KSEA POWERSHAVER SYSTEM S2

K030009 · Karl Storz Endoscopy · HRX · Apr 2, 2003 · Orthopedic

Device Facts

• Record ID: K030009
• Device Name: KSEA POWERSHAVER SYSTEM S2
• Applicant: Karl Storz Endoscopy
• Product Code: HRX · Orthopedic
• Decision Date: Apr 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Karl Storz Powershaver System S2 is intended to provide controlled cutting, shaving and abrading of bone and tissue during arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ) conducted by qualified surgeons.

Device Story

Powershaver System S2 is an arthroscopic surgical system; components include power unit, handpieces, footswitch, power cord, shaver blades, drill chucks, and sagittal saws. Used by surgeons in clinical/OR settings for controlled cutting, shaving, and abrading of bone and tissue during arthroscopic procedures. System provides mechanical power to surgical attachments to facilitate tissue removal and bone modification. Benefits include precise tissue/bone management during minimally invasive joint surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of an electromechanical power unit, handpieces, footswitch, and accessories (blades, chucks, saws). Operates as an arthroscopic surgical instrument for bone/tissue resection. No specific materials or software algorithms described.

Indications for Use

Indicated for qualified surgeons performing arthroscopic surgical procedures on the knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ) requiring controlled cutting, shaving, and abrading of bone and tissue.

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: | Renate A. MacLaren, Ph.D.<br>Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Arthroscopic Shaver |
| | Trade Name: (optional)<br>KSEA Powershaver System S2 |

Indication: The Karl Storz Powershaver System S2 is intended to provide controlled cutting, shaving and abrading of bone and tissue during arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ) conducted by qualified surgeons.

Device Description: The Powershaver System S2 is comprised of a power unit, handpieces, a footswitch, and a power cord. Other accessories include shaver blades, drill chucks, and sagittal saws.

Substantial Equivalence: The KSEA Powershaver System S2 is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences between the KSEA Powershaver System S2 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.

ed: Benatefl. Macfar

Signed:

Renate A. MacLaren, Ph.D Senior Regulatory Affairs Specialist

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APR 0 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030009

Trade/Device Name: KSEA Powershaver System S2 Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: December 30, 2002 Received: January 2, 2003

Dear Dr. MacLaren:

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 - Renate A. MacLaren, Ph.D.

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), 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) you may obtain. 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,

Sincerely yours,

Mark A. Milliken

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

# KO30009

Device Name: KSEA Powershaver System S2

Indication for Use: The Karl Storz Powershaver System S2 is intended to provide controlled cutting, shaving and abrading of bone and tissue during arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ) conducted by qualified surgeons.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|----------------------|-----------------------------------------------------------|
| | <div> (Division Sign-Off) </div> |
| | Division of General. Restorative and Neurological Devices |
| 510(k) Number | K030009 |
| Prescription Use: | OR Over-The-Counter Use: |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |