(30 days)
The Water Bottle Cap irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The EndoChoice water bottle cap system is comprised of a polycarbonate standard water bottle cap, medical grade PVC tubing that extends from the endoscope connector into the water bottle, and a medical grade Stainless Steel cylinder that serves as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down in the water bottle. Flexible pump tubing of larger diameter is connected to the top of the water bottle cap and runs to the tubing compression ring. This flexible tubing is the part of the device that is placed into the irrigation pump. From the tubing compression ring, more rigid tubing runs to the rigid tubing luer connector and the one way check valve which prevents reverse direction fluid from the endoscope into the tubing set. Once connected, the device provides flow of sterile irrigation water during endoscopy procedures. Connectors / accessories are used to connect to the different endoscopes. Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination. A female luer connector is used to connect the device to the series 160 / 180 Olympus endoscopes. Customers may use a luered blunt needle to connect to series 140 endoscopes. The cap of the system and associated tubing is connected to standard bottles, providing sterile water to rinse tissue for improved viewing and access. The water bottle cap system is supplied sterile and can be used up to 24 hours. EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles. The device can be used with any peristaltic irrigation pump that accepts industry standard irrigation tubing.
The provided document is a 510(k) Pre-market Notification for a medical device called the "EndoChoice Water Bottle Cap Irrigation System." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria and performance metrics for a novel technology.
As such, many of the requested elements for describing a typical AI/ML or diagnostic device study (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of device submission. This device is a fairly simple mechanical system (tubing and connectors) for irrigation during endoscopic procedures.
However, I can extract the relevant information regarding acceptance criteria (implied by the substantial equivalence argument) and the "study" (non-clinical testing) that supports it.
1. Table of Acceptance Criteria and Reported Device Performance
Note: For this type of device (a mechanical irrigation system being modified from a predicate), "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance. Instead, the acceptance criteria are implicitly met by demonstrating that the modified device's performance, materials, and intended use are equivalent to the predicate device, and that it passes standard benchtop functional and biocompatibility tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: Operate as intended without malfunction, provide irrigation. | "Benchtop functional performance testing" conducted (all test results passed). |
| Biocompatibility: Materials are safe for patient contact. | "Biocompatibility testing in conformance with ISO 10993-1.0" conducted (all test results passed). |
| Material Equivalence: Modified materials maintain safety and function. | Materials changed (various PVC and Polycarbonate formulations), but testing confirmed safety and efficacy is equivalent to predicate device. |
| Intended Use Equivalence: Same indications for use. | Intended use is "identical" to the predicate device. |
| Design Equivalence: Overall design and operating principle maintained. | Design and operating principle are "identical" or "equivalent" to the predicate device. |
The other requested information is largely not applicable because this is a 510(k) submission for a modified, substantially equivalent device, not a de novo submission for an AI/ML algorithm or a complex diagnostic. The "study" mentioned is standard non-clinical testing rather than a clinical trial assessing diagnostic accuracy.
Here's why and what information can be provided for the remaining points:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. "Benchtop functional performance testing" and "Biocompatibility testing" are typically laboratory-based tests on device units, not on patient data. There's no "test set" in the sense of patient data.
- 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): Not applicable. Ground truth as typically defined for diagnostic performance is not relevant here. The "ground truth" for functional testing is whether the device performs its intended mechanical action (e.g., fluid flow, absence of leaks) and for biocompatibility, whether it meets ISO standards. These are verified by engineering and toxicology experts, not clinical diagnosticians.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There's no "test set" requiring adjudication in the context of clinical diagnostic performance.
- 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 mechanical irrigation system, not an AI/ML-driven diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For functional performance, the ground truth is defined by engineering specifications and successful execution of mechanical actions (e.g., fluid delivery, no leaks). For biocompatibility, the truth is compliance with ISO 10993-1.0. These are determined by laboratory test results and standard adherence, not clinical expert consensus or pathology.
- 8. The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML algorithm or a learning system.
- 9. How the ground truth for the training set was established: Not applicable. (See #8)
§ 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.