(27 days)
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.
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.
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.
§ 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.