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The Niagara®, Niagara® Slim-Cath®, and Brevia® Dual Lumen Catheters are indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis therapy via the jugular, subclavian or femoral vein.

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The provided text is a 510(k) summary for Bard Access Systems' Niagara®, Niagara® Slim-Cath®, and Brevia® Dual Lumen Catheters. This document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than presenting a de novo study with specific acceptance criteria and detailed performance data against them.

Therefore, many of the requested elements for a study proving device meets acceptance criteria cannot be extracted directly from this document. The submission asserts equivalence based on unchanged indications for use, technological characteristics, and "safety and performance testing," but does not detail that testing or specific acceptance criteria.

Here's an attempt to address your request based on the provided text, with explicit notes where information is not available or not applicable to this type of regulatory submission:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)

This 510(k) submission argues for substantial equivalence to predicate devices, rather than establishing new acceptance criteria and proving performance against them in a de novo study. The core "acceptance criteria" for a 510(k) is that the new device is as safe and effective as a legally marketed predicate device.

The document states:
"Based on the indications for use, technological characteristics, and safety and performance testing, the subject Niagara®, Niagara® Slim-Cath®, Brevia® Dual Lumen catheters met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates."

Since specific performance metrics and acceptance criteria for this device are not defined in the context of a new study, a table cannot be constructed. Instead, the "performance" shown is that it is equivalent to the predicate devices.

Supplementary Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not applicable. This document does not describe a clinical "test set" in the context of a de novo study with human subjects. The evaluation is based on demonstrating equivalence to existing predicate devices.
   • Data Provenance: Not applicable. No new clinical data from a prospective or retrospective study is presented. The assessment relies on a comparison of design, materials, and intended use to previously approved devices.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable. No new clinical test set or ground truth establishment by experts is described in this regulatory submission. The comparison is to established predicate devices.

3. Adjudication Method for the Test Set:

   • Not applicable. No new clinical test set requiring adjudication is described.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable. This is not a study involving human readers or AI assistance. It's a submission for a physical medical device (catheter) based on substantial equivalence.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Not applicable. This is not an AI algorithm.

6. Type of Ground Truth Used:

   • Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) is established by the safety and effectiveness profile of the predicate devices (Niagara® Short Term Dialysis Catheters K965178, Niagara® Slim-Cath® Short Term Dialysis Catheters K010778, Brevia® Short Term Dialysis Catheters K881743). The new devices are deemed substantially equivalent to these.

7. Sample Size for the Training Set:

   • Not applicable. This is not a machine learning model or AI device that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. (See #7)

Summary of the Document's Nature:

This 510(k) pertains to a Special 510(k) submission, which typically indicates a change to an existing device that does not alter its fundamental scientific technology or intended use. The core of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device already legally marketed in the U.S. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness.

The document explicitly states:

• "The intended use has not changed from the predicate catheters."
• "The indications for use has not changed from the predicate catheters."
• "Technological similarities between the subject Niagara®, Niagara® Slim-Cath®, Brevia® Dual Lumen catheters and the predicate devices remain identical. There are no new questions raised regarding safety or efficacy of the subject Niagara®, Niagara® Slim-Cath®, Brevia® Dual Lumen catheters."

Therefore, the "proof" that the device meets "acceptance criteria" is the FDA's concurrence that it is substantially equivalent to existing, approved devices based on the submission's arguments about design, materials, sterilization, principles of operation, and indications for use, supported by general "safety and performance testing" which is not detailed here.

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