Search Results
Found 1 results
510(k) Data Aggregation
(197 days)
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.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Design and Design Specifications are equivalent to predicate. | "The technological characteristics of the Split Cath® II are identical to the predicate device in terms of design, design specifications..." |
| Performance (Tensile strength, joint strength, leakage, recirculation, flow performance, flexural) is equivalent to predicate. | "In Vitro performance data for the legally cleared Medcomp Ash Split Cath® II, included tensile strength, joint strength, leakage, recirculation, flow performance, and flexural apply to the Split Cath® II since there are no significant material or design changes." |
| Manufacturing process and method of sterilization are equivalent to predicate. | "...manufacturing process and method of sterilization [are identical to the predicate device]." |
| Biocompatibility meets ISO 10993 for permanent contact devices. | "Biocompatibility testing on the Ash Split Cath® II demonstrates the lumen materials meet the requirements of ISO 10993 for a permanent contact device." |
| Peel testing and force @ break performance are acceptable after solvent change. | "Performance data is submitted for peel testing and force @ break only due to a change in solvent from the predicate device (solvent was cleared under K972207)." |
| Chemical testing for ointment is acceptable. | "Chemical testing is submitted for recent ointment testing performed by Medcomp." |
| Clinical outcome for translumbar technique is not detrimental to catheter function. | "Properly inserted catheters via the translumbar technique do not have a detrimental affect on the clinical outcome as to catheter function." |
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."
Ask a specific question about this device
Page 1 of 1