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The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder.

The Memcath Urology Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a PVC catheter tube with pre-loaded, self-deploying PTFE sheath membrane to increase lubricity during insertion. This catheter system also includes a polyurethane snap ring and polycarbonate/acrylic guide ring to secure the sheath.

The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder. The device was found substantially equivalent to the Sherwood-Davis & Geck Argyle Rob-Nel Urological Catheter (K810216).

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify the sample sizes used for each test. The studies were conducted by Memcath Technologies LLC and submitted to the FDA in the United States. They appear to be prospective tests performed on newly manufactured devices.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for these tests is based on established engineering and materials performance standards for medical devices and their intended use, rather than expert clinical consensus in interpreting data.

4. Adjudication Method for Test Set

Not applicable. The tests are objective measurements against defined specifications.

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

Not applicable. This device is a physical medical catheter, not an AI/software-as-a-medical-device (SaMD) that typically undergoes MRMC studies.

6. Standalone Performance Study

Yes, standalone performance studies were conducted. The "Testing" section explicitly states that "Products were tested for" a list of attributes, and "All product testing met specifications." This indicates that the device's performance was evaluated independently against pre-defined criteria.

7. Type of Ground Truth Used

The ground truth used for these performance tests is based on engineering specifications and established regulatory standards for urological catheters, often with reference to predicate devices. For example, "Flow Rate," "Stiffness," and "Kink Resistance" have objective, measurable benchmarks that must be met. "SAL" pertains to sterility standards, and "EtO Residuals" to acceptable levels of ethylene oxide post-sterilization.

8. Sample Size for Training Set

Not applicable. This device is a physical medical device, not an AI/machine learning model, so there is no "training set."

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for a physical medical device.

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