(31 days)
The AMPLATZER® TorqVue® Low Profile Delivery System is indicated to provide a pathway through which devices are introduced into the peripheral vasculature.
The AMPLATZER TorqVue Low Profile Delivery System is a sterile, single-use device designed to facilitate the introduction of devices to a location within the peripheral vasculature. The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 4 and 5 French. The catheters will be provided in 60 cm and 80 cm usable lengths. The system includes the following components:
• Delivery Catheter - used to deliver transvenous devices
• Loader- used to help introduce the selected implantable device into the delivery catheter
• Delivery Wire (optional) – attaches to the implantable device and facilitates advancement through the catheter, placement and, if desired, recapture of the specified implantable device. [If this surgical accessory (Product Code = DWS) is included, the labeling will specify compatibility with the appropriate implantable devices.]
• Plastic Vise (included with delivery wire) – a handle that is attached to the Delivery Wire by means of a set screw
• Hemostasis Valve- used on the proximal end of the Loader to minimize bleeding from the Delivery Catheter and for flushing air from the system
Here's an analysis of the provided text regarding the acceptance criteria and study for the AMPLATZER® TorqVue® Low Profile Delivery System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Characteristics) | Reported Device Performance |
|---|---|
| Catheter integrity | Confirmed substantially equivalent to predicate device |
| Catheter kink resistance | Confirmed substantially equivalent to predicate device |
| Leak resistance | Confirmed substantially equivalent to predicate device |
| Hub strength | Confirmed substantially equivalent to predicate device |
| Ability to deliver various implantable devices | Confirmed substantially equivalent to predicate device |
Explanation: The document explicitly states that "Verification and validation testing confirms that the functional characteristics of the AMPLATZER® TorqVue® Low Profile Delivery Systems 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." The specific numerical acceptance criteria (e.g., "kink resistance must withstand X N of force") and the exact performance values (e.g., "kink resistance withstood Y N") are not provided in this summary. The evaluation is made against a predicate device, seeking "substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "Verification and validation testing" and "laboratory verification tests and in vitro performance information."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies described are primarily laboratory and in vitro performance tests, not clinical studies involving expert interpretation of patient data to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided as the described tests are laboratory and in vitro performance assessments, not studies requiring human expert adjudication of results.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not relevant to this device. This device is a medical delivery system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
A standalone performance evaluation in the context of an algorithm or AI was not performed or described. This is a medical device, not a software algorithm. The "standalone" performance here refers to the device's functional characteristics tested in a lab setting, which were indeed conducted without human operator variables, beyond basic operation.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests was established through objective laboratory measurements and in vitro performance evaluations against pre-defined engineering and performance specifications, likely derived from the predicate device's characteristics or internal design requirements. It's not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. A training set typically refers to data used to train machine learning models, which is not relevant here.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable as there is no mention of a training set or machine learning in the context of this device.
§ 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).