(90 days)
The Reprocessed Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The Reprocessed Steerable Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is filtered with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise less than or equal to 90 degrees. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
The provided text describes a 510(k) submission for a Reprocessed Steerable Introducer. This document is a premarket notification to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the same way a novel device might.
Therefore, many of the requested elements (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for a novel AI/diagnostic device) are not applicable to this type of submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a reprocessed device seeking 510(k) clearance, the "acceptance criteria" are primarily that the reprocessed device performs, as originally intended, equivalently to the predicate device, and that the reprocessing method is validated and does not compromise safety or efficacy. The reported "performance" focuses on demonstrating this equivalence through various tests.
| Acceptance Criteria (Implicit for Reprocessed Device) | Reported Device Performance |
|---|---|
| Material/Design Equivalence to Predicate | The design, materials, and intended use are identical to predicate devices. The mechanism is identical, utilizing the same standard mechanical design, materials, and sizes. No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
| Biocompatibility (Device remains biocompatible after reprocessing) | Biocompatibility testing was conducted. |
| Validation of Reprocessing (Reprocessing renders device safe and functional) | Validation of reprocessing was conducted. Each individual Introducer is tested for appropriate function of its components prior to packaging and labeling. |
| Sterilization Validation (Device remains sterile after reprocessing) | Sterilization Validation was conducted. |
| Functional Equivalence (Device performs as originally intended) | Function test(s) were conducted. Performance testing demonstrates that Reprocessed Steerable Introducer performs as originally intended. |
| Packaging Integrity (Packaging protects sterility and device integrity) | Packaging Validation was conducted. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "Bench and laboratory testing" and that "Each individual Introducer is tested for appropriate function." This implies a sample size determined by the validation protocols for reprocessing, biocompatibility, sterilization, and function, but specific numbers are not provided in this summary.
- Data Provenance: Not applicable in the context of a clinical study. The data provenance here would relate to the in-house testing conducted by Stryker Sustainability Solutions during their reprocessing validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: This is a reprocessed medical device, not a diagnostic or AI device that requires expert-established ground truth on clinical images or data. The "ground truth" here is the original design specifications and performance of the predicate device, against which the reprocessed device's performance is compared through engineering and lab testing.
4. Adjudication Method for the Test Set
- Not Applicable: There is no "adjudication method" in the sense of expert consensus on clinical cases. Performance is objectively measured against specifications through validated test methods.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This is not an AI/diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is not an AI/diagnostic device.
7. The Type of Ground Truth Used
- Engineering Specifications and Predicate Device Performance: The "ground truth" for this reprocessed device is the original design specifications, material properties, and demonstrated performance characteristics of the predicate (original, new) devices. The testing aims to confirm that the reprocessed device meets these established performance benchmarks.
8. The Sample Size for the Training Set
- Not Applicable: This is not an AI/diagnostic device that uses a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable: This is not an AI/diagnostic device that uses a "training set."
§ 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).