Search Results

The Mahurkar 13.5 Fr Cuffed Catheter with curved extensions is intended to be used as an acute or chronic central venous access device for hemodialysis, apheresis, and infusion.
The Mahurkar 13.5 Fr Cuffed Silicone catheter is designed for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.

The Mahurkar 13.5 Fr Cuffed Catheter with curved extensions is a radiopaque silicone tube with two D-shaped lumina. The lumina can be distinguished by the color-coded luer-lock adapters on the clear silicone rubber extensions: the red adapter indicates the proximal lumen, and the blue adapter indicates the distal lumen. During hemodialysis and apheresis, the proximal lumen provides "arterial" outflow from the patient and the distal lumen provides "venous" return.
The Mahurkar 13.5 Fr Cuffed Catheter with curved extensions is available in four (4) implantable lengths (36 cm, 40 cm, 45 cm, and 50 cm), and will be packaged in single, catheter kit and catheter tray configurations.

The provided text is a 510(k) summary for a medical device (Mahurkar 13.5 Fr Cuffed Catheter with Curved Extensions) and an FDA clearance letter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and a detailed study report with quantitative performance metrics.

Therefore, much of the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text. The document states that "test results demonstrate that the device is substantially equivalent to the predicate device," but it does not detail those test results or the specific criteria met.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overarching acceptance criterion is "substantial equivalence" to the predicate device.
• Reported Device Performance: The document generally states that performance data were compared and demonstrate substantial equivalence. No specific performance values (e.g., flow rates, durability, biocompatibility test results) are provided.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not available.
• Data Provenance: Not available (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable/not available. This type of device relies on engineering/biocompatibility testing rather than expert-derived ground truth for diagnostic accuracy.
• Qualifications: Not applicable/not available.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not available. This is relevant for studies involving human interpretation or clinical endpoints that require consensus, which is not described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. This type of study is for diagnostic devices where human readers interpret results, often with AI assistance. This device is a catheter, not a diagnostic tool requiring human interpretation in that sense.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance

• Was a standalone performance study done? Not applicable. This device does not have an "algorithm" in the sense of AI or a diagnostic computing component. Its performance is related to its physical and functional characteristics.

7. Type of Ground Truth Used

• Type of Ground Truth: The document implies that the "ground truth" for proving substantial equivalence was the performance of the predicate device, against which the new device's performance data were compared. The specific parameters of comparison are not detailed. It would likely involve engineering specifications, material properties, and in vitro/in vivo functional tests.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• How Ground Truth Was Established: Not applicable.

Summary of available information:

• Device Name: Mahurkar 13.5 Fr Cuffed Catheter with Curved Extensions
• Intended Use: Acute or chronic central venous access for hemodialysis, apheresis, and infusion.
• Predicate Device: PermCath Dual Lumen Catheters (Quinton Instrument Co.)
• Performance Data: Performance data for the Mahurkar 13.5 Fr Cuffed Catheter with curved extensions were compared to that of the predicate device and were deemed to "demonstrate that the device is substantially equivalent."
• Unique Characteristic: Curved extensions (compared to the predicate).

In conclusion, the provided text serves as a regulatory summary for substantial equivalence rather than a detailed technical report of performance against specific, quantifiable acceptance criteria.

Ask a specific question about this device