(128 days)
The LifeGuard™ Safety Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood. The LifeGuard™ Safety Infusion Set facilitates safe removal of the needle by encapsulating the needle during vascular port de-accessing to help prevent needlestick injuries.
The LifeGuard™ Infusion Set is a standard 90° non-coring needle intravascular administration set with a sharps injury protection. The LifeGuard™ Infusion Set is designed for use with vascular access devices. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. The components that comprise the LifeGuard™ Safety Infusion Set includes the following: a PVC tubing set; a white clamp to prevent fluid flow; a universal female luer lock connector to connect to infusion/aspiration devices; a white cap to close the female luer; a winged needle holder to secure the infusion set to the patient with a pre-attached 90° non-coring needle to access the implanted port and allow the user to pull the needle up into the safety position; a needle trap encapsulates the needle after de-accessing the needle from the implanted port; and a needle guard shrouds the needle before use. Some models include a Ysite as an alternate female luer injection site with an additional white cap and white clamp to prevent fluid flow. A thermoformed tray with a heat sealed tyvek lid provides a sterile barrier. The LifeGuard™ Safety Infusion Set is fabricated from biocompatible, medical grade materials. The LifeGuard™ Safety Infusion Sets are supplied as sterile, non-latex, nonpyrogenic, intended for single use only and are manufactured out of non-DEHP PVC. De-accessing the needle is done as with any standard non-coring needle, using a one-handed (dominant hand) technique to remove the needle while stabilizing the port with the nondominate hand. As the needle is removed, the passive sharps injury protection feature is actuated by sliding the needle holder upward, · which encapsulates the needle within the needle trap.
The provided text describes a medical device, the LifeGuard™ Safety Infusion Set, and details its performance through a "Simulated Use Study". This study focuses on the effectiveness of the sharps injury protection feature.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Failure rate of sharps injury protection | Less than 1.1% (at 95% confidence) or less than 1.5% (at 99% confidence) |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: n=500 for the Simulated Use Study.
- Data Provenance: The document does not specify the country of origin. It is a "Simulated Use Study," implying controlled conditions rather than retrospective or prospective patient data from real-world usage.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide details on the number or qualifications of experts used to establish ground truth for this specific "Simulated Use Study." The study focuses on a measurable mechanical failure rate of the safety feature.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the test set. Given the nature of a "failure rate" for a mechanical safety feature, an adjudication process involving human interpretation is unlikely in the same way it would be for diagnostic imaging.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a mechanical infusion set with a safety feature, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable. The device is a physical medical device, not an algorithm. The "Simulated Use Study" evaluates the physical device's performance, which inherently includes human interaction (users pulling the needle up) to actuate the safety feature but measures the device's mechanical success.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the Simulated Use Study appears to be based on the direct observation and quantification of the mechanical failure of the sharps injury protection feature. There is no indication of expert consensus, pathology, or outcomes data being used to establish this specific ground truth. It's a binary outcome: the safety feature either successfully encapsulates the needle or it fails.
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The sample size for the training set:
- The document does not mention a "training set." The study described is a "Simulated Use Study" to test the performance of the final device, not to train a machine learning model.
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How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned in the context of this device's evaluation.
§ 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.