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Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein.

Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein. The major modifications are: 1) extended selection of interchangeable components manufactured by additional suppliers; 2) additional contract manufacturer for the device: 3) Gamma Irradiation as additional sterilization method.

The Zyno Medical Administration Set is an intravenous administration set used to deliver fluids from a container to a patient's vascular system.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion of Nonclinical Testing: "All nonclinical testing results successfully demonstrated that the Zyno Medical Administration Sets performed as intended. Conclusions drawn from the nonclinical testing is that the testing data demonstrated that the device is as safe, as effective, and performs as well as the legally marketed device cleared in K120685."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each of the nonclinical tests (Biocompatibility, Pyrogenicity, Chemical, Microbial Ingress, DEHP, Sterilization, Bench, Integration, and Aging Testing). It only states that "extensive verification and validation testing" was performed and that "All results successfully met acceptance criteria."

The data provenance is not specified regarding country of origin, nor is it explicitly stated whether the data was retrospective or prospective. Given these are bench and lab-based tests for a medical device administration set, they are inherently prospective controlled tests conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The nonclinical tests appear to rely on established testing methods and standards (e.g., ISO standards, FDA guidance documents) rather than subjective expert consensus for establishing ground truth. Compliance with these standards is the metric, not expert opinion.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple experts. Since no human clinical studies were performed, and the testing was nonclinical (bench, lab-based), an adjudication method is not applicable and therefore not mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Zyno Medical Administration Sets." The submission focuses on demonstrating substantial equivalence through nonclinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable to the Zyno Medical Administration Sets. This device is a physical medical administration set, not an AI algorithm or software device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The device's performance stands alone in its physical and functional testing.

7. The Type of Ground Truth Used

The ground truth for the nonclinical tests was based on established industry standards and regulatory guidance. For example:

• Biocompatibility: Likely ISO 10993 series.
• Sterilization: Compliance with relevant sterility assurance levels.
• Physical/Mechanical Testing: Adherence to performance specifications to ensure proper function and safety.
• Integration Testing: Successful operation with the Z-800 series infusion pumps, demonstrating compatibility and correct fluid delivery.
• Pyrogenicity, Chemical, Microbial Ingress, DEHP, Aging: Compliance with specific test methods and limits defined in relevant standards and guidance documents (e.g., "Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]" and "Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions").

8. The Sample Size for the Training Set

This question is not applicable. The Zyno Medical Administration Set is a physical medical device, not a machine learning or AI model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set for a physical medical device.

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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.

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.

1. 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.

2. 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).

3. 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.

4. 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.

5. 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).

6. 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.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. See point 7.

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