(242 days)
The Hickman® TriFusion™ Triple Lumen Long-Term Central Venous Catheter is indicated for use in attaining short term or long term vascular access for intravenous infusion therapy and blood sampling via the internal jugular vein, external jugular vein, and subclavian vein. All Hickman® TriFusion™ catheters are designed for apheresis, and the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as blood withdrawal. The Hickman® TriFusion™ catheter incorporates three large, equal size lumens appropriate for apheresis procedures.
The Hickman® TriFusion™ Catheters are open-ended triple lumen radiopague polyurethane catheters. The Hickman® TriFusion™ Catheters are 12 Fr triple lumen catheters with up to 27 cm insertion length. The Hickman® TriFusion™ Catheters have three equal sized lumens with the distal lumen extending beyond the proximal lumens. The proximal end of the Hickman® TriFusion™ Catheter consists of three Luer connectors, occlusion clamps, and priming volume ID tags. Catheters are provided sterile in two kit configurations, an Intermediate Tray and a Microintroducer (MI) Tray.
The document describes a 510(k) premarket notification for the "Hickman® TriFusion™ Catheter" (K172511). This is a medical device, and the evaluation focuses on its substantial equivalence to a predicate device, rather than a standalone study proving novel performance against clinical acceptance criteria.
Therefore, the requested information on acceptance criteria, reader studies, and training set details as typically applied to AI/software as a medical device (SaMD) are not explicitly present in the provided text. The document details verification tests to ensure the device meets specified engineering and biocompatibility standards, not clinical performance acceptance criteria in the context of diagnostic accuracy or comparative effectiveness with human readers.
However, I can extract the information that is present, aligning with your request as best as possible given the nature of the document.
Summary of Device Acceptance Criteria and Performance (Based on Verification Testing):
The "acceptance criteria" for this device are implicitly tied to passing the various engineering and biocompatibility verification tests, demonstrating that it performs as intended and is safe. The "reported device performance" is that the device meets these standards and is "substantially equivalent" to its predicate device. Specific quantitative acceptance criteria or performance metrics beyond passing are not generally outlined for these types of mechanical devices in this format.
| Acceptance Criteria (Implied by Test) | Reported Device Performance |
|---|---|
| Catheter Assembly Burst Strength | Met Bard internal standards and procedures |
| Catheter Assembly Tensile | Conformed to ISO 10555-1:2013 |
| Catheter Joint Durability Leak Test | (Test conducted) |
| Luer Configuration: Luer Gauging | (Test conducted) |
| Luer Configuration: Liquid Leak | (Test conducted) |
| Luer Configuration: Air Leak | (Test conducted) |
| Luer Configuration: Unscrewing Torque | Conformed to ISO 594-1:1986 |
| Luer Configuration: Ease of Assembly | (Test conducted) |
| Luer Configuration: Resistance to Overriding | Conformed to ISO 594-2:1998 |
| Luer Configuration: Stress Cracking | (Test conducted) |
| Luer Configuration: Separation Force | (Test conducted) |
| Cuff Tensile | Conformed to ISO 10555-1:2013 |
| Tip Tensile | (Test conducted) |
| Gravity Flow | Same as predicate (e.g., 115 ml/min for Lumen with White Clamp) |
| Catheter Stiffness | (Test conducted) |
| Priming Volume | Conformed to FDA Guidance 1995 |
| Catheter Collapse | (Test conducted) |
| Radiopacity | Conformed to ASTM F640:2012, ISO 10555-1:2013, FDA Guidance 1995 |
| Biocompatibility (Cytotoxicity) | Conformed to ISO 10993-5:2009 |
| Biocompatibility (Sensitization) | Conformed to ISO 10993-10:2010 |
| Biocompatibility (Intracutaneous Reactivity) | (Test conducted) |
| Biocompatibility (Acute Systemic Toxicity) | Conformed to ISO 10993-11:2006 |
| Biocompatibility (Material-Mediated Pyrogenicity) | (Test conducted) |
| Biocompatibility (Subchronic Toxicity) | Conformed to ISO 10993-11:2006 |
| Biocompatibility (Genotoxicity) | Conformed to ISO 10993-3:2003 |
| Biocompatibility (Implantation) | Conformed to ISO 10993-6:2007 |
| Biocompatibility (Hemocompatibility) | Conformed to ISO 10993-4 (2002, amended 2006) |
| Sterilization (Ethylene Oxide) | Validated per ANSI/AAMI/ISO 11135, AAMI TIR28:2016 |
| Sterilization (Residuals) | Conformed to ISO 10993-7:2008 |
| Bacterial Endotoxins | Conformed to ANSI/AAMI ST72, USP |
Detailed Information as Available from the Document:
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A table of acceptance criteria and the reported device performance
- See table above. The "acceptance criteria" are implied by the standards and internal protocols to which the device was tested and found compliant. The "reported device performance" is that it "meets the requirements" and demonstrates "substantial equivalence" to the predicate. Specific numerical performance targets for each test are not provided in this summary. For "Gravity Flow Rates," a specific metric for the predicate device is provided (e.g., 115 ml/min for a specific lumen), and the subject device is stated to be "Same as predicate," implying it also achieved these rates.
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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 describes verification tests for a physical medical device (catheter) to ensure it meets engineering and biocompatibility standards. It does not refer to a "test set" in the context of clinical image data or a dataset for an algorithm.
- Sample sizes for individual engineering or biocompatibility tests are not disclosed in this summary.
- Data provenance (country of origin, retrospective/prospective) is not applicable or provided for these types of device verification tests.
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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 question is not applicable to the type of device and study described. There is no "ground truth" established by experts in a clinical context for this physical catheter's performance evaluation. The ground truth for engineering tests is typically defined by the test standard itself (e.g., a specific pressure for a burst test, or a specific chemical concentration for a biocompatibility test).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable to the device and study described. Adjudication methods are typically used in clinical trials or reader studies where human interpreters make subjective assessments.
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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 is not applicable. This document pertains to a physical medical device (catheter) and its substantial equivalence evaluation, not an AI/SaMD.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable. This document pertains to a physical medical device (catheter), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- As described in point 3, this concept isn't directly applicable for a physical device's engineering and biocompatibility testing. The "ground truth" for verifying the device essentially aligns with whether it meets the specifications and passes the predefined tests according to the cited standards and internal protocols. For example, for "Catheter Assembly Burst Strength," the ground truth would be whether the catheter burst at or above a specified pressure.
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The sample size for the training set
- This is not applicable, as there is no algorithm or "training set" described.
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How the ground truth for the training set was established
- This is not applicable.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”