(150 days)
For the administration of fluids from a container into the patient's vascular system through a vascular access device.
The proposed devices consist of Intravascular Administration Sets. They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.
The proposed devices consist of a spike tip protector, non-vented spike, drip chamber, tubing, check valve, slide clamp, regulating roller clamp, Clearlink Luer activated valve (LAV), Interlink injection site, 3 Port Manifold, Stopcock, female Luer, two-piece male Luer lock and male Luer cap. The proposed devices are used to administer solution directly from a container to a patient vascular system. These sets can be used with or without a Baxter infusion pump.
This document is a 510(k) summary for the Baxter Healthcare Corporation's Intravascular Administration Sets with Stopcock and Manifold (K223175). It does not contain information about a study comparing device performance against specific acceptance criteria in the context of an AI/human-in-the-loop setting. This type of submission is for medical devices that are substantially equivalent to a predicate device, and the focus is on demonstrating that the new device's technological characteristics do not raise new questions of safety or effectiveness.
Therefore, many of the requested items (e.g., reporting device performance against acceptance criteria, sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not present in this document because they are generally applicable to the evaluation of AI/ML-enabled medical devices or those requiring de novo classification, not typical 510(k) submissions for physical devices like administration sets.
However, I can extract information related to the device's performance testing which demonstrates its safety and effectiveness, as well as the types of studies conducted for substantiation.
Here's an attempt to answer based on the provided text, acknowledging that many requested fields are not applicable:
1. A table of acceptance criteria and the reported device performance
The document states: "All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use." However, specific quantitative acceptance criteria and corresponding reported device performance values are not explicitly provided in a table format in this summary. Instead, it lists the types of tests performed and the standards they conform to.
| Test Type | Standard / Description | Acceptance Status (as stated in document) |
|---|---|---|
| Luer Tests | ISO 80369-7 "Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications" | Met Acceptance Criteria |
| ISO 594-1 "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements" | Met Acceptance Criteria | |
| ISO 594-2 "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings" | Met Acceptance Criteria | |
| Biocompatibility | ISO 10993-1, Biological Evaluation of Medical Devices and FDA-2013-D-0350 Guidance for Industry and FDA Staff. Tests included: Cytotoxicity, Sensitization, Intracutaneous (Irritation) Reactivity, Acute Systemic Toxicity, 30 Day Systemic Repeat Dose Toxicity Study, Material Mediated Pyrogen, Hemolysis. | "Biocompatible and appropriate for its intended use" |
| Particulate Matter | USP Particulate Matter in Injections | Met USP Acceptance criteria |
| Sterility | ANSI/AAMI/ISO 11137-2, "Sterilization of health care products - Radiation-Part 2: Establishing the sterilization dose." Doses typically 14.3 - 22.4 kGy, validated for 10^-6 SAL. | Met Acceptance Criteria |
| Shelf Life | Aging testing performed. | Supported a 2-year shelf-life claim |
| Microbial Ingress Testing | Baxter's testing strategy (previously cleared under K203609) simulating clinical use for spike, injection sites, and Luer Connector Sites. | Met Acceptance Criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the various bench tests. Data provenance in terms of country of origin is not mentioned, and the tests are described as non-clinical bench tests or evaluations of materials. This is not a study involving human patient data, so "retrospective or prospective" doesn't apply in the same way as for AI/clinical studies.
3. 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 is not an AI/ML device requiring expert ground truth for image/data interpretation. Ground truth for these tests is based on adherence to established international standards (ISO, USP) and validated testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring adjudication of expert interpretations for ground truth.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of these Intravascular Administration Sets is established through adherence to recognized international standards and validated scientific testing protocols. For example:
- Luer connectors: Conformance to ISO 80369-7, ISO 594-1, ISO 594-2.
- Biocompatibility: Conformance to ISO 10993-1 and FDA guidance.
- Particulate matter: Conformance to USP .
- Sterility: Conformance to ANSI/AAMI/ISO 11137-2.
- Microbial ingress: Baxter's internally validated "testing strategy."
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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.