(117 days)
The Andorate® Disposable Suction Valve is used to control the suction of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.
The Andorate® Disposable Air/Water valve is used to control the air/water function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.
The subject devices are intended for single-use and are supplied sterile. Disposable suction and air/water help prevential safety risks and eliminate the need for manual cleaning and reprocessing. The subject devices are easily incorporated into infection prevention policies as a single use item. The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image. while 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 suction and air/water are housed together with biopsy valve and auxiliary water connector in a single tray and packaged in sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate device.
The provided document is a 510(k) Premarket Notification for medical devices, specifically for disposable suction and air/water valves used with endoscopes. It outlines the regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device.
Based on the provided document, here's a description of the acceptance criteria and the study that proves the device meets them:
Crucially, this submission is for physical medical devices (disposable valves), not an AI/software device. Therefore, many of the questions related to AI acceptance criteria (e.g., ground truth, expert adjudication, MRMC studies, training set) are not applicable to this document.
The primary acceptance criteria for these physical devices are based on bench testing demonstrating functional performance, safety, and compatibility, along with biocompatibility testing and sterilization validation. The study performed is a series of non-clinical, bench-top tests.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance / Testing Result |
|---|---|---|
| Functional Performance | Andorate® Disposable Suction Valve: | |
| Assembling Integrity | Test conducted (Result stated as met) | |
| Endoscope Compatibility | Test conducted (Result stated as met) | |
| Depression Force | Test conducted (Result stated as met) | |
| Vacuum Leak Test | Test conducted (Result stated as met) | |
| Suction Flow Test | Test conducted (Result stated as met) | |
| Andorate® Disposable Air/Water Valve: | ||
| Endoscope Compatibility Testing | Test conducted (Result stated as met) | |
| Air Leakage Testing | Test conducted (Result stated as met) | |
| Assembling Integrity Verification | Test conducted (Result stated as met) | |
| Air Flow Test | Test conducted (Result stated as met) | |
| Depression Force Testing | Test conducted (Result stated as met) | |
| Water Flow Test | Test conducted (Result stated as met) | |
| Sterilization | Sterility Assurance Level (SAL) | EO sterilization cycle achieved SAL of 10⁻⁶ |
| EO residuals | Below maximum levels defined in ANSI/AAMI/ISO 10993-7:2008 | |
| Shelf Life | Maintain sterile barrier & intended performance for 1 year | Accelerated aging, seal strength, dye penetration, microbial barrier, vacuum leak, and sterility tests conducted (Result stated as met) |
| Biocompatibility | Acute Systemic Toxicity | Test conducted (Result stated as biocompatible) |
| In Vitro Cytotoxicity | Test conducted (Result stated as biocompatible) | |
| Skin Sensitization | Test conducted (Result stated as biocompatible) | |
| Irritation | Test conducted (Result stated as biocompatible) |
Note on "Reported Device Performance": The document states that "The bench testing was performed to support substantial equivalence" and "The test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance before the expiration date," and "The test result shows that the subject devices are biocompatible." While specific quantitative results are not detailed in this summary, the submission asserts that all tests were conducted and the devices met the necessary criteria for their intended use and substantial equivalence claim.
Regarding the AI-specific questions, they are largely N/A for this K200495 submission which is for physical medical devices.
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." These are physical devices. The "test set" would be a quantity of manufactured valves used for bench testing. The document states "The bench testing was performed to support substantial equivalence. The following testing were performed on subject devices from initial production lots, including sterilization." It does not specify the exact number of units per test.
- Data Provenance: Not applicable in the context of an AI dataset. The data provenance here refers to the results of physical and chemical tests conducted on the manufactured valves. The manufacturer is GA Health Company Limited. The shelf-life tests were conducted by "Sanitation Environment Technology Institute, Soochow University," which implies the testing was done in China (where Soochow University is located). The document does not specify whether the data is retrospective or prospective, as it's not a clinical study in that sense; rather, it's product testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a physical device submission, not an AI/diagnostic software. Ground truth for these devices is established through engineering specifications, material science, and established medical device testing standards (e.g., for flow rates, leak integrity, biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable for a physical device bench test. Test results are typically objective measurements against predefined 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:
- N/A. No MRMC study was conducted or is applicable for this physical medical device. The device is a disposable valve, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. No algorithm is involved. This is a physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- N/A (in the AI sense). The "ground truth" for this device's performance is defined by established engineering and medical device standards for mechanical integrity, fluid dynamics (suction/air/water flow), material properties (biocompatibility), and sterilization efficacy. For example, a "Vacuum Leak Test" would have a specific maximum allowable leak rate as its ground truth.
8. The sample size for the training set:
- N/A. There is no "training set" as this is a physical medical device, not an AI model.
9. How the ground truth for the training set was established:
- N/A. Not applicable. There is no AI training set.
§ 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.