The DeRoyal Industries, Inc. DeFogger is indicated for use during endoscopic, laparoscopic, gastroscopic, and arthroscopic procedures, as well as any other procedures which require the use of an endoscope device, to prevent fogging of the endoscope lens.

Device Description

The DeRoyal Industries, Inc. DeFogger functions in the same manner as predicate devices in that it is intended to be used during endoscopic, laparoscopic, gastroscopic procedures, as well as any other procedures which require the use of an endoscope device to prevent fogging of the endoscope lens.

Device Design/ Materials UsedPhysical Properties: The DeRoyal Industries, Inc. DeFogger is made of materials commonly used for this purpose. The primary material components are a solution consisting of Monawet MO-70E, Isopropyl Alcohol, and Water. The solution is applied with an Adhesive-Backed X-Ray Detectable Polyurethane Foam Pad.

AI/ML Overview

The provided text describes a medical device, the DeRoyal Industries, Inc. DeFogger, and its 510(k) submission for market clearance. However, the document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any details related to AI/algorithm performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and technological characteristics. This type of submission typically relies on existing knowledge of similar devices rather than new, extensive clinical studies with specific performance metrics like those for AI/software devices.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and studies, as this information is not present in the provided text. The document confirms that the device was cleared by the FDA (K982465) based on substantial equivalence to existing devices, inferring that its performance would be similar to those already on the market.

Summary

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DeRoyal Industries, Inc.

DeFogger

510(k) Summary

Summary of the Safety and Effectiveness Information Upon Which an Equivalence Determination Could Be Based

SUBMITTER INFORMATION

NAME:	DeRoyal Industries, Inc.	TELEPHONE:	(423) 938-7828
ADDRESS:	200 DeBusk LanePowell, TN 37849	CONTACT:	Lois Marsh
		DATE OF PREPARATION:	July 14, 1998

DEVICE NAMES

NAME:	DeRoyal Industries, Inc. DeFogger
COMMON/USUAL NAME:	Endoscope Fog Reduction Device
CLASSIFICATION NAME (if known):	Endoscope and/or Accessories

PREDICATE OR LEGALLY MARKETED DEVICES

Struckmeyer, O.R. Concepts, Inman Medical Corporation, Dexide, and Eagle Medical International.

DEVICE DESRIPTION

DEVICE INTENDED USE

The DeRoyal Industries, Inc. DeFogger is indicated for use during endoscopic, gastroscopic, and arthroscopic procedures to prevent fogging of the endoscope lens.

Characteristics andMaterials	DeRoyal	Predicate Devices
Solution	Surfactant in Water and IsopropylAlcohol.	Same or Similar Material
Solution Container	6 gram Plastic, Squeeze Bottle	Same
Sponge	Adhesive-Backed, X-RayDetectable Foam Pad	Same or Similar Material
Disposable	Yes	Yes
Sterility	Sterile	Yes

TECHNOLOGICAL COMPARISON WITH PREDICATE DEVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | | |998

Ms. Lois Marsh Regulatory Affairs DeRoval Industries, Inc. 200 DeBusk Lane Powell, TN 37849

Re: K982465

DeRoyal Industries, Inc. DeFogger Dated: July 14, 1998 Received: July 15, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 KOG

Dear Ms. Marsh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market لمدينة

المنتشب the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely your

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __________________________________________________________________________________________________________________________________________________

Device Name:

DeRoyal Industries, Inc. DeFogger

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	Colin M. Callahan for RB6/LLY
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number	K982465

Prescription Use	OR	Over-The-Counter Use ______
(Per 21 CFR §801.109)

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.