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The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.

The EndoChoice water bottle cap system is a sterile disposable device designed to fit commercially available sterile water bottles for providing sterile water during endoscopic procedures. The water bottle cap system is designed with a clip that is placed on the tubing to stop water flow from the water bottle when the endoscope is not in use.

The device attaches via a connector to the air/water port of an endoscope. The water bottle cap itself is attached to a standard sterile water bottle. Air supplied from the processor unit then pressurizes the water bottle, providing water flow when then air/water valve of the endoscope is depressed. Some models provide a feature that provides an option to use a CO2 air source. Instructions state that the device is to be used by trained endoscopy professionals.

This document is a 510(k) premarket notification for the EndoChoice Water Bottle Cap System. It details the device, its intended use, and its substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Benchtop functional performance testing" and "Laboratory validation testing of sterilization" without specifying exact sample sizes for each test. It also states "Biocompatibility testing in conformance with ISO 10993-1." The nature of these tests (benchtop, laboratory) suggests that they would likely use a dedicated number of device units or components for each specific test, rather than a broad "test set" like clinical trials.

The document does not detail the provenance of data (e.g., country of origin, retrospective/prospective). Given these are non-clinical hardware tests, such details are typically not relevant or included.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This section is not applicable to this document. The document describes non-clinical performance and safety testing (functional, sterilization, biocompatibility). These tests do not involve human interpretation or the establishment of ground truth by clinical experts in the same way, for example, an imaging diagnostic device would. Performance is measured against engineering specifications and industry standards (e.g., ISO 10993-1) by qualified laboratory personnel.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations (e.g., in clinical trials for diagnostic devices). Since the testing described is non-clinical and objective (functional, sterilization, biocompatibility), there is no need for such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

This section is not applicable. The device (water bottle cap system for endoscopes) is a medical accessory, not an AI-assisted diagnostic or therapeutic device. It does not involve human readers interpreting data, nor does it have an AI component to assist human performance in diagnosis or treatment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This section is not applicable. As mentioned above, the device is a medical accessory and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

For the non-clinical testing:

• Benchtop functional performance testing: Ground truth would be established by the functional specifications and design requirements of the device (e.g., water flow rate, pressure resistance, connection integrity).
• Laboratory validation testing of sterilization: Ground truth is established by validated sterilization methods and industry standards (e.g., microbial load reduction, sterility assurance level).
• Biocompatibility testing in conformance with ISO 10993-1: Ground truth is established by the requirements of the ISO 10993-1 standard for biological evaluation of medical devices.

8. The Sample Size for the Training Set:

This section is not applicable. As a hardware medical accessory, this device does not utilize a "training set" in the context of machine learning or AI development.

9. How the Ground Truth for the Training Set was Established:

This section is not applicable for the same reasons as #8.

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