KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS

K982837 · Karl Storz Endoscopy · GWG · Nov 6, 1998 · Neurology

Device Facts

• Record ID: K982837
• Device Name: KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
• Applicant: Karl Storz Endoscopy
• Product Code: GWG · Neurology
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These instruments are manually operated surgical devices intended for use by qualified surgeons for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

Device Story

Karl Storz GAAB and CHAVANTES-ZAMORANO Neuroendoscope Sets are manually operated surgical instruments. Used by qualified surgeons in clinical settings to visualize brain ventricles and facilitate diagnostic or therapeutic interventions. Devices consist of surgical-grade stainless steel and medical-grade silicone. No electronic or automated components; operation is purely mechanical/optical.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: surgical grade stainless steel and medical grade silicone. Manually operated surgical instruments. No energy source or software.

Indications for Use

Indicated for qualified surgeons performing diagnostic and therapeutic procedures within the brain ventricles.

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 logo is white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The background of the image is black.

## Nir 6 1998 510(k) SUMMARY OF SAFETY AND EFFEC

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>Neuroendoscope | | |
| | Trade Name: (optional)<br>Karl Storz GAAB Neuroendoscope and CHAVANTES-<br>ZAMORANO Neuro-endoscope Sets | | |

Indication: The KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuroendoscope Sets are intended for use by qualified surgeons for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

Device Description: The Karl Storz GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuro-endoscope Sets are manually operated surgical devices. The body contact portions of the KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuro-endoscope Sets are composed of surgical grade stainless steel and medical grade silicone, which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.

The Karl Storz GAAB Neuroendoscope and CHAVANTES-Substantial Equivalence: ZAMORANO Neuro-endoscope Sets are substantially equivalent to the predicate devices since the basic features and intended uses are the same.

Signed:

Surj Kennan
Kevin Kennan

Senior Regulatory Affairs Specialist

000086

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 6 1998

Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy 600 Corporate Pointe Culver City, California 90230-7600

Re: K982837

> Trade Name: KSEA GAAB Neuroendoscope and CHAVANTES-ZAAMORANO Neuroendoscope

Regulatory Class: II Product Code: GWG Dated: August 07, 1998 Received: August 12, 1998

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 (OS) 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.

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.

Image /page/1/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

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Page 2 - Mr. Kevin Kennan

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 is white text on a black background. The word "STORZ" is in large, bold letters, and the words "Karl Storz Endoscopy" are in smaller letters below. The logo is simple and modern.

## 510(k) Number (if known): K 982837

Device Name: KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuroendoscope Sets

Indications for Use: These instruments are manually operated surgical devices intended for use by qualified surgeons for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|----------|
| Division of General Restorative Devices | |
| 510(k) Number | 14982837 |

| Prescription Use:<br>(Per 21 CFR 801.109) | X | OR Over-The-Counter Use: | |
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(Optional Format 1-2-96)
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