VIEWPOINT PASSIVE TOOL OPTION

K990868 · Philips Medical Systems (Cleveland), Inc. · HAW · Mar 30, 1999 · Neurology

Device Facts

• Record ID: K990868
• Device Name: VIEWPOINT PASSIVE TOOL OPTION
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: HAW · Neurology
• Decision Date: Mar 30, 1999
• Decision: SESE
• Submission Type: Special
• 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-operative procedures.

Device Story

ViewPoint Passive Tool Option is an image-assisted surgery device providing intra-operative orientation and reference. System uses diagnostic patient images for presurgical planning. Passive tracking technology replaces active IRED-based tools; Position Sensor Assembly (PSA) emits infrared signals reflected by markers on wireless tools. PSA detects reflected signals via two optical detectors. System operates in OR; used by surgeons. Output includes visual orientation and reference information on a display. Benefits include improved surgical navigation and tool tracking without active power sources on tools. Registration uses scanned and anatomical fiducials. Software processes data to provide MPR and surface rendering for physician guidance during intracranial and spinal procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on comparative technical specifications, including tool accuracy and digitizer volume, against the predicate device.

Technological Characteristics

Optical tracking system using infrared signals emitted from a Position Sensor Assembly (PSA) and reflected by passive markers on wireless tools. PSA utilizes two optical detectors. System supports MPR and surface rendering. Software runs in a UNIX environment. PSA can be mounted on a mobile pedestal, OR table, or ceiling.

Indications for Use

Indicated for intra-cranial surgical procedures involving space occupying lesions or malformations (soft tissue, vascular, osseous) and spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

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 3.0 Software (K970604)

Submission Summary (Full Text)

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3/30/99

# SUMMARY C TY AND EFFECTIVENESS (As required by 21 CFR 807.92)

| 1. | General Information | | | |
|----|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Classification: | Class II<br>Image Assisted Surgery Device | | |
| | Common/Usual Name: | Image Assisted Surgery Device Option | | |
| | Proprietary Name: | ViewPoint Passive Tool Option | | |
| | Establishment Registration: | Picker International, Inc.<br>World Headquarters<br>595 Miner Road<br>Highland Heights, Ohio 44143<br>Contact: Elaine K. Keeler, Ph.D.<br>Phone Number: [phone]<br>FDA Owner Number: #1580240<br>FDA Registration Number: #1525965 | | |
| | Performance Standards: | No applicable performance standards have been<br>issued under section 514 of the Food, Drug and<br>Cosmetic Act. | | |

### 2. Intended Uses

The ViewPoint Passive Tool Option does not change the existing intended use and indications for use for the ViewPoint as defined below.

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-operative procedures.

The ViewPoint is indicated for use in:

- Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or t resection of spinal neoplasms.

#### 3. Device Description

The Passive Tool Option for the ViewPoint system allows for optical tracking of wireless tools. The position sensor assembly provided with this option emits an infrared signal that is reflected off reflective markers mounted on the tools.

| PICKER INTERNATIONAL, INC. | (PASSIVE) 03/12/99 | I - 1 |
|----------------------------|--------------------|-------|
|----------------------------|--------------------|-------|

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## Safety and Effectiveness 4.

The ViewPoint system with the Passive Tool Option is substantially equivalent to the ViewPoint system described in the 510(k) submission K970604. The following chart has been compiled to demonstrate this substantial equivalency.

| Parameter | ViewPoint Passive Tool Option | Predicate Device - ViewPoint 3.0<br>Software (K970604) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tools | A long and short wireless tool<br>with a minimum of three<br>reflective markers per tool. | A long and short tool with a minimum<br>of four IREDs per tool. |
| Average Tool Accuracy | Same. | 2.0 - 5.0 mm |
| Type of Detector | Infrared signals emitted from the<br>Position Sensor Assembly (PSA)<br>are reflected off of reflective<br>markers mounted on the tool.<br>The reflected signal is detected by<br>the PSA with two optical<br>detectors. The assembly is either<br>on a mobile pedestal, mounted to<br>the OR table or mounted to the<br>ceiling. | Infrared signals emitted from diodes<br>on a hand-held tool are detected by a<br>Position Sensor Assembly with two<br>optical detectors. The assembly is<br>either on a mobile pedestal, mounted<br>to the OR table or mounted to the<br>ceiling. |
| Active Digitizer Volume | Same. | Silo shape comprised of 0.5m radius<br>hemisphere and a cylinder with 0.5m<br>radius and 0.5m length. Detector<br>Positioning Feature added to guide<br>user in finding center of active<br>digitizer volume. |
| Registration Technique | Same. | Scanned Fiducials and Anatomical<br>Fiducials. |
| Operating Software<br>Structure | Same. | UNIX environment with three major<br>processes: Import, Surgery<br>Application and Foot Switch. Uses a<br>Graphical User Interface to facilitate<br>interaction with user. |
| Image Manipulation | Same. | MPR and surface rendering. |
| Other Features | Same. | Detector Positioning Feature. |
| Parameter | ViewPoint Passive Tool Option | Predicate Device - ViewPoint 3.0<br>Software (K970604) |
| Intended Use | Same. | The ViewPoint is intended for use as a<br>device which uses diagnostic images of<br>the patient acquired specifically to<br>assist the physician with presurgical<br>planning and to provide orientation<br>and reference information during intra-<br>operative procedures. |
| Indications for Use | Same. | The ViewPoint is indicated for use in:<br>Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous) Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms. |

# Substantial Equivalence Chart

PICKER INTERNATIONAL, INC.

03/12/99 (PASSIVE)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the bird's body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 1999

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143

K990868 Re: Trade Name: ViewPoint Passive Tool Option Regulatory Class: II Product Code: HAW Dated: March 12, 1999 Received: March 16, 1999

Dear Dr. Keeler:

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 (QS) 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 - Elaine K. Keeler, Ph.D.

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,

Celina 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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Page 1 of 1

**510(k) Number (if known):** _

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

ViewPoint Passive Tool Option Device Name:

Indications for Use:

The ViewPoint Passive Tool Option does not change the existing intended use and indications for use for the ViewPoint as defined below.

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-operative procedures.

The ViewPoint is indicated for use in:

Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)

Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
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| (Division Sign-Off) | |
|---------------------|-----------------------------|
| Division | General Restorative Devices |
| 510(k) Number | K990868 |

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)