(294 days)
The Endotics System is intended to provide 360° visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The Endotics Probe (colonoscope component of the Endotics Colonoscope System) is a single use disposable device. The Endotics Probe cannot be reprocessed.
Endotics is an endoscopic system to be used for the examination of the final section of the intestine, the ends of which are marked by the anal sphincter and by the ileocecal valve, known as the colonrectum. The system comprises two parts, which can be sold separately, namely: the"disposable probe", and the "workstation", equipped with a command console. Thanks to its flexibility, the disposable probe can easily adapt its shape to that of the colon. The motion, based on the "caterpillar" principle, is ensured by an anchoring system, placed by the ends of a flexible body. The colonoscope includes on its distal segment a viewing system, featuring a CMOS digital camera and a LED light source. The probe is further equipped with a steering system, which enhances the efficiency in terms of both motion and vision (maximum flexion angle: 180° in every direction). The endoscope is activated pneumatically. This device allows the use of specific surgical tools through a working channel. The exit of the working channel is centred compared to the robot and it is located near the camera, which is therefore slightly decentred. When the tool exits the probe, it is immediately detected and the operator can then visually pilot it over the zone to be treated. The anchoring system performs a double action. By extracting the air from inside the intestine it enables the intestine linings to approach the robot precisely at the point in which they will then be mechanically anchored. This system produces a steady hold on the intestine lining but prevents any damage or trauma from occurring. Endotics Workstation is composed of an electro-pneumatic system, controlled by a Panel PC which displays the different progress phases of the device and the images delivered by the internal camera, and of a command console for controlling the probe's movements. Only the Endotics disposable probe can be connected to this workstation. The probe is linked to the workstation by means of an electro-pneumatic connector is placed on a twistable arm which is connected to the machine's main block. This arm is fitted on the inside with pneumatic tubes and electric cables which connect the probe to the workstation's electro-pneumatic system and which connect the camera (placed by the probe's head) to a video system. The arm is also equipped with an electronic board which acts as an opto-insulator between the camera and the electric features of the workstation. The electro-pneumatic distributor is controlled by a computerised system, on which specifically designed command software has been installed. The monitor also displays the probe's status, indicating its current motion phase e the captured pictures. The associated accessories include: Stiffening accessory, Waterjet accessory.
Here's an analysis of the acceptance criteria and study details for the Endotics device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Primary Endpoints) | Reported Device Performance (Endotics) |
|---|---|
| Efficacy: | Efficacy: |
| * Statistical comparison between the Polyp Detection Rate (PDR)/Adenoma Detection Rate (ADR) of Traditional Colonoscopy (TC) and that of the ENDOTICS. ENDOTICS performance must be not inferior to TC with p-value |
§ 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.