BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE

K960081 · Mitsubishi Cable America, Inc. · FCQ · Mar 12, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960081
• Device Name: BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE
• Applicant: Mitsubishi Cable America, Inc.
• Product Code: FCQ · Gastroenterology, Urology
• Decision Date: Mar 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Mitsubishi Battery Powered Endoscopic Light Source is intended for use as a light source for diagnostic endoscopes.

Device Story

Lightweight, portable, battery-powered light source for diagnostic endoscopes; utilizes 3V lithium battery and 1.7W halogen bulb; manual on/off switch; connects via friction-fit adaptors to endoscope light cable posts; used by clinicians in diagnostic settings; provides illumination for target visualization; reusable design allows for sterilization and battery replacement.

Clinical Evidence

Bench testing only.

Technological Characteristics

Incandescent light source; 1.7-watt halogen bulb; 3-volt lithium battery; leakproof case; friction-fit connectivity; reusable; sterilizable.

Indications for Use

Indicated for use as a light source for diagnostic endoscopes in patients requiring endoscopic examination.

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

• Xomed-Treace E-Luminator™ II Battery Powered Disposable Endoscope Light Source (K932771)

Submission Summary (Full Text)

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510(k) Summary: #K960081
MAR 12 1996

# Battery Powered Endoscopic Light Source

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:** January 4, 1996

2) **Name of Device:** Battery Powered Endoscopic Light Source
**Proprietary/Trade Name:** (Not yet determined)
**Common/Usual Name:** Battery Powered Light Source
**Classification:** Class II
**Classification Name:** Light Source, Incandescent, Diagnostic (78FCQ)

3) **Name of Predicate or Legally Marketed Device:**
The Mitsubishi Battery Powered Endoscopic Light Source is substantially equivalent to the “Xomed-Treace E-Luminator™ II Battery Powered Disposable Endoscope Light Source” that was approved by FDA for marketing on August 24, 1994, under 510(k) No. K932771.

4) **Description of Device:**
The Mitsubishi Battery Powered Endoscopic Light Source is a lightweight, portable, battery powered light source intended for use with diagnostic endoscopes. The light source is powered by one three-volt lithium battery contained within a leakproof case and controlled by a manual on/off switch. Illumination is provided by a 1.7-watt halogen bulb. The unit may be connected by friction-fit to most manufacturers’ endoscopes via adaptors (supplied separately) that attach to the endoscope light cable post.

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510(k) Summary: #K960081
Mitsubishi Cable America, Inc.
Battery Powered Endoscopic Light Source
January 4, 1996
Page 2

5) **Intended Use of Device:**

The Mitsubishi Battery Powered Endoscopic Light Source is intended for use as a light source for diagnostic endoscopes.

6) **Comparison of Technological Characteristics:**

The Mitsubishi Battery Powered Endoscopic Light Source is substantially equivalent¹ to the predicate or legally marketed Xomed-Treace E-Luminator™ II Battery Powered Disposable Endoscope Light Source. Mitsubishi’s device employs the same design considerations and operating principles. However, the Mitsubishi device can be sterilized and its battery can be replaced to allow the device to be reused. Any differences between the Mitsubishi and Xomed-Treace devices do not raise new questions regarding safety or effectiveness. Each device delivers incandescent light to the endoscope to illuminate 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.