INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY

K961713 · KARL STORZ Endoscopy-America, Inc. · HRX · May 31, 1996 · Orthopedic

Device Facts

• Record ID: K961713
• Device Name: INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: May 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA instrument set for arthroscopic percutaneous discectomy is designed to be used to visualize and treat vertebral disc herniations in the lumbar region of the spine using a posterolateral approach and fluoroscopic control.

Device Story

Manually operated, reusable surgical instrument set for arthroscopic percutaneous discectomy; includes arthroscopes, forceps, cannulae, sheaths, dilation rods, dilation sheaths, trephines, puncture needles, and curettes. Used by surgeons in clinical settings to access, visualize, and treat lumbar disc herniations. Instruments facilitate posterolateral access to the spine; used in conjunction with fluoroscopic imaging for guidance. Provides mechanical access and tissue manipulation capabilities to treat herniated discs; benefits patient through minimally invasive surgical approach.

Clinical Evidence

No clinical data provided; device relies on established design and material characteristics.

Technological Characteristics

Materials: surgical grade stainless steel or chrome-plated brass. Manual operation; reusable. Form factor: long instruments for surgical access. No energy source or software.

Indications for Use

Indicated for patients with lumbar vertebral disc herniations requiring surgical treatment via posterolateral approach under fluoroscopic control.

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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S10R7
Karl Storz Endoscopy
Karl Storz
End
600 Corporate
Culver City, CA 90230
Phone [phone]
Fax [phone]
10 52
K961713
MAY 3 | 1996

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The 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**
Arthroscope, Arthroscopic forceps, cannulae, sheaths, dilation rods, dilation sheaths, Trephine, Spinal Needles, Curettes

**Trade Name**
Karl Storz Arthroscopes, Karl Storz Arthroscopic forceps, Karl Storz cannulae and sheaths, Karl Storz dilation rods and dilation sheaths, Karl Storz puncture needles, Karl Storz trephines, Karl Storz curettes

**Indication:** The KSEA instrument set for arthroscopic percutaneous discectomy is designed to be used to visualize and treat vertebral disc herniations in the lumbar region of the spine using a posterolateral approach and fluoroscopic control.

**Device Description:** The KSEA instrument set for arthroscopic percutaneous discectomy are manually operated, reusable surgical devices consisting of arthroscopes, forceps, cannulae, sheaths, dilation rods, dilation sheaths, trephines, puncture needles and curettes. 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 are surgical grade stainless steel or chrome plated brass.

**Substantial Equivalence:** The KSEA instrument set for arthroscopic percutaneous discectomy procedures are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA instruments 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: Betty M. Johnson
Manager, Regulatory Affairs

006