(78 days)
This camera head has been designed to be used with the CV-180 EXERA II video system center or OTV-S7Pro VISERA Pro video system center, endoscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment.
AUTOCLAVABLE CAMERA HEAD OTV-Y0017 is an imaging device used with specified Olympus video system center, light source, endoscope, and other ancillary equipment for observation of endoscopic image on a video monitor.
The provided text is a 510(k) summary for a medical device (AUTOCLAVABLE CAMERA HEAD OTV-Y0017) and does not contain information about acceptance criteria or a study proving that the device meets those criteria.
This document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device. It focuses on comparing the new device's technological characteristics, intended use, and general specifications to an already approved device. The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or if different, these differences do not raise new questions of safety and effectiveness.
Therefore, I cannot provide the requested information from the given text. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or details of a study methodology.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect sizes, or human reader improvement with AI assistance.
- Details of a standalone algorithm-only performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states, "OTV-Y0017 is basically identical to the predicate device except for a change to the intended use (expanding beyond the bladder, urethra and kidney), specifications and method of sterilization." This indicates that the primary argument for approval is substantial equivalence rather than a new performance study against specific acceptance criteria.
§ 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.