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 The unit may be connected by friction-fit to most manufacturers' halogen bulb. endoscopes via adaptors (supplied separately) that attach to the endoscope light cable post.

AI/ML Overview

This 510(k) submission (K960081) for the Mitsubishi Battery Powered Endoscopic Light Source does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document describes a medical device, its intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence. It is a 510(k) summary, which focuses on regulatory clearance based on equivalence rather than detailed performance study results against specific criteria.

Therefore, I cannot provide the following information based on the given text:

A table of acceptance criteria and the reported device performance: This document does not list specific performance criteria (e.g., light output in lumens, battery life in hours, specific spectral characteristics) that the device must meet, nor does it provide detailed study results demonstrating performance against such criteria.
Sample size used for the test set and the data provenance: There is no mention of a formal "test set" or any data collection for evaluating performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as no test set or ground truth establishment is described.
Adjudication method: Not applicable as no test set or ground truth establishment is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: MRMC studies are typically for diagnostic imaging devices involving human interpretation, which is not relevant for a light source. No such study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is a physical light source, not an algorithm. This question is not applicable.
The type of ground truth used: Not applicable as no test set or ground truth establishment is described.
The sample size for the training set: Not applicable as this is a physical device, not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable as this is a physical device, not a machine learning algorithm.

Key takeaway from the document:
The submission demonstrates substantial equivalence to "Xomed-Treace E-Luminator II Battery Powered Disposable Endoscope Light Source" (K932771). The key arguments for equivalence are:

Same design considerations and operating principles.
Differences (sterilizable, replaceable battery) do not raise new questions regarding safety or effectiveness.
Both deliver incandescent light to illuminate the target.

Summary

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MAR 12 1996

510(k) Summary: #K960081

Battery Powered Endoscopic Light Source

1)	Name of Submitter:	Mitsubishi Cable America, Inc.
	Address:	520 Madison AvenueNew York, NY 10022
	Telephone:	(212) 888-2270
	Contact Person:	Dr. Ronald J. Ehmsen(714) 771-7656
	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:

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

ર) Intended Use of Device:

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

Comparison of Technological Characteristics: 6)

The Mitsubishi Battery Powered Endoscopic Light Source is substantially equivalent 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.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.