(245 days)
The intended use of the Balloon Goggle is to help the endoscope with being inserted into the gastrointestinal tract with or without the aid of gas (air or CO2) insufflation.
Concentric Balloon Goggle
I am sorry, but the provided text from the FDA letter (K112698) does not contain information about acceptance criteria or a study proving device performance for the "Concentric Balloon Goggle." The document is a 510(k) substantial equivalence letter, which states that the device is substantially equivalent to legally marketed predicate devices.
This type of letter primarily focuses on:
- Confirmation of Substantial Equivalence: It asserts that the device (Concentric Balloon Goggle) is substantially equivalent to pre-existing, legally marketed devices.
- Regulatory Classification: It specifies the regulation number, name, and regulatory class (Class II) for the device.
- General Controls: It reminds the applicant of their obligations regarding general controls, such as annual registration, listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
- Indications for Use: It includes an "Indications for Use" statement, which describes the intended purpose of the device: "The intended use of the Balloon Goggle is to help the endoscope with being inserted into the gastrointestinal tract with or without the aid of gas (air or CO2) insufflation."
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications from this document. This information would typically be found in a separate submission report, such as a validation study report, that supports the 510(k) application, but it is 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.