KSEA NEURO-FIBERSCOPE

K991069 · KARL STORZ Endoscopy-America, Inc. · GWG · Jun 3, 1999 · Neurology

Device Facts

• Record ID: K991069
• Device Name: KSEA NEURO-FIBERSCOPE
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GWG · Neurology
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

The Neuro-Fiberscope is indicated for use in viewing the ventricles and cavities of the brain.

Device Story

The KSEA Neuro-Fiberscope is a manually operated, flexible fiberoptic telescope used for visualizing brain ventricles and cavities. It utilizes fiber-optic technology to transmit images to the clinician. The device is intended for use by physicians in a surgical setting. It is constructed from medical-grade polyurethane for body-contact components. The device provides direct visualization to assist the surgeon during neuroendoscopic procedures, facilitating diagnostic or therapeutic interventions within the brain.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Flexible fiberoptic telescope; medical-grade polyurethane body-contact materials; manually operated; non-powered/fiber-optic light transmission.

Indications for Use

Indicated for viewing ventricles and cavities of the brain in patients requiring neuroendoscopic procedures.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The word "STORZ" is written in large, bold, white letters at the top of the logo. Below that, the words "Karl Storz Endoscopy" are written in a smaller, less bold font. The background of the image is black and has a grainy texture.

JUN 3

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

K991069

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan<br>Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Flexible Fiberscope |
| | Trade Name: (optional)<br>Karl Storz Neuro-Fiberscope |

Indication: The Neuro-Fiberscope is indicated for use in viewing the ventricles and cavities of the brain.

Device Description: The KSEA Neuro-Fiberscope is a manually operated surgical devices. The KSEA Neuro-Fiberscope is a flexible fiberoptic telescope which utilizes fiber-optic technology. The body contact portions of the KSEA Neuro-Fiberscope are composed of medical grade polyurethane.

Substantial Equivalence: The KSEA Neuro-Fiberscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Neuro-Fiberscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.

Signed:

Kevin Kennan

Senior Regulatory Affairs Specialist

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle head in profile, facing right, with three parallel lines forming the body and wing. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1999 JUN

> Mr. Kevin A. Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230

Re: K991069 Trade Name: KSEA Neuro-Fiberscope Regulatory Class: II Product Code: GWG Dated: March 30, 1999 Received: March 31, 1999

Dear Mr. Kennan:

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 - Mr. Kevin A. Kennan

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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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in a stylized font, with the letter "O" replaced by a target symbol. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The logo is in white against a black background.

510(k) Number (if known): 991069

Device Name: KSEA Neuro-Fiberscope

Indications for Use: The Neuro-Fiberscope is indicated for use in viewing the ventricles and cavities of the brain.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign | |
|----------------|---------|
| Division | |
| 510(k) Number | K991069 |

| Prescription Use:<br>(Per 21 CFR 801.109) | X |
|-------------------------------------------|---|
|-------------------------------------------|---|

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