(77 days)
The AMPLATZER® TorqVue® Delivery System is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
The AMPLATZER® TorqVue® Catheter Delivery System is a sterile, single-use device designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature. The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 5-12 French (2.5-4.8 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 (optional), Plastic Vise, Hemostasis Valve.
The provided text describes a 510(k) premarket notification for the AMPLATZER® TorqVue® Delivery System. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Test Data" section.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Catheter Integrity | Not explicitly detailed, but implied to meet performance standards for a delivery system. | "confirms that the functional characteristics... are substantially equivalent to the predicate device" |
| Catheter Kink Resistance | Not explicitly detailed, but implied to meet performance standards for a delivery system. | "confirms that the functional characteristics... are substantially equivalent to the predicate device" |
| Leak Resistance | Not explicitly detailed, but implied to meet performance standards for a delivery system. | "confirms that the functional characteristics... are substantially equivalent to the predicate device" |
| Hub Strength | Not explicitly detailed, but implied to meet performance standards for a delivery system. | "confirms that the functional characteristics... are substantially equivalent to the predicate device" |
| Device Delivery Capability | Ability to deliver various implantable devices through the system. | "the ability to deliver various implantable devices" and "substantially equivalent to the predicate device" |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set (i.e., the specific number of devices or trials for each verification and validation test).
The data provenance is from laboratory verification and validation testing. There is no mention of country of origin for the data or whether it was retrospective or prospective, as this was a pre-market submission for a physical medical device, not a data-driven AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes validation for a physical medical device, not an AI or diagnostic imaging device where expert ground truth establishment for a test set would typically be required. The "ground truth" for this device's performance is based on direct physical testing against established functional requirements and comparison to a predicate device.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for AI-powered diagnostic tools assisting human readers, which is not the case for this delivery system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the submission is for a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.
7. The type of ground truth used
The "ground truth" for this device's performance was established through laboratory verification and validation testing against functional requirements and by demonstrating substantial equivalence to a predicate device (Medtronic® SelectSite™ Deflectable Catheter Delivery System). This involves engineering and performance metrics rather than medical pathology, outcomes, or expert consensus in the diagnostic sense.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable for the same reason 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).