(124 days)
The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapter and suction cleaning adapter
Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.
Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.
Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.
Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.
Disposable AW Channel Cleaning Adapter, it is attached to the air/water cylinder of the endoscope, used for the air water channel pre-cleaning after the procedure.
Disposable Suction Cleaning Adapter also as one of accessories of the pre-cleaning endoscopic irrigation. The one end can be connected to the biopsy channel. the other end be connected to the water container. It is used to aspirate reprocessing fluids through the instrument channel port of the endoscope.
The Endoscope Valves Systemare used to fit to multiple endoscope working channels/ports to enable anendoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials. It includes an air/water valve, a suction valve, a biopsy valve, a water connector, AW channel cleaning Adapterand suction cleaning adapter.All valvesare single-use device and packed individually in a sealed package or different types of valves products is packed into one package units. The valves are manufactured for use with OLYMPUS Endoscope Series, FUJIFILM Endoscope 700 Series, and Pentax 90 series endoscope.Some valvemay besold as both sterileand non-sterile.
The provided text is a 510(k) Summary for a medical device (Disposable Endoscope Valves System) seeking FDA clearance based on substantial equivalence to a predicate device. This type of submission generally focuses on non-clinical testing to demonstrate performance, safety, and equivalence, rather than a clinical study in the traditional sense of evaluating efficacy in human subjects.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" with specific numerical targets in a table format for the performance tests. Instead, it states that "All evaluation acceptance criteria were met" for biocompatibility and that performance testing was conducted to verify "all design specifications" and "substantial equivalence to the predicate device." The reported device performance is summarized as meeting these unspecified criteria.
Here's how we can infer the "acceptance criteria" and "reported performance" based on the described tests:
| Acceptance Criteria (Inferred from testing purpose) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| No cytotoxicity | Met |
| No irritation | Met |
| No intracutaneous reactivity | Met |
| AW Channel Cleaning Adapter: | |
| Adequate Water flow | Met design specifications |
| Performance comparable to predicate device | Met design specifications |
| Suction Cleaning Adapter: | |
| Adequate Suction flow | Met design specifications |
| Performance comparable to predicate device | Met design specifications |
| Compatibility: | |
| Functional with claimed endoscope models | Compatible with all claimed endoscopes (Pentax, Olympus, Fujifilm Gastrointestinal Endoscopes) |
| Sterilization: | |
| Sterility per ISO 11135 | Validated routine control and monitoring parameters established |
| Shelf-life: | |
| 3-year shelf life | Evaluated by accelerated aging test; 3-year shelf-life confirmed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the performance tests (e.g., water flow, suction flow, side-by-side or compatibility tests). The data provenance is implied to be from the manufacturer's internal testing. The country of origin of the manufacturer is China. The nature of the tests (performance, biocompatibility) implies they are prospective tests performed on new device samples.
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 type of information is usually associated with clinical studies involving human observers or expert reviews of complex data (e.g., medical images). For a device like an endoscope valve system, "ground truth" is established through engineering and laboratory testing protocols, often by qualified technicians and engineers following established standards. The document does not mention the use of experts in the sense of medical specialists establishing ground truth for the performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies where multiple human readers assess data and discrepancies need to be resolved. The non-clinical tests described (biocompatibility, water/suction flow, side-by-side, compatibility, sterilization, shelf-life) involve objective measurements and established protocols rather than subjective interpretation requiring adjudication.
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
Not applicable. The submitted device is a physical medical device (endoscope valves system), not an AI-powered diagnostic or assistive tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The submitted device is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described, the "ground truth" is based on:
- Biocompatibility: Established ISO standards (ISO 10993-1:2009) and laboratory test results demonstrating the absence of toxic or reactive responses.
- Performance (Water flow, Suction flow): Design specifications and performance characteristics of the predicate device, against which the proposed device was compared ("Side by side test").
- Compatibility: Successful functional operation with the specified endoscope models.
- Sterilization: Adherence to the validated sterilization parameters per ISO 11135.
- Shelf-life: Results from accelerated aging tests projecting a 3-year product life.
8. The sample size for the training set
Not applicable. As a physical medical device, there is no "training set" in the context of an AI algorithm. The device's design and manufacturing processes are refined through engineering development, not machine learning training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.