(129 days)
The Chariot™ Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the peripheral vasculature.
The Chariot™ Guiding Sheath is designed to perform as an introducer sheath for delivering interventional and diagnostic devices into the peripheral vasculature. The guiding sheath has a coiled shaft design and comes with a straight (ST) or preformed multipurpose (MP) tip shape. It is equipped with a cross-cut hemostatic valve or Tuohy-Borst adapter to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast medium. It is also packaged with a dilator to facilitate delivery over a guidewire. The guiding sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The outer surface of the guiding sheath has a hydrophilic coating from the distal tip to approximately 9 cm from the hub. The distal tip has a radiopaque marker band approximately 6 mm from the distal edge, to help with guiding sheath placement. A copolyester elastomer hub is over molded onto the proximal section of the guiding sheath. It incorporates a luer fitting which serves as a junction to the hemostatic valve.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Chariot Guiding Sheath:
This document is a 510(k) summary for a medical device called the "Chariot Guiding Sheath." The summary outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device, as required for FDA clearance.
Important Note: The provided document describes physical and functional performance tests for a medical device (guiding sheath), not a diagnostic or AI-driven device. Therefore, many of the requested categories (like "Number of experts used to establish ground truth," "Adjudication method," "MRMC study," "Standalone AI performance," "Ground truth type," and "Training set ground truth") are not applicable to this type of device and study. The criteria and studies are focused on physical properties, biocompatibility, and functional performance.
Acceptance Criteria and Reported Device Performance
The provided text does not present a formal table of acceptance criteria with specific numerical targets and corresponding device performance values. Instead, it describes various tests performed and states that the results "provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." It also notes: "No new safety or performance issues were raised during the testing."
However, based on the listing of "in-vitro performance tests," we can infer the tested parameters, which implicitly represent the performance areas that needed to meet acceptable standards.
| Acceptance Criteria Area (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Dilator Entry Profile | Conforms to requirements |
| Sheath Length | Conforms to requirements |
| Sheath Inner and Outer Diameter | Conforms to requirements |
| Dilator Inner and Outer Diameter | Conforms to requirements |
| Dilator Length | Conforms to requirements |
| Sheath Tensile | Conforms to requirements |
| Sheath to Hub Tensile | Conforms to requirements |
| Dilator to Hub Tensile | Conforms to requirements |
| Sheath Tip Tensile | Conforms to requirements |
| Hub Function and Luer Compatibility | Conforms to requirements |
| Valve Leakage | Conforms to requirements |
| Dye Flow Rate | Conforms to requirements |
| Sheath Burst Pressure | Conforms to requirements |
| Device Visual Appearance | Conforms to requirements |
| Radiopacity | Conforms to requirements |
| Sheath Kink Resistance | Conforms to requirements |
| Torque Strength | Conforms to requirements |
| Particulates | Conforms to requirements |
| Coating Integrity | Conforms to requirements |
| Cytotoxicity | No adverse findings (biocompatible) |
| Hemolysis (Extract Method) | No adverse findings (biocompatible) |
| Sensitization | No adverse findings (biocompatible) |
| Intracutaneous Reactivity | No adverse findings (biocompatible) |
| Acute Systemic Toxicity | No adverse findings (biocompatible) |
| Materials Mediated Pyrogenicity | No adverse findings (biocompatible) |
| Hemolysis (Direct Contact) | No adverse findings (biocompatible) |
| Partial Thromboplastin Time | No adverse findings (biocompatible) |
| In Vitro Hemocompatibility | No adverse findings (biocompatible) |
| Complement Activation | No adverse findings (biocompatible) |
| In Vivo Thromboresistance | No adverse findings (biocompatible) |
| USP Physicochemical | Conforms to requirements |
Study Details
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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 exact sample sizes used for each performance test. It only states that "bench testing" and "biocompatibility testing" were performed.
- Data Provenance: The studies are "bench testing" (in-vitro performance) and "biocompatibility testing." These are laboratory tests conducted on the physical device itself, not on patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" do not apply.
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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):
- N/A. This device is a physical medical instrument (a guiding sheath). Ground truth in the context of expert opinion for diagnostic accuracy is not relevant here. The "ground truth" for these tests would be established by validated test methods and physical measurements in a laboratory setting against engineering specifications and regulatory standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically for resolving discrepancies in expert opinion for diagnostic tasks. For physical device testing, results are typically objective measurements or observations against predefined pass/fail criteria.
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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:
- N/A. This is not an AI-assisted diagnostic device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This 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 consists of validated physical measurements and observations against established engineering specifications and regulatory standards (e.g., ISO, ASTM standards, and FDA guidance documents like "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"). Biocompatibility results are compared against established biological safety criteria.
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The sample size for the training set:
- N/A. This is not an AI/machine learning device; therefore, there is no "training set."
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How the ground truth for the training set was established:
- N/A. See point 7.
§ 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).