(142 days)
The Disposable Endoscopy Adapter Set 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.
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Disposable 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.
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Disposable 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.
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Disposable 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.
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Disposable Water Jet Adapter: 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 Endoscopy Adapter Set 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. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.
This document pertains to the 510(k) premarket notification for a medical device called the "Disposable Endoscopy Adapter Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. Therefore, the questions related to AI/MRMC studies, human reader improvement, and extensive clinical ground truth establishment are not applicable in this context.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Nature of the Device and Submission:
The Disposable Endoscopy Adapter Set is a collection of sterile units (Air/Water Valve, Suction Valve, Biopsy Valve, Water Jet Adapter) intended to be fitted to endoscope working channels/ports to control fluid/gas flow and prevent leakage/back-flow. This is a Class II device.
The submission is a 510(k), which aims to demonstrate that the new device is "substantially equivalent" to a predicate device already on the market (in this case, "Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B, K200769" from Wilson Instruments (SHA) Co., LTD). Substantial equivalence is primarily proven through comparison of technological characteristics and non-clinical performance data, rather than large-scale clinical trials.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a physical medical device (endoscopy adapters) and not an AI/software device, the "acceptance criteria" are not framed in terms of AI performance metrics (like sensitivity, specificity, AUC) but rather through adherence to recognized standards and successful completion of pre-defined non-clinical tests to demonstrate equivalence to the predicate.
| Acceptance Criterion (Regulatory/Technical Standard) | Reported Device Performance (Test Results) | Notes |
|---|---|---|
| Biocompatibility | Meets ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" requirements. Materials (Silicone Rubber, ABS, SUS304 for proposed device vs. SIR, ABS, TPE, Stainless steel 304 for predicate) deemed "Substantially equivalent supported by biocompatibility testing." | This ensures the materials used in the device are safe for contact with the body. |
| Sterilization Efficacy & Residuals | Meets ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices" and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" requirements. Sterilization method (EO Sterilization) is "Same" as predicate. | Ensures the device is sterile and safe for use, and that no harmful residuals remain from the sterilization process. |
| Physical Properties/Functional Performance | "The following bench tests were performed on Disposable Endoscopy Adapter Set: Appearance, Physical properties. The results of all testing were passing." Specific comparisons made for "Compatible Endoscopes" (Olympus, PENTAX, Fujifilm) for various valve types, stated as "Substantially equivalent supported by bench testing." | These tests evaluate the device's ability to perform its intended function, such as controlling fluid/gas flow, preventing back-flow/leakage, and compatibility with various endoscopes. This demonstrates the device functions as intended and similarly to the predicate. |
| Comparison to Predicate Device's Intended Use | "Substantially equivalent" in Indication for Use. Detailed functional descriptions of each valve type (Air/Water, Suction, Biopsy, Water Jet Adapter) are presented as functionally equivalent to the predicate. | The intended use of the proposed device aligns with that of the predicate, minimizing new risks. |
| Comparison to Predicate Device's Technological Characteristics (General) | "Substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use" as the predicate device. Differences are stated as "do not raise any questions regarding its safety and effectiveness." | This general statement underpins the substantial equivalence claim. |
| Product Code, Regulation Number, Classification | "Same" as predicate (ODC, 21 CFR 876.1500, Class II respectively). | Demonstrates the device fits within the same established regulatory framework as the predicate. |
| Environment of Use | "Same" as predicate (Hospital/clinics). | Assures suitability for the intended clinical environment. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify exact sample sizes for the "bench tests" performed. For physical device testing, sample sizes are typically determined by statistical methods for device validation (e.g., AQL sampling plans) or by industry standards for specific tests, but these details are not provided in this high-level summary.
- Data Provenance: The testing was performed as part of the submission by Yangzhou Fartley Medical Instrument Technology Co., Ltd. and their consultant Shanghai Thinkwell Consulting Co., Ltd. The country of origin for the manufacturing and testing would be China. The data would be considered prospective with respect to the regulatory submission, meaning the tests were specifically conducted to support this 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this 510(k) submission. "Ground truth" for physical device performance (like fluid flow, material properties, sterility) is established through standardized laboratory testing, rather than expert consensus on medical images or clinical outcomes. The "experts" would be the engineers, microbiologists, and other technical personnel who conducted and validated the bench tests, adhering to established international standards (ISO). Their specific number or qualifications are not typically detailed in the public 510(k) summary, as their expertise is presumed in conducting validated tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are for interpreting subjective data, typically in diagnostic imaging studies where multiple readers might interpret the same case. For physical device performance, tests have objective pass/fail criteria based on measured parameters and adherence to specifications.
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. This is a 510(k) for a physical medical device, not an AI-assisted diagnostic tool. No AI component is mentioned, and therefore, no MRMC study or AI-related effectiveness claim was made or required.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no algorithm or software component mentioned for this device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Bench Testing: Objective measurements of physical properties, appearance, and functional performance (e.g., flow control, prevention of back-flow/leakage, compatibility with endoscopes).
- Biocompatibility Testing: Laboratory tests to ensure the materials are non-toxic and compatible with biological systems.
- Sterilization Validation: Microbiological testing to confirm sterility assurance level (SAL) and ethylene oxide residuals meet standards.
- Adherence to Standards: Compliance with recognized international standards (ISO 10993, ISO 11135-1) serves as the "ground truth" for safety and performance in these areas.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
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.