(155 days)
The Endoscopic Clean Connecting Tubes includes five subsets as below, they are intended to o provide sterile water and/ or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.
The Endoscopic CO2 Source Tubing is intended to be used with a CO2 insufflator along with Clean Cap or Hybrid Irrigation Tubing to supply CO2 to a GI endoscope during GI endoscopic procedures.
The proposed device includes two (2) categories:
- Endoscopic Clean Connecting Tubes
- Endoscopic CO2 Source Tubing
The proposed device, Endoscopic Clean Connecting Tubes, is to connect an air/ CO2 source, a sterile water source (water bottle), and an endoscope to supply air/ CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. It is supplied in sterile.
The Endoscopic Clean Connecting Tubes includes five (5) subsets:
- Irrigation Tube;
- Clean Cap
- Clean Cap with CO2 Source Tube
- Hybrid Irrigation Tubing
- Hybrid Irrigation Tubing With CO2 source tube
The Endoscopic CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope. It is composed of one female luer connector, one male luer connector, one rigid tube and air/gas filter. The air/gas filter can filter particulates from the CO2 source and keeps fluid from flowing into the CO2 Source.
The Endoscopic Clean Connecting Tubes and CO2 Source Tubing are provided sterile. The both device is sterilized by EO and the shelf life is three (3) years.
The provided text describes a 510(k) premarket notification for "Endoscopic Clean Connecting Tubes" and "Endoscopic CO2 Source Tubing." This documentation focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the performance of an AI/ML device against specific acceptance criteria.
Therefore, I cannot provide the information requested in the prompt because the provided text pertains to a Class II medical device (endoscopic accessories) and not an AI/ML device. The submission does not describe an AI/ML algorithm requiring a test set, expert ground truth labeling, MRMC studies, or standalone performance metrics for an AI system. The non-clinical testing mentioned refers to standard medical device performance tests like water flow rate, leakage, compatibility, and biocompatibility, not AI performance metrics.
§ 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.