(31 days)
The Pure-Vu EVS System is intended to connect to standard or slim colonoscopes to help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices.
The Pure-Vu EVS System enables cleaning of the GI tract during endoscopy using a standard or slim colonoscope with a length of 1630mm - 1710mm and an outer diameter range of 11.7mm - 13.2mm or gastroscope with a length of 950 – 1030mm and an outer diameter of 9.2 - 10mm The EVS Flex Channel , which fits alongside the endoscope and is connected to an external Workstation, generates fluid and gas to break up debris The debris & fluids are removed through the suction channel of the EVS Flex Channel into an external waste container/bag.
The Pure-Vu EVS System consists of the following main components:
Disposable device which includes a Flex Channel section and an Umbilical Section (US) - The EVS Flex Channel fits alongside the endoscope to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water or saline and gas, and evacuates debris and fluids. The Workstation includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the GI tract, and suction of fluid and matter from the GI tract. Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line. Waste Containers for collecting the GI content & fluids that are suctioned from the GI tract through the suction lines. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fluid and matter from the GI tract. A foot pedal activates the cleansing, suction and purging functions, and enables switching between cleansing modes used by the physician.
The provided text describes modifications to the Pure-Vu EVS System and its substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or a study proving the device meets those criteria, nor any of the detailed information requested.
The document is a 510(k) summary for the Pure-Vu EVS System, a device intended for intra-procedural GI tract cleansing during endoscopy. It focuses on demonstrating substantial equivalence to previously cleared devices (Pure-Vu System K220007 and K210981) due to design changes.
Here's an analysis of the provided information against your requested points:
1. A table of acceptance criteria and the reported device performance
- Not found. The document includes tables comparing the technological characteristics of the subject device with its predicate, such as dimensions, flow rates, and materials. However, it does not present specific acceptance criteria (e.g., minimum pressure tolerance, maximum steering angle impact) with corresponding reported performance values against those criteria. It states that "Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance," but does not provide the specifics of that performance or the criteria used to judge it.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: For "System Validation Testing," it states "Validation testing for the entire Pure Vu EVS system (WS and disposable devices) was performed with 6 physicians." This is the only mention of human-involved testing with a specific number.
- Data provenance: Not specified.
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 found. There is no mention of establishing ground truth or the qualifications of the 6 physicians involved in the validation testing. Their role is described as performing "Validation testing," not establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not found. No adjudication method is described.
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 found. This is not an AI-powered device, and no MRMC study or comparative effectiveness study involving human readers or AI assistance is mentioned. The device is a physical system for irrigation and cleaning.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. The device is a mechanical/electro-mechanical system, not an algorithm, so this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not found. The document does not describe the establishment or type of ground truth for any evaluation.
8. The sample size for the training set
- N/A. As this is not an AI/machine learning device, there is no concept of a "training set."
9. How the ground truth for the training set was established
- N/A. As there is no training set, this is not applicable.
In summary, the provided document outlines the technical specifications, modifications, and verification/validation testing conducted for the Pure-Vu EVS System to demonstrate its substantial equivalence to previously cleared devices. It details various engineering tests (environmental conditioning, dimensions, head pull, steering, pressure, bond strength, software verification) and mentions system validation with 6 physicians. However, it does not provide the kind of detailed clinical study data, acceptance criteria, or ground truth information typically associated with performance evaluation against specific clinical endpoints or for AI/software-as-a-medical-device.
§ 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.