(37 days)
The I.V. extension set with a 0.22 micron air venting filter is indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter.
The MICRO-VOLUME Extension Set product line consists of sterile, single use disposable devices indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter. These intravascular administration sets provide a clinician the ability to increase the distance between the patient and the fluid administration source. The overall set configuration consists of a female Luer connector, non-DEHP microbore tubing, a 0.22 micron hydrophilic filter, and a male Luer lock connector at the distal end of the set. The filter housing also contains a 0.1 micron hydrophobic filter which vents air to the atmosphere. The MICRO-VOLUME Extension Set with a 0.22 micron filter is designed to remove air and particulate matter and has a maximum pressure of 45 psi (2241 kPa). The product is sterile and non-pyrogenic.
The provided 510(k) summary (K113227) is for an intravenous administration extension set, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device testing, such as sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance, is not applicable to this submission.
The submission focuses on demonstrating substantial equivalence to a predicate device for a physical medical product. The "acceptance criteria" and "study" mentioned refer to non-clinical design verification tests for the physical components of the extension set.
Here's an analysis of the provided information, tailored to the nature of this medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "All test results meet the acceptance criteria." However, the specific acceptance criteria values for each test are not explicitly detailed in the provided document. The document lists the types of tests conducted.
| Test Type | Reported Device Performance |
|---|---|
| Bond Strength tests | Met acceptance criteria (specific values not provided in 510(k)) |
| Bond Pressure tests | Met acceptance criteria (specific values not provided in 510(k)) |
| ISO Luer Tests | Met acceptance criteria (specific values not provided in 510(k)) |
| Biocompatibility | Met acceptance criteria (specific values not provided in 510(k)) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as the described tests are for physical product components and not for an AI/ML algorithm's performance on a dataset. The tests would involve physical samples of the device components. Data provenance, in this context, would relate to the manufacturing and testing environment, not to patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the device is a physical product (IV extension set), not an AI/ML device requiring expert consensus for ground truth on patient data. Ground truth for physical tests would involve established engineering standards and validated measurement methods, not clinical experts.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Physical component tests typically rely on objective measurements against engineering specifications, rather than adjudicating subjective interpretations.
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
This information is not applicable as the device is a physical IV extension set, not an AI-assisted diagnostic or treatment device. MRMC studies are specific to evaluating the clinical impact of AI systems on human performance with medical images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical IV extension set and does not involve an algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" would be established by engineering specifications, international standards (e.g., ISO for Luer connections), and validated laboratory test methods. The tests (Bond Strength, Bond Pressure, ISO Luer, Biocompatibility) aim to ensure the device meets these pre-defined physical and safety criteria.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical IV extension set and does not involve an AI/ML training set. Design and manufacturing processes would involve samples for quality control and process validation, but this is distinct from AI/ML training data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as point 8.
Summary for K113227 (MICRO-VOLUME Extension Set):
This 510(k) submission is for a conventional Class II medical device – an intravenous administration extension set. The "acceptance criteria" and "study" refer to a series of non-clinical, benchtop, and biocompatibility tests designed to demonstrate the physical and safety performance of the device and its substantial equivalence to a predicate device. The document states that all conducted tests met their respective acceptance criteria, confirming the device's appropriate design for its intended use. There is no AI/ML component to this device, so questions related to AI/ML specific testing methodologies are not relevant.
§ 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.