KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY

K960903 · KARL STORZ Endoscopy-America, Inc. · GCJ · Aug 22, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960903
• Device Name: KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities is intended for use by qualified surgeons during endoscopic surgery of superficial veins and fascia of the lower extremities, including vein discission and paratibial fasciotomy.

Device Story

Manually operated, reusable surgical instrument set; includes rigid endoscope, sheath, scissors, forceps, knives, and adapters. Used by surgeons in clinical settings for endoscopic access to lower extremity veins and fascia. Instruments facilitate visualization and mechanical tissue manipulation (cutting, dissecting, grasping) during vein discission and paratibial fasciotomy. Provides direct visualization of surgical site to assist surgeon in performing minimally invasive procedures; improves surgical access compared to open techniques.

Clinical Evidence

Bench testing only; no clinical data provided. Safety established via history of use of body contact materials.

Technological Characteristics

Manually operated, reusable surgical instruments. Materials have established history of medical use. Rigid endoscope, sheath, scissors, forceps, knives, and adapters. Non-powered, mechanical operation.

Indications for Use

Indicated for qualified surgeons performing endoscopic surgery on superficial veins and fascia of the lower extremities, specifically for vein discission and paratibial fasciotomy.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Submission Summary (Full Text)

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Karl Storz
Endoscopy-America, Inc.
600 Corporate Pointe
Culver City, California 90230-7600
Phone [phone]
Toll Free 800 421 0837
Fax [phone]
K960903

AUG 22 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 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:**
Marika Anderson
Regulatory Affairs Specialist

**Device Identification:**
Common Name
Endoscope
Telescope sheaths
Knives
Scissors
Dissectors
Bipolar Forceps and Cable
Adapter
Trade Name
KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities

**Indication:** The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities is intended for use by qualified surgeons during endoscopic surgery of superficial veins and fascia of the lower extremities, including vein discission and paratibial fasciotomy.

**Device Description:** The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities are manually operated, reusable surgical devices consisting of a rigid endoscope, sheath, scissors, forceps, knives, and adapters. The instruments and endoscope are long enough to gain access to the surgical site. The body contact materials have a long history of use in medical devices and do not pose any new issues of safety and effectiveness.

**Substantial Equivalence:** The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities 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 Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities 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
Regulatory Affairs Specialist

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