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510(k) Data Aggregation
(103 days)
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
The MAHURKAR™ Triple Lumen Catheter is intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
The MAHURKAR™ Triple Lumen Dialysis Catheter is a 12 Fr radiopaque polyurethane catheter with two large lumens (arterial and venous) and one smaller medial lumen running longitudinally along the length of the catheter shaft. The two large lumens either have curved or straight extensions and the smaller medial lumen have a straight extension. At the distal end of the catheter there is a tapered green, soft radiopaque catheter tip. Each lumen terminates at a separate location along the catheter shaft, designated as the arterial, venous, or medial outlets. The catheter is available in four implantable lengths (13 cm, 16 cm, and 24 cm) with two clear silicone catheters extensions and three internal lumina distinguished by color coded adapters
The provided text describes a 510(k) summary for the MAHURKAR™ Triple Lumen Dialysis Catheter, focusing on its substantial equivalence to predicate devices and performance testing. However, it does not contain information typically associated with acceptance criteria and study details for an AI/ML powered device, specifically due to the device being a physical medical product (catheter) rather than a software-as-a-medical-device (SaMD).
Therefore, a significant portion of your requested information (sample size for test/training, number of experts, adjudication, MRMC, standalone performance, ground truth types) is not applicable to this physical device submission.
Here's a breakdown of what can be extracted and what cannot:
Acceptance Criteria and Device Performance
The submission focuses on demonstrating substantial equivalence to predicate devices through performance data related to physical and functional aspects of the catheter. The "acceptance criteria" are implied by the successful testing showing equivalence and mechanical integrity.
| Acceptance Criterion (Implied) | Reported Device Performance | Comments |
|---|---|---|
| Catheter mechanical integrity maintained after power injections | "Tensile testing and leak and burst testing to ensure catheter mechanical integrity was not diminished after power injections." | Testing was performed to ensure the catheter's physical structure remains intact after high-pressure injections, a key safety and functionality aspect. The implication is that the device met these standards. |
| Accurate Central Venous Pressure (CVP) Monitoring | "Central Venous Pressure testing was conducted to verify that the catheter was capable of being used for accurate pressure monitoring as compared to the predicate device." | This confirms the device's ability to fulfill its CVP monitoring function. The implication is that the device performs accurately for CVP monitoring. |
| Substantial Equivalence to Predicate Devices | "Results of the verification / validation testing demonstrate that the modified device is substantially equivalent to the legally marketed predicate devices." | The overall acceptance criterion is to prove substantial equivalence to existing, legally marketed devices (K020089 and K083675) for the expanded indications. The reported performance confirms this. |
| Adherence to maximum recommended infusion rate for power injection | Maximum recommended infusion rate is 5 mL/sec for power injection of contrast media. | This is an intended use specification, and the prior testing (mechanical integrity) supports the catheter's ability to safely handle this rate. |
Study Details for a Physical Medical Device (Catheter)
The following details are not relevant or available for this physical device as they typically apply to AI/ML software evaluations.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical catheters subjected to various engineering tests (tensile, leak, burst, CVP). Data provenance would be from materials testing and physical experiments, not country of origin of data in a clinical sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical catheter's mechanical integrity is established by engineering standards and measurement equipment, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This method is used for resolving discrepancies in expert labeling or diagnoses, not for physical product testing.
- 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 is for AI-assisted diagnostic tools, not a physical medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is based on engineering specifications, physical measurements from testing (e.g., pressure readings, force measurements during tensile tests, observation of leaks/bursts), and comparison to the established performance of predicate devices.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what is present:
The study described is a series of engineering verification and validation tests aimed at demonstrating the MAHURKAR™ Triple Lumen Dialysis Catheter's performance characteristics (mechanical integrity, pressure monitoring capability) and its substantial equivalence to predicate devices (Mahurkar™ Triple Lumen Dialysis Catheter K020089 and Bard Power-Trialysis Triple Lumen Dialysis Catheter K083675). The data provenance is from laboratory testing of the physical device. The "ground truth" for this context is the adherence to engineering standards and comparison against the known performance of the predicate devices.
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