(83 days)
The AMPLATZER® TorqVue FX Delivery System is intended to provide a pathway through which devices are introduced within the chambers of the heart.
The AMPLATZER® TorqVue® FX Delivery Systems (also referred to herein as ITV FX) are general purpose delivery systems designed to provide a pathway through which devices are introduced within the chambers of the heart. The ITV FX Delivery Systems are an extension of the AMPLATZER TorqVue (ITV) Delivery System product line. The technological characteristics of the ITV FX are the same as the predicate devices, with the following differences: The TorqVue FX Delivery System contains a flex . delivery cable assembly that incorporates a nitinol core wire surrounded by a stainless steel coil capped by a hub and a self-sealing hemostasis valve. The flex cable assembly provides rigidity for advancing devices through the sheath and allows the core wire to be extended out of the coil to provide flexibility for confirming correct placement of the deployed device. The Torq Vue FX Delivery System contains an 0.035" . compatible extension wire, which is only used for attaching to the delivery cable in vivo when there is a need to replace the sheath with a larger sheath. The standard ITV and ITV FX dilators fit over the extension wire and delivery cable core wire. The ITV FX Delivery System sheath will be offered with a 45° curve with a 60-cm useable length (6Fr, 7Fr, 8Fr) or 80-cm usable length (7Fr, 8Fr. 9Fr. 10Fr, 12Fr, 13Fr) and will be recommended for use with a subset of the AMPLATZER occluders that currently recommend the Torq Vue (45°) Delivery Systems. The ITV FX Delivery System includes a delivery sheath, dilator, delivery cable, extension wire, loader, delivery cable vise, two hemostasis valves, and for the 10, 12 and 13Fr products a flush adaptor to enable connection with syringes for flushing the sheath lumen. The sheaths are radiopaque for visibility under fluoroscopy.
The AMPLATZER® TorqVue® FX Delivery System is a catheter delivery system. The information provided describes the device's technical characteristics, its comparison to predicate devices, and the testing performed to demonstrate substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" in a quantified manner with corresponding "reported device performance." Instead, it states that "Results from testing of the proposed and predicate devices show the proposed device conforms to the requirements for its intended use." The testing performed serves as the basis for this conformance.
Here's a table summarizing the tests performed, which implicitly served as the "acceptance criteria" through successful completion:
| Acceptance Criteria (Functional/Safety Test Category) | Reported Device Performance (Implicitly Met) |
|---|---|
| Delivery Cable and Extension Wire Specific Tests | |
| Delivery Cable and Extension Wire Dimensional Tests | Conforms to dimensional requirements |
| Delivery Cable Vacuum Decay | Meets vacuum decay specifications |
| Extension Wire Connection Reliability | Demonstrates reliable connection |
| Delivery Cable Core Wire Distal Tip Flexibility | Meets flexibility requirements |
| Delivery Cable and Extension Wire Corrosion Testing | Demonstrates corrosion resistance |
| Delivery Cable Distal Torque to Failure | Meets torque to failure specifications |
| Delivery Cable Force Transmission | Demonstrates adequate force transmission |
| Delivery Cable Distal Core Tensile | Meets tensile strength requirements |
| Delivery Cable Core to Extension Wire Tensile | Meets tensile strength requirements |
| Delivery Cable Hub to Coil Tensile | Meets tensile strength requirements |
| Hemostasis Valve Leak Testing | Meets leak testing specifications |
| Device Interaction Testing with Other Components | |
| Advancement/Deployment Test | Successful advancement and deployment of devices |
| Recapture Test | Successful recapture of devices |
| Visual Inspection Post-Interaction Testing | No adverse visual changes post-interaction |
| Overall System Performance & Validation | |
| Design Validation Testing (animal study) | Successful performance in an animal model |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of units, number of tests for each type) used for the bench and laboratory testing. It broadly states "Bench and laboratory testing was performed."
The data provenance is from bench and laboratory testing, indicating controlled environments. There is one mention of an "animal study" for "Design Validation Testing." The country of origin for the data is not explicitly stated but is implied to be within the US, given the submitter's location (Plymouth, MN) and the FDA submission process. All studies appear to be prospective as they were conducted to support the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the described testing does not involve human interpretation or subjective assessment that would require expert consensus for ground truth. The tests are primarily engineering and performance-based, with results measured against predetermined specifications.
4. Adjudication method for the test set
This section is not applicable for the same reasons as #3. The testing involves objective measurements rather than subjective interpretations requiring adjudication.
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
This section is not applicable. The device is a physical medical device (catheter delivery system), not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. As a physical medical device, the concept of "standalone algorithm performance" is not relevant. The device itself is the "standalone" entity whose physical and functional performance is being evaluated.
7. The type of ground truth used
The "ground truth" for the acceptance criteria is based on engineering specifications, design requirements, and established industry standards for medical device performance and safety. For example, a "Tensile Test" would have an established maximum force the component must withstand, which serves as its ground truth. The "animal study" would have defined success metrics related to device delivery and placement.
8. The sample size for the training set
This section is not applicable. This device is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reason as #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).