← Product Code [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW) · K963221 # OPTICAL DIGITIZER OPTION FOR VIEW POINT (K963221) _Philips Medical Systems (Cleveland), Inc. · HAW · Jan 10, 1997 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K963221 ## Device Facts - **Applicant:** Philips Medical Systems (Cleveland), Inc. - **Product Code:** [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW.md) - **Decision Date:** Jan 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4560 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for 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. ## Regulatory 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](/device/K961168.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 {1} # 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K963221](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K963221) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com