DCI ENDOSCOPE

K993539 · KARL STORZ Endoscopy-America, Inc. · GWG · Dec 15, 1999 · Neurology

Device Facts

• Record ID: K993539
• Device Name: DCI ENDOSCOPE
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GWG · Neurology
• Decision Date: Dec 15, 1999
• 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

Rigid, panoramic neuroendoscope utilizing rod lens technology; used for visualization of brain ventricles and performance of diagnostic/therapeutic procedures. Operated by qualified surgeons in a surgical setting. Device provides direct optical visualization; no electronic processing or software components. Body contact portions constructed of surgical grade stainless steel.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rigid, panoramic telescope; rod lens technology; surgical grade stainless steel construction. Manual operation; no energy source or software.

Indications for Use

Indicated for qualified surgeons to view brain ventricles and perform diagnostic and therapeutic 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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K 9935539

Image /page/0/Picture/1 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and 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 logo is likely used to identify the company and its products.

## DEC 1 5 1999 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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>Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Neuroendoscope<br><br>Trade Name: (optional)<br>Karl Storz Direct Coupled Interface (DCI) Endoscope |

Indication: The KSEA DCI Endoscope is indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

Device Description: The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Substantial Equivalence: The KSEA DCI Endoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA DCI Endoscope 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 Kennah

Senior Regulatory Affairs Specialist

Image /page/0/Picture/11 description: The image shows a black and white close-up of a textured, circular object. The object appears to be densely packed with small, irregular shapes, creating a rough and uneven surface. The lighting is diffused, with no strong shadows, which emphasizes the texture of the object.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare. The symbol features a staff with two snakes coiled around it, and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1999

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

Re: K993539

> Trade Name: Direct Coupled Interface (DCI) Endoscope Regulatory Class: II Product Code: GWG Dated: October 18, 1999 Received: October 19, 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.

Stephen Rhodes

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Device Name: Karl Storz Direct Coupled Interface (DCI) Endoscope

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 | K993539 |

| Prescription Use: | | OR Over-The-Counter Use: | |
|----------------------|--|--------------------------|--|
| (Per 21 CFR 801.109) | | | |

(Optional Format 1-2-96)