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510(k) Data Aggregation
(58 days)
The AMPLATZER TorqVue 45°x45°, LA1, and LA2 Delivery Sheaths are intended to provide a pathway through which devices are introduced within the chambers of the heart.
The AMPLATZER TorqVue LA and AMPLATZER TorqVue 45x45 Delivery Sheaths are general purpose delivery sheaths designed to access and deliver a device to the chambers of the heart. The TV45x45 Delivery Sheath is curved approximately 45° in two dimensions resulting in a three-dimensional geometry. The TVLA1 provides a single 45° curve on the distal end of the sheath. The TVLA2 provides the same 45° curve as the TVLA1 with a second superior curve at the distal tip of 20-30°. The sheaths are offered in five sizes each (9Fr, 10Fr, 12Fr, 13FR, and 14Fr). The TVLA sheaths and are 80 cm in length and the TV45x45 sheath is 100 cm in length. The devices include a sheath to enable device delivery, a dilator to ease entrance into and through the vasculature, and a flush adaptor for the 10, 12, 13, and 14Fr sizes to enable connection with syringes for flushing the sheath lumen. The sheaths and dilators are radiopaque for visibility under fluoroscopy. For added visibility, the sheaths also have a radiopaque marker band near the distal tip.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the AMPLATZER® TorqVue® Delivery Sheaths.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes various functional and safety tests performed on the AMPLATZER TorqVue Delivery Sheaths to demonstrate their substantial equivalence to a predicate device. The document does not explicitly state numerical "acceptance criteria" for each test but implies that the device "conforms to the requirements for its intended use" if the tests are passed.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional Tests | Conformance to specified dimensions for various sheath sizes (9Fr, 10Fr, 12Fr, 13Fr, 14Fr), lengths (80 cm for TVLA, 100 cm for TV45x45), and curve geometries. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Trackability Test | Ability of the sheath to be maneuvered through the vascular system. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Kink Test | Resistance of the sheath to kinking during use. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Flushability Test | Ability to effectively flush the lumen of the sheath. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Handoff / Advancement Force Test | Acceptable forces required to advance the device. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Recapture Force Test | Acceptable forces required to recapture the device. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Visual Inspection | Absence of defects or inconsistencies upon visual examination. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Post-Interaction Testing | Maintenance of integrity and functionality after simulated interactions. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath Tip Tensile Test | Resistance of the sheath tip to tensile forces. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath Transition Tensile Test | Resistance of transitions within the sheath to tensile forces. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath Surface Inspection | Absence of surface imperfections. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath torque to failure | Resistance of the sheath to torque until failure. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Dilator Hub Tensile Test | Resistance of the dilator hub to tensile forces. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath Hub Tensile Test | Resistance of the sheath hub to tensile forces. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath Luer Leak Test (water and air) | Absence of leaks in the luer connection with water and air. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Design validation testing (animal study) | Performance and safety of the device in a relevant biological model. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Bench and laboratory testing" and "Design validation testing (animal study)". However, it does not specify the sample size for the test set used for these various tests. It also does not provide data provenance (e.g., country of origin, retrospective or prospective) for any of the studies, beyond stating that they were "Bench and laboratory testing" and an "animal study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for any of the described tests. The tests appear to be primarily engineering and animal model-based, rather than human expert-driven interpretation.
4. Adjudication Method for the Test Set:
Given the nature of the bench, laboratory, and animal studies described, an adjudication method is not mentioned and is likely not applicable in the same way it would be for studies involving human interpretation or clinical outcomes. The tests appear to have objective pass/fail criteria based on engineering specifications or physiological responses in the animal model.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench, laboratory, and animal studies to demonstrate substantial equivalence, not a clinical study involving human readers and interpretations. Therefore, no effect size for human readers improving with or without AI assistance is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This device is a physical medical device (catheter delivery system), not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable.
7. The Type of Ground Truth Used:
The ground truth for the bench and laboratory tests would have been established by engineering specifications, material properties, and performance standards for medical devices of this type. For the "design validation testing (animal study)," the ground truth would be based on physiological responses, procedural success, and absence of adverse events observed in the animal model, as determined by veterinary experts and scientific observation.
8. The Sample Size for the Training Set:
This device is a physical medical device, and the described studies are for its functional and safety validation. There is no concept of a "training set" as would be used for machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the context of this device and its validation, this question is not applicable.
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