(194 days)
The Clean Connecting Tube (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air(via an air pump) or CO2(Via a CO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction pump or electrosurgical unit.
The Clean Connecting Tube is intended for 24 hour multiple-patient use and then discarded. The Clean Connecting Tube design minimizes infection control risks that are associated with manual cleaning and sterilization.The maximum number of patient is up to 15 in 24 hours , and maximum duration of us shall not exceed 15h. The check valve attached to the irrigation tubing shall be replaced after every patient use. The Clean Connecting Tube is manufactured for use in conjunction with sterile water bottle, and together with irrigation pump. The Clean Connecting Tube is designed to be attached to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.
I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and study proving a device meets these criteria. The document is a 510(k) premarket notification letter from the FDA regarding a "Clean Connecting Tube" device and its substantial equivalence to a predicate device.
It primarily discusses:
- The FDA's review and determination of substantial equivalence.
- Regulatory classifications and requirements for the device.
- A comparison of the proposed device ("Clean Connecting Tube") with a predicate device ("Universal Irrigation Solution Hybird™").
- Non-clinical performance data (bench tests, compliance with ISO standards), stating "The results of all testing were passing."
- A clear statement that "No Clinical Study is included in this submission."
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance (beyond "passing" for bench tests).
- Sample sizes for a test set or data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document indicates that substantial equivalence was primarily established through a comparison of technological characteristics and non-clinical bench testing, rather than human-in-the-loop or standalone AI performance studies typically associated with the type of acceptance criteria you are asking about.
§ 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.