KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION

K962393 · KARL STORZ Endoscopy-America, Inc. · GCM · Sep 17, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962393
• Device Name: KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GCM · Gastroenterology, Urology
• Decision Date: Sep 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The KSEA Set for Endoscopic Assisted Intubation is designed to be used by qualified surgeons and physicians to view the larynx during intubation.

Device Story

Device consists of rigid telescope and BUMM clip; used for endoscopic assisted intubation. Rigid telescope utilizes Hopkins rod-lens technology for panoramic visualization. BUMM clip secures telescope to laryngoscope. Used by surgeons/physicians in clinical settings to facilitate airway management. Provides direct visualization of larynx to assist intubation procedure; improves accuracy of tube placement; reduces potential for airway trauma.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Rigid, straight-shafted, panoramic telescope using Hopkins rod-lens technology. Materials: surgical grade stainless steel. Components: rigid telescope, BUMM clip for laryngoscope attachment.

Indications for Use

Indicated for qualified surgeons and physicians to view the larynx during intubation.

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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STORZ
Karl Storz Endoscopy

# 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 is accurate and complete to the best of KSEA’s knowledge.

## Applicant:

Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
[phone]

*K962393*

## Contact:

Kevin Kennan
Regulatory Affairs Specialist

*SEP 17 1996*

## Device Identification:

**Common Name:**
Telescopes and accessories used in Laryngoscopy

**Trade Name:** (optional)
Karl Storz Set for Endoscopic Assisted Intubation

## Indication:

The KSEA Set for Endoscopic Assisted Intubation is designed to be used by qualified surgeons and physicians to view the larynx during intubation.

## Device Description:

The KSEA Set for Endoscopic Assisted Intubation is comprised of a Rigid Telescope and a BUMM Clip. KSEA Rigid Telescopes for Endoscopic Assisted Intubation are rigid, straight-shafted, panoramic telescopes which utilize Hopkins rod-lens technology. The KSEA BUMM Clip is used to secure the KSEA rigid telescope to a laryngoscope. The body contact portions of the KSEA Set for Endoscopic Assisted Intubation are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

## Substantial Equivalence:

The KSEA Set for Endoscopic Assisted Intubation is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Set for Endoscopic Assisted Intubation and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.

Signed:
*Kevin Kennan*
Regulatory Affairs Specialist

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