(262 days)
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intraprocedural 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:
Add-on - The Add-on is mounted on standard commercially available colonoscopes allowing the physician to clean the colon.
Workstation (WS) - The Workstation operates by using cyclic irrigation and evacuation of colon content. Irrigation is based on mixture of liquid and air. The workstation includes: Monitoring & Control Unit that continuously monitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulators enabling water & airflow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. External on\off foot pedals that operate the cleansing process to be used by the physician.
WS Cartridge (WSC) connects the Add on to the WS and saline or water bag.
Loading fixture to aid the nurse in mounting the Add-on to a colonoscope.
Unloading fixture to aid the nurse in removing the Add-on from a colonoscope.
The Pure Vu System is an accessory to standard colonoscopes designed to facilitate intraprocedural cleaning of a poorly prepared colon by irrigating, cleaning, and evacuating fluids and matter. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a comprehensive study for de novo approval. Therefore, the information provided mainly pertains to the performance validation for demonstrating substantial equivalence.
Here's an analysis of the available information regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, explicit quantitative acceptance criteria for clinical performance are not detailed as they would be for a de novo submission or a comprehensive clinical trial for a novel device. The primary "acceptance criterion" in a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented are primarily to support this claim, focusing on safety and effectiveness.
| Aspect | Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Pass standard biocompatibility tests for mucosal-contacting devices (cytotoxicity, irritation, sensitization). | All materials and manufacturing processes of disposable kits passed cytotoxicity (Growth Inhibition Test - Extraction Method), irritation (Intracutaneous Reactivity Test), and sensitization (Skin sensitization) tests, and were found biocompatible. |
| Electrical Safety & EMC | Conform to IEC 60601-1 and 60601-1-2 medical electrical equipment safety standards. | System components (workstation, loading/unloading fixtures) were tested and found compliant with IEC 60601-1 and 60601-1-2. |
| Software Validation | Validate software per IEC 62304:2006 (Medical Device Software). | Pure Vu software has been validated per IEC 62304:2006 and followed the company's Software Life-Cycle Processes. |
| Bench Tests | Meet requirements for intended use regarding bound strength, pressure, overall system performance, Add-on movement, and steering segment abilities. | Performance tests after preconditioning confirmed the Pure Vu System meets its requirements for intended use, including bound strength, pressure, overall System performance, Add-on movement, and steering segment abilities. |
| Clinical Effectiveness | Comparable effectiveness to predicate device in improving colon cleansing level during colonoscopy. | A prospective animal study (in swine) showed that in 30/35 (86%) of procedures where the colon cleansing level was inadequate prior to Pure Vu, 100% (35/35) of animals had an excellent colon cleansing level following the use of Pure Vu. Physicians reported satisfaction with ease of advancement, navigation, stiffness, and torque response, finding it easy and intuitive to operate. No immediate or delayed adverse events were reported. |
| Clinical Safety | No immediate or delayed adverse events, such as mucosal injury. | No immediate adverse events (e.g., mucosal injury) or delayed adverse events were reported in any of the 35 animal procedures. |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Study (Effectiveness & Safety):
- Sample Size: 35 procedures in swine.
- Data Provenance: Prospective animal study (swine model), likely conducted in a research facility. The specific country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Animal Study:
- Number of Experts: 4 experienced gastroenterologists.
- Qualifications: "Experienced gastroenterologists." No further details on years of experience or specific board certifications are provided in this summary.
4. Adjudication Method for the Test Set
- The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for the animal study. The statement "The physicians were satisfied with the Pure Vu ease of advancement and navigation, level of stiffness, and its torque response. They found Pure Vu easy to use and intuitive to operate" suggests individual assessments by the gastroenterologists involved in the procedures. The colon cleansing level was presumably assessed by these same gastroenterologists.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. without AI Assistance
- No MRMC comparative effectiveness study was done. The Pure Vu System is a mechanical device for colon cleaning during colonoscopy, not an AI-assisted diagnostic tool for image interpretation. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The Pure Vu System is a physical medical device, not an algorithm or software-only diagnostic tool. It is used with human intervention (trained medical personnel using standard colonoscopes). Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The device's cleaning function is mechanical assistance during a procedure performed by a human.
7. The Type of Ground Truth Used
- Animal Study: The ground truth for effectiveness (colon cleansing level) and safety (adverse events) in the animal study was established by the performing gastroenterologists based on direct observation during the procedures. This could be considered a form of expert assessment/consensus during live procedures.
8. The Sample Size for the Training Set
- The document does not specify a separate "training set" in the context of device performance. The animal study of 35 procedures appears to be the primary performance validation used for this 510(k) submission. For software validation (IEC 62304), there would have been internal testing and verification, but details on sample size for that are not provided in this summary.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as a distinct training set for performance evaluation (as would be seen in AI/machine learning models) is not detailed in this 510(k) summary for this type of device. The verification and validation of the device's functional aspects (biocompatibility, electrical safety, bench tests) would involve established engineering and quality assurance practices rather than a "ground truth" derived from a training dataset in the clinical sense.
§ 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.