Search Results

The 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 endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.

Water Bottle Cap System

The provided documents do not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. The documents are a 510(k) clearance letter from the FDA for a "Water Bottle Cap System" and its Indications for Use.

The letter states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the FDA found that the new device is as safe and effective as a device already on the market, but it does not detail specific performance studies with acceptance criteria.

The information provided covers:

• Device Name: Water Bottle Cap System
• Regulation Number: 21 CFR 8876.1500 (Endoscope and Accessories)
• Regulatory Class: II
• Product Code: FEO
• Indications for Use: "The 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 endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles."

None of the requested information regarding specific acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a performance study is present in these documents. The 510(k) summary (which is not provided here but would typically accompany such a clearance) would contain more detailed information about the basis for substantial equivalence, including any performance data submitted.

Ask a specific question about this device