(28 days)
The nextaro® v, 20/20 is indicated for the transfer and mixing of drugs contained in vials.
The nextaro® v, 20/20 is a sterile-packaged transfer device with ventilation on solvent side with built-in particle filter (15µm nominal) installed on solvent and drug side and a female Luer-Lock adapter for the connection of a single-use syringe for a low-particle withdrawal of the prepared drug solution.
The nextaro® v, 20/20 consists of two components already assembled (screwed together) in the delivery condition. Each of the components has a plastic spike which is used to perforate the seals of a solvent vial, or lyophilizated pharmaceutical vial, respectively. The components have a male and female Luer adapter to create an air-tight inner media-carrying system with open ends at the spikes.
Both components are equipped with a filter element to prevent particles (fragments of vial seals, undissolved pharmaceutical) from being administered into the patient's circulatory system.
To be used as intended, the spike of the blue ("upper") part of the nextaro® v, 20/20 is used to perforate the seal of the solvent vial. The assembly is flipped vertically and the spike of the white ("bottom") part of the device is used to perforate the seal of the pharmaceutical vial. The solvent transfer process starts immediately due to the vacuum in the pharmaceutical vial.
The spike of the upper part has two lumen allows air to enter the solvent vial so that ventilation takes place during the transfer. The other lumen ensures that the solvent is transferred to the pharmaceutical vial.
After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, the blue component of the device is removed from the white part by unscrewing, a standard syringe with a male Luer is attached to the exposed female Luer of the device to aspirate the prepared solution.
The provided text describes a 510(k) premarket notification for a medical device called nextaro® v, 20/20. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device (nextaro® Transfer System).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the "Testing verified that all acceptance criteria were met." However, it does not provide the specific numerical acceptance criteria for each test or the exact performance values observed for the proposed device (nextaro® v, 20/20). It only lists the tests performed and the standards used.
| Test Name | Testing Standard | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document, but affirmed as "met acceptance criteria") |
|---|---|---|---|
| Penetration force | ISO 22413 (using a test procedure outlined in Annex B of ISO 8536-2) | Not provided in document | Met acceptance criteria |
| Fragmentation | ISO 22413 | Not provided in document | Met acceptance criteria |
| Transfer performance (practical transfer and residual volume) | Internal performance standard | Not provided in document | Met acceptance criteria |
| Verification of the design specification for Transfer devices with housing | ISO 22413 | Not provided in document | Met acceptance criteria |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample sizes used for any of the performance tests.
The provenance of the data (e.g., country of origin, retrospective or prospective) is not mentioned.
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 document describes performance testing of a physical medical device (intravascular administration set), not software or an AI algorithm requiring expert ground truth for interpretation. The tests mentioned are physical and functional assessments.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging AI devices to assess the impact on human reader performance. The device in question is a physical transfer system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone study was not done. This concept is relevant for AI algorithms. The nextaro® v, 20/20 is a physical medical device, not an AI algorithm. Its performance is inherent to its design and function.
7. The Type of Ground Truth Used:
For the performance tests mentioned (Penetration force, Fragmentation, Transfer performance, Design verification), the "ground truth" would be established by the defined specifications and requirements of the relevant ISO standards (ISO 22413, ISO 8536-2) and the internal performance standard. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic tools, but rather objective measurements against pre-defined engineering and safety limits.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 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.