(135 days)
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
| Acceptance Criteria (Category) | Reported Device Performance |
|---|---|
| Safety & Effectiveness | |
| Biocompatibility | Successfully met acceptance criteria. |
| Pyrogenicity | Successfully met acceptance criteria. |
| Chemical Testing | Successfully met acceptance criteria. |
| Microbial Ingress | Successfully met acceptance criteria. |
| DEHP Testing | Successfully met acceptance criteria. |
| Sterilization Testing | Successfully met acceptance criteria. |
| Functional Performance | |
| Bench Testing (physical & mechanical) | Successfully met acceptance criteria. |
| Integration Testing (with Z-800 series infusion pumps) | Successfully met acceptance criteria. |
| Aging Testing | Successfully met acceptance criteria. |
| Material & Design Standards | |
| Tubing Material | Approved Standard PVC (Same as predicate) |
| Single Use | Yes (Same as predicate) |
| Sterile | Yes (Same as predicate) |
| ISO 8536-4:2010 Compliant | Yes (Same as predicate) |
| ISO 10993 Compliant | Yes (Same as predicate) |
| Operation Mode | For use with Z-800 series of infusion pumps or gravity feed (Same as predicate) |
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.
§ 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.