ENDOSCOPE INTRODUCER KIT

K955717 · Mitsubishi Cable America, Inc. · FDE · Apr 18, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K955717
• Device Name: ENDOSCOPE INTRODUCER KIT
• Applicant: Mitsubishi Cable America, Inc.
• Product Code: FDE · Gastroenterology, Urology
• Decision Date: Apr 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Mitsubishi Endoscope Introducer Kit is intended to provide an open channel to allow insertion of a small diameter endoscope during laparoscopic choledochoscopy.

Device Story

Endoscope Introducer Kit provides access channel for small diameter endoscopes during laparoscopic choledochoscopy. Device consists of internal dilator with luer fitting and external sheath with hemostasis valve and luer fitting. Dilator features lumen for flexible guidewire passage; available in straight or curved configurations. Used by physicians in clinical/surgical settings. Facilitates endoscope insertion; minimizes trauma; maintains access during procedure. No active energy delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Components: internal dilator, external sheath, hemostasis valve, luer fittings. Materials: unspecified medical-grade materials consistent with predicate. Design: straight or curved dilator with guidewire lumen. Energy: none (passive device). Sterilization: compatible with standard sterilization methods.

Indications for Use

Indicated for patients undergoing laparoscopic choledochoscopy requiring an open channel for small diameter endoscope insertion.

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

• Candela Introducer Sheath System (K912443)

Submission Summary (Full Text)

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K955717

510(k) Summary: #K95

**Endoscope Introducer Kit**

1) **Name of Submitter:** Mitsubishi Cable America, Inc.
**Address:** 520 Madison Avenue
New York, NY 10022
**Telephone:** [phone]
**Contact Person:** Dr. Ronald J. Ehmsen
[phone]
**Date Submitted:** December 15, 1995

2) **Name of Device:** Endoscope Introducer Kit
**Proprietary/Trade Name:** (Not yet determined)
**Common/Usual Name:** Endoscope Introducer Sheath
**Classification:** Class II
**Classification Name:** Sheath, For Endoscope (78FED)

3) **Name of Predicate or Legally Marketed Device:**
The Mitsubishi Endoscope Introducer Kit is substantially equivalent to the “Candela Introducer Sheath System” that was approved by FDA for marketing on August 16, 1991, under 510(k) No. K912443.

4) **Description of Device:**
The Mitsubishi Endoscope Introducer Kit consists of an internal dilator (with luer fitting to accommodate a hemostasis valve) contained within an external sheath (with attached hemostasis valve and luer fitting). The dilator may be straight or curved and has a lumen to allow passage of a flexible guidewire.

5) **Intended Use of Device:**
The Mitsubishi Endoscope Introducer Kit is intended to provide an open channel to allow insertion of a small diameter endoscope during laparoscopic choledochoscopy.

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510(k) Summary: #K95
Mitsubishi Cable America, Inc.
Endoscope Introducer Kit
December 15, 1995
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6) **Comparison of Technological Characteristics:**

The Mitsubishi Endoscope Introducer Kit is substantially equivalent¹ to the predicate or legally marketed Candela Introducer Sheath System. Mitsubishi’s devices employ the same design considerations, materials of construction and operating principles. The Mitsubishi devices also employ lengths, diameters, and smoothly finished contours similar to those of the predicate devices and can be sterilized. Any differences between the Mitsubishi and Candela devices do not raise new questions regarding safety or effectiveness. None of the devices actively delivers any form of energy to the target under observation.

¹ The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.