KSEA NEUROENDOSCOPES AND ACCESSORIES

K021050 · KARL STORZ Endoscopy-America, Inc. · GWG · Jun 26, 2002 · Neurology

Device Facts

• Record ID: K021050
• Device Name: KSEA NEUROENDOSCOPES AND ACCESSORIES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GWG · Neurology
• Decision Date: Jun 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neuroendoscope Set is intended for use by qualified surgeons in endoscopic pituitary surgery. TheNeuroendoscopes is intended for viewing the sella and pituitary gland in endoscopic pituitary surgery. The Sheath is intended to be used to protect the Neuroendoscope and provides irrigation during the endoscopic procedures. The KSEA Suction Tube is intended to remove blood, fluid, excised tissue, and debris from the operation site.

Device Story

KSEA Neuroendoscopes and Accessories are rigid, straight-shafted telescopes utilizing Hopkins rod lens technology; intended for use by qualified surgeons in endoscopic pituitary surgery. System includes irrigation sheaths for scope protection and irrigation, and suction tubes for removal of blood, fluid, tissue, and debris from the surgical site. Devices are used in clinical settings to provide visualization of the sella and pituitary gland. Operation is manual; surgeon views the surgical site through the endoscope to guide procedures. Benefit includes minimally invasive access and visualization during pituitary surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Rigid, straight-shafted telescopes; Hopkins rod lens optical system; surgical grade stainless steel construction. Manual operation; no electronic or software components.

Indications for Use

Indicated for use by qualified surgeons during endoscopic pituitary surgery for viewing the sella and pituitary gland, providing irrigation, and removing blood, fluid, tissue, and debris.

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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## Ko21050 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: | James A. Lee, Ph.D.<br>Senior Regulatory Affairs Specialist |
| Device Identification: | <b>Common Name:</b><br>Endoscopic Instruments |
| | <b>Trade Name:</b> (optional)<br>KSEA Neuroendoscopes and Accessories |

Indication: The KSEA Neuroendoscopes and Accessories are intended for use by qualified surgeons during endoscopic pituitary surgery.

Device Description: The KSEA Neuroendoscopes are straight shafted, rigid telescopes that utilize Hopkins rod lens. The accessory instruments include the irrigation sheaths, suction tubes, etc. The body contact materials are surgical grade stainless steel.

Substantial Equivalence: The KSEA Neuroendoscopes and Accessories are substantially equivalent to the predicate devices since the basic design, dimensions. stainless steel, and intended use are similar. The minor differences between the KSEA Neuroendoscopes Set and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed:

James A. Lee, Ph.D. Senior Regulatory Affairs Specialist

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 6 2002

James A. Lee, Ph.D. Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Drive Culver City, California 90230

Re: K021050

Trade Name: Neuroendoscopes and Accessories Regulation Number: 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: March 29, 2002 Received: April 1, 2002

Dear Dr. Lee:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. James A. Lee

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ha
Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Not yet assigned.

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K02/050

Device Name: Neuroendoscopes and Accessories

Indications for Use: The Neuroendoscope Set is intended for use by qualified surgeons in endoscopic pituitary surgery.

TheNeuroendoscopes is intended for viewing the sella and pituitary gland in endoscopic pituitary surgery.

The Sheath is intended to be used to protect the Neuroendoscope and provides irrigation during the endoscopic procedures.

The KSEA Suction Tube is intended to remove blood, fluid, excised tissue, and debris from the operation site.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X OR Over-The-Counter Use: **__**
(Per 21 CFR 801.109) do
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K021050