(47 days)
The Ivenix LVP Epidural Administration Set with NRFit Connector (SET-0030-1) is intended for the controlled administration of pharmaceutical drugs or other therapies via the epidural pathway. The Ivenix LVP Epidural Administration Set is intended only for use with the Ivenix Infusion System in a hospital or outpatient.
The Ivenix LVP Epidural Administration Set with NRFit connector is comprised of a primary channel inlet tubing with a vented cap spike, a cassette which contains the fluid pumping mechanism and serves as the interface to the Ivenix LVP, and outlet tubing for connection to patient access. The end of the outlet tubing is fitted with a NRFit connector that is compliant to ISO 80369-6:2013.
The Ivenix LVP Epidural Administration Set with NRFit Connector provides a sterile fluid path for the delivery of pharmaceutical drugs and other therapies via the epidural pathway, provides a means for a clinician to aseptically connect to the fluid source and to the patient access site, and interfaces with the LVP to enable measurement and control of the fluid delivery.
The Ivenix LVP Epidural Administration Set with NRFit Connector is intended for use within the Ivenix Infusion System for controlled fluid delivery; it is not recommended for gravity infusion.
The provided text describes the 510(k) premarket notification for the Ivenix LVP Epidural Administration Set with NRFit Connector. It is not an AI/ML medical device, and therefore, many of the requested categories in your prompt are not applicable.
However, I can extract information related to the acceptance criteria and the studies performed to demonstrate substantial equivalence for this specific device, which is a hardware medical device (an administration set).
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance
The document presents performance testing results to demonstrate that the new subject device (with NRFit connector) is substantially equivalent to the predicate device (with luer connector). The "acceptance criteria" can be inferred from the standards and requirements the device was tested against.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Conformance to ISO 80369-6:2016 for NRFit connector | The NRFit connector was tested against the requirements of ISO-80369-6:2016, using the methods described in ISO-80369-20:2015, by an accredited test laboratory. All requirements were met. |
| Connector bond strength (meets ISO 8536-4:2019 requirements) | The epidural administration set with NRFit met the pull strength requirements of ISO 8536-4:2019. |
| Flow accuracy and shelf life meets functional requirements | The epidural administration set with NRFit connector met all functional requirements of the Ivenix epidural set with luer connector (the predicate device). |
| Microbial Ingress (maintains sterile fluid path) | The sterile fluid path of the administration set was challenged, under simulated worst-case conditions, at the patient access device, with four strains of bacteria (2 gram positive, 2 gram negative). Test results showed no growth of microorganism in any test article, demonstrating the integrity of the NRFit connector to maintain the sterile fluid path under simulated conditions of use. |
| Biocompatibility (equivalent to predicate device material) | The polymer material of the NRFit connector is identical to the standard luer connector of the predicate device in its final finished form in formulation, processing, sterilization, and geometry (with the exception of the geometry necessary to meet the requirements of ISO 80369-6:2016), and no other chemicals have been added. Therefore, no additional biocompatibility testing was conducted. (This implies an "acceptance" that no new testing was needed due to material equivalence). |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the sample sizes used for each of the bench tests (e.g., how many connectors were tested for bond strength or how many sets for flow accuracy). For microbial ingress, it mentions "any test article" implying multiple articles were tested for each of the four bacteria strains.
- Data Provenance: This was "bench testing" performed by the manufacturer, or by an "accredited test laboratory" on behalf of the manufacturer. This is typical for a hardware device submission. The data is prospective for the purpose of this submission. The country of origin is not specified but implicitly within the regulatory framework of the U.S. FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a hardware administration set, not an AI/ML algorithm that requires expert "ground truth" for diagnostic or predictive purposes. The "ground truth" here is objective physical and biological performance as measured against established standards.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML algorithm with subjective interpretations requiring adjudication.
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 a hardware device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device.
7. The type of ground truth used
The "ground truth" for this device is based on:
- International standards (ISO 80369-6:2016, ISO 80369-20:2015, ISO 8536-4:2019).
- Functional requirements for existing predicate devices.
- Objective measurements of physical properties (e.g., pull strength, flow accuracy, sterility maintenance).
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.