(147 days)
The Disposable Endoscope Valve Sets is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector.
-
Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
-
Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction. whilst preventing inflow of air.
-
Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The Disposable Endoscope Valves Set is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an Air/Water Valve, a Suction Valve, a Biopsy Valve and an Auxiliary Water Connector.
-
The Suction Valve component of the Disposable Endoscope Valves Set is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image.
-
The Air/Water Valve component of the Disposable Endoscope Valves Set is designed to be attached to the air/ water port of the endoscope, the activation of the air/ water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
-
The Biopsy Valve component of the Disposable Endoscope Valves Set is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
-
The Auxiliary Water Connector component of the Disposable Endoscope Valves Set is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle.
The provided text is a 510(k) summary for the Disposable Endoscope Valves Set (AF series). It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance testing. It does not describe a study involving human-in-the-loop performance, expert readers, or AI assistance for image interpretation. Therefore, many of the requested elements are not applicable to the information contained in this document.
Here's an analysis based only on the provided text:
Preamble:
The document describes a medical device (Disposable Endoscope Valves Set) that physically controls fluids and gases during endoscopic procedures. It is not a device that performs AI-assisted image analysis or requires human interpretation of images for its function. Consequently, specific criteria related to AI performance, human reader studies (MRMC), or a comprehensive test set with ground truth established by experts for diagnostic accuracy are not found in this regulatory submission. The studies described are engineering and performance validation tests for the physical device.
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, but does not provide a formal table of acceptance criteria with corresponding performance data. Instead, it states that "Non-clinical testing...was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance...". The individual tests are listed, implying that the acceptance criterion for each was successful completion.
Summary of Performance Tests Implemented (Implied Acceptance: "Met All Specifications"):
| Component Tested | Performance Tests Implemented | Implied Acceptance Criteria & Reported Performance |
|---|---|---|
| Suction Valve | - Endoscope Compatibility | Passed (met all design specifications) |
| - Depression Force | Passed (met all design specifications) | |
| - Leakage Test | Passed (met all design specifications) | |
| - Suction Flow | Passed (met all design specifications) | |
| Air/Water Valve | - Endoscope Compatibility | Passed (met all design specifications) |
| - Air flow rate | Passed (met all design specifications) | |
| - Water flow rate | Passed (met all design specifications) | |
| - Leakage Test | Passed (met all design specifications) | |
| - Depression Force | Passed (met all design specifications) | |
| - Backflow Performance Test | Passed (met all design specifications) | |
| Biopsy Valve | - Endoscope Compatibility | Passed (met all design specifications) |
| - Leakage Test | Passed (met all design specifications) | |
| Auxiliary Water Connector | - Endoscope Compatibility | Passed (met all design specifications) |
| - Leakage Test | Passed (met all design specifications) | |
| - Water Flow Rate | Passed (met all design specifications) | |
| - Backflow Performance Test | Passed (met all design specifications) |
Other Non-Clinical Testing:
- Biocompatibility: In accordance with ISO 10993 series (MTT Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity, Pyrogen Test).
- Sterilization Validation: In accordance with ISO 11135, ISO 11737-2, ISO 10993-7, USP .
- Shelf Life and Sterile Barrier System: In accordance with ASTM F1980, ISO11607-1, ISO11607-2, ASTM F 1929, ASTM D 3078, DIN 58593-6, ASTM F88/F88M, ASTM D4169.
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each "bench-A" performance test. It mentions that "performance tests were implemented on both the subject device and the predicate device," implying a comparative, laboratory-based testing approach.
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for engineering validation.
- Data Provenance: Laboratory testing, likely conducted by the manufacturer (Alton (Shanghai) Medical Instruments Co. Ltd.) in China, as part of their regulatory submission for the U.S. FDA. The tests are non-clinical, likely prospective validation tests performed on newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical instrument, not an AI or diagnostic imaging device that requires expert-established ground truth from medical images. The "ground truth" for its performance is engineering specifications and physical measurements, not clinical diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human reader studies or for training/validating AI models with subjective interpretations (e.g., radiology image interpretation). This document describes the engineering performance validation of a physical device.
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
No. An MRMC study is not applicable as this is a physical medical instrument (endoscope valves), not a diagnostic algorithm or AI-assisted interpretation tool. The document explicitly states "N/A, no clinical studies are available for the subject device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical set of valves, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance relates to its physical and functional specifications (e.g., flow rates, leakage prevention, depression force, material compatibility, sterility, shelf life). These are established through engineering standards and testing, not clinical outcomes or expert consensus on medical images.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established in this context.
§ 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.