(34 days)
The AMPLATZER® Reliant™ Catheter Delivery System is intended to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart.
The AMPLATZER® Reliant™ Catheter Delivery System is a sterile. single-use device designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart. The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 6-12 French (2.0-4.0 mm). The catheters currently come in 60 cm and 80 cm usable lengths. The system includes the following components: Delivery Catheter, Dilator, Loader, Delivery Wire, Vise, Hemostasis Valve.
The provided text describes a 510(k) premarket notification for the AMPLATZER® Reliant™ Catheter Delivery System. This is a medical device submission, and the "study" referred to here is the set of verification and validation tests conducted to demonstrate substantial equivalence to a predicate device, rather than a clinical study with human patients and outcomes data in the typical sense for a diagnostic AI device.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "Verification and validation testing confirms that the functional characteristics of the AMPLATZER® Reliant™ Catheter Delivery System are substantially equivalent to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices."
Specific numerical acceptance criteria and performance values are not provided in this summary. The 510(k) summary typically provides a high-level overview, with detailed test reports available to the FDA reviewer.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Catheter integrity | Demonstrated substantial equivalence to predicate device. |
| Catheter kink resistance | Demonstrated substantial equivalence to predicate device. |
| Leak resistance | Demonstrated substantial equivalence to predicate device. |
| Hub strength | Demonstrated substantial equivalence to predicate device. |
| Ability to deliver various implantable devices | Demonstrated substantial equivalence to predicate device. |
| Functional characteristics for intended use | Demonstrated substantial equivalence to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample sizes for each of the "verification and validation testing" categories (catheter integrity, kink resistance, etc.). These would typically be detailed in the full test reports.
- Data Provenance: The tests are described as in vitro performance information and laboratory verification tests. This indicates the testing was conducted in a controlled lab setting, not on patient data. Therefore, there is no country of origin for patient data, nor is it retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This concept is not applicable here. Ground truth, in the context of diagnostic AI, refers to the definitive determination of a condition (e.g., presence of disease) that the AI is trying to detect. For a physical medical device like a catheter delivery system, the "ground truth" for its performance is established through standard engineering and materials testing, adhering to recognized industry standards. The performance is measured against established physical and mechanical specifications, not expert interpretation of images or patient outcomes.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies among expert interpretations of complex data (e.g., medical images) to establish a consensus ground truth. Since the "test set" here refers to physical products undergoing engineering tests, this methodology is not relevant.
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. MRMC studies are used for evaluating the impact of diagnostic aids (like AI) on human reader performance for tasks such as image interpretation. This device is a catheter delivery system, a physical tool for introducing other devices, not a diagnostic aid that enhances human reading of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical catheter delivery system, not a software algorithm.
7. The Type of Ground Truth Used:
As explained in point 3, the concept of "ground truth" in the diagnostic AI sense doesn't apply directly here. The "truth" for this device's performance is derived from:
- Engineering specifications and standards: The device is tested against predefined physical and mechanical properties and performance criteria (e.g., minimum tensile strength, maximum leak rate, resistance to kinking).
- Predicate device performance: The primary goal of a 510(k) is to demonstrate substantial equivalence. Therefore, the "truth" is often relative to the established performance characteristics of the legally marketed predicate device.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reasons as point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).