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The FLUME catheter is intended for bladder drainage via urethral or suprapubic route.

The FLUME catheter is intended for the drainage of urine from the bladder. The FLUME catheter is a sterile indwelling urinary catheter intended for single use. The FLUME catheter is made using polyurethanebased polymers. The catheter has an inflatable retention balloon attached to the catheter shaft. The catheter has a dual lumen tube. The larger lumen is for urine drainage. The smaller lumen is used to inflate and deflate the balloon with sterile water. The distal end has two opposite eye holes, which are used for drainage. The product is available in standard sizes. The catheter may be placed following the institutions' standard practice for either urethral bladder drainage or via percutaneous suprapubic access to the bladder.

This document is a 510(k) summary for the FLUME catheter, which seeks to expand its indications for use to include suprapubic drainage. This is a special 510(k) submission, meaning it relies heavily on the predicate device (FLUME catheter K212151) as the current device has no changes in design, materials, or manufacturing processes.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against specific criteria for the expanded indication of suprapubic use. Instead, it relies on the predicate device's established performance and extensive non-clinical testing.

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

The document does not describe a new "test set" in the traditional sense of a clinical or ex-vivo study with a defined sample size for the expanded indication.

• Sample Size: Not applicable/not provided for a specific test set related to the suprapubic indication as it's a Special 510(k) leveraging prior data.
• Data Provenance: The biocompatibility data is "leveraged from the predicate device." This suggests the data was generated previously for the predicate device, but its original provenance (e.g., country, retrospective/prospective) is not detailed in this summary.

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

Not applicable. This is not a study involving expert-established ground truth for a test set. The submission relies on non-clinical data and risk assessment.

4. Adjudication Method for the Test Set

Not applicable. There is no described test set requiring adjudication in this summary.

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

No. The document explicitly states "SUMMARY of NON-CLINICAL TESTING." There is no mention of an MRMC comparative effectiveness study.

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

Not applicable. This device is a physical urological catheter, not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" for the safety aspects (biocompatibility, pyrogenicity) is based on standardized testing protocols (e.g., ISO 10993-1 for biocompatibility, bacterial endotoxin testing for pyrogenicity) and internal risk assessments concluding equivalence. For functional equivalence, the ground truth is the established performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The FLUME catheter is intended for the drainage of the urinary tract.

The FLUME catheter is a sterile indwelling urinary catheter intended for single use. The FLUME catheter is made using polyurethane-based polymers. The catheter has an inflatable retention balloon attached to the catheter has a dual lumen tube. The larger lumen is for draining urine from the urinary tract. The smaller lumen is used to inflate and deflate the balloon with sterile water. The distal end has two opposite eye holes, which are used for drainage. The product is available in size 14 Fr with a smooth shaft.

The provided text is a 510(k) summary for the FLUME catheter, which is a urological catheter. It discusses the device's indications for use, its comparison to a predicate device (Teleflex Rusch All-Silicone Foley Catheter K980870), and the non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria and the study that proves the device meets those criteria for an AI/ML-driven medical device. Specifically, there is no mention of:

• AI/ML performance metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test or training sets for an AI model
• Data provenance for AI/ML data
• Expert ground truth establishment for AI/ML models
• Adjudication methods for AI/ML ground truth
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
• Standalone AI algorithm performance
• Types of ground truth for AI/ML (e.g., pathology, outcomes data)
• How ground truth for a training set was established for an AI model

The FLUME catheter is a physical medical device, and the testing described (Biocompatibility, Sterilization Validation, Transportation simulation/package integrity/shelf-life, and Performance/Functional testing per ASTM F623-19) are standard non-clinical tests for such devices to demonstrate physical and biological safety and performance, not AI/ML algorithm performance.

Therefore, I cannot extract the requested information based on the provided input. The document does not describe a study involving an AI/ML component.

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