PERCUTANEOUS ENDOSCOPIC DISCECTOMY

K960222 · Richard Wolf Medical Instruments Corp. · HRX · Mar 8, 1996 · Orthopedic

Device Facts

• Record ID: K960222
• Device Name: PERCUTANEOUS ENDOSCOPIC DISCECTOMY
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: HRX · Orthopedic
• Decision Date: Mar 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The instruments are used for Percutaneous Lumbar Disc Decompression. This involves partial or complete removal of human intervertebral disc hernias or degenerative diseases within the lumbar region. The goal is to decompress spinal structures like roots of nerves. Performing procedures like the mentioned PDD (Percutaneous Disc Decompression) is restricted to trained surgeons. The procedure is normally supported by the use of navigational systems (e.g. CT's, MRI, or Neuronavigation).

Device Story

Percutaneous Discectomy System consisting of forceps, dilators, working sleeves, cannulas, trephines, and deflectors; used for partial or complete removal of lumbar intervertebral disc material. Procedure performed by trained surgeons via small incisions; utilizes tubular sheaths for percutaneous access; often supported by navigational systems (CT, MRI). Instruments enable punching, grasping, cutting, suction, and irrigation to decompress spinal nerve roots. Benefit: minimally invasive removal of disc material to relieve spinal compression.

Clinical Evidence

No clinical tests were performed. Bench testing conducted to verify structural integrity and prevent breakage of jaws and instrument components.

Technological Characteristics

Manual surgical instruments; medical grade stainless steel construction; includes forceps, dilators, working sleeves, cannulas, trephines, and deflectors. Features extended shafts and integrated tubular sheaths for percutaneous access. Supports mechanical functions: punching, grasping, cutting, suction, and irrigation.

Indications for Use

Indicated for patients with spinal compression syndromes, specifically lumbar intervertebral disc hernias or degenerative disc disease requiring decompression of spinal nerve roots.

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.

Predicate Devices

• Arthroscopy instruments (Richard Wolf)
• Discectomy devices (AcuFlex)
• Discectomy devices (Smith + Nephew)
• Discectomy devices (Aesculap)

Submission Summary (Full Text)

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k960222

# 510(k) Summary of Safety and Effectiveness

1.0 **Classification Name:**
Orthopedic Manual Surgical Instruments


MAR - 8 1996

2.0 **Common / Usual Name:**
Percutaneous Discectomy System

3.0 **Trade Name:**
Forceps, dilator, working sleeves, cannulas, trephines, deflectors

4.0 **Equivalence:**
These devices are equivalent to existing 510(k) Arthroscopy instruments sold by Richard Wolf, Discectomy devices sold by AcuFlex, Smith + Nephew, and Aesculap.

5.0 **Description:**
Discectomy Instruments are made of medical grade stainless steel. They are used for partial or complete removal of intravertebral disc material in patients suffering from spinal compression syndromes. Percutaneous access is achieved by small incisions and introduction of sleeves.

6.0 **Intended Use:**
The instruments are used for Percutaneous Lumbar Disc Decompression. This involves partial or complete removal of human intervertebral disc hernias or degenerative diseases within the lumbar region. The goal is to decompress spinal structures like roots of nerves. Performing procedures like the mentioned PDD (Percutaneous Disc Decompression) is restricted to trained surgeons. The procedure is normally supported by the use of navigational systems (e.g. CT's, MRI, or Neuronavigation).

7.0 **Technological Characteristics:**
Basic arthroscopic instruments are equipped with longer shafts and integrated in a set of tubular sheaths to establish access. As the intended use includes punching, grasping, cutting, as well as suction / irrigation, all the functions are provided in the selected instruments.

8.0 **Performance Data:**
Instruments have been tested to assure there is no breakage of the jaw or other parts of the instrument.

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9.0 Clinical Tests:
No Clinical tests were performed.

10.0 Data Conclusion:
The new Richard Wolf Discectomy Instruments are substantially equivalent to existing instruments in the market and have been tested to allow usage with a minimal chance of breakage.

By: Robert L. Casarsa
Quality Assurance Manager
RICHARD WOLF MEDICAL INSTRUMENT CORPORATION
Date: Feb 28, 1996

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