KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME

K961244 · KARL STORZ Endoscopy-America, Inc. · HRX · May 7, 1996 · Orthopedic

Device Facts

• Record ID: K961244
• Device Name: KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: May 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are indicated for use in endoscopic carpal ligament release.

Device Story

System consists of straight-shafted, rod-lens arthroscopes and associated surgical accessories including sheaths, obturators, knives, dilators, and retractor with guiding tube. Used by surgeons in clinical settings to perform endoscopic carpal ligament release. Device provides visualization of anatomical structures to facilitate surgical intervention for carpal tunnel syndrome. Benefits include minimally invasive access to carpal ligament.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Straight-shafted, rod-lens telescope system. Materials are standard medical-grade biocompatible materials with established history of use. Manual surgical instrumentation.

Indications for Use

Indicated for patients requiring endoscopic carpal ligament release for the treatment of carpal tunnel syndrome.

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

600 Corporate Pointe
Culver City, California 90230-7600
Phone [phone]

Toll Free 800 421 0837
Fax [phone]

k961244

MAY - 7 1996

# 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 CRF 807.92. All data included in this documents 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
- arthroscopes
- knives
- dilators
- sheaths
- obturators
- retractor with guiding tube

**Indication:** These devices are indicated for use in endoscopic carpal ligament release.

**Device Description:** The KSEA arthroscopes for use in endoscopic carpal ligament release are straight-shafted, rod-lens telescopes. Accessories are available for use with the arthroscopes include sheaths, obturators, knives, dilators, and a retractor with guiding tube. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatibility for human use.

**Substantial Equivalence:** The KSEA instruments for endoscopic carpal ligament release are substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the KSEA instruments for the endoscopic treatment of carpal tunnel syndrome 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 the devices.

**Signed:**
Betty M. Johnson
Manager, Regulatory Affairs

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