Search Results
Found 1 results
510(k) Data Aggregation
(115 days)
The Medcomp Ash Split-Cath XL is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously vand is ideally placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are intended for femoral vein insertion.
The Medcomp Ash Split-Cath-XL 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. A polyurethane sleeve is positioned between the hub to cuff location. 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.
The provided text describes a 510(k) premarket notification for a medical device, the Medcomp Ash Split-Cath-XL hemodialysis catheter. This submission focuses on comparing the proposed device to a predicate device and outlining performance data. The document does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, comprehensive study designs, expert involvement, or AI-related metrics.
Here's an attempt to answer your questions based on the available information, with clear indications of where the information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Material & Design Equivalence: Identical in design and materials to predicate device. | "The proposed device is a product line extension to the legally marketed device, and is identical in design and materials." |
| Functionality (Flow vs. Pressure): Adequate flow characteristics under pressure relevant to hemodialysis. | "In Vitro performance data for the proposed device includes: • Flow vs. Pressure." (No specific quantitative performance values or acceptance criteria are provided in the document.) |
| Safety (Implicit from predicate): Implied to meet safety standards of predicate device regarding force at break, leakage, recirculation, mechanical hemolysis, chemical resistance, packaging, sterilization, and biocompatibility. | "Since the design and materials remain unchanged the following testing or documentation is not deemed necessary and is not included in this submission: • Force at break • Leakage • Recirculation • Mechanical hemolysis • Chemical resistance • Packaging data • Sterilization data • Biocompatibility data." |
| Intended Use: Suitable for long-term vascular access for hemodialysis and apheresis, with specific indication for femoral vein insertion for catheters > 40cm. | The device's intended use matches the stated indications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "In Vitro performance data" for "Flow vs. Pressure."
- Data Provenance: The study appears to be in vitro testing. Country of origin and whether it's retrospective or prospective are not mentioned, but given it's a 510(k) for a medical device in the US, the testing would typically be expected to meet US regulatory standards.
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. This device is a physical hemodialysis catheter, and the performance data described (
Flow vs. Pressure) does not involve human expert interpretation for "ground truth." The evaluation seems to be based on engineering and physical performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. The testing is in vitro and does not involve adjudication by experts as would be required for image interpretation or clinical outcomes where subjectivity might be a factor.
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
- No. This document describes a physical medical device (hemodialysis catheter), not an AI diagnostic or assistive tool. Therefore, an MRMC study and AI-related metrics are irrelevant and not included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the in vitro testing is based on physical measurements (e.g., flow rates, pressure differentials) under controlled experimental conditions. It's not a ground truth derived from expert consensus, pathology, or clinical outcomes data in the usual sense for diagnostic algorithms.
8. The sample size for the training set
- Not Applicable. This is a physical medical device. There is no concept of a "training set" as would be used for machine learning. The device's design is based on previous validated designs (predicate devices) and engineering principles.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for a machine learning model, this question does not apply.
Ask a specific question about this device
Page 1 of 1