Search Results

THE MEDCOMP ASH SPLIT-CATH II IS 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. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40cm ARE INTENDED FOR FEMORAL VEIN INSERTION.

The Medcomp Ash Split-Cath II is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, with eight side holes. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement. The arterial and venous lumens are designed to be split, or peeled apart, prior to insertion to provide two free-floating lumens within the vessel. The side holes are orientated to allow 360-degree arterial uptake and venous return. The lumens are connected to the extensions via a soft pliable hub with suture wing. Red and blue luer connectors and clamps identify the arterial and venous extensions. Priming volume information is printed an identification ring housed within the extension line clamp.

The provided text describes a 510(k) premarket notification for the Medcomp Ash Split-Cath II Hemodialysis Catheter. This is a medical device, not an AI/ML-driven solution or a diagnostic tool that would typically involve acceptance criteria based on metrics like sensitivity, specificity, or reader performance. Therefore, many of the requested points are not applicable.

The "acceptance criteria" for this type of medical device submission are typically met by demonstrating substantial equivalence to a previously legally marketed predicate device. This is achieved through performance data showing that the new device is as safe and effective as the predicate.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not applicable in the context of this 510(k) submission. The "test set" primarily refers to in vitro performance data of the device itself, comparing its physical and functional properties to the predicate. There is no mention of a "test set" in the sense of clinical data or patient data. The provenance of the in vitro test data is not specified (e.g., country of origin), but it would have been generated in a lab setting. It is not retrospective or prospective patient data.

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

Not applicable. Ground truth for a physical device's performance (e.g., tensile strength, flow rate) is established through standardized engineering and laboratory testing protocols, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical assessments or image interpretations involving human readers. The performance data here is based on objective laboratory measurements.

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 device is a catheter, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance relies on objective physical and mechanical testing standards (e.g., tensile strength, flow rate measurements as per ISO 10993 for biocompatibility) compared to the performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML model that requires training data.

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

Not applicable. This is not an AI/ML model.

Ask a specific question about this device

The Medcomp Safety Slide Clamp is intended to provide a secondary extension tube clamp on the Medicomp Ash Split-Cath, Duo-Flow 400XL and Duo-Split Catheters to prevent leakage during connection or disconnection of the bloodlines.

Medcomp selected a standard "off the shelf" slide clamp designed to pinch or occlude a variety of medical tubing. This slide clamp is widely used throughout the medical device industry to prevent air or fluid communication.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp Safety Slide Clamp:

Unfortunately, the provided text does not contain a detailed table of acceptance criteria or specific performance data with numerical metrics. It focuses more on the problem the device addresses (faulty original clamps) and the fact that a "simulated use testing" was performed, which is referred to as "Performance Data (Simulated Use Testing V-1026)". There are no explicit performance metrics, target values, or reported device performance against those targets.

However, based on the information provided, we can infer some aspects:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document mentions "52-week simulated use testing." While the specific number of devices or tests performed is not explicitly stated as a sample size, the duration (52 weeks) indicates a prolonged test. It also refers to "performance data (Simulated Use Testing V-1026)", which implies a specific test protocol.
• Data Provenance: The study was conducted by Medcomp ("Medcomp confirmed the complaints and determined the root cause... Medcomp has determined that to prevent possible leakage..."). It is a retrospective analysis in the sense that the need for the device arose from existing complaints. The testing itself (simulated use) would be considered prospective for the new clamp design. The country of origin for the data is not explicitly stated, but Medcomp is a US-based company (Harleysville, PA).

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

• The document does not mention the use of external experts to establish ground truth for the simulated use testing. The "ground truth" for the effectiveness of the clamp seems to be based on the direct observation during the simulated use testing and the conclusion of Medcomp's internal assessment that the clamp prevented the target failure mode.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method involving multiple reviewers for establishing ground truth within the simulated use testing. The evaluation appears to be a direct assessment of the clamp's function during the simulated use.

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

• No, an MRMC comparative effectiveness study was not conducted or mentioned. This approval is for a device modification (a clamp), and the "study" described is a simulated use test, not a comparative human reader study. Therefore, there's no discussion of human reader improvement with or without AI assistance.

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

• This question is not applicable as the device is a physical medical device (a clamp), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

• The ground truth for the simulated use testing was direct observation of physical performance and absence of failure modes (e.g., no leakage, no damage to the extension tube). It is performance-based ground truth derived from a physical test.

8. The Sample Size for the Training Set

• This question is not applicable as the device is a physical medical device (a clamp), not an AI algorithm. There is no concept of a "training set" in this context.

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

• This question is not applicable as the device is a physical medical device and does not involve a training set.

Ask a specific question about this device

The Medcomp Ash Split-Cath™ Double Lumen Catheter is designed for chronic hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the jugular vein. Although this catheter may be inserted into the subclavian vein, the internal jugular is the preferred site.

Medcomp Ash Split-Cath 28cm & 32cm Double Lumen Catheter

The provided text describes a 510(k) premarket notification for the Medcomp Ash Split-Cath 28cm & 32cm, a double lumen catheter designed for chronic hemodialysis and apheresis. This document is a letter from the FDA to Medcomp, indicating that the device has been deemed "substantially equivalent" to devices marketed prior to May 28, 1976.

This document is a regulatory letter approving a medical device based on substantial equivalence, not a study describing acceptance criteria and device performance data.

Therefore, I cannot extract the requested information as the document does not contain:

1. A table of acceptance criteria and reported device performance: This document is an approval letter, not a performance report.
2. Sample size used for the test set and data provenance: No study data is provided.
3. Number of experts and their qualifications for ground truth: No study data is provided.
4. Adjudication method for the test set: No study data is provided.
5. MRMC comparative effectiveness study details or effect size: No study data is provided, and this type of study is typically for AI/software, not a physical medical device like a catheter.
6. Standalone (algorithm only) performance: Not applicable to a physical medical device.
7. Type of ground truth used: No study data is provided.
8. Sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm.
9. How ground truth for the training set was established: Not applicable.

The letter explicitly states that the device is "substantially equivalent" to predicate devices, meaning its safety and effectiveness are considered comparable to devices already on the market, rather than being evaluated through a new clinical performance study with specific acceptance criteria detailed in this document. Any performance details would have been submitted as part of the 510(k) application, but are not included in this FDA response letter.

Ask a specific question about this device