(20 days)
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the 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 doctor offices.
The Pure Vu system comprises the following components:
Oversleeve - The Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the colon.
Workstation (WS) - The Workstation operates by using simultaneous irrigation and evacuation of colon content. Irrigation is based on a mixture of liquid (water or saline) and gas (air). The workstation includes:
Monitoring & Control Unit that continuously monitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. External foot pedals that control the cleansing process to be operated by a physician.
WS Connector (WSC) connects the Oversleeve to the WS and saline or water bag.
Loading fixture to aid the nurse in mounting the Oversleeve onto a colonoscope.
This 510(k) submission is for the Pure Vu System, which is intended to connect to standard colonoscopes to facilitate intra-procedural cleaning of a poorly prepared colon. The submission is for a modification of the device to comply with Slim colonoscopes and extends the hydrophilic coating on the Oversleeve.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics of the device itself (e.g., a specific percentage improvement in cleaning, or a defined force of suction).
However, the "Performance Data" section states: "Performance tests were conducted for all modifications to the Pure Vu System. Specifically, the company performed the following bench tests: Steering test, Head pull test, Loading and maintenance of pressure during the loading procedure."
The "Substantial Equivalence Discussion" then concludes: "Performance data demonstrate that the Pure-Vu System is substantially equivalent." This implies that the results of these bench tests met internal acceptance criteria for demonstrating that the modified device performs comparably to the predicate device. Without further details on the specific values or thresholds used in these tests, a quantitative table of acceptance criteria and reported performance cannot be generated from this document.
2. Sample Size Used for the Test Set and Data Provenance
The document only mentions "bench tests" for performance data. It does not provide details on specific sample sizes for these tests, nor does it indicate the provenance of any data (e.g., country of origin, retrospective/prospective). As an accessory to a medical device (colonoscope), it's possible that clinical studies involving patient data were not part of this specific 510(k) submission focused on modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance data mentioned are "bench tests," which typically do not involve establishing ground truth by human experts in the way clinical studies do.
4. Adjudication Method for the Test Set
This information is not provided in the document. As the performance data are "bench tests," an adjudication method by human experts is not applicable in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this document. The submission focuses on modifications to an accessory device and bench testing for substantial equivalence, not a comparative effectiveness study involving human readers and AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, the Pure Vu System is a mechanical device designed to assist a human operator (trained medical personnel) during a colonoscopy. It is not an AI algorithm with standalone performance.
7. The Type of Ground Truth Used
For the mentioned "bench tests" (Steering test, Head pull test, Loading and maintenance of pressure during the loading procedure), the "ground truth" would be the engineering specifications and expected physical properties or performance thresholds of the device components. This is not "expert consensus, pathology, or outcomes data" in the typical sense for medical image analysis or diagnostic devices.
8. The Sample Size for the Training Set
No training set is mentioned as this device is not an AI or machine learning algorithm requiring training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned.
§ 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.