(31 days)
The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. There is a hydrophilic coating on the distal portion of the device. The length of the coating is determined by the product code number.
This document describes a 510(k) premarket notification for a medical device, the RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP). Given the nature of a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove performance against specific acceptance criteria through a clinical study in the way one might for a novel device requiring a PMA.
Here's an analysis of the provided text in response to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present specific quantitative acceptance criteria in the way a clinical trial might for a new device's performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the device's performance characteristics are substantially equivalent to the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same intended use as predicate device. | "The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site." This is stated to be substantially equivalent to the predicate. |
| Design/Materials Equivalence: Same design and materials as predicate device. | "The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) in this submission is the same device that was cleared under K915414, the Terumo Angiographic Catheter. There are no changes in the design or materials." |
| Technology/Principles of Operation Equivalence: Same technology/principles of operation as predicate device. | "The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is operated manually or by a manual process." This is stated to be substantially equivalent to the predicate. |
| Performance Equivalence (Risk/Hazard Analysis): Performance characteristics are substantially equivalent, justified by a risk/hazard analysis and comparison to predicate. | "A risk/hazard analysis was conducted according to EN ISO 14971... Performance characteristics for this new indication for use were determined. Then it was justified that the performance of the RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is substantially equivalent to the performance of the Terumo Angiographic Catheter cleared under K915414." Specific performance metrics (e.g., maximum injection pressure by size) are provided as specifications, which are implicitly considered equivalent or acceptable. |
| Biocompatibility: Blood contacting materials are biocompatible. | "Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1... Results of the testing demonstrate that the blood contacting materials are biocompatible." |
| Sterilization: Sterilization conditions are validated to a SAL of 10⁻⁶. | "Sterilization conditions have been validated in accordance with EN ISO 11135-1... The device is sterilized to a SAL of 10⁻⁶." |
| Manufacturing Controls: Visual, functional, dimensional, and sterility tests are in place. | "Manufacturing controls include visual, functional, dimensional and sterility tests." |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not describe a test set or data provenance in the context of a clinical study or a performance evaluation against a specific set of clinical data. This is because the submission is for a 510(k) where substantial equivalence is being claimed with a predicate device with no changes in design or materials. The "performance" section refers to a risk/hazard analysis and a justification of equivalence, not a new comparative study using a clinical test set. The biocompatibility and sterilization validation are described, which would use specific samples for those tests, but not a general "test set" for overall device performance in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. As explained above, there was no clinical "test set" requiring ground truth established by experts for performance evaluation in this 510(k) submission.
4. Adjudication Method for the Test Set
This information is not applicable and not provided for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI
This information is not applicable and not provided. This device is a manual, physical catheter; it does not involve AI or any software requiring a multi-reader multi-case study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This device is a medical catheter and does not involve any algorithms.
7. The Type of Ground Truth Used
This information is not applicable and not provided for a clinical performance test set. The "ground truth" here is essentially the already-cleared performance and characteristics of the predicate device (K915414, the Terumo Angiographic Catheter) against which the current device is deemed substantially equivalent due to being the same design and materials.
8. The Sample Size for the Training Set
This information is not applicable and not provided. Since there's no machine learning or AI algorithm involved, there's no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as #8.
Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):
The "study" in this context is the 510(k) submission itself, which argues for substantial equivalence to a predicate device (K915414, the Terumo Angiographic Catheter).
- Proof of Equivalence: The key "proof" lies in the explicit statement: "The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) in this submission is the same device that was cleared under K915414, the Terumo Angiographic Catheter. There are no changes in the design or materials."
- Risk Analysis: A risk/hazard analysis (according to EN ISO 14971) was performed to ensure that the identical device (now with a slightly different name/marketing) still meets safety standards and that its performance characteristics remain acceptable and equivalent to the already-cleared predicate.
- Biocompatibility Testing: Blood contacting materials were tested according to ISO 10993 to confirm biocompatibility.
- Sterilization Validation: Sterilization processes were validated according to EN ISO 11135-1 to ensure sterility.
- Manufacturing Controls: Ongoing manufacturing controls (visual, functional, dimensional, sterility tests) are in place to ensure consistent quality.
Conclusion:
This 510(k) submission represents a situation where the device is claimed to be identical in design and materials to a previously cleared predicate device. Therefore, the "acceptance criteria" are largely met by demonstrating that the device is the predicate device, and the "study" is the documentation proving this identity and confirming standard manufacturing and biological safety aspects. No new clinical performance studies comparing it to a control or evaluating its accuracy against a ground truth dataset were required or performed because the device itself is not new.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).