired diagnostic images to provide real-time orientation and reference information to the surgeon. Used in the operating room, it assists physicians in navigating space-occupying lesions or malformations. The output is displayed on a high-resolution monitor, allowing the surgeon to visualize the probe tip location relative to patient anatomy. This aids in surgical planning and intra-operative guidance, potentially improving surgical precision.

Clinical Evidence

Bench testing only. The device complies with the draft voluntary industry standard 'Neurological Standard for Image-Interactive Stereotactic and Localization Systems (ASTM 10th Draft 9/94)'. No clinical data provided.

Technological Characteristics

Infrared-based optical tracking system; infrared-emitting diodes on handheld wand; position sensor assembly with two optical detectors. Connectivity supports DICOM v3.0. Sterilization method: ETO (ethylene oxide) for the wand. Complies with ASTM 10th Draft 9/94 for image-interactive stereotactic systems.

Indications for Use

Indicated for patients undergoing intra-cranial surgical procedures involving space-occupying lesions or malformations, including soft tissue, vascular, and osseous structures, to assist physicians with presurgical planning and intra-operative orientation.

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

• ViewPoint (K961168)

Submission Summary (Full Text)

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K963221

JAN 13 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

(As required by 21 CFR 807.92)

JAN 10 1997

## 1. General Information

Classification: Class II
Image Assisted Surgery Device

Common/Usual Name: Image Assisted Surgery Device Option

Proprietary Name: ViewPoint - Optical Digitizer Option

Establishment Registration: Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965

Performance Standards: No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act.

The device does comply with the draft voluntary industry standard titled “Neurological Standard for Image-Interactive Stereotactic and Localization Systems (ASTM 10th Draft 9/94).”

## 2. Intended Uses

The Optical Digitizer Option for ViewPoint does not change the intended use of the ViewPoint system.

The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).

PICKER INTERNATIONAL, INC.

(OPTICAL)

8/12/96

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# 3. Device Description

The Optical Digitizer Option uses infrared emitting diodes to determine the position and orientation of the probe during intra-operative localization. This option has accuracy and resolution similar to that provided with the ultrasonic digitizer currently used with ViewPoint.

# 4. Safety and Effectiveness

The ViewPoint System with the Optical Digitizer Option is substantially equivalent to the ViewPoint System described in the 510(k) K961168 in safety and effectiveness. The following chart has been compiled to demonstrate the Optical Digitizer’s substantial equivalence to this device.

## SUBSTANTIAL EQUIVALENCE CHART

| Parameter | ViewPoint with Optical Digitizer Option | Predicate Device ViewPoint (K961168) |
| --- | --- | --- |
| Type of Digitizer | Infrared signals emitted from diodes on a hand-held wand are detected by a Position Sensor Assembly with two optical detectors. The assembly is either on a mobile pedestal, mounted to the OR table or mounted to the ceiling. | Ultrasonic pulses emitted from two locations on a hand-held wand are detected by four microphones in a detector array which is mounted to the OR table. |
| Active Digitizer Volume | Silo shape, with 1 meter diameter and 1 meter length. | 0.75 cubic meter (26.5 cu. ft.) |
| Max. Digitizer Rate | 30 Hz for one or two tools; for three tools, the rate is 30 Hz for one of the tools and 15 Hz for the other two. | 100 pts/sec/emitter |
| Wand/Localizer Average Accuracy | Same | 2.0 - 5.0 mm |
| Registration Technique | Same | Scanned Fiducials |
| Type of Sterilization | Same | Wand is ETO Sterilizable. |

PICKER INTERNATIONAL, INC.
(OPTICAL)
8/12/96
I - 2

{2}

| Parameter | ViewPoint with Optical Digitizer Option | Predicate Device ViewPoint (K961168) |
| --- | --- | --- |
| Computer | Same | A superscalar RISC microprocessor with sufficient RAM memory and image storage capabilities. Single high resolution monitor. Networking capabilities which support DICOM v3.0. |
| Operating Software | Same operating software, selections for the optical wands and Position Sensor Assembly have been added. | Operating software uses a graphical user interface to facilitate user interaction. Multiplanar reformatting and surface rendering capabilities included. Software is able to show diagnostic images at the location of the probe tip. |
| Intended Use | The Optical Digitizer Option for ViewPoint does not change the intended use of the ViewPoint system. | The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous). |

PICKER INTERNATIONAL, INC.
(OPTICAL)
8/12/96
I - 3