(158 days)
The Glo-Tip® Spray Catheter is used in conjunction with an endoscope to spray the gastrointestinal mucosa.
The Glo-Tip® Spray Catheter (subject device) is a sterile, single use device compatible with the accessory channel of an endoscope. The device consists of a long, thin polytetrafluoroethylene (PTFE) tube (catheter) with a stylet (metal wire) that together are introduced into the ductal area or elsewhere in the GI tract. Fluid (e.g., water or saline) can be injected through the catheter to spray the tissue that needs cleaning. The Glo-Tip® Spray Catheter can also be used in chromoendoscopy (to apply a dye to the mucosa of the gastrointestinal tract through an endoscope to aid in disease detection).
The provided text describes the Glo-Tip® Spray Catheter and its performance data, but it does not detail a study involving AI or human readers. The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, many of the requested categories related to AI performance, human reader studies, and ground truth establishment in that context are not applicable.
Here's the information that can be extracted and a note on the unavailable information:
- Table of acceptance criteria and the reported device performance:
| Requirement | Acceptance Criteria (summary) | Reported Device Performance |
|---|---|---|
| Packaging shall maintain functional integrity of the device following EO sterilization and shipping. | Meet user requirements and have acceptable visual appearance following two sterilization cycles and simulated shipping conditions. | Packages met acceptance criteria. |
| Product must perform intended use over labeled shelf life. | Same requirements as above, except following two sterilization cycles and aging. | Product performed as intended over labeled shelf life. |
| Sterile product must be adequately packaged to maintain sterile barrier during expected shipping conditions. | Non-opened sterile packaging shall not show any signs of functional damage, such as holes in the pouch and/or voids in the seal area after simulated shipping conditions. | No signs of functional damage. |
| Package maintains sterile barrier over labeled shelf life. | Same requirements as above previous, except following aging. | Package has acceptable sterile barrier. |
| Device must be a Glo-tip device. | Distal tip of device must be fluoroscopically visible. | Tip is fluoroscopically visible. |
| The product label shall contain accurate dimensional/compatibility information (Catheter outer diameter and length). | Catheter outer diameter: 6.9 Fr with acceptable tolerance. Working length: 235 with acceptable tolerance. | Device dimensions are in accordance with labeling. |
| In accordance with ISO 8600-1:2013, Clause 4.3: The maximum insertion portion width shall not be larger than that stated in the instruction manual. | Maximum insertion portion width |
§ 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.