(161 days)
The Medtronic ConfidaTM Brecker Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI).
The Medtronic Confida™ Brecker Guidewire was developed for use in diagnostic and interventional procedures including transcatheter aortic valve implantation (TAVI) procedures for the treatment of aortic valve disease. The Medtronic ConfidaTM Brecker Guidewire (model number GWBC30) is available in one size and is comprised of a stainless steel wire, 0.035" in diameter, and 260cm in length. The distal end of the Medtronic Confida™ Brecker Guidewire is comprised of a preformed 360° curved tip. The Medtronic Confida™ Brecker Guidewire is an external communicating device having limited (
The provided document is a 510(k) summary for the Medtronic Confida™ Brecker Guidewire (K150465). It describes the device and its intended use, and compares it to a predicate device (K132623). The document focuses on establishing substantial equivalence through non-clinical testing.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria for each test or detailed quantitative performance data in a table format. Instead, it lists the non-clinical evaluations performed and concludes that the subject device "performs as well as the legally marketed predicate device."
Without specific acceptance criteria metrics and detailed performance results from the provided text, a table like the one requested cannot be accurately generated.
However, the types of non-clinical evaluations performed are listed, suggesting that the criteria for acceptance would be satisfactory outcomes for these tests compared to the predicate device's expected performance or established safety standards.
Inferred Information for a Hypothetical Table:
| Test Name | Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|
| PTFE Coating Adhesion (Coating Integrity) | Satisfactory coating adhesion and integrity. | Performed "as well as the legally marketed predicate device," implying satisfactory coating integrity. |
| ISO Cytotoxicity Study | No cytotoxic effects. | Performed "as well as the legally marketed predicate device," implying no cytotoxic effects. |
| ISO Maximization Sensitization Study | No sensitization potential. | Performed "as well as the legally marketed predicate device," implying no sensitization potential. |
| ISO Intracutaneous Study | No intracutaneous irritation. | Performed "as well as the legally marketed predicate device," implying no intracutaneous irritation. |
| ISO/USP Pyrogen Study Material Mediated | No pyrogenic response. | Performed "as well as the legally marketed predicate device," implying no pyrogenic response. |
| ISO Acute Systematic Toxicity Study | No acute systemic toxicity. | Performed "as well as the legally marketed predicate device," implying no acute systemic toxicity. |
| In Vivo Thromboresistance | Acceptable thromboresistance. | Performed "as well as the legally marketed predicate device," implying acceptable thromboresistance. |
| In Vitro Hemolysis Study | Acceptable level of hemolysis. | Performed "as well as the legally marketed predicate device," implying an acceptable level of hemolysis. |
| C3a Compliment Activation | Acceptable level of C3a complement activation. | Performed "as well as the legally marketed predicate device," implying acceptable C3a complement activation. |
| SC5b-9 Compliment Activation | Acceptable level of SC5b-9 complement activation. | Performed "as well as the legally marketed predicate device," implying acceptable SC5b-9 complement activation. |
| Overall Conclusion | Demonstrates substantial equivalence to predicate device. | "The result of the non-clinical testing demonstrate the subject device... performs as well as the legally marketed predicate device..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample sizes used for each of the non-clinical tests. These typically involve a certain number of samples of the device or its materials subjected to the various assays.
- Data Provenance: Not explicitly stated as retrospective or prospective, or location of data origin (e.g., country). Non-clinical bench and lab testing often does not fit neatly into "retrospective" or "prospective" as clinical studies do. The testing was conducted by Medtronic CoreValve, LLC.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable to the provided document. The submission is for a medical device (guidewire) and relies on non-clinical (bench and biocompatibility) testing, not on interpretation of diagnostic images or clinical data by human experts. Therefore, "ground truth" in the context of expert consensus (as asked for in the prompt) is not relevant here.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically used in clinical studies or studies involving multiple human readers for diagnostic interpretation. It is not applicable to the non-clinical evaluations listed for this guidewire. These tests have defined laboratory protocols and pass/fail criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size.
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms or imaging modalities, especially with human readers, which is not the subject of this 510(k) submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
No, a "standalone algorithm performance" study was not done. The device is a physical medical guidewire, not an algorithm or AI software, so this type of study is not relevant.
7. The type of ground truth used
The "ground truth" for the non-clinical evaluations would be defined by the standardized protocols and reference methods used for each test (e.g., ISO standards for biocompatibility, material testing standards). For example, for cytotoxicity, the "ground truth" is determined by established cell viability assays against negative and positive controls. For coating adhesion, it would be based on validated physical testing methods. It is not expert consensus, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
This question is not applicable. The device is a physical guidewire, not an AI/ML algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for a physical device.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.