(132 days)
The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.
The SoloPath™ Balloon Expandable TransFemoral Introducer is an intravascular catheter introducer and is Intended for travel over a 0.038″ or smaller guidewire. The device includes a flexible Sheath composed of reinforced polymer that is compressed, folded and wrapped around a central, removable balloon dilatation catheter (the Expander). One radiopaque marker is located on the Sheath to indicate the end of the expandable portion of the Sheath.
The Expander balloon is non-compliant and size limited. The Expander has both an inflation lumen and a guidewire lumen. The Expander is configured to be used with standard inflation devices having an appropriate pressure rating, a male Luer lock coupler, and a capacity of 25-CC.
The Sheath is terminated, at its proximal end, by a hub having a straight through hemostasis port capable of accepting catheters equal to the full sheath inner diameter. An aspiration and infusion port, terminated with a 3-way stopcock, permits infusion of heparinized saline into the central port of the Sheath hub, prior to and during the procedure. The Expander incorporates a T connector, the through lumen port being terminated with a hemostasis valve for guidewire introduction, while the right angle port is for inflation of the Expander balloon. A separate aspiration and infusion side port, terminated with a 3-way stopcock, is also provided which permits fluid transfer into or from the guidewire lumen of the Expander.
This document describes a 510(k) premarket notification for a medical device, not a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria, study design for AI evaluation, and ground truth establishment is not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The device described is the SoloPath™ Balloon Expandable TransFemoral Introducer, intended for use in the femoral artery. The acceptance criteria are based on demonstrating substantial equivalence to a predicate device (SoloPath™ Balloon Expandable TransFemoral Introducer, K092014) and satisfying product design specifications for its intended use through in vitro bench testing.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | Per ISO 10993-1, including: Cytotoxicity, Complement Activation, PTT, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen, Hemolysis | All biocompatibility tests were conducted to support the safety and effectiveness of the device. (Implied: Passed/Met criteria for substantial equivalence) |
| Leakage Testing | Hemostasis and Dilator Leakage Testing | Conducted to support safety and effectiveness. (Implied: Passed/Met criteria for substantial equivalence) |
| Design/Functional Testing | Bend Testing, Inflation/Deflation Testing, Tensile Testing | Conducted to support safety and effectiveness and demonstrate equivalence to the predicate device. (Implied: Passed/Met criteria for substantial equivalence) |
| Overall Conclusion | "The results of testing demonstrate that the SoloPath™ Balloon Expandable TransFemoral Introducer is substantially equivalent to the predicate device in design, function, and indications for use." |
Study Information (as applicable to this type of device submission):
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of units or samples used for each in vitro bench test (e.g., how many devices were bent, inflated, or tested for tensile strength).
- Data Provenance: The tests are in vitro bench tests, meaning they were conducted in a laboratory setting, not on patient data. There is no information regarding country of origin or whether it's retrospective or prospective, as these terms are typically associated with clinical studies involving human subjects.
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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 to this type of device submission. The "ground truth" for in vitro bench testing typically involves predefined engineering specifications, regulatory standards (like ISO 10993-1), and performance thresholds. There's no mention of experts establishing a "ground truth" in the diagnostic sense.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are relevant in studies where multiple human readers or algorithms interpret data and discrepancies need to be resolved. For in vitro engineering tests, the results are typically quantitative measurements against known standards.
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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 is not applicable. This submission is for a physical medical device (catheter introducer), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. As stated above, this is not an AI 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 testing is based on pre-defined engineering specifications, international standards (like ISO 10993-1), and successful comparison to the performance characteristics of the legally marketed predicate device. There is no "expert consensus" or "pathology" relevant to the performance evaluation described.
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The sample size for the training set:
- This is not applicable. There is no "training set" as this is not a machine learning or AI device.
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How the ground truth for the training set was established:
- This is not applicable. No training set was used.
§ 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).