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510(k) Data Aggregation
(395 days)
The Medcomp Split Cath® Rg 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 femoral vein.
The Split Cath® Rg Long Term Catheter provides two dedicated (arterial/venous) access lumens. Each lumen is connected through an extension line with female luer connectors. The transition between lumen and extension is housed within a molded hub. To prevent recirculation, the venous end of the lumen is approximately 1.0" longer than the arterial. The catheter is capable of providing consistent flows up to 400ml/min.
The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material that is rigid upon insertion and once it reaches body temperature becomes soft to reduce vessel trauma.
The dialysis extensions are color coded with a white luer, red sleeve, and red clamp for the arterial lumen. The easy identification of the venous lumen, there is a white luer, blue sleeve, and blue clamp.
The proposed device is 14 French in size and comes in the following lumen lengths: 24.28. 32, 36, and 40cm. The catheter is packaged in separate components as they are assembled during retrograde insertion. After the lumen is inserted, it is attached to the Attachable Hub and Extension Assembly using the Lumen Clamp.
The document provided is a 510(k) premarket notification for a medical device called the MEDCOMP® Split Cath® Rg. It describes the device, its intended use, comparison to predicate devices, and performance testing. However, it does not contain the detailed acceptance criteria or the study results in the format requested, specifically for an AI/CAD/ML device.
This document is for a blood access catheter, which is a physical medical device, not an AI/CAD/ML software or system. Therefore, the specific questions regarding AI/CAD/ML device performance (sample size for test/training sets, experts for ground truth, MRMC comparative effectiveness, standalone performance, etc.) are not applicable to this submission.
Despite the non-applicability of some questions, I will extract the relevant information regarding performance criteria and testing as presented in the document for the physical device.
Acceptance Criteria and Device Performance (for a physical medical device, not AI/CAD/ML)
The document primarily focuses on demonstrating substantial equivalence to predicate devices for a physical blood access catheter. The "Performance Standards" section explicitly states: "Performance standards have not been established by the FDA under section 514 of the Federal Food, Drug and Cosmetic Act."
Instead of acceptance criteria for diagnostic performance (like sensitivity/specificity), the document details non-clinical bench testing to ensure the safety and effectiveness of the physical device, especially considering a change in insertion method (retrograde vs. antegrade) and the presence of a new stainless steel cannula.
Here's a summary of the reported information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test (Nonclinical) | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets requirements of ISO 10993 | "Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993." |
| 0 Air Leakage | No Air Leakage | Not explicitly detailed, but implied to meet expectations as part of successful performance bench testing. |
| _ Liquid Leakage | No Liquid Leakage | Not explicitly detailed, but implied to meet expectations as part of successful performance bench testing. |
| _ Force at Break | Meets force requirements | Not explicitly detailed, but implied to meet expectations as part of successful performance bench testing. |
| _ Recirculation | Meets recirculation limits | Not explicitly detailed, but implied to meet expectations as part of successful performance bench testing. |
| _ Flow vs. Pressure | Achieves consistent flows up to 400ml/min | "The catheter is capable of providing consistent flows up to 400ml/min." (This is a design specification, not a test result, but implies the test would confirm it). |
| _ Priming Volume | Meets specified priming volume | Not explicitly detailed, but implied to meet expectations as part of successful performance bench testing. |
| Mechanical Hemolysis | Acceptable hemolysis levels (due to change in blood flow path) | "mechanical hemolysis testing was performed on the proposed device... Furthermore, the proposed device was evaluated for MRI safety..." (No specific numeric result given, but the submission implies acceptable results for substantial equivalence). |
| MRI Safety | Safe for MRI (due to stainless steel cannula) | "the proposed device was evaluated for MRI safety due to the presence of the stainless steel cannula." (No specific result given, but the submission implies acceptable results for substantial equivalence). |
| Hub Assembly Integrity | Sure fit of cannula to lumen, followed by compression ring and hub clamps | "The sure fit of this cannula to lumen, followed by application of the compression ring and hub clamps, is essential to device integrity following the insertion and assembly procedure." (This is a design objective, and successful testing is implied for substantial equivalence). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The testing described is non-clinical bench testing.
- Data Provenance: N/A for this type of physical device testing. The tests are bench tests performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable (N/A). This is a submission for a physical medical device. "Ground truth" in the context of expert consensus for AI/CAD/ML algorithms is not relevant here. The "ground truth" for these tests are objective measurements (e.g., leakage, force, flow rates, ISO standards adherence).
4. Adjudication method for the test set
- Not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for expert consensus on AI/CAD/ML ground truth, not for physical device bench testing.
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 (N/A). This is for a physical medical device, not an AI/CAD/ML system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable (N/A). This is for a physical medical device, not an AI/CAD/ML system.
7. The type of ground truth used
- Not applicable (N/A). For this physical device, "ground truth" is established by objective engineering and material science standards, measurements, and adherence to performance specifications (e.g., ISO standards for biocompatibility, measured flow rates, leakage tests).
8. The sample size for the training set
- Not applicable (N/A). This is a physical medical device. There is no "training set."
9. How the ground truth for the training set was established
- Not applicable (N/A). This is a physical medical device. There is no "training set" or "ground truth" in the AI/CAD/ML sense.
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