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510(k) Data Aggregation
(115 days)
The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is not indicated for use in the neurovasculature or the coronary vasculature.
The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and an introducer sheath. The Halo One Thin-Walled Guiding Sheath consists of a thin-walled (Up to 1F reduction in outer diameter compared to standard sheaths of equivalent French size) sheath made from braided single-lumen tubing, fitted with a female luer hub at the proximal end a formed atraumatic distal tip. The thin-wall design reduces the thickness of the sheath wall to help facilitate intravascular access from access sites including but not limited to radial, femoral, popliteal, and pedal. A detachable hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, is connected to the sheath luer hub. The sheath is supplied with a compatible vessel dilator that snaps securely into the hemostasis valve hub. The sheath has a strain relief feature located at the luer hub and a radiopaque platinum-iridium marker located close to the distal tip. The sheath is supplied in 4F, 5F and 6F compatible sizes and lengths of 90cm, 70cm, 45cm, 25cm and 10 cm. A vessel dilator which is 0.035" guide wire compatible is provided with each sheath. The 4F and 5F 10cm sheaths will also be offered with a 0.018" guide wire compatible dilator. All sheath configurations (lengths) are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The shorter sheath configurations (25cm and 10cm) are also provided without this coating.
The provided text is a 510(k) Summary for the Halo One Thin-Walled Guiding Sheath, a medical device. It describes the device, its intended use, and comparative testing to a predicate device to demonstrate substantial equivalence.
However, the questions you've asked about acceptance criteria and studies are typically related to Software as a Medical Device (SaMD) or AI/ML-driven devices. Such devices usually involve performance metrics like accuracy, sensitivity, and specificity, and their studies often involve expert readers, ground truth establishment, and statistical analysis like MRMC studies.
The Halo One Thin-Walled Guiding Sheath is a physical medical device (a catheter introducer). The "performance data" in this document refers to a series of in vitro (laboratory) tests to ensure the physical and material properties of the sheath meet design specifications and are safe for use. These are not clinical studies in the typical sense of evaluating diagnostic accuracy or reader improvement with an AI algorithm.
Therefore, many of your questions are not applicable to the information provided in this 510(k) summary for a physical medical device. I will address the applicable parts based on the document's content.
Analysis based on the provided document:
The document describes the Halo One Thin-Walled Guiding Sheath, a physical medical device, and its substantial equivalence to a predicate device. The performance data presented is for non-clinical in vitro testing and biocompatibility assessments, not a study evaluating human-in-the-loop performance or algorithmic accuracy.
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A table of acceptance criteria and the reported device performance:
The document lists numerous in vitro tests conducted. However, it does not provide a specific table of quantitative acceptance criteria and corresponding performance values for each test. Instead, it states a general conclusion: "The subject device, the Halo One Thin-Walled Guiding Sheath, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
Here's a list of the types of tests mentioned, which imply associated acceptance criteria:
Test Type | Implied Acceptance Criteria (General) | Reported Device Performance (General) |
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Visual Inspection (Outer Surface) | No visible defects, proper finish | Met all predetermined acceptance criteria |
Simulated Use | Proper function during simulated procedures (e.g., connection, flushing, guidewire compatibility) | Met all predetermined acceptance criteria |
Dimensional Testing | Conformance to specified dimensions (ID, OD, length, marker position) | Met all predetermined acceptance criteria |
Radiopacity | Sufficient visibility under fluoroscopy | Met all predetermined acceptance criteria |
Penetration Force of Dilator/Sheath | Within specified range for ease of entry | Met all predetermined acceptance criteria |
Trackability of Dilator and Sheath | Ability to navigate vasculature without unwanted resistance | Met all predetermined acceptance criteria |
Visual Inspection (Tip Rollback) | No unacceptable tip rollback/buckling | Met all predetermined acceptance criteria |
Bend Radius/Kink | Resistance to kinking within specified parameters | Met all predetermined acceptance criteria |
Valve Leak | No leakage from the valve | Met all predetermined acceptance criteria |
Sheath Leak | No leakage from the sheath | Met all predetermined acceptance criteria |
Sheath and Dilator Tensile Forces | Ability to withstand specified tensile forces without breaking | Met all predetermined acceptance criteria |
Hub Torque/Stress Cracking | Resistance to cracking under torque | Met all predetermined acceptance criteria |
Hub Stress Cracking (48 Hour Test) | Resistance to cracking over time | Met all predetermined acceptance criteria |
Packaging (Visual Inspection, Emission, Heat Seals, Seal Strength) | Intact packaging, sterile barrier integrity | Met all predetermined acceptance criteria |
Particulate Characterization | Particulate count within acceptable limits | Met all predetermined acceptance criteria |
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Material Mediated Pyrogenicity) | No adverse biological reactions, non-toxic, non-pyrogenic, compatible with blood | Met ISO 10993-1 requirements and passed tests |
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Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each in vitro test. For physical device performance testing, sample sizes are typically determined by statistical rationale for verification/validation (e.g., lot sizes, AQLs) but are not explicitly stated here.
- Data Provenance: The tests were performed "in vitro" (i.e., laboratory testing, not on human subjects or patient data). The testing was conducted as part of the device manufacturing and submission process, managed by ClearStream Technologies Ltd. in Ireland. The document does not specify a country of origin for the data beyond the manufacturer's location. These are non-clinical, prospective tests specifically conducted for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as the device is a physical medical device, not an AI/ML-driven diagnostic tool where "ground truth" is established by expert interpretation of medical images or data. The "ground truth" for this device would be its physical and material properties meeting engineering specifications and safety standards, confirmed through validated testing methods.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in medical image interpretation studies (e.g., radiology) to resolve discrepancies between readers' assessments. For in vitro physical device testing, results are typically objective measurements or pass/fail determinations based on established protocols.
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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:
This question is not applicable. An MRMC study is designed to evaluate the impact of a diagnostic tool (often AI) on human reader performance. This document pertains to a physical medical device, not a diagnostic AI tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This device is a physical medical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a physical medical device like this, the "ground truth" is typically defined by:
- Engineering Specifications: The design parameters the device must meet (e.g., diameter, length, tensile strength).
- Industry Standards: Compliance with relevant ISO standards (e.g., ISO 10993-1 for biocompatibility).
- Regulatory Guidance: Conformance to FDA guidance documents for medical devices.
- Risk Assessment: Demonstration that the device mitigates identified risks.
The biocompatibility "ground truth" was established based on ISO 10993-1, classifying the device and requiring specific biological tests (cytotoxicity, sensitization, etc.).
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The sample size for the training set:
This question is not applicable. There is no "training set" in the context of a physical medical device submission like this. Training sets are relevant for AI/ML algorithms that learn from data.
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How the ground truth for the training set was established:
This question is not applicable for the same reason as #8.
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