KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY

K970055 · KARL STORZ Endoscopy-America, Inc. · HRX · Mar 5, 1997 · Orthopedic

Device Facts

• Record ID: K970055
• Device Name: KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Mar 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Karl Storz Multidrive Mini Shaver and blades are designed to provide controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures of the ankle, wrist, elbow and TMJ.

Device Story

Motorized surgical system for arthroscopy; includes Multidrive Mini Shaver and associated blades. Used in ankle, wrist, elbow, and TMJ procedures. Device provides controlled mechanical shaving, abrading, and cutting of bone and tissue. Operated by surgeons in clinical/OR settings. Blades are either reusable or sterile single-use instruments; designed as accessories to arthroscopes to access surgical sites. Output is mechanical tissue/bone removal; assists surgeon in site preparation or debridement. Benefits include precise tissue management during minimally invasive procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Motorized surgical shaver system. Blades constructed from surgical grade stainless steel. Form factor includes long instruments for arthroscopic access. System includes both reusable and sterile single-use components.

Indications for Use

Indicated for patients undergoing arthroscopic surgical procedures of the ankle, wrist, elbow, and TMJ requiring controlled shaving, abrading, or cutting 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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STORZ
Karl Storz Endoscopy

Karl Storz
Endoscopy America, Inc.
600 Corporate Pointe
Culver City, California 90230-7600
Phone [phone]
Toll Free 800 421 0837
Fax [phone]
K970055

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR - 5 1997

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 are accurate and complete to the best of KSEA’s knowledge.

**Applicant:**
Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230
[phone]

**Contact:**
Renate A. MacLaren, Ph.D.
Senior Regulatory Affairs Specialist

**Device Identification:**
**Common Name**
Shaver for Arthroscopy
Arthroscopic Shaver Blades

**Trade Name**
Karl Storz Multidrive Mini Shaver
Karl Storz Mini Shaver Blades

**Indication:** The Karl Storz Multidrive Mini Shaver and blades are designed to provide controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures of the ankle, wrist, elbow and TMJ.

**Device Description:** The Karl Storz Multidrive Mini Shaver and blades are motorized surgical devices and include reusable and sterile, single use instruments. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to arthroscopes. The body contact materials of the blades are surgical grade stainless steel.

**Substantial Equivalence:** The Karl Storz Multidrive Mini Shaver and blades are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the Karl Storz Multidrive Mini shaver, blades and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.

**Signed:**
Renate A. MacLaren, Ph.D.
Senior Regulatory Affairs Specialist

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