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The Mahurkar(TM) Acute Single Lumen Catheters provides temporary access for acute hemodialysis. The flexible tubing permits percutaneous insertion into subclavian, jugular, and femoral veins.

The Mahurkar(TM) Acute Dual Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion.

The Mahurkar(TM) Acute Triple Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion.

The Mahurkar(TM) Acute High Pressure Triple Lumen Catheters are intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

The Mahurkar™ Acute Single Lumen Catheter is a radiopaque, polyurethane tube that features a single-lumen design on the proximal end. A rotatable suture wing, for securing the catheter to the patient, is attached to the hub and five outflow holes are arranged in a spiral near the tapered tip. The single lumen catheter is available in 8.0 Fr outer diameter and in implant lengths 15 cm and 19.5 cm. An optional, disposable Y-adapter can be used to convert the single extension to a dual.

The Mahurkan™ Acute Dual Lumen Catheter is a radiopaque, polyurethane tube that features a two-lumen design on the proximal end. The color-coded adapters on each lumen indicate arterial and venous flow. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected, by a hub, to a dual lumen shaft that is available in pre-curved and straight configurations. The shaft extends to side slots near the distal tip. The dual lumen catheter is available in 8.0 Fr. 10.0 Fr. 11.5 Fr. or 13.5 Fr outer diameters and a variety of implant lengths ranging from 9 cm to 24 cm. It is offered as a single device or as convenience kits.

The Mahurkar™ Acute Triple Lumen Catheter and the Mahurkar™M Acute High Pressure Triple Lumen Catheter are radiopaque, polyurethane tubes that features a three-lumen design on the proximal end. The color-coded adapters on each lumen indicate arterial flow, venous flow, and medial infusion. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected, by a hub, to a triple lumen shaft that extends to side slots near the distal tip. The triple lumen catheter is available in 12 Fr outer diameter and a variety of implant lengths ranging from 13 cm to 24 cm. They are offered as a single device or as convenience kits.

The FDA 510(k) summary for the Mahurkar™ Acute Single, Dual and Triple Lumen Catheters does not describe acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial for diagnostic performance.

This submission is for modifications to an already cleared device, primarily regarding changes to priming volumes on labels and instructions for use, and an update to static flow rate tables for the triple lumen catheter to align with ISO 10555-1. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that these changes do not negatively impact the device's substantial equivalence to its predicate and that the updated information is accurate and compliant with relevant standards.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" and "reported device performance" as one might expect for a new diagnostic or AI device. Instead, the performance data provided is focused on demonstrating that the modified aspects of the existing device are substantially equivalent to the predicate device and meet relevant regulatory standards.

• Note: No changes to materials were made for this submission, so previous biocompatibility data was referenced. |
  | Performance Testing (Engineering): | |
  | - Priming Volumes: Demonstrate accuracy of new priming volume labels | - "Engineering testing analysis were performed... to establish the equivalence with the predicate devices."
• "The test regimen evaluated the devices for priming volumes and cleaning agent compatibility."
• Conclusion: Supported the update to the priming volumes printed on the label, IFU and device. |
  | - Cleaning Agent Compatibility: Ensure compatibility with common agents | - "The test regimen evaluated the devices for priming volumes and cleaning agent compatibility."
• Specific results not detailed, but implied as satisfactory to support equivalence. |
  | - Static Flow Rates (Triple Lumen): Align with ISO 10555-1 (minimum flowrates)| - "Additionally, the triple lumen catheter has been evaluated for static flow rates of the medial lumens."
• Conclusion: Supported the update to the static flow rates of the triple lumen's medial lumen to align with ISO 10555-1. |
  | Substantial Equivalence: | |
  | - Demonstrate that material, design, and principle of operation remain the | - "No material, design or principle of operation changes have been made to the Mahurkar™ Acute Catheters, Kits and Trays for the purposes of this submission."
• "The Mahurkar™ Acute Single, Dual and Triple Lumen Catheters, kits and trays have equivalent design, materials and principles of operation and technology when compared to the predicate device."
• This is the overarching conclusion of the 510(k) summary. |

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated with specific numbers for each test. The document mentions "the Mahurkar™ Acute Catheters" as the subject of biocompatibility tests and "the devices" for engineering tests. Given this is an engineering and labeling change, the "sample" would likely refer to a certain number of manufactured catheters used for physical testing, rather than patient data.
• Data Provenance: The biocompatibility testing was conducted previously and references "Good Laboratory Practice (GLP)." The engineering tests were likely conducted in-house by Covidien, LLC. There is no mention of country of origin for any data or whether it was retrospective or prospective, as these are not relevant for this type of submission focused on engineering changes to an existing device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this 510(k) submission. "Ground truth" established by experts, as typically seen in AI/diagnostic device submissions, would involve clinical interpretations or medical diagnoses. This submission pertains to physical device characteristics (priming volumes, flow rates, material compatibility) and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for clinical interpretive tasks, especially with ambiguous cases, to establish a definitive "ground truth." This is not relevant for the engineering and biocompatibility testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No. This is not an AI device, nor is it a diagnostic device that would typically undergo MRMC studies. This submission concerns physical catheters.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the biocompatibility tests, the "ground truth" would be established by validated laboratory assays and adherence to international standards (ISO 10993). For the priming volumes and flow rates, the "ground truth" would be the physically measured values according to established and validated engineering test methods, with the alignment of flow rates to ISO 10555-1 serving as a standard for accuracy.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set is involved.

In summary: This 510(k) is for minor modifications (labeling and a standard alignment) to an already cleared medical device (catheters). The "study" described focuses on demonstrating that these changes do not alter the substantial equivalence of the device, primarily through engineering performance testing (priming volumes, flow rates, cleaning agent compatibility) and by referencing prior biocompatibility testing. It is not an AI/diagnostic device submission, so many of the requested categories are not relevant.

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