VIEWPOINT ENT/ORTHOPEDIC OPTION

K991256 · Philips Medical Systems (Cleveland), Inc. · HAW · Oct 8, 1999 · Neurology

Device Facts

• Record ID: K991256
• Device Name: VIEWPOINT ENT/ORTHOPEDIC OPTION
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: HAW · Neurology
• Decision Date: Oct 8, 1999
• 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-operative procedures. The ViewPoint is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as: - 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. - ENT procedures. - Orthopedic surgical procedures.

Device Story

ViewPoint ENT/Orthopedic Option is an image-assisted surgery device. It utilizes pre-acquired patient diagnostic images to assist physicians in presurgical planning and provides intra-operative orientation and reference information. Used in clinical settings (OR) by physicians; the device maps patient anatomy to diagnostic images to guide surgical navigation. It aids in visualizing surgical tools relative to anatomical structures, potentially increasing surgical precision and safety during complex procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Image-assisted surgery system; utilizes diagnostic imaging data for stereotactic navigation; provides intra-operative orientation relative to rigid anatomical structures. Technical details regarding specific hardware, materials, or software architecture are not specified in the provided documentation.

Indications for Use

Indicated for patients requiring stereotactic surgery where reference to rigid anatomical structures is possible, including intracranial procedures (lesions/malformations), spinal procedures (stabilization, decompression, neoplasm resection), ENT procedures, and orthopedic procedures.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 1999 8

K991256

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

## General Information 1.

Classification:

Class II Image Assisted Surgery Device

Image Assisted Surgery Device Option

Common/Usual Name:

ViewPoint ENT/Orthopedic Option

Proprietary Name:

Establishment Registration:

Picker International, Inc. World Headquarters 595 Miner Road Highland Heights, Ohio 44143 Contact: Elaine K. Keeler, Ph.D. Phone Number: [phone]

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.

## 2. Intended Uses

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 any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:

- 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.
- ENT procedures. .
- Orthopedic surgical procedures. .

PICKER INTERNATIONAL, INC.

(BS) O/ORTHO) 10/8/99

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three figures instead of the traditional snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 OCT !

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

Re: K991256

> Trade Name: ViewPoint ENT/Orthopedic Option Regulatory Class: II Product Code: HAW Dated: July 12, 1999 Received: July 13, 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.

{2}------------------------------------------------

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.

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

{3}------------------------------------------------

W. W.

Page 1 of 1

## 510(k) Number (if known): K991256

ViewPoint ENT/Orthopedic Option Device Name:

## 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-operative procedures.

The ViewPoint is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:

- 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.
- ENT procedures. •
- Orthopedic surgical procedures.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | |
|--------------------------------------------------------|------------------------------------------|--------------------------|-----------------------------------------|---------|
| <div><br/></div> | | | | |
| (Division Sign-Off) | | | | |
| | | | Division of General Restorative Devices | K991256 |
| | | 510(k) Number | | |
| Prescription Use | <div style="text-align:center;">OR</div> | Over-The-Counter Use | | |
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | | |