(185 days)
The Zyno Medical 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 Zyno Medical's I.V. Administration Set is a single use, latex-free, non-DEHP device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. Depending on configuration, the device may include the following components: tubing, protective cap(s), drip chamber (s) with spike, tubing, back check valve(s), needleless Y-site(s), slide clamp(s), roller clamp(s), pinch clamp(s), 0.22 micron filter or 1.2 micron filter, male luer lock (with cap), and pressure activated valve(s). Seven (7) representative administration sets and one (1) representative extension set are described in the application package to illustrate the device confiqurations.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Zyno Medical Administration Set (K120685).
Important Note: The provided text is a 510(k) summary for a medical device that is substantially equivalent to existing predicate devices. This type of submission relies heavily on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving novel performance against specific, quantifiable acceptance criteria in a clinical study. Therefore, many of the typical "AI/software device" study questions (like MRMC, training sets, expert ground truth) are not applicable to this type of submission.
Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) summary, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to predicate devices and meeting relevant safety standards. There aren't specific numerical performance metrics (like sensitivity/specificity for a diagnostic AI) listed in the summary.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Intended Use | "administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein." | This is met by the device's design and intended function, as described. The study demonstrated functional equivalence to predicate devices. |
| Material Composition | Constructed of high-grade extruded DEHP-free Polyvinyl Chloride (PVC). | Verified through material specifications. Substantially equivalent or identical to predicate devices. |
| Sterilization | Sterilized with Ethylene Oxide gas. | Verified through sterilization testing, ensuring sterility for patient safety. |
| Components | May include: tubing, protective cap(s), drip chamber (s) with spike, tubing, back check valve(s), needleless Y-site(s), slide clamp(s), roller clamp(s), pinch clamp(s), 0.22 micron filter or 1.2 micron filter, male luer lock (with cap), and pressure activated valve(s). | Device configurations are described and are identical/similar to predicate devices. Bench testing confirms components function as expected. |
| Safety and Effectiveness | Complies with safety and effectiveness criteria. | Demonstrated through bench testing, sterilization testing, and biocompatibility testing, showing substantial equivalence to predicate devices. |
| Performance Standards | "met its intended use requirements" and "complies with the safety and effectiveness criteria." | Non-clinical testing included evaluation studies and testing to relevant safety standards. Predicate devices were also tested for direct comparison where appropriate. |
| Substantial Equivalence | Demonstrated substantial equivalence to predicate devices: Baxter Healthcare Corporation (K981792), Amsino International, Inc (K973107), Health Line International Corporation (K060352). | This is the overarching "acceptance criterion" for a 510(k) submission like this. The device was found to be substantially equivalent based on intended use, basic design, function, materials, and non-clinical test results. |
Study Details (Applicable to this type of device/submission)
This 510(k) is for a basic medical device (intravascular administration set), not an AI/software device. Therefore, the study conducted is primarily non-clinical bench testing for substantial equivalence. Clinical studies in the AI/software sense were not necessary or performed.
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Sample size used for the test set and the data provenance:
- Sample Size: The document states, "When appropriate, predicate devices were tested using the exact same method and sample size, for direct comparison of results." However, the specific number of units tested for the Zyno Medical Administration Set itself is not explicitly stated in the provided summary. This information would typically be found in the full 510(k) submission, not the summary.
- Data Provenance: This refers to bench testing. The testing was conducted by or on behalf of Zyno Medical, LLC in Natick, MA, USA. It is prospective bench testing based on design specifications to confirm performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device like an I.V. administration set, "ground truth" isn't established by human experts in the same way it would be for an AI diagnostic. Ground truth is derived from engineering specifications, industry standards, and measurable physical properties (e.g., flow rates, leak integrity, material strength).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As there are no human interpretive "readings" involved, there's no adjudication method in play for the test set. Performance is objectively measured against 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:
- Not Applicable. This is a physical medical device, not an AI or software-assisted diagnostic tool. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device. The device's performance is standalone in the sense that its physical properties and function are tested independently of a human "loop" for its intended use (fluid administration).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's testing is based on engineering specifications, recognized industry standards, and performance characteristics of legally marketed predicate devices. For example, ground truth for sterility is a sterile state, ground truth for material properties is adherence to chemical/physical specifications, and ground truth for functional performance (e.g., integrity, flow) is meeting pre-defined acceptable ranges.
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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.