(78 days)
The AquaPulse® Auxiliary Water Connector is used in conjunction tubing (not supplied), intended to provide irrigation via irrigation fluids such as sterile water supplied to the Fujifilm GI endoscopes during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
The subject device is intended for single-use and are supplied sterile. The auxiliary water connector is manufactured for use in conjunction with irrigation tubing, and together with Fujifilm 500/600/700 series endoscope. It is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle. The auxiliary water connector is packed individually in a sealed packed. The subject device is supplied as sterile. The subject device in this submission have the same operation and method of action with the predicate device.
The provided text describes a 510(k) premarket notification for the AquaPulse® Auxiliary Water Connector but does not include information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical outcomes. The document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical performance for diagnostic or treatment purposes.
However, I can extract the information provided regarding the non-clinical performance data and frame it to answer some of your questions, interpreting the "performance test" results as the reported device performance to meet inferred "acceptance criteria" for basic functionality.
Here's an attempt to structure the available information, noting where specific details requested are not present in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for these tests. However, it implies that the device "passed" or "met expectations" for each test. The reported device performance is that these tests were "conducted" and presumably "passed" to support substantial equivalence.
| Item No. | Acceptance Criteria (Inferred from Test Type) | Reported Device Performance |
|---|---|---|
| 9.1.1 | Compatibility with irrigation tubing (e.g., proper fit, secure connection) | Test conducted; device demonstrated compatibility. |
| 9.1.2 | Compatibility with endoscope (e.g., proper fit, secure connection with Fujifilm GI endoscopes) | Test conducted; device demonstrated compatibility. |
| 9.1.3 | Water Flow Test (e.g., adequate and unobstructed water flow) | Test conducted. |
| 9.1.4 | Air Leakage Test (e.g., no detectable air leakage) | Test conducted; no leakage reported (by passing inference). |
| 9.1.5 | Water Leakage Test (e.g., no detectable water leakage) | Test conducted; product passed, preventing fluid leakage. |
| 9.1.6 | Backflow Performance Test (e.g., effective prevention of backflow) | Test conducted; product passed, preventing backflow. |
| 9.2 | Sterility Assurance (SAL of 10⁻⁶ and EO residuals below ANSI/AAMI/ISO 10993-7:2008) | Device sterilized in a validated EO sterilization cycle with SAL of 10⁻⁶. EO residuals below maximum levels. |
| 9.3 | Shelf Life (Maintain sterile barrier and intended performance for 1 year) | Accelerated aging, seal strength, dye penetration, microbial barrier, vacuum leak, and sterility tests conducted. Performance tests conducted after accelerated aging, implying successful maintenance. |
| 9.4 | Biocompatibility (Meet FDA guidelines for mucosal membrane contact for ≤ 24 hours, including systemic toxicity, cytotoxicity, skin sensitization, irritation) | Tests conducted according to FDA guidelines; device shown to be biocompatible. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that the bench testing was performed on "subject devices from initial production lots, including sterilization." However, it does not specify the exact number of devices (sample size) used for each test.
- Data Provenance: The tests were conducted internally by the manufacturer or by contracted labs (e.g., Sanitation Environment Technology Institute, Soochow University for shelf life, and unnamed labs for biocompatibility). The data is from non-clinical bench testing. The country of origin for the manufacturing is Hong Kong, China, where the submitter is located. This is retrospective data collected for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the type of tests described. The "ground truth" for the non-clinical bench tests is defined by the physical or chemical properties being measured (e.g., presence/absence of a leak, flow rate, bacterial growth after sterilization, chemical residual levels). No human experts or consensus were required to establish ground truth for these objective measurements.
4. Adjudication Method for the Test Set
This question is not applicable as the tests are objective bench tests, not evaluations requiring human adjudication or interpretation (like reading medical images).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The device is an auxiliary water connector, not a diagnostic imaging device or an AI-enabled system that would typically undergo an MRMC study.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as there is no AI component or image reading involved in the device's function or evaluation described.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
This question is not applicable. The AquaPulse® Auxiliary Water Connector is a physical medical device, not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.
7. Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on objective measurements and predefined physical/chemical standards. For example:
- Leakage/Flow: Absence of visible leaks, demonstrable flow, etc.
- Sterility: A Sterility Assurance Level (SAL) of 10⁻⁶.
- Biocompatibility: Conformance to specific ISO 10993 standards and FDA guidelines through laboratory test results (e.g., cell viability, observed irritation).
8. Sample Size for the Training Set
This question is not applicable. The device is a physical hardware product, not a machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above (no training set for a physical 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.