(37 days)
The Pure-Vu EVS System is intended to connect to standard and slim colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the irrigation 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 EVS System enables colon cleaning during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid and gas to break up feces. The fecal matter & fluids are removed through the suction channel of the Oversleeve into an external waste container.
The Pure-Vu EVS System consists of the following main components:
Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes 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 fecal material 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 fluids and feces from the colon.
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 the Pure-Vu EVS System, its indications for use, technological characteristics, and a comparison to its predicate device. It also briefly mentions performance data. However, the document does not contain specific acceptance criteria, detailed study results, or information regarding sample sizes for training/test sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.
Therefore, based only on the provided text, I cannot complete the requested table and answer all questions definitively.
Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated, inferred from testing) | Reported Device Performance (Summary from text) |
|---|---|---|
| Pure-Vu EVS Disposables | ||
| Functionality (after aging) | Meets requirements after 1-year simulated aging | Functionality meets requirements after simulated aging of one year. |
| Dimensional Compliance | Dimensions comply with product specifications | Dimensional compliance demonstrated. |
| Steering Impact | No negative impact on colonoscope bending/steering | Oversleeve's impact on colonoscope bending/steering was evaluated. |
| System Performance | Compliance with pressure, air, and water flow specifications | System complies with product specifications for pressure, air, and water flow. |
| Pressure Resistance | Withstands specific pressure without leakage | Withstands specific pressure without leakage. |
| Bond Strength | Tensile force of bonds meets requirements | Tensile force of bonds verified. |
| Packaging Integrity | Integrity of packaging and labels maintained after environmental conditioning and transport simulation. | Packaging integrity and labels maintained. |
| Biocompatibility | No toxicological risk to the patient | Biocompatibility testing done to determine if there was any toxicological risk. |
| Pure-Vu EVS Workstation (WS) | ||
| Environmental Conditioning & Transport | Maintains visual and functional integrity after simulation (ASTM D4169, DC13) | Visual inspection and functionality tests passed after preconditioning simulations. |
| Software Compliance | Embedded updated software complies with WS design modifications | Software verification and validation demonstrated compliance. |
| Cleaning Verification | Compatibility with cleaning agents noted in IFU | Compatibility with cleaning agents demonstrated. |
| IPX Rating | Meets IPX2 per IEC 60529 | Meets IPX2 per IEC 60529. |
| Safety & EMC | Complies with IEC 60601 standards | Complies with safety and EMC tests per IEC 60601. |
| Overall System Performance | Design changes have no impact on overall system performance (compared to predicate) | Design verification and validation testing concluded that design changes have no impact on the Pure-Vu System performance. |
Detailed Study Information (Not available in the provided text):
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified in the provided text. The document only mentions "Validation testing for the WS and disposable device was performed with 4 physicians." This appears to refer to human factors or usability testing rather than a clinical performance study with a test set of patient data.
-
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 specified in the provided text.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
-
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/Not specified. This device is for intra-procedural cleaning during colonoscopy, not an AI-powered diagnostic imaging device requiring reader studies in this context. The document describes a physical medical device (Pure-Vu EVS System) for colon cleaning, not an AI algorithm.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not specified. As above, this is a physical medical device, not an AI algorithm. Its performance is intrinsically "human-in-the-loop" as it assists a physician during a colonoscopy.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in the provided text. The performance data section focuses on engineering verification and validation testing (e.g., pressure, flow rates, dimensional compliance, biocompatibility, software compliance) rather than a clinical ground truth for a diagnostic claim. The clinical outcome (effective colon cleaning) is assumed to be evaluated during the "Validation testing for the WS and disposable device was performed with 4 physicians," but the specific metrics and how "ground truth" for cleaning effectiveness were established are not detailed here.
-
The sample size for the training set:
- Not applicable/Not specified. There is no mention of a "training set" as this is a physical medical device, not an AI model requiring machine learning training.
-
How the ground truth for the training set was established:
- Not applicable/Not specified. See point 7.
In summary, the provided document is a 510(k) summary for a physical medical device. It covers the technical performance verification and validation to demonstrate substantial equivalence to a predicate device. It does not contain the detailed clinical study information typically found for AI/ML-based devices regarding diagnostic performance, ground truth, reader studies, and sample sizes for algorithmic evaluation. The "performance data" section focuses on engineering tests (e.g., environmental, mechanical, flow, pressure, software validation) and a mention of "validation testing for the WS and disposable device was performed with 4 physicians" which likely refers to human factors or usability rather than an effectiveness study using a "test set" of patient data for an algorithm.
§ 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.