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THE MEDCOMP HEMO-FLOW™ DOUBLE LUMEN CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.

Device Description

The Medcomp Hemo-Flow™ Double Lumen 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 clamps for ease in identification.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medcomp Hemo-Flow™ Double Lumen Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance	Comments
In Vitro Performance	Recirculation (for hemodialysis catheters)	Tested	The submission states "In Vitro performance data... include: Recirculation". No specific numerical acceptance criteria (e.g., maximum recirculation percentage) or corresponding numerical performance values are provided in this summary.
In Vitro Performance	Flow Performance (for hemodialysis catheters)	Tested	The submission states "In Vitro performance data... include: Flow Performance". No specific numerical acceptance criteria (e.g., minimum flow rates at specific pressure drops) or corresponding numerical performance values are provided in this summary.
Substantial Equivalence	Intended Use	Substantially Equivalent	Compared to predicate devices.
Substantial Equivalence	Insertion Method	Substantially Equivalent	Compared to predicate devices.
Substantial Equivalence	Design	Substantially Equivalent	Compared to predicate devices.
Substantial Equivalence	Materials	Substantially Equivalent	Compared to predicate devices.
Substantial Equivalence	Performance	Substantially Equivalent	Compared to predicate devices.
Substantial Equivalence	Labeling	Substantially Equivalent	Compared to predicate devices.
Substantial Equivalence	Manufacturing Process	Substantially Equivalent	Compared to predicate devices.
Substantial Equivalence	Method of Sterilization	Substantially Equivalent	Compared to predicate devices.
New Features Comparison	55cm length	Accepted as modified	This modification, along with femoral insertion instructions, was noted as a change from the predicate and was accepted.
New Features Comparison	Femoral insertion instructions for use	Accepted as modified	This modification, along with the 55cm length, was noted as a change from the predicate and was accepted.

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

Sample Size for Test Set: Not specified. The document only mentions "In Vitro performance data" for Recirculation and Flow Performance. There is no information regarding the number of catheters tested or the conditions of the test.
Data Provenance: Not specified. The testing is in vitro, so it does not involve human subjects or geographic locations. The submission does not indicate if the testing was performed internally by Medcomp or by an external laboratory.

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

Not Applicable. This submission does not involve a clinical study requiring human interpretation or ground truth establishment by experts in the context of diagnostic accuracy. The performance data is based on in vitro (bench) testing.

4. Adjudication Method for the Test Set

Not Applicable. As the performance data is from in vitro testing, there is no adjudication method for a test set in the sense of clinical interpretation or expert consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. The document explicitly states: "Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices." Therefore, no MRMC study was conducted, and no effect size for human readers with/without AI assistance is provided.

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

Not Applicable. This device is a physical medical device (catheter), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The type of ground truth used

In Vitro Measurement Standards. For the recirculation and flow performance testing, the "ground truth" would be the direct measurement of relevant physical parameters (e.g., flow rates, pressure differentials, concentration changes to assess recirculation) against pre-defined engineering or performance standards for hemodialysis catheters. These standards are not explicitly detailed in the provided summary but would typically be established based on industry best practices and regulatory guidance for blood access devices.

8. The sample size for the training set

Not Applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant.

Summary of Device Acceptance:

The Medcomp Hemo-Flow™ Double Lumen Catheter was accepted based on its substantial equivalence to existing predicate devices (K994105 and K012562). The manufacturer demonstrated this equivalence through design, materials, manufacturing process, and intended use comparison.

The primary performance data provided was in vitro testing for "Recirculation" and "Flow Performance." The submission asserted that because the design and materials remained largely unchanged from the predicates (except for a 55cm length and femoral insertion instructions), no further clinical studies were necessary. The FDA's 510(k) clearance indicates that these in vitro tests and the comparison to predicates were deemed sufficient to demonstrate the device's safety and effectiveness for its stated intended use. Specific acceptance values for recirculation and flow performance are not detailed in this summary.

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