(86 days)
The Irrigation Pump and Irrigation Biopsy Valve System is intended to provide a manual, foot-controlled delivery of fluid from commercially available sterile water bottles to flexible gastrointestinal endoscopes to facilitate the irrigation and lavage of debris within the gastrointestinal tract.
The Irrigation Pump is intended as a disposable, manual, foot-controlled, irrigation pump with a bottle cap and back-flow valve that delivers fluid from sterile water bottles.
The Irrigation Biopsy Valve is intended as a disposable, replaceable valve that connects the Irrigation Pump to the accessory channel of a flexible, endoscope.
The Irrigation Pump and Irrigation Biopsy Valve System is intended to provide a manual, foot-controlled delivery of fluid from commercially available sterile water bottles to flexible gastrointestinal endoscopes to facilitate the irrigation and lavage of debris within the gastrointestinal tract.
The provided text describes a 510(k) premarket notification for the "US Endoscopy Irrigation Pump and Valve System". This document details the regulatory submission and approval for a medical device, not a diagnostic algorithm or AI product. Therefore, many of the requested categories in your prompt are not applicable to this type of submission.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly list "acceptance criteria" in the way one would for a diagnostic algorithm with performance metrics like sensitivity, specificity, or AUC. Instead, the device's acceptable performance is demonstrated through its design characteristics, comparison to predicate devices, and functional bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for Intended Use | Substantially equivalent to predicate devices based on design, comparison, and performance testing. |
| Biocompatibility | All components that come into indirect contact with the patient have a long history of use in medical devices and are biocompatible. |
| Functional Bench Testing | Performance testing consisted of functional bench testing (details not provided in the summary). |
| No Direct Patient Contact | No components come into direct contact with the patient. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is an irrigation pump and valve system, not a diagnostic software that uses a "test set" of patient data. The "testing" referred to is functional bench testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in the context of diagnostic algorithms refers to a verified diagnosis or outcome. For this device, performance is evaluated through engineering and functional tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no expert adjudication for this type of device submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI or diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would be related to its functional specifications (e.g., fluid delivery rate, pressure, leak integrity) which are assessed through engineering tests, not clinical "ground truth" data.
8. The sample size for the training set
Not applicable. No "training set" is used for this type of medical device submission.
9. How the ground truth for the training set was established
Not applicable.
§ 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.