(34 days)
The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.
The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
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1. Acceptance Criteria and Reported Device Performance:
This document is a 510(k) clearance letter for an "I.V. Administration Set." It is a regulatory document stating that the FDA has reviewed the manufacturer's premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.
Crucially, this type of document is a clearance, not a study report. It does not contain acceptance criteria (e.g., specific performance metrics like sensitivity, specificity, or precision) or reported device performance data in the way one would see for a novel AI/ML device or a device requiring specific clinical efficacy or safety studies for its primary function.
For a traditional medical device like an I.V. Administration Set, "acceptance criteria" are implicitly met through the demonstration of substantial equivalence to a predicate device. This typically involves:
- Design and Material Specifications: The new device must meet comparable specifications to the predicate in terms of materials, dimensions, and construction.
- Performance Benchmarking: The new device must perform comparably to the predicate for its intended function (e.g., flow rate, pressure resistance, sterility, biocompatibility). These are usually physical and chemical tests rather than clinical performance studies with human subjects that yield metrics like sensitivity.
- Safety Standards: The device must comply with relevant safety standards (e.g., ISO standards for blood compatibility, sterility, and biocompatibility).
The document does not provide a table of acceptance criteria or reported device performance in the format requested because this information is part of the underlying 510(k) submission, not the public-facing clearance letter. The clearance letter only states that the FDA found the device "substantially equivalent" based on the submitted data.
If this were an AI/ML device submission, a table like the one requested would be a key component of the FDA's summary of the submission. Since it's a conventional I.V. administration set, the clearance is based on established equivalence.
Therefore, for questions 2-9, the answer directly from the provided text is that the information is not present, as this is a regulatory clearance letter, not a clinical study report.
Here's how to interpret the lack of information for a device like an I.V. Administration Set in the context of the questions:
2. Sample size used for the test set and the data provenance:
- Not Applicable (N/A) / Not provided in this document. For an I.V. Administration Set, "test sets" would refer to engineering and biocompatibility tests rather than clinical imaging data sets. The document is a regulatory decision, not a study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A / Not provided in this document. "Ground truth" in this context would likely refer to the established performance characteristics and safety profiles of predicate devices and the new device's ability to meet those. This would involve engineering experts, material scientists, and quality control professionals, not typically "radiologists" as the example suggests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A / Not provided in this document. Clinical adjudication methods are not typically part of the regulatory review for a simple administration set.
5. 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 study is relevant for AI-powered diagnostic devices where human interpretation is involved. This device is an I.V. administration set, which is a physical fluid delivery device, not a diagnostic or AI-assisted interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This question pertains to AI algorithms. The device is a traditional medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A / Not provided in this document explicitly. For this device, ground truth would be established through:
- Engineering specifications and test standards: Meeting validated physical and chemical properties (e.g., flow rate, pressure, material integrity).
- Biocompatibility testing: Compliance with ISO 10993 series standards.
- Sterility testing: Compliance with relevant sterility assurance levels.
8. The sample size for the training set:
- N/A. This question refers to training data for AI/ML models. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A. This question refers to AI/ML models. This is not an AI/ML device.
In summary: The provided document is a 510(k) clearance letter for a conventional medical device (I.V. Administration Set). It confirms regulatory approval based on "substantial equivalence" to existing devices, but it does not contain the detailed study data or performance metrics that would be found in a clinical study report, especially for an AI-powered device. The questions posed are highly relevant to AI/ML medical devices but are mostly not applicable to the information contained within this specific regulatory letter for a traditional device.
§ 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.