KSEA SPINOSCOPE

K023187 · Karl Storz Endoscopy · HRX · Dec 2, 2002 · Orthopedic

Device Facts

• Record ID: K023187
• Device Name: KSEA SPINOSCOPE
• Applicant: Karl Storz Endoscopy
• Product Code: HRX · Orthopedic
• Decision Date: Dec 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The Spinoscope is intended for use to view and facilitate treatment of disc herniations in the lumbar region of the spine (including disc prolapses and foramen stenoses).

Device Story

The Karl Storz Spinoscope is a fiber optic endoscope with a remote eyepiece designed for use in the lumbar region of the spine. It functions as a visualization tool to assist physicians in the treatment of disc herniations, disc prolapses, and foramen stenoses. The device is operated by a physician in a clinical or surgical setting. It provides direct visualization of the spinal anatomy, allowing the clinician to guide treatment interventions. The device is constructed from surgical-grade stainless steel, ensuring biocompatibility. By facilitating clear visualization, the Spinoscope aids in the precise management of spinal conditions, potentially improving surgical outcomes for patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use similarities.

Technological Characteristics

Fiber optic endoscope with remote eyepiece; body contact portions composed of surgical grade stainless steel. Device is a passive visualization instrument.

Indications for Use

Indicated for patients requiring visualization and treatment of lumbar disc herniations, including disc prolapses and foramen stenoses.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Submission Summary (Full Text)

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## 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: | Common Name:<br>Arthroscope<br><br>Trade Name: (optional) |

Karl Storz Spinoscope

Indication: The Spinoscope is intended for use to view and facilitate treatment of disc herniations in the lumbar region of the spine (including disc prolapses and foramen stenoses).

Device Description: The KSEA Spinoscope is a fiber optic endoscope with a remote eyepiece. The body contact portions of the KSEA Spinoscope 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 Karl Storz Spinoscope is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Spinoscope 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:

Murklee

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karl Storz Endoscopy James A. Lee, Ph.D. Senior Regulatory Affairs Specialist 600 Corporate Pointe Drive Culver City, California 90230-7600

Re: K023187

Trade/Device Name: Karl Storz Spinoscope Regulation Number: 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: September 23, 2002 Received: September 24, 2002

Dear Dr. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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" (21 CFR 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,

Miriam C. Provost

for 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): K023187

Device Name: Spinoscope

Indications for Use: The Spinoscope is intended for use to view and facilitate treatment of disc herniations in the lumbar region of the spine (including disc prolapses and foramen stenoses).

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Miriam C. Provost
(Division Sign-Off)

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

510(k) Number K023187