(71 days)
The Sidekick® and Usher® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.
The Sidekick® and Usher® Support Catheters are single lumen catheters with a standard luer fitting hub and separate attachable hemostatic valve. The catheters are recommended to support the Crosser® CTO Recanalization Catheters 14S/14P and S6.
The Sidekick® Support Catheter is available in straight, angled, tapered and non-tapered configurations in 70cm and 110cm effective lengths. The Usher® Catheter is tapered and is available in straight and angled configurations in 83cm effective lengths. The Sidekick® and straight Usher® Catheters have a single radiopaque marker 1mm from the distal tip. The angled Usher® Support Catheter configurations have three radiopaque markers at the distal tip for enhanced visualization of the catheter tip and angle under fluoroscopy. The most proximal radiopaque marker is located 15mm from the distal tip.
The product hub identifies SD for Sidekick® Catheter, USH for Usher® Catheter, A for Angled and T for Tapered; in addition to the sheath profile and effective length in centimeters. A guidewire introducer is provided to facilitate the guidewire passage through the optional hemostatic valve. The guidewire introducer shaft color matches the shaft color of the recommended support catheter.
The provided text describes the Sidekick® and Usher® Support Catheters and their 510(k) submission for substantial equivalence. It outlines various performance tests conducted to demonstrate their safety and effectiveness compared to predicate devices. However, the document does NOT contain information related to an AI/ML powered device, therefore no information about acceptance criteria or studies based on AI model performance are relevant.
Table of Acceptance Criteria and Reported Device Performance
The document describes several in vitro tests and biocompatibility tests conducted, and it generally states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Sidekick® and Usher® Support Catheters are comparable to the predicate devices and performs at least as safely and effectively as the legally marketed device." and that the devices "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum leak rate) and the reported device performance values against these criteria are not detailed in the provided 510(k) summary. The document simply lists the types of tests performed.
| Test Category | Specific Test | Acceptance Criteria (Not Detailed in Document) | Reported Device Performance (Not Detailed in Document) |
|---|---|---|---|
| Mechanical/Physical | Ablation Efficiency | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) |
| Catheter Burst | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Catheter Leak | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Catheter Inner Diameter | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Catheter Outside Diameter | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Catheter Effective Length | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Catheter Hub Testing | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Hub Leak Testing | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Hub Luer Taper | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Kink Resistance | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Track Without Damage | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Tensile Strength | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Delivery of Recommended Devices | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Tracking Force | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Catheter Tip Visualization | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Ease of Guidewire Loading | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Particulate Evaluation | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Coating Integrity | (Implicit: comparable to predicate) | (Implicit: comparable to predicate) | |
| Packaging | Pouch Visual Inspection | (Implicit: per internal stability program) | (Implicit: per internal stability program) |
| Dye Penetration | (Implicit: per internal stability program) | (Implicit: per internal stability program) | |
| Pouch Tensile | (Implicit: per internal stability program) | (Implicit: per internal stability program) | |
| Biocompatibility | Cytotoxicity | (Implicit: compliant with ISO 10993-1) | (Implicit: compliant with ISO 10993-1) |
| Sensitization | (Implicit: compliant with ISO 10993-1) | (Implicit: compliant with ISO 10993-1) | |
| Intracutaneous Reactivity | (Implicit: compliant with ISO 10993-1) | (Implicit: compliant with ISO 10993-1) | |
| Acute Systemic Toxicity | (Implicit: compliant with ISO 10993-1) | (Implicit: compliant with ISO 10993-1) | |
| Pyrogen Testing | (Implicit: compliant with ISO 10993-1) | (Implicit: compliant with ISO 10993-1) | |
| Hemolysis | (Implicit: compliant with ISO 10993-1) | (Implicit: compliant with ISO 10993-1) | |
| Complement Activation | (Implicit: compliant with ISO 10993-1) | (Implicit: compliant with ISO 10993-1) | |
| In-vivo Thrombogenicity | (Implicit: compliant with ISO 10993-1) | (Implicit: compliant with ISO 10993-1) | |
| Shelf Life | Accelerated Aging | (Implicit: compliant with ASTM F1980-07) | (Implicit: compliant with ASTM F1980-07) |
The study proving the device meets acceptance criteria appears to be a series of in vitro performance and biocompatibility tests, as well as shelf-life stability testing. The document states that these tests were performed "Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures" and "in accordance with ISO 10993-1:2009".
Regarding the specific questions about AI/ML device testing criteria:
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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):
- This information is not applicable as the document describes a traditional medical device (catheter), not an AI/ML powered device that would use a test set of data. The "test set" in this context refers to the physical units of the catheters and packaging tested in the various in vitro and biocompatibility studies. The specific number of units tested for each in vitro test is not provided. The provenance of the data is that it was generated from "in vitro" testing and "in-vivo" biocompatibility testing (referring to animal studies, typically).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable as the device is not an AI/ML powered diagnostic or image analysis tool. Ground truth is not established by human experts in this context. The "ground truth" for catheter performance is defined by engineering specifications, regulatory standards, and established test methods.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert panel reviews for AI/ML models to resolve discrepancies or establish ground truth. For physical device testing, the outcome is typically pass/fail based on objective measurements against pre-defined engineering specifications.
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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 information is not applicable. MRMC studies are designed to evaluate the impact of AI on human reader performance for diagnostic tasks. This device is a catheter, not an AI system for clinicians.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This device is a physical catheter, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this traditional device, the "ground truth" is based on engineering specifications, established regulatory standards (e.g., ISO, ASTM), and internal test protocols designed to ensure the device performs as intended and is safe. The comparison is made against the performance of predicate devices.
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The sample size for the training set:
- This information is not applicable. As this is not an AI/ML device, there is no "training set."
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How the ground truth for the training set was established:
- This information is not applicable, as there is no training set for a device of this nature.
§ 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).