Search Results

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 FDA 510(k) premarket notification describes a medical device, the "EndoChoice Water Bottle Cap System," and makes a case for its substantial equivalence to a legally marketed predicate device. However, it does not contain the kind of detailed information about acceptance criteria and a study that proves the device meets them, as requested in your prompt.

Here's why and what information is available:

This document is a 510(k) submission, which is a premarket notification demonstrating that the device is at least as safe and effective as a legally marketed predicate device. It typically relies on comparing the new device to an existing one (the predicate) and showing that any differences do not raise new questions of safety or effectiveness. This is different from a PMA (Premarket Approval) which requires clinical trials to demonstrate safety and effectiveness for novel devices.

Therefore, the document does not provide:

• A table of acceptance criteria and reported device performance in terms of specific metrics like sensitivity, specificity, accuracy, etc.
• Sample sizes used for a test set, data provenance, ground truth establishment for an AI/diagnostic device.
• The number of experts or their qualifications for ground truth.
• Adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Ground truth type for a diagnostic device.
• Training set sample size or how its ground truth was established.

What the document does provide, and how it relates to proving safety and effectiveness for this type of device (an accessory for endoscopes):

1. Acceptance Criteria and Device Performance (Implicit):

For this device, the "acceptance criteria" are implicitly tied to demonstrating that the modified device performs comparably to the predicate device and meets safety standards, particularly concerning its function in supplying sterile water and biocompatibility.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not specified quantitatively. The "benchtop functional performance testing" and "biocompatibility testing" would have involved a certain number of device units, but this specific number is not disclosed in the summary.
• Data Provenance: The testing was "non-clinical testing" and "benchtop," meaning it was conducted in a laboratory/engineering environment, not on human patients. The country of origin for the testing facilities is not specified but would typically be where the manufacturer (EndoChoice, Inc. in Alpharetta, GA) conducts its R&D or uses contract labs. It is prospective testing performed on the modified device.

3. Number of Experts and Qualifications for Ground Truth:

• For this type of device, "ground truth" isn't established by medical experts in the way it would be for an AI diagnostic device. Instead, the "truth" is determined by engineering and material science standards (e.g., a pump correctly delivers water, a material does not cause a toxic reaction).
• The experts involved would be engineers, material scientists, and quality control personnel who conducted and evaluated the benchtop and biocompatibility tests. Their specific number and qualifications are not mentioned in this summary but are implicit to the conduct of these types of tests under regulatory standards.

4. Adjudication Method:

• Not applicable in the context of this 510(k) submission for a non-diagnostic accessory. Test results would be objectively measured against predefined engineering specifications and ISO standards; there's no "adjudication" by multiple human reviewers for interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the device (often AI) is intended to assist or replace that interpretation. The EndoChoice Water Bottle Cap System is a physical accessory, not an interpretive diagnostic tool.

6. Standalone (Algorithm Only) Performance:

• No, a standalone performance study in the context of an algorithm or AI was not done. This device does not contain an algorithm or AI. It is a mechanical accessory.

7. Type of Ground Truth Used:

• For functional performance, the "ground truth" is adherence to engineering specifications for flow rate, pressure capability, leak prevention, and durability (post-aging). This is determined by objective physical measurements against established design requirements.
• For biocompatibility, the "ground truth" is conformance to ISO 10993-1 standards, meaning the materials do not elicit an unacceptable biological response. This is determined by specified laboratory tests (e.g., cytotoxicity, sensitization, irritation).

8. Sample Size for the Training Set:

• Not applicable. There is no AI or algorithm that requires a "training set" for this device.

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

• Not applicable, as there is no training set for this device.

Ask a specific question about this device

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.

Ask a specific question about this device

The EndoChoice water bottle cap system is intended to be used with an air source from an endoscope 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 designed to supply sterile water and air to the endoscope during endoscopic procedures.

The provided 510(k) summary for the EndoChoice Water Bottle Cap System details performance testing for substantial equivalence to a predicate device, rather than defining specific acceptance criteria for an AI/CAD/ML device. Therefore, much of the requested information regarding AI/CAD/ML study design (like sample sizes for training/test sets, ground truth establishment, MRMC studies, and expert qualifications) is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document only states "multiple uses" for the water flow and leaking tests.
• Data Provenance: Not specified. The testing was conducted by EndoChoice, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a hardware device focused on fluid delivery and biocompatibility, not an AI/CAD/ML device requiring expert ground truth for interpretation.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 device is a water bottle cap system, not an AI/CAD/ML diagnostic or assistive tool.

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

• Not Applicable. See point 5. The device's performance is inherently standalone in its function (delivering water and air), but not in the context of an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Engineering Specifications and Standard Tests: The "ground truth" for this device's performance relies on meeting engineering specifications for water flow and leak prevention, and compliance with the ISO 10993 standard for biocompatibility. There is no diagnostic ground truth involved.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not a machine learning device.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed as "Performance Data" and "Biocompatibility Data."

• Performance Data: "We tested our EndoChoice Water Bottle Cap System to ensure that our system performs as well as the predicate device. The testing included sufficient water flow through the system over multiple uses without leaking." The comparison is against the predicate device (United States Endoscopy Water bottle cap system, K101146) to establish substantial equivalence.
• Biocompatibility Data: "The EndoChoice Water Bottle Cap System was tested for biocompatibility in accordance with ISO 10993."

The submission concludes that, "Based on the technological characteristics and overall performance of the devices, EndoChoice, Inc. believes that the water bottle cap system and the predicate device selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness." This statement summarizes the outcome of the performed studies.

Ask a specific question about this device