(120 days)
CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures. The catheters can also be used to exchange one guidewire for another or to provide support to facilitate the placement of guidewires.
The CES Infusion Catheters contain a single lumen and a variable stiffness shaft in order to traverse and deliver agents to the coronary, peripheral and neurovasculatures. The outside of the shaft includes a hydrophilic coating and the lumen is lined with PTFE in order to increase lubricity and trackability. The proximal shaft is reinforced with a stainless steel braid to enhance pushability.
The provided text describes a medical device (CES Infusion Catheters) and its clearance through the FDA 510(k) pathway. This pathway establishes substantial equivalence to existing predicate devices, rather than proving device performance against specific, pre-defined acceptance criteria through a dedicated study.
Therefore, the information required to answer your questions regarding acceptance criteria, study details, and ground truth establishment is not available in this document.
Here's a breakdown of why this information is missing based on the provided text:
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Acceptance Criteria and Reported Device Performance:
- The document states: "Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act."
- This explicitly indicates that there are no formal performance (acceptance) criteria set by the FDA for this device type at the time of clearance. The clearance is based on substantial equivalence to predicate devices, implying similar safety and effectiveness without needing to meet new, specific performance metrics.
- The document's "Biocompatibility" section states "All applicable biocompatibility tests were successfully performed on the CES Infusion Catheters." While this indicates successful testing, the specific acceptance criteria for these tests (e.g., cytotoxicity levels, irritation scores) are not detailed, nor are the quantitative results.
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Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set):
- The 510(k) pathway typically relies on comparison to existing predicate devices and may involve bench testing, animal studies, or limited human clinical data if necessary to demonstrate equivalence. It does not inherently require a prospective clinical study with a control group, expert adjudication, or formal ground truth establishment in the manner of a novel device approval that needs to prove efficacy against specific endpoints.
- The document only mentions "Biocompatibility" tests. It does not describe any other studies that would generate the kind of performance data (e.g., sensitivity, specificity, accuracy) typically associated with AI/algorithm performance.
- There is no mention of a test set, training set, experts, or ground truth in the context of device performance.
In summary, the provided document is a 510(k) clearance letter and associated summary information, which focuses on establishing "substantial equivalence" of a medical device to existing predicate devices. It does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies) that would be present for a clinical trial or an AI/software device performance study proving efficacy against defined endpoints.
§ 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).