(25 days)
The System 83 Plus Endoscope Washer/Disinfector is designed for the simultaneous reprocessing of up to two flexible endoscopes used in the gastrointestinal and/or pulmonary tracts. These flexible scopes may be high level disinfected when the washing/disinfection cycle of the System 83 Plus is used with the labeled contact conditions for the germicide as in the predicated device.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Custom Ultrasonics, Inc. regarding their "System 83 Plus" device. This document does not contain information about acceptance criteria for a device, a study proving it meets such criteria, or any details about AI/ML algorithm performance.
The document primarily focuses on:
- The FDA's determination of substantial equivalence for the "System 83 Plus" to a legally marketed predicate device.
- Instructions for marketing the device under general controls provisions.
- Contact information for compliance and regulatory questions.
- The Indications for Use statement for the System 83 Plus, which describes its function as an endoscope washer/disinfector for reprocessing up to two pre-cleaned submersible endoscopes. It states that the device provides high-level disinfection when the washing/disinfection cycle meets the labeled contact conditions for the germicide, similar to the predicate device.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance.
- Number and qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Training set sample size.
- Ground truth establishment for the training set.
These details are typically found in a device's design validation studies, clinical trial reports, or specific performance testing documentation, which are not part of this FDA clearance letter.
§ 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.