(43 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 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 Connector (WSC) connects the Oversleeve to the WS and saline or water bag.
Loading fixture to aid the nurse in mounting the Oversleeve on to a colonoscope.
The provided document is a 510(k) summary for the Pure-Vu System, which is an add-on device for colonoscopes. It describes modifications to an already cleared predicate device (Pure-Vu System K160015). As such, it focuses on demonstrating substantial equivalence rather than presenting an exhaustive clinical study to establish new performance criteria.
Therefore, the document does not contain specific acceptance criteria, a detailed study proving performance against such criteria, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone algorithm performance, or details about training sets. Instead, it relies on performance tests to ensure the modified device functions as intended and remains substantially equivalent to its predicate.
Here's a breakdown of the information that is available based on your request, and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it states that "Performance tests were conducted for all modifications to the Pure-Vu System" and concludes that "In all instances, the Pure-Vu System functioned as intended." This implies that the device met internal performance specifications for the tested modifications, which would be aligned with the performance of the predicate device.
The document lists the following performance tests conducted:
- Biocompatibility
- Electrical Safety and EMC
- Software validation
- Bench tests
- Bond strength
- Pressure test
- System test
- Steering test
It also details changes in specifications for the modified device compared to the predicate, such as:
| Characteristic | Modified Device Performance | Predicate Device Specification |
|---|---|---|
| Air / Water pressure (bar) | Up to 23 psi | Up to 26 psi |
| Water flow rate (cc / min) | Up to 645 cc/min | Up to 630 cc/min |
| Air flow rate (cc / min) | Same as predicate | Up to 1350 cc/min |
| Material (Biocompatibility) | Re-tested to ISO 10993 | Complies with ISO 10993 |
| Safety Standards (Electrical) | Re-tested to IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 |
The acceptance criteria for these tests would likely be that the modified device's performance falls within an acceptable range, ideally demonstrating equivalence or improvement without introducing new safety or effectiveness concerns, and that it passes the listed regulatory standards (ISO 10993, IEC 60601-1/-1-2).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance tests" and "Bench tests" but does not specify sample sizes for these tests or the data provenance. These are likely internal engineering and quality assurance tests rather than clinical studies with human subjects.
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)
This information is not provided. Given that the listed performance tests are primarily engineering and safety assessments (biocompatibility, electrical safety, bench tests), there would typically not be "expert ground truth" in the clinical sense established by physicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically associated with clinical studies involving expert reviews of outcomes, which is not described here.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is not an AI diagnostic tool; it's a mechanical system for intra-procedural colon cleaning. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The Pure-Vu System is a physical device that connects to colonoscopes and is operated by trained medical personnel. It is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests described (biocompatibility, electrical safety, bench tests), the "ground truth" would be engineering specifications, compliance with international standards (e.g., ISO 10993, IEC 60601-1), and the intended functional performance of the device's components against design requirements. Clinical ground truth like pathology or outcomes data is not mentioned for the modifications made in this 510(k).
8. The sample size for the training set
This information is not provided and is not applicable as this is a medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated above.
§ 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.