Search Results

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is a radiopaque dual lumen polyurethane catheter intended to remove and return blood. The two lumens are designed in a Circle Crescent (Circle "C") configuration. The distal venous lumen extends beyond the arterial lumen to reduce recirculation.

The lumens are connected to the extensions via a molded hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on identification rings on the clamps for ease in identification. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during long-term placement.

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is available in varied implantable lengths, with straight or J-Cannula versions.

This 510(k) summary is for the LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter.
Here's an analysis of the provided text for acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• The document states that "in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device." This implies that the predicate device's performance metrics served as the de facto acceptance criteria for these in-vitro tests, and the LifeJet™ F16 met or performed comparably to these.
• Specific numerical acceptance thresholds or performance values are not provided in this document. The FDA's substantial equivalence determination supports that the device met the necessary criteria.

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

• Sample Size for Test Set: Not explicitly stated. The performance data is based on "in-vitro performance data," which refers to laboratory testing, not human subjects. The number of samples/units tested for each in-vitro test (tensile strength, leak testing, flow rate, stiffness) is not provided.
• Data Provenance: The data is in-vitro (laboratory testing). It is not derived from human subjects, so concepts like country of origin or retrospective/prospective do not directly apply in the same way they would for clinical data.

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

• Not Applicable. This study did not involve human expert interpretation of data to establish a ground truth. Performance was determined through physical and mechanical testing comparing the device's characteristics to a predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. There was no human interpretation or adjudication process for the in-vitro tests described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not conducted as this study focused on in-vitro performance testing of a physical medical device, not on AI or diagnostic imaging interpretation.

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

• Not Applicable. This pertains to a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the in-vitro performance tests: The ground truth was based on the established performance characteristics and safety profile of the legally marketed predicate device (Super C™ (LifeJet™) Hemodialysis/Apheresis Chronic Catheter). The new device's performance was compared to this predicate to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device without a "training set" in the context of machine learning or algorithms.

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

• Not Applicable. As there is no training set for this type of device submission, this question is not relevant.

Ask a specific question about this device