(23 days)
ClearField Anti-Fog Sterile Wipe is intended for use as an agent to keep external viewing surfaces clear of water vapor and condensation.
Sterile cloth pre-saturated with 5cc of Anti-Fog solution. Single Use.
The provided text is a 510(k) summary for the ClearField Anti-Fog Sterile Wipe, K974454. This document primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.
Therefore, it is not possible to extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text because it does not describe a performance study in that manner.
The document states:
- Intended Use: "Intended for use as an agent to keep external viewing surfaces clear of water vapor and condensation."
- Substantial equivalence is based upon equivalent technological characteristics of the solution, cloth and ink of this device compared to the predicate device.
This indicates that the submission relies on demonstrating that the new device is fundamentally the same as a previously cleared device (K904871/B ClearField Anti-Fog Sterile Wipe) in its design and materials, rather than providing new clinical or performance study data with defined acceptance criteria.
In summary, the document does not contain the information required to populate the table or answer the questions regarding study specifics, acceptance criteria, or performance outcomes.
§ 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.