(24 days)
Intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract including, but not limited to the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.
The ProtectiScope CS, Non-intrapull colonoscope is a software controlled device intended for use to visualize the colon to the level of the cecum. The ProtectiScope CS, Non-intrapull colonoscope includes a system control unit, flexible insertion tube, control body, and umbilicus. The insertion tube features a disposable sleeve that is discarded after the colonoscopy procedure is completed. The ProtectiScope CS, Non-intrapull colonoscope is designed for use in both diagnostic and therapeutic colonoscopy procedures. The insertion tube is designed to accommodate biopsy tools and equipment to remove intestinal polyps and other therapeutic uses. The design change included in this submission is removal of the air assisted push technology feature of the device. The modified Protectiscope CS, Non-Intrapull device is manually advanced through the large bowel for visualization of the colon.
The provided text describes a 510(k) premarket notification for a medical device called the "ProtectiScope CS, Non-intrapull colonoscope." This submission is based on substantial equivalence to a predicate device and focuses on a design change (removal of air-assisted push technology).
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or specifics about training sets or ground truth establishment.
The document is a regulatory submission for premarket clearance and primarily discusses:
- Device Description
- Intended Use and Indications for Use
- Substantial Equivalence to a predicate device (ColonoSight 520B, K032688) with the key difference being the manual advancement of the device.
- FDA's letter confirming substantial equivalence.
Therefore, I cannot provide the requested information for the acceptance criteria and study details.
§ 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.