5MM ENDOSCOPE

K960637 · Origin Medsystems, Inc. · GCJ · Jun 14, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960637
• Device Name: 5MM ENDOSCOPE
• Applicant: Origin Medsystems, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The 5mm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a 5mm diameter endoscope as their visualization component.

Device Story

Rigid endoscope; components include shaft, scope body, illuminator port, eyepiece, light fiber optics, image rod, and front window. Used in OR or surgical settings by physicians to visualize internal body cavities. Provides optical visualization; used standalone or with compatible surgical instruments. Benefits patient via minimally invasive visualization.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rigid endoscope; 5mm diameter; materials include light fiber optics, image rod, and front window. Optical visualization principle. No electronic or software components.

Indications for Use

Indicated for visualization of body cavities or surgical working cavities during endoscopic procedures; compatible with surgical devices accepting 5mm diameter endoscopes.

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.

Predicate Devices

• ORIGIN Small Diameter Endoscope

Submission Summary (Full Text)

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ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION
JUN 14 1996
5mm Endoscope
K 960637
Class II

# 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.

## 21 CFR §807.92 a(1)

Submitter: ORIGIN® Medsystems, Inc.
135 Constitution Avenue
Menlo Park, CA 94025
[phone]
contact person: Mr. Anthony Durso
date prepared: February 7, 1996

## 21 CFR §807.92 a(2)

Trade name: 5mm Endoscope
Common name: Endoscope
Classification name: Endoscope and/or Accessories

## 21 CFR §807.92 a(3)

Identification of predicate(s): Substantial equivalence for the 5mm Endoscope is based on its similarities to the predicate: the ORIGIN Small Diameter Endoscope. The 5mm Endoscope shares the same intended use as the predicate device. The 5mm Endoscope also is similar to the predicate device in terms of materials and technological characteristics.

## 21 CFR §807.92 a(4)

Device Description-parts and function/concept: The 5mm Endoscope is a rigid endoscopic device which is comprised of a shaft, scope body, illuminator port, eyepiece, light fiber optics, image rod, and front window. The 5mm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a 5mm diameter endoscope as their visualization component.

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