(30 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 bodly 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 enables colon cleansing during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and a slim colonoscope outer diameter range of 11.7mm – 13.3mm and a standard colonoscope outer diameter range of 12.8mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid to break up feces. The fecal matter & fluids are removed through the suction channels of the Oversleeve into an external waste receptacle.
The Pure-Vu 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 colon 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/saline and gas, and evacuates fecal material & fluids. The Workstation [WS] includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of fluids and feces from the colon. 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. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician. Loading fixture- The loading fixture is reusable and aids in assembling the Oversleeve onto the colonoscope. Unloading aids - A disposable 60cc lure lock syringe and 3-way stopcock used in unloading the Oversleeve from the colonoscope are provided in the disposable packaging.
The provided document describes the Pure-Vu System, a device intended to facilitate intra-procedural cleaning of a poorly prepared colon during colonoscopy. This submission is a special 510(k) to improve the overall ease of use of the system by reducing the size and weight of the Workstation and making other minor modifications to the Oversleeve and loading fixture. The document asserts that these changes do not raise new issues of safety or effectiveness.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of acceptance criteria with specific numerical targets. Instead, it describes various tests performed to demonstrate that the modifications did not negatively impact the device's performance and that it remains substantially equivalent to the predicate device. The performance is reported as meeting "requirements" or demonstrating "efficiency and integrity."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality after simulated aging (1 year) | "Pure Vu Disposables functionality meets the requirements following a simulated aging of one year." |
| Sub-system and system functionality as intended | "Simulation (bench test) was conducted and to support the sub system and system's use as intended and its substantial equivalence." (Specific tests like Dimensions, Steering (Angulation), Pressure, Bond Strength were conducted). |
| Packaging efficiency and integrity after environmental conditioning and transport simulation | "Disposable package undergone environmental conditioning and transport simulation (by DDL labs) in order to demonstrate efficiency and integrity of the packaging and their accompanying labels following the simulation." |
| Absence of toxicological risk (Biocompatibility) | "biocompatibility testing was done to determine if there was any toxicological risk to the patient as per ISO 10993-5." (Implied acceptance: no toxicological risk). |
| Workstation functionality after environmental conditions and distribution cycle simulation | "After the preconditioning simulations, the Pure Vu WS undergone verification testing including visual inspection and functionality tests." (Implied acceptance: device remains functional). |
| Software validation for updated embedded software | "The embedded updated software to comply with the WS design modifications was tested via software validation." (Implied acceptance: software functions correctly and complies with design). |
| Safety and EMC compliance | "Safety and EMC tests per IEC 60601." (Implied acceptance: device complies with relevant safety and electromagnetic compatibility standards). |
| Usability and validation for WS and disposable device | "Usability and validation testing for the WS and disposable device has been performed in two separate studies with 3 physicians and 15 nurses." (Implied acceptance: usable and validated by intended users). |
| Loading and unloading validation | "Validation testing for the new sealing plug used during loading and unloading was performed." (Implied acceptance: the new component functions as intended for loading and unloading). Also "Environmental conditions and distribution cycle simulation performed by DDL (USA) as per ASTM D4169-16 along with shipping integrity. After the preconditioning simulations, the Pure Vu WS undergone verification testing including visual inspection and functionality tests." (Implied acceptance: robust against environmental stresses and functional). |
| Overall design changes not impacting performance | "Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance." |
| Substantial Equivalence to Predicate Device | "substantially equivalent" |
2. Sample size used for the test set and the data provenance:
- Sample Size:
- Usability Testing: 3 physicians and 15 nurses for two separate studies for the Workstation and disposable device.
- Other tests (e.g., disposable units, disposable package, workstation environmental, loading/unloading) do not specify a "sample size" in terms of clinical cases or patients. These are primarily engineering verification and validation tests performed on manufactured units.
- Data Provenance: The document does not specify the country of origin for the participants in the usability studies or whether these studies were retrospective or prospective. Bench testing was performed by various laboratories (Carmel Environmental Laboratory, DDL labs, Hermon Laboratory, DDL (USA)).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the usability studies, the "experts" were the users themselves: 3 physicians and 15 nurses. Their qualifications are not further detailed beyond their professional roles.
- For other engineering tests, the acceptance criteria are likely against established engineering specifications and regulations (e.g., ISO, ASTM, IEC standards), so no explicit "ground truth experts" in the medical sense are mentioned for these tests.
4. Adjudication method for the test set:
The document does not describe any formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth, particularly in a medical diagnostic context. The usability studies would likely involve observation and feedback collection, but not a consensus determination of a medical finding.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an intra-procedural cleaning system for colonoscopy, not an AI-assisted diagnostic imaging device requiring human reader interpretation studies.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is a medical device for physical intervention (cleaning), not a standalone diagnostic algorithm. The device works with a human operator (trained medical personnel).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the usability studies, the "ground truth" would be user feedback and observed performance regarding ease of use and functionality, rather than a medical diagnostic ground truth. For the engineering tests, the ground truth is against established technical specifications, regulatory standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for safety/EMC), and internal functional requirements.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
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.