(81 days)
The modified Brite Tip® Catheter Sheath Introducer is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices.
Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
These devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.
This 510(k) submission describes a device modification for the Cordis Brite Tip® Catheter Sheath Introducer, not a clinical study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, study design, and ground truth for a new device's performance is not directly available in this document.
Here's a breakdown of what can be extracted and why certain requested information is absent:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. This document is a 510(k) for a modified device. The determination of "substantial equivalence" is based on similarity to a predicate device (Brite Tip® Catheter Sheath Introducer, K954595). The acceptance criteria are implicit in showing that the modifications do not alter the fundamental safety and effectiveness of the device compared to the predicate. There are no new performance metrics or acceptance criteria explicitly defined for the modified device in this document, nor is there a study reporting new performance numbers. The FDA's letter states, "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent...". This means the acceptance criterion was "substantial equivalence" to the predicate, which implies the modified device performs comparably in its intended use.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This submission is not a clinical study with a "test set" in the context of AI/diagnostic device performance. It's a regulatory submission for a device modification. The basis for substantial equivalence typically involves engineering analyses, bench testing (e.g., sterilization, material compatibility, functional testing), and comparison to the predicate device's design and materials. No patient data or test set in the traditional sense is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. See point 2. There's no test set in the typical AI/diagnostic study sense, and therefore, no experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set:
- Not Applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This document is not for an AI device. It describes a conventional medical device (catheter sheath introducer). Therefore, an MRMC study related to AI performance is not relevant or included.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- Not Applicable. For a device modification submission, the "ground truth" is typically established through engineering design specifications, biocompatibility testing (as mentioned in the document), and functional testing to ensure the modified device continues to meet its intended purpose and safety profile, consistent with the predicate device. It's not about establishing diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary of what the document does convey regarding device acceptance and study (or lack thereof):
The "study" in this context is the 510(k) premarket notification process itself, where the manufacturer (Cordis Corporation) presented evidence to the FDA to demonstrate substantial equivalence to a previously cleared predicate device.
- Acceptance Criteria (Implicit): The primary acceptance criterion was Substantial Equivalence to the predicate device (Cordis Brite Tip® Catheter Sheath Introducer, K954595, cleared October 02, 1995). This implies that the modified device must demonstrate:
- Same intended use.
- Similar technological characteristics (design, construction, materials).
- No new questions of safety or effectiveness.
- Performance characteristics comparable to the predicate.
- "Study" That Proves Acceptance (The 510(k) Submission):
- The submission outlines that the modified device is "similar in design, construction, indication for use, and performance characteristics to other commercially available sheath introducers," specifically referencing their own predicate.
- Biocompatibility: "All appropriate biocompatibility tests were performed on the materials used in the modified Brite Tip® Catheter Sheath Introducer." This implicitly serves as evidence that the new materials (if any) or modified device components meet safety standards.
- The FDA then reviewed this information and determined that the modified device is substantially equivalent.
In essence, for this type of device modification, the "proof" is a regulatory assessment based on comparison to an already approved device, rather than a de novo clinical trial with new performance metrics.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).