Search Results

The Medcomp Hemo-Flow Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site is the subclavian vein as required.

The Medcomp Hemo-Flow Catheter is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, open at the distal tip, with two side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement.

The lumens are connected to the extensions via a soft pliable hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the extensions for ease in identification.

The provided text describes the Medcomp Hemo-Flow Catheter and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria or a study design for a specific performance metric with quantitative results. Instead, it generally states that in vitro performance data "demonstrates that this device is substantially equivalent to legally marketed devices."

Given the information provided, I can infer the acceptance criteria are implicitly defined by the performance of the predicate device and relevant industry standards. The "study" described is a comparison demonstrating substantial equivalence through in vitro testing and biocompatibility assessments.

Here's an attempt to structure the information based on your request, with significant limitations due to the level of detail in the original document:

Acceptance Criteria and Performance Data for Medcomp Hemo-Flow Catheter

The Medcomp Hemo-Flow Catheter's acceptance criteria are implicitly based on demonstrating substantial equivalence to its predicate device, the Medcomp Ash Split-Cath (K972207), and compliance with relevant standards for hemodialysis catheters.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical thresholds or target values for these metrics. The acceptance is based on demonstrating "substantial equivalence" to legally marketed devices and compliance with ISO 10993.

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

The document states "In Vitro performance data," indicating laboratory testing.

• Sample Size: Not specified.
• Data Provenance: In vitro testing, likely conducted in a laboratory setting. No country of origin is specified for the data, nor whether it was retrospective or prospective (as it's in vitro, these terms aren't directly applicable in the same way as clinical data).

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

N/A. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis). The performance data mentioned for the Medcomp Hemo-Flow Catheter is in vitro (tensile strength, leakage, recirculation, flow performance), which relies on standardized testing methods rather than expert consensus on ground truth in the same way clinical studies would.

4. Adjudication Method (for the test set)

N/A. As the performance data is from in vitro testing of mechanical and hemodynamic properties, an adjudication method for establishing ground truth (like 2+1 or 3+1 for expert review) is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on in vitro performance and biocompatibility to demonstrate substantial equivalence, not on human reader performance with or without AI assistance.

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

N/A. This question is relevant for AI/algorithm-based devices. The Medcomp Hemo-Flow Catheter is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

For the in vitro performance data (tensile strength, joint strength, leakage, recirculation, and flow performance), the "ground truth" would be established by:

• Standardized measurement protocols: Following established test methods and specifications for each performance characteristic.
• Predicate device performance: Comparing the results against the known performance characteristics of the legally marketed predicate device (Medcomp Ash Split-Cath) to establish substantial equivalence.
  For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993 standards.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" is relevant for machine learning or AI models. This device is a physical catheter, and thus, a training set for an algorithm is not applicable.

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

N/A. See point 8.

Ask a specific question about this device