KARL STORZ TWIN TRANSILLUMINATOR

K962032 · KARL STORZ Endoscopy-America, Inc. · MQW · Jul 5, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K962032
• Device Name: KARL STORZ TWIN TRANSILLUMINATOR
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: MQW · Ear, Nose, Throat
• Decision Date: Jul 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4350
• Device Class: Class 1

Indications for Use

The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures.

Device Story

Manual, reusable, nonsterile transilluminator; used in ENT procedures to transilluminate sinus tissue. Device provides localized light source to assist physician visualization of sinus anatomy. Operates via fiber optic or standard illumination; handheld by clinician. No electronic processing or automated output; purely mechanical/optical tool for visual guidance during surgery or examination.

Clinical Evidence

Bench testing only; no clinical data provided. Biocompatibility of body-contact materials established via historical use in medical devices.

Technological Characteristics

Manual, reusable, nonsterile transilluminator. Fiber optic or standard light transmission. Materials have established history of biocompatibility. No electronic components, software, or energy source beyond external light coupling.

Indications for Use

Indicated for transillumination of sinus tissue during ENT procedures in patients undergoing such examinations.

Regulatory Classification

Identification

An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.

Submission Summary (Full Text)

{0}

K962032

600 Corporate Events
600 Corporate Events
1000
1000
1000
1000

# 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
Transilluminator

Trade Name
Karl Storz Universal Twin Transilluminator
Karl Storz Universal Fiber Optic Twin Transilluminator

**Indication:** The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures.

**Device Description:** The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are manual, reusable, nonsterile medical devices. The body contact materials of these devices have a long history of biocompatibility with medical devices.

**Substantial Equivalence:** The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator 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 Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator 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
Marika Anderson
Regulatory Affairs Specialist

000038