Search Results
Found 1 results
510(k) Data Aggregation
(119 days)
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
The Medtronic Confida™ Brecker Curve™ 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 ConfidaTM Brecker Curve™ Guidewire is manufactured of 304 stainless steel and is polytetrafluoroethylene (PTFE) coated, which is consistent with guidewires presently in commercial distribution and with the same intended use. The device diameter is 0.035 inches and 260 cm in length. The distal end of the Medtronic Confida TM Brecker Curve™ Guidewire is comprised of a preformed curved tip. The loop configuration has a 540° curved tip which is 30 mm in width and aids in anchoring of the distal spring tip during diagnostic and interventional procedures, including TAVI.
The provided text describes a 510(k) summary for the Medtronic Confida™ Brecker Curve™ Guidewire (K132623). This type of submission relies on demonstrating "substantial equivalence" to predicate devices, rather than conducting a de novo study with specific performance criteria for AI-powered devices or clinical efficacy studies in the same way modern AI/ML devices might.
Therefore, many of the requested categories related to AI performance, expert consensus, and clinical trial methodologies are not applicable to this document. The "acceptance criteria" here are based on physicochemical and functional performance characteristics compared to existing devices.
Here's a breakdown of the information as it relates to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table format. Instead, it lists the non-clinical evaluations performed to demonstrate substantial equivalence to predicate devices. The implication is that the device met the internal specifications for these tests, which are deemed comparable to the cleared predicates.
| Acceptance Criteria (Non-Clinical Evaluation Performed) | Reported Device Performance |
|---|---|
| Visual Inspection | Met (implied by substantial equivalence claim) |
| Overall Length | Met (implied by substantial equivalence claim) |
| Proximal Outer Diameter | Met (implied by substantial equivalence claim) |
| Coil Outer Diameter | Met (implied by substantial equivalence claim) |
| Tip Curve Rotation | Met (implied by substantial equivalence claim) |
| Tip Curve Outer Diameter | Met (implied by substantial equivalence claim) |
| Tip Tensile | Met (implied by substantial equivalence claim) |
| Tip Stiffness | Met (implied by substantial equivalence claim) |
| Loop Compression | Met (implied by substantial equivalence claim) |
| Proximal Stiffness | Met (implied by substantial equivalence claim) |
| Coil Length | Met (implied by substantial equivalence claim) |
| PTFE Coating Adhesion | Met (implied by substantial equivalence claim) |
| PTFE Coating, Simulated Clinical Use | Met (implied by substantial equivalence claim) |
| Corrosion Resistance | Met (implied by substantial equivalence claim) |
| Anchoring | Met (implied by substantial equivalence claim) |
| Usability for Design Validation | Met (implied by substantial equivalence claim) |
| Flexibility | Met (implied by substantial equivalence claim) |
| Torque | Met (implied by substantial equivalence claim) |
| Biocompatibility (ISO 10993-1:2009 requirements) | Met (implied by substantial equivalence claim) |
| Packaging and Shelf Life Testing | Met (implied by substantial equivalence claim) |
| Sterilization Validation Adoption (SAL of 10^-6) | Met (implied by substantial equivalence claim) |
2. Sample Size Used for the Test Set and the Data Provenance
This is a physical medical device, not a software/AI device. Therefore, the concept of a "test set" in the context of data provenance (country of origin, retrospective/prospective) and sample size for testing data does not apply in the same way as an AI/ML product.
The non-clinical evaluations would have involved physical samples of the guidewire, but the document does not specify the sample sizes for each test. The provenance would be from manufacturing lots used for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as this is a physical medical device, not an AI/ML device requiring expert ground truth for image or data interpretation. Performance is assessed through physical and chemical testing.
4. Adjudication Method for the Test Set
Not applicable for a physical medical device. Performance is determined by standardized laboratory testing methods.
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 is a physical medical device, not an AI-assisted diagnostic or interpretive tool. There are no "human readers" in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This is a physical medical device; there is no standalone algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" is defined by established engineering and material science standards (e.g., ISO, ASTM) and the performance characteristics of the predicate devices. These are not "expert consensus, pathology, or outcomes data" in the AI sense, but rather objective measurements against predefined specifications.
8. The Sample Size for the Training Set
Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for a physical guidewire.
Ask a specific question about this device
Page 1 of 1