KSEA C-MOUNT ARTHROSCOPES

K983142 · Karl Storz Endoscopy · HRX · Dec 7, 1998 · Orthopedic

Device Facts

• Record ID: K983142
• Device Name: KSEA C-MOUNT ARTHROSCOPES
• Applicant: Karl Storz Endoscopy
• Product Code: HRX · Orthopedic
• Decision Date: Dec 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

These instruments are manually operated surgical devices intended for arthroscopic procedures of the shoulder and knee.

Device Story

KSEA C-Mount Arthroscope is a manually operated surgical telescope used for large joint arthroscopic procedures, specifically shoulder and knee. Device features 30° and 70° viewing angles. Constructed from surgical grade stainless steel. Operated by surgeons in clinical settings to visualize joint interiors during surgery. Provides optical visualization to assist in surgical decision-making and intervention.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manually operated surgical telescope; 30° and 70° viewing angles; surgical grade stainless steel construction; non-powered optical device.

Indications for Use

Indicated for patients undergoing arthroscopic procedures of the shoulder and knee.

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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K983142

DEC Pres 10008

## 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] |
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Contact: Kevin Kennan Regulatory Affairs Specialist

Device Identification: Common Name: Arthroscope

> Trade Name: (optional) Karl Storz C-Mount Arthroscope

Indication: The KSEA C-Mount Arthroscope is intended for large joint arthroscopic procedures.

The Karl Storz C-Mount Arthroscope are manually operated surgical Device Description: devices. The KSEA C-Mount Arthroscope are 30° and 70° view Telescopes. The body contact portions of the KSEA C-Mount Arthroscope 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 C-Mount Arthroscope is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz C-Mount Arthroscope 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:

ed:

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 image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1998 DEC

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

Re: K983142 Trade Name: KSEA C-Mount Arthroscope Regulatory Class: II Product Code: HRX Dated: September 2, 1998 Received: September 8, 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 (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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510(k) Number (if known): K q 8> | 42-

Device Name: KSEA C-Mount Arthroscopes

Indications for Use: These instruments are manually operated surgical devices intended for arthroscopic procedures of the shoulder and knee.

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Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | 2983142 |

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

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