Search Results

The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.

The device is an intravascular catheter known by the trade name SUPERCATH 5 (PROPOSED). It is available in four models, with a check valve, with a side-notch needle, with a check valve and a side-notch needle, and without both a check valve and a notched needle. The SUPERCATH 5 (PROPOSED) is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 (PROPOSED) is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The SUPERCATH 5 (PROPOSED) catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely. Pressing the button on the needle hub activates the coiled spring in the hub, retracting the metallic introducer needle into the needle hub. The SUPERCATH 5 (PROPOSED) introducer needle has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the vein, blood flows inside of the catheter and returns down along the inside of the catheter tube. The SUPERCATH 5 (PROPOSED) is available in 14G, 18G, 20G, 20G, 22G and 24G.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Over 500 tests were performed across different test conditions and five different catheter sizes for the SUPERCATH 5 (PREDICATE). It is explicitly stated that these results are considered applicable to the SUPERCATH 5 (PROPOSED) due to the nature of the modifications not affecting the safety feature.
• Data Provenance: The study was a "simulated use clinical environment" test. The document does not specify the country of origin where the actual testing took place, but the manufacturer is Japanese (TOGO MEDIKIT CO., LTD.). It was a prospective study designed to evaluate the safety feature.

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

• Number of Experts: Eight (8) healthcare professional volunteers were recruited for the simulated clinical use study.
• Qualifications of Experts: The volunteers "routinely use this type of catheter in their clinical practice." No further specific qualifications (e.g., years of experience, specific medical specialty) are provided.

4. Adjudication Method for the Test Set

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The evaluation parameter was whether the needle completely retracted. It appears to be a direct observation of a functional outcome rather than an interpretation requiring adjudication between experts. The "no failures" observation suggests a clear binary outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This study is focused on the mechanical safety feature of a medical device (intravascular catheter) and does not involve AI or human readers interpreting data.

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

• No, a standalone (algorithm-only) performance test was not done. This device is a physical medical instrument, not an algorithm, and the test involved human operation in a simulated environment.

7. The Type of Ground Truth Used

• The ground truth used was functional outcome observation. The primary evaluation parameter was a direct and observable physical event: whether the metal introducer needle completely retracted into the plastic needle hub after pressing the safety button.

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this device is a physical medical instrument and not an AI/machine learning algorithm. The study described is a performance validation test for a safety feature.

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

• This information is not applicable, as there is no training set for this type of device.

Ask a specific question about this device