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This intrauterine pressure monitoring catheter (IUPC) is for use on patients requiring intrapartum intrauterine pressure monitoring. Additionally it may be used for amniofusion and of Amniotic fluid sampling

This disposable device is a catheter with a pressure transducer located at the distal tip to monitor the intrauterine pressure. The sensor/transducer is a thick film/ceramic strain gage connected via 4 leads to a connector in proximal end. This end connector interfaces with a reusable cable designed for the proper connection to the monitor in use. The IUPC has a separate fluid infusion and sampling lumen with three holes near the distal end that terminates at the proximal end with a luer fitting/cap. Incorporated in the connector housing at the proximal end is a switch for electronic zeroing of the transducer. This switch can also be used for periodic rezeroing of the system during use without the need for removal and replacement of the catheter. The distal end of the catheter holding the sensor is rounded and blunt while the catheter is soft, flexible polyurethane. The introducer, is designed to ease the insertion of the flexible catheter and is of a split sheath design for easy removal from the catheter after insertion. A Velcro attachment devise is supplied to attach the catheter firmly in place on the patients thigh to prevent inadvertent slippage or dislodgment during use.

The provided 510(k) submission for the "Easy Trans Tip" Intrauterine Pressure Transducer Catheter (IUPC) does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The document is a summary of safety and effectiveness, focused on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a specific study.

Therefore, I cannot populate the requested tables and sections. The submission primarily addresses:

1. Device Information: Trade name, common name, classification, and product description.
2. Equivalent Devices: Lists predicate devices with 510(k) numbers.
3. Intended Use: Specifies the medical applications of the device.
4. Comparison to Predicate Devices: Asserts substantial equivalence based on intended use, materials, dimensions, and mechanical properties.

To answer your request, the following information is not present in the provided text:

• Acceptance Criteria Table: No specific performance thresholds are mentioned.
• Reported Device Performance: No test results or performance metrics are provided.
• Sample Size for Test Set: No testing of the device performance is described.
• Data Provenance: Not applicable as no test data is presented.
• Number of Experts/Qualifications for Ground Truth: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No such study is mentioned or referenced.
• Standalone Performance Study: No specific performance study (beyond the claim of substantial equivalence) is documented.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set & How Ground Truth Established for Training Set: Not applicable, as this is related to studies validating specific performance metrics which are not present in this submission.

This 510(k) is a substantial equivalence submission, which means the manufacturer is asserting that their device is as safe and effective as existing legally marketed devices, primarily based on design and intended use similarities, rather than presenting a performance study with detailed acceptance criteria and results.

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