(296 days)
The ClariVein™ Infusion Catheter is intended for the infusion of physician-specified agents in the peripheral vasculature.
The ClariVein™ Infusion Catheter (ClariVein™-IC) is an infusion catheter system designed to introduce physician-specified medicaments into the peripheral vasculature. Infusion is through an opening at the distal end of the catheter and fluid delivery is enhanced by the use of a rotating dispersion wire to mix and disperse the infused fluid in the blood stream and on the vessel wall. The dispersion wire, connected to an interface cartridge for proximal connection to the motorized handle, extends through the catheter lumen. Prior to drug infusion the catheter sheath is inserted into the vasculature and once the catheter tip is positioned at the treatment site, the catheter sheath is retracted to expose the dispersion wire tip. Wire rotation is controlled by a 9V DC motorized Handle Unit. The Handle Unit also provides a grip and syringe holder to facilitate physiciancontrolled infusion.
The provided text describes the ClariVein™ Infusion Catheter and its non-clinical performance testing. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested about sample sizes, ground truth establishment, or multi-reader studies.
The document focuses on demonstrating substantial equivalence to predicate devices and adherence to general safety standards for infusion catheters.
Here's an attempt to extract the requested information based on the provided text, combined with an explanation of what is not present:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for performance metrics. Instead, it refers to industry standards and general performance adequacy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 10555-1 ("Sterile, Single-Use Intravascular Catheters - Part 1: General Requirements") | "ClariVein™-IC will be tested in accordance with ISO 10555-1" (This indicates a commitment to meet the standard, but no specific results are reported in this document.) |
| Adequate performance for: | "Additional testing (i.e., Dispersion Wire Tip Fatigue, Dispersion Wire Tip Tensile Test, System Simulated Procedure, and Wire Drive System Mechanical Strength) has already been conducted and shown that ClariVein™-IC performs adequately without failure." |
| - Dispersion Wire Tip Fatigue | Performed adequately without failure. |
| - Dispersion Wire Tip Tensile Test | Performed adequately without failure. |
| - System Simulated Procedure | Performed adequately without failure. |
| - Wire Drive System Mechanical Strength | Performed adequately without failure. |
Missing Information: Specific quantitative thresholds for "adequate performance" for each test are not provided. For example, what is the maximum acceptable fatigue, minimum tensile strength, or specific system performance metrics?
Study Information (Based on provided text)
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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):
- Sample Size: Not specified. The document mentions "additional testing" without giving specific units or quantities for the tests (e.g., number of catheters tested for fatigue).
- Data Provenance: Not specified. The testing is non-clinical, likely conducted by the manufacturer, but the location or whether it was prospective/retrospective is not mentioned.
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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 is not applicable as the "testing" described is non-clinical (mechanical and safety testing of the device itself) rather than clinical performance based on expert interpretation of medical data. There is no mention of human experts establishing ground truth for these non-clinical tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to adjudication in studies where human readers are interpreting medical data, which is not the type of study described here.
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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:
- Not applicable. This is a non-clinical 510(k) submission for an infusion catheter, not an AI or imaging device requiring MRMC studies.
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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 concensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" would be established by engineering specifications, material standards, and validated testing methodologies (e.g., fatigue cycles, force applied for tensile strength, simulated physiological conditions for system performance). There is no "expert consensus" in the medical sense or pathology data involved in these types of non-clinical tests.
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The sample size for the training set:
- Not applicable. This device is not an AI or machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).