(90 days)
The Intravenous Power Injector Extension Set is intended to allow for the aspiration, injection or gravity/pump flow of fluids and may be used with low pressure power injectors having a maximum pressure setting of 325 psi and maximum flow rate of 10 ml/second. When used with a low pressure power injector, the Intravenous Power Injector Extension Set must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.
The Intravenous Power Injector Extension Set is an IV extension set intended for the aspiration and/or delivery of fluids and may be used with power injectors having a maximum pressure setting of 325 psi and maximum flow rate of 10 ml/second.
The Intravenous Power Injector Extension Set consists of polyvinyl chloride (PVC) tubing with non-DEHP plasticizer, configured with a male luer with hex lock hub on its distal end and a female luer lock on its proximal end. A slide clamp is positioned over the tubing to obstruct the fluid flow when needed by sliding the tubing into the narrow portion of the slide clamp.
The Intravenous Power Injector Extension Set is available in a configuration with and without a needle-free valve. The configuration with the valve allows access to the fluid delivery pathway without the use of a needle while maintaing a closed system for the fluid path. The valve is attached to the female luer lock.
The Intravenous Power Injector Extension Set is provided sterile for single use only. It is packaged with a commercially available skin protectant prep pad and a commercially available StatLock® stabilization device.
The provided text describes a medical device, the "Intravenous Power Injector Extension Set," and its substantial equivalence to predicate devices, but it does not contain the specific details required to complete all sections of your request. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence, primarily through performance bench testing rather than complex clinical studies involving human patients, AI, or expert adjudication.
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
Acceptance Criteria and Study Details (Limited Information Available):
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred from "adequate") |
|---|---|
| Functionality (e.g., fluid flow, pressure resistance) | Deemed "adequate for its intended use" |
| Integrity (e.g., no leaks, structural soundness) | Deemed "adequate for its intended use" |
| Safety (e.g., biocompatibility not explicitly stated but implied) | Deemed "adequate for its intended use" |
Study Details:
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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 mentions "performance (bench) testing." Bench testing typically involves a certain number of units of the device. However, the specific sample sizes for these tests are not provided in the 510(k) summary.
- Data provenance is not specified beyond "Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, Georgia 30014 USA." This implies the testing was conducted by the manufacturer, likely in the US, but whether it's prospective or retrospective isn't relevant for bench testing.
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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 this type of device and study. The testing described is "performance (bench) testing" for a physical medical device (an IV extension set). Ground truth for such a device would be established through a pass/fail criteria based on engineering specifications and regulatory standards, not through expert opinion on clinical findings.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are relevant for studies involving subjective assessments or disagreements in clinical interpretations (e.g., imaging studies). Bench testing involves objective measurements against predefined specifications.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for an intravenous extension set. The device is a physical product, not an AI or diagnostic tool that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" for the performance testing would be engineering specifications and regulatory standards for characteristics like pressure resistance, flow rates, luer lock integrity, and material compatibility. This is inferred from the mention of "Accepted scientific methods, such as performance (bench) testing, do exist for assessing the effect of the differences in characteristics."
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The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI device or a model being trained.
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How the ground truth for the training set was established:
- This is not applicable for the same reason as above.
§ 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.