(12 days)
The Arisure™ Closed Vial Adapter is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The Arisure™ Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
The Arisure Closed Vial Adapter is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The Arisure Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
The Arisure Closed Vial Adapter is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.
The Arisure™ Closed Vial Adapter's acceptance criteria and the study proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Characteristic | Arisure™ Closed Vial Adapter Performance | Equivalence to Predicate (Y/N) |
|---|---|---|
| Misuse Test | Tested and meets requirements | Y |
| Detachment Force (Horizontal) | Tested and meets requirements | Y |
| Detachment Force (Vertical) | Tested and meets requirements | Y |
| Flow Rate | Tested and meets requirements | Y |
| Trapped Air Volume | Tested and meets requirements | Y |
| Residual Fluid | Tested and meets requirements | Y |
| Vial attachment force | Tested and meets requirements | Y |
| Vial pressure | Tested and meets requirements | Y |
| Valve Detachment Torque | Tested and meets requirements | Y |
| Biocompatibility (ISO 10993) | Meets biological requirements (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Hemolysis, Materials Mediated Pyrogenicity) | Y |
| Chemical Compatibility | Tested and meets requirements | Y |
| Sterile package integrity testing | Tested and meets requirements | Y |
| Distribution testing | Tested and meets requirements | Y |
| Shelf Life Testing | Tested and meets requirements | Y |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., how many devices were tested for "Misuse Test" or "Flow Rate"). It generally states that "The following tests were conducted on the Arisure Closed Vial Adapter device to demonstrate equivalency of the performance characteristics to the predicate device(s)."
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied that these are lab-based performance tests related to the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a medical accessory (vial adapter), and the tests described are physical, chemical, and biological performance tests, not clinical evaluations requiring human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable, as the tests are objective performance metrics rather than assessments requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, and the Arisure™ Closed Vial Adapter is a medical accessory.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the Arisure™ Closed Vial Adapter. It is a physical medical device, not a software algorithm that operates without human intervention. The performance tests evaluate the device's physical and functional properties.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests described are the established scientific and engineering standards and specifications relevant to medical device performance, such as ISO 10993 for biocompatibility and internal specifications for parameters like detachment force, flow rate, trapped air volume, etc.
8. The Sample Size for the Training Set
This information is not applicable. The Arisure™ Closed Vial Adapter is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this 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.