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The ERBEFLO® 2 Disposable Tubing System is intended to provide sterile water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.

The ERBEFLO® 2 Disposable Tubing System products are manufactured with medical grade materials or agents used in the medical device industry such as plastics, brass, adhesive, etc. The devices consist of tubing sets, port connectors, channel adapter, and back flow valve to deliver sterile water source through designated pumps and to/or through a scope channel of various endoscopes for irrigation in endoscopy procedures. Clinicians connect the associated products to a water source (i.e., a sterile water bottle) and then to a designated pump and endoscope. The ERBEFLO® 2 Disposable Tubing System are provided sterile and are disposable.

The ERBEFLO® 2 Disposable Tubing System, as described in K190469, is intended to provide a sterile water source through an irrigation pump and an endoscope for endoscopic procedures. The information provided outlines several evaluation and testing types that address different aspects of the device's performance, safety, and efficacy. However, it does not present a formal table of acceptance criteria with corresponding reported performance for each criterion. It rather lists the types of tests performed and general conclusions about meeting performance specifications or demonstrating adequacy.

Here's an attempt to structure the information based on the provided text, while acknowledging that a direct "acceptance criteria" table is not explicitly given:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for any of the described tests (e.g., number of tubing systems, connectors, or test cycles). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The tests described are primarily engineering and performance evaluations, not diagnostic accuracy studies involving expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (functional, mechanical, sterility), an adjudication method in the context of expert consensus is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on the safety and efficacy of the device itself through various engineering and sterilization tests, not on its impact on human readers' performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the ERBEFLO® 2 Disposable Tubing System is a physical medical device (tubing system), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is based on:

• Established performance specifications (for visual inspection, flow, pressure, tensile strength, durability, connections).
• Recognized standards (for biocompatibility, sterilization, packaging, ethylene oxide residuals).
• Demonstrated functional properties (sufficient back flow protection, 24-hour multi-patient use, usability according to instructions).

8. The Sample Size for the Training Set

This information is not applicable as the product is a medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this device.

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