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The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices, is intended for the delivery of continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.

The CIMPAX® C-CAT catheter kit is a sterile, single use, closed tip, multi-perforated catheter with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. The kit is intended for adult patients requiring the delivery of contiguous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management or as perineural delivery. Routes of administration may be intraoperative or percutaneous. The device is intended to be used in healthcare /hospital facilities.

The CIMPAX® C-CAT catheter is a multi-perforated catheter supplied in a kit which contains components for catheter placement. The drug infusion segment is placed between the blue tip of the catheter and the first blue marking after the tip. The catheter is designed with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. Attached to the catheter is a standard female luer lock that is compatible with and can be used with infusion pumps as well as with syringes for bolus injections with standard make luer connections.

The catheter is placed usually through an incision or wound in order to provide continuous or intermittent administration of local anesthetic to the area affected. This allows only the local nerve endings (pain receptors) to be anesthetized as opposed to giving a systemic pain relief medication to the patient.

The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the CIMPAX C-CAT Anaesthesia Catheter kit. This document is a regulatory submission for medical devices, demonstrating substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria for an AI/ML product.

Therefore, the document does not contain any information related to:

• Acceptance criteria for an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity, AUC).
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test sets or data provenance for AI/ML model evaluation.
• Number of experts, qualifications of experts, or adjudication methods for establishing ground truth in the context of AI/ML.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML model evaluation (e.g., pathology, outcomes data).
• Sample size for training sets or how ground truth was established for training sets in an AI/ML context.

The document discusses acceptance criteria and studies, but these relate to the physical and biological safety and performance of a medical catheter, not an AI/ML device. For example, it mentions:

• Non-Clinical Testing: Bench testing including mechanical and performance testing (e.g., peak tensile force, burst pressure, kink testing, liquid leakage under pressure, radiopacity, flow testing), biocompatibility, sterilization, packaging, and shelf-life testing.
• Biocompatibility Testing: According to ISO 10993-1 series, covering cytotoxicity, sensitization, irritation, systemic toxicity, Ames Test, in vitro mammalian chromosome aberration, hemolytic properties, and material mediated rabbit pyrogen.
• Flow Test: Performed according to DS/EN 1618, measuring water flow through the catheter.
• Tensile strength: Tested in accordance with ISO 10555-1.
• Packaging: Complies with ISO 11607-1:2014 and EN 865-5:2009.
• Stability: Tested according to ASTM F 1980 Accelerated Aging and ISO 11607-1:2009.
• Sterilization: Method is Ethylene Oxide (EO), complying with EN ISO 11135-1.

In summary, the provided text describes the regulatory process for a physical medical device (an anesthesia catheter) and outlines its non-clinical performance and safety testing to demonstrate substantial equivalence, not information relevant to the performance and acceptance of an AI/ML device.

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