(261 days)
CADD® Yellow High Volume Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid/spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility).
The intended population is pediatrics and adults.
The CADD® Yellow High Volume Administration Set with NRFit™ connector device is designed to deliver local or regional anesthetics indicated for regional anesthetic infusion applications. The CADD® Yellow High Volume Administration Set with NRFit™ connector consists of components that have a non-Luer taper that allows connection of compatible components that, when used together as a system, help reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.
The NRFit™ connector of the neuraxial ISO 80369-6 compliant non-Luer system is incompatible with standard Luer tapers; therefore, the two systems cannot mate together effectively. The NRFit™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.
The CADD® Yellow High Volume Administration Set with NRFit™ connector devices are colorcoded yellow to indicate medication intended for regional anesthetic delivery.
All CADD® Yellow High Volume Administration Set with NRFit™ connector devices are intended for prescription use only.
The provided text describes a 510(k) premarket notification for a medical device called the "CADD® Yellow High Volume Administration Set with NRFit™ connector." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way one might evaluate a diagnostic or AI-driven device.
Therefore, the requested information points, particularly those pertaining to acceptance criteria and studies specifically designed to prove device performance in a comparative effectiveness or standalone clinical context with human interaction or disease detection, are not directly addressed in this type of regulatory submission. This submission primarily focuses on bench testing and biocompatibility to show that the new device, with its modified connector, is as safe and effective as the previously approved device.
However, I can extract information related to the non-clinical testing performed and the standards met, which serve as the "acceptance criteria" for this type of device modification.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (an administration set), the "acceptance criteria" are defined by compliance with recognized international standards for medical device safety, biocompatibility, and connector functionality, as well as pre-established internal specifications for certain tests. The "reported device performance" is that all testing met these pre-established specifications.
| Category | Specific Test / Criterion | Reported Device Performance (Met Acceptance Criteria) |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Met pre-established specifications |
| Sensitization (ISO 10993-10) | Met pre-established specifications | |
| Intracutaneous Reactivity (Irritation) (ISO 10993-10) | Met pre-established specifications | |
| Acute Systemic Toxicity (ISO 10993-11) | Met pre-established specifications | |
| Pyrogenicity (bacterial-mediated & material-mediated) | Met pre-established specifications | |
| Hemocompatibility (ISO 10993-4) | Met pre-established specifications | |
| Subchronic Toxicity (ISO 10993-11) | Met pre-established specifications | |
| Genotoxicity (ISO 10993-3) | Met pre-established specifications | |
| Extractables and Leachables (ISO 10993-17, ISO 10993-18) | Met pre-established specifications | |
| Toxicological Risk Assessment (ISO 10993-1) | Met pre-established specifications | |
| Particulates | Met pre-established specifications | |
| Ethylene Oxide Residuals (ISO 10993-7) | Met pre-established specifications | |
| Packaging | Sterile Barrier Integrity | Met pre-established specifications |
| Seal Strength | Met pre-established specifications | |
| Packaging Stability | Met pre-established specifications | |
| Distribution Simulation | Met pre-established specifications | |
| Device Performance | Connector compatibility and incompatibility (ISO 80369-1, -6) | Met pre-established specifications |
| Dimensional Testing | Met pre-established specifications | |
| Leakage | Met pre-established specifications | |
| Mechanical Requirements (resistance to cracking, tensile strength, over-riding threads, torque) | Met pre-established specifications |
The core "acceptance criterion" for the primary modification (the NRFit™ connector) is its compliance with ISO 80369-6:2016 (Small bore connectors for liquids and gases in healthcare Applications - Part 6: Connectors for Neuraxial Applications) and its intentional incompatibility with standard Luer connectors (addressed by adherence to ISO 80369-1:2010 for general requirements). The reported performance is that the device conforms to these standards and the connectors are not compatible with standard luer connectors, achieving the risk mitigation objective.
The remaining information requested is largely not applicable or not explicitly stated for this type of 510(k) submission, which evaluates a physical administration set largely through non-clinical (bench) testing and biocompatibility assessments, rather than clinical studies involving patient outcomes, diagnostic accuracy, or human reader performance.
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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)
- Not applicable / Not provided in the document. The testing described is primarily non-clinical (bench and lab testing for physical properties and biocompatibility). Sample sizes for these types of tests are typically determined by relevant ISO standards or internal quality procedures and are not usually detailed in this summary document. Data provenance is not specified for these lab 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)
- Not applicable. This device is a physical administration set, not a diagnostic tool requiring expert interpretation for ground truth establishment. Engineering and lab technicians perform the non-clinical tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for clinical studies, particularly those involving human reviewers of data like medical images. This document describes non-clinical testing.
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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 device is a medical administration set, not an AI-driven diagnostic or assistive technology for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria established by the international standards (e.g., ISO 80369-6 for connector dimensions and functionality, ISO 10993 series for biocompatibility) and internal engineering specifications. There is no expert consensus or pathology involved in this context.
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The sample size for the training set
- Not applicable. This is not a device that utilizes machine learning and therefore does not have a "training set."
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How the ground truth for the training set was established
- Not applicable. As above, no training set.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.