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THE MEDCOMP SPLIT CATH® II CATHETER IS INDICATED FOR USE IN ATTAINING LONG TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS IN THE ADULT PATIENT. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AND INFERIOR VENA CAVA AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN OR INFERIOR VENA CAVA INSERTION. TRANSLUMBAR INSERTION VIA INFERIOR VENA CAVA IS INDICATED WHEN ALL OTHER ACCESS SITES ARE IDENTIFIED AS NON-VIABLE.

The Medcomp 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 three side holes on each tip. 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 is a 510(k) summary for the Medcomp Split Cath® II Hemodialysis Catheter. This document describes the device, its intended use, and its comparison to a predicate device for regulatory clearance. It is not a study that provides detailed performance data, acceptance criteria, or an analysis of how the device meets those criteria.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, training set details) cannot be extracted from this document, as this type of information is typically found in detailed scientific studies, not regulatory summaries focused on substantial equivalence.

However, I can extract information regarding the type of performance data submitted and how the ground truth was "established" in the context of this regulatory submission.

1. A table of acceptance criteria and the reported device performance

This document does not specify formal acceptance criteria with numerical targets. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance data presented are qualitative statements about the device's similarity to the predicate and the types of tests performed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any "test set" in the traditional sense. The document refers to "in vitro performance data" and "numerous published clinical papers."
• Data Provenance:
  • In Vitro Data: Likely conducted by the manufacturer, Medcomp, or their contracted labs. No country of origin is specified.
  • Clinical Data: Based on "numerous published clinical papers." These are likely retrospective reviews of existing literature. No specific country of origin is mentioned, but such papers would typically originate from various medical institutions globally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document relies on in vitro laboratory tests and published clinical literature. There is no mention of a "test set" for which experts established ground truth in the context of this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no "test set" and expert adjudication in the manner 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 device is a medical 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 device is a medical catheter, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this regulatory submission is established through:

• Comparison to the predicate device: The fundamental "ground truth" for 510(k) clearance is that the device is "substantially equivalent" to a legally marketed predicate device. This implies that the predicate's established safety and effectiveness serve as the benchmark.
• Established laboratory testing standards: For in vitro performance, the ground truth is against standard material and device performance tests (tensile strength, leakage, flow, biocompatibility per ISO 10993).
• Published clinical literature/outcomes data: For the translumbar indication, the ground truth leans on "numerous published clinical papers" which "stress that this technique is for a very small patient population as an absolute last resort when all other traditional access sites have been exhausted" and that "Properly inserted catheters via the translumbar technique do not have a detrimental affect on the clinical outcome as to catheter function." This refers to established clinical practice and observed patient outcomes from the medical community.

8. The sample size for the training set

Not applicable. There is no "training set" for this type of device.

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

Not applicable. There is no "training set."

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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.

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The Medcomp Ash Split-Cath 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 Ash Split-Cath 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 six 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 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. The clamps incorporate I.D. Rings which indicate priming volume and site care information.

Acceptance Criteria and Device Performance for Medcomp Ash Split-Cath Hemodialysis Catheter

This document describes the acceptance criteria and performance data for the Medcomp Ash Split-Cath Hemodialysis Catheter, as presented in the K013162 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for each test. Instead, it indicates that the in-vitro performance data was "sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device." This implies that the observed performance in these tests met the established engineering specifications and benchmarks set by the predicate device (K972207 Medcomp Ash Split-Cath).

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified. The document states "In Vitro performance data," which typically involves testing a defined number of units, but the exact sample size for each test is not provided.
• Data Provenance: The data is from in-vitro testing (bench testing) conducted by Medcomp®. No information is provided regarding the country of origin or whether it was retrospective or prospective, as it's not clinical data.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This submission focuses on in-vitro performance data for a medical device and does not involve human expert interpretation of data or images for ground truth establishment. Clinical data was explicitly "not deemed necessary."

4. Adjudication Method for the Test Set

• Not applicable. As the study involves in-vitro bench testing, there is no adjudication method in the context described (e.g., for expert disagreement on clinical cases). The results of the physical tests are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The submission states, "Clinical data was not deemed necessary since in-vitro testing was sufficient To demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device." Therefore, there is no information on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. This submission concerns a physical medical device (catheter), not an AI algorithm.

7. Type of Ground Truth Used

• Engineering Specifications / Predicate Device Performance: The "ground truth" for the in-vitro tests is implicitly established by the engineering specifications for the device and, more importantly, by the performance of the legally marketed predicate device (K972207 Medcomp Ash Split-Cath) that the modified device is compared against for substantial equivalence.

8. Sample Size for the Training Set

• Not applicable. This submission does not involve machine learning or AI, and therefore, there is no "training set."

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, this question is not relevant.

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