KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE

K963029 · KARL STORZ Endoscopy-America, Inc. · HRX · Nov 27, 1996 · Orthopedic

Device Facts

• Record ID: K963029
• Device Name: KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA Slotted Whisker Arthroscopic Blade is designed to provide controlled shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures in both large joints (shoulder, hip, and knee) and small joints (elbow, wrist, ankle and TMJ), including debridement in patellar chondromalacia and smoothing of meniscal edges, the glenoid labrum, or rotator cuff.

Device Story

Sterile, single-use surgical arthroscopic blade; accessory to arthroscopes. Used by surgeons in clinical settings for controlled tissue shaving, abrading, debridement, or cutting during arthroscopic procedures. Mechanical operation; blade geometry facilitates access to joint spaces. Enables precise tissue removal/smoothing; aids in joint repair and debridement. Benefits patient through minimally invasive surgical access and effective tissue management.

Clinical Evidence

Bench testing only.

Technological Characteristics

Surgical grade stainless steel construction; sterile, single-use; mechanical cutting/abrading blade; accessory to arthroscopes.

Indications for Use

Indicated for patients undergoing arthroscopic surgical procedures in large joints (shoulder, hip, knee) and small joints (elbow, wrist, ankle, TMJ) requiring tissue shaving, abrading, debridement, or cutting, including patellar chondromalacia debridement and smoothing of meniscal edges, glenoid labrum, or rotator cuff.

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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K

Karl Storz

Endoscopy-America, Inc.

600 Corporate Pointe

Culver City, California 90230-7600

Phone [phone]

Toll Free 800 421 0837

Fax [phone]

NOV 27 1996

k963029

# 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 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:
Betty M. Johnson
Manager, Regulatory Affairs

Device Identification:
Common Name
Surgical Arthroscopic Blade

Trade Name
Karl Storz Slotted Whisker Arthroscopic Blade

Indication: The KSEA Slotted Whisker Arthroscopic Blade is designed to provide controlled shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures in both large joints (shoulder, hip, and knee) and small joints (elbow, wrist, ankle and TMJ), including debridement in patellar chondromalacia and smoothing of meniscal edges, the glenoid labrum, or rotator cuff.

Device Description: The KSEA Slotted Whisker Arthroscopic Blade is sold as a sterile, single use device. The blade is long enough to gain access to the surgical area and is designed to be used as an accessory to arthroscopes. The body contact materials of the blades are surgical grade stainless steel.

Substantial Equivalence: The KSEA Slotted Whisker Arthroscopic Blade is 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 KSEA Slotted Whisker Arthroscopic Blade 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:
Marika Anderson
Senior Regulatory Affairs Specialist

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