Search Results

The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheters are indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required. Catheters greater than 40cm in length are intended for femoral vein insertion.

The NovoFlo™ Catheter LT Dual Lumen Long Term Hemodialysis Catheter is manufactured from soft radiopaque polyurethane material which provides increased patient comfort while providing excellent biocompatibility. The Hemodialysis Catheter can be connected to an extracorporeal tubing system via a connecting tube equipped with a Luer-Lock connector. The proximal lumen (red clamp) provides "arterial" blood outflow from the patient, the distal lumen (blue clamp) provides "venous" blood return to the patient. Important information such as priming volume and catheter length is printed on both sides of the clamp. The catheter comes in a variety of sizes and lengths with straight or curved extensions.

The provided text describes a medical device called the "NovoFlo Catheter LT Dual Lumen Long Term Hemodialysis Catheter" and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance metrics, or a study that uses statistical analysis with human readers or standalone algorithm performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data as might be found in a PMA (Premarket Approval) submission or detailed clinical trial reports.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance thresholds (e.g., sensitivity, specificity, accuracy). The acceptance criteria were based on demonstrating substantial equivalence to the predicate device in terms of design, materials, performance, biocompatibility, safety, and product effectiveness.
• Reported Device Performance: No specific quantitative performance metrics (e.g., flow rates, complication rates, longevity) are reported for the NovoFlo™ Catheter itself. The document states there are "no major differences in design, materials, performance, biocompatibility, safety and product effectiveness" compared to the predicate device.

2. Sample size used for the test set and the data provenance:

• Not applicable. This device is not an AI/diagnostic device that uses a "test set" of patient data in the computational sense. The "tests" mentioned are engineering studies and biocompatibility tests. No human patient data test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No "ground truth" establishment by experts on a test set is described.

4. Adjudication method for the test set:

• Not applicable. No test set adjudication is described.

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:

• Not applicable. This is not an AI device, and no MRMC study is mentioned.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable in the context of diagnostic/AI performance studies. The "ground truth" for the device's substantial equivalence likely refers to established industry standards (ISO, FDA guidances) and the performance characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

9. How the ground truth for the training set was established:

• Not applicable.

Summary based on provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable. The provided document details a 510(k) submission for a physical medical device, not a diagnostic algorithm. The "tests" were engineering studies and biocompatibility evaluations, not clinical studies with patient data test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No "ground truth" involving expert consensus on patient data is mentioned.

4. Adjudication method for the test set:

• Not applicable.

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:

• Not applicable. This is not an AI device, and no MRMC study was performed.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used:

• For the purpose of the 510(k) submission, the "ground truth" was the established characteristics and performance of the legally marketed predicate device (Medcomp Hemo-Flow Catheter), as well as adherence to recognized industry standards (ISO 10555, ISO 10993) and FDA guidance documents.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

9. How the ground truth for the training set was established:

• Not applicable.

Ask a specific question about this device