(141 days)
The Adelante Breezeway Delivery Sheath is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.
The Adelante® Breezeway Delivery Sheath is designed to facilitate the introduction of catheters to any r from heart chambers, including the left atrium via a transseptal puncture. This introducer delivery sheath of the nearl chambere, moldarity the ide port with a three-way stopcock, hemostatic valve, and a dilator. The distal tip of the sheath has side flush portholes. The dilator can be locked on to the sheath. The sheath is supplied in 10 F and two overall lengths, 63 cm and 81 cm, and dilator is supplied in two r rie sheath is oupplied in 10 r and the dilator profile curves are 55, 70, 90, 120 degrees. There are no accessories supplied with this device.
The provided text describes the acceptance criteria and the results of the functional and performance testing for the Adelante® Breezeway Delivery Sheath. However, it does not describe a study involving an AI/Machine Learning device or any human-in-the-loop performance. This document is a 510(k) premarket notification for a medical device (a catheter introducer), not an AI algorithm.
Therefore, many of the requested items related to AI/ML studies are not applicable or cannot be extracted from this text.
Here's a breakdown of the information that can be extracted, along with explanations for the missing AI-specific details:
Acceptance Criteria and Device Performance
| Test Name/ Description | Acceptance Criteria | Reported Device Performance (Pass/Fail) |
|---|---|---|
| Sheath visual and dimensional tests (includes curve verification) | Specific visual and dimensional specifications | Pass |
| Dilator visual and dimensional tests (includes curve verification) | Specific visual and dimensional specifications | Pass |
| Dilator to TS needle and Guidewire visual and dimensional tests | Free and smooth insertions and other insertion/transition requirements | Pass |
| Sheath joints bonding tests | All joints must withstand a designated pull force | Pass |
| Dilator body to hub bond test | Hub bond to dilator tube must withstand a designated pull force | Pass |
| Sheath and Dilator fit, functionality, and transition tests | Compatibility with Luer fitting, compatibility with 10 F device, dilator to sheath fit must be within specifications | Pass |
| Air leakage testing | The sheath must not leak prior to and after the insertion of a dilator and a catheter/device | Pass |
| Sheath side port holes flush test | The sheath must be capable of aspiration/flushing with and without inserted dilator/device. | Pass |
| Torque response test | Minimum 1:1 torqueability, Pre-determined torque force | Pass |
| Insertion and withdrawal of dilator into sheath hemostatic valve test | Insertion and withdrawal force must be within specifications | Pass |
| Device insertion and withdrawal test | No damage when using the Seldinger method | Pass |
| Kink and Roll tests | Free of kinks and bends | Pass |
| Radio-detectability test | Device must be radio-detectable and visible under fluoroscopy | Pass |
| Exposure to Ethylene Oxide sterilization and Thermal shock | Device must be physically and functionally unaffected by EtO and thermal shock exposure | Pass |
| Testing of EtO residual levels | EtO residuals must be within limits | Pass |
| Product sterility testing | Product must remain sterile | Pass |
| Bioburden testing | Bioburden levels must be within limits | Pass |
| Endotoxins testing | Endotoxins (LAL) levels must be within limits | Pass |
Study Details (as applicable to a medical device, not an AI study)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample sizes (number of devices tested) for the functional and performance tests. It mentions "Functional and performance testing was conducted" but provides no numerical details.
- Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as these are lab/bench tests on manufactured devices, not clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of device performance, is established by adherence to engineering specifications and regulatory standards, not expert consensus on interpretations. The tests appear to be physical and chemical characterizations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for clinical data interpretation, not for objective physical/chemical device testing.
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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 MRMC study was done. This device is a physical medical instrument (a delivery sheath), not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for this device's performance tests is based on engineering specifications, manufacturing standards, and regulatory requirements. For example, a bond must withstand a "designated pull force," and residual levels "must be within limits."
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The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable.
Summary regarding AI/ML aspects:
The provided document is a 510(k) summary for a traditional medical device (Adelante® Breezeway Delivery Sheath) and details its functional and performance testing against established acceptance criteria. It does not involve any AI or Machine Learning components, therefore, questions related to AI studies, training/test sets, expert adjudication, or reader studies are not applicable to the information presented. The "study" referenced is a series of benchtop and lab tests to ensure the device meets its design specifications and safety requirements.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).