(71 days)
TEVADAPTOR is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
The TEVADAPTOR® Closed Drug Reconstitution and Transfer System is a system of components that allows the reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion solution container. The TEVADAPTOR® Closed Drug Reconstitution and Transfer System prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron.
The purpose of this Special 510(k) is to add an additional design of one of the components, the TEVADAPTOR® Syringe Adaptor Lock.
The Syringe Adaptor (SA) Lock is one component of the system which is intended for connection to a standard Luer lock syringe. A non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor Lock to ther components of the TEVADAPTOR® system. The TEVADAPTOR® Syringe Adaptor Lock includes a stainless steel needle that is shielded at all times during preparation, use and disposal. The Syringe Adaptor Lock is supplied with a cap.
Disconnection of a syringe is not possible with the Syringe Adaptor Lock, because of a design change from the syringe adaptor that introduces a two-component distal hub. One of these components attaches, and rotates within the second component, together with the syringe, if disconnection is attempted.
The components of the TEVADAPTOR® system available separately are:
- Vial Adaptor 20 mm with 13 mm Vial Converter
- Vial Adaptor 28 mm
- Syringe Adaptor
- Syringe Adaptor Lock
- Spike Port Adaptor
- Connecting Set
- Luer Lock Adaptor
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (TEVADAPTOR® Syringe Adaptor Lock) |
|---|---|
| Bidirectional flow | Demonstrated equivalence with the Syringe Adaptor |
| Needle to Syringe Adapter Luer-lock disconnection test | Demonstrated equivalence with the Syringe Adaptor |
| Breakage of SA Lock Luer retention teeth | Demonstrated equivalence with the Syringe Adaptor |
| Disconnection of male luer and SA Lock | Demonstrated equivalence with the Syringe Adaptor; specifically, disconnection of a syringe is not possible with the Syringe Adaptor Lock due to a two-component distal hub design. |
| Luer fitting compliance with ISO 594/1 & 2 (including Gauging test, Resistance for overriding, Unscrewing torque, Ease of assembly, Liquid leakage, Air leakage, Separation force of conical fitting assembly, Stress cracking) | Demonstrated equivalence with the Syringe Adaptor |
| Visual inspection for absence of cracks | Demonstrated equivalence with the Syringe Adaptor |
| Sterility Assurance Level (SAL) | 10⁻⁶ (supplied sterile, same as remainder of TEVADAPTOR® components cleared under K141448) |
| Biocompatibility | All materials within the fluid path are unchanged from the Syringe Adaptor cleared under K141448 or K071741. No additional tests were carried out. |
| Risk Mitigation | New risks identified from design changes (Syringe Adaptor Lock) were adequately mitigated and verified by bench testing. |
Study that Proves the Device Meets Acceptance Criteria:
The study conducted was a bench testing evaluation to demonstrate equivalence of the new TEVADAPTOR® Syringe Adaptor Lock with the existing TEVADAPTOR® Syringe Adaptor (predicate device).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state a specific numerical sample size for the bench tests. It broadly mentions "bench testing has been carried out."
- Data Provenance: The study was conducted by Teva Medical Ltd., which is based in Israel (North Industrial Zone, Kiryat Shmona 10258, ISRAEL). The data is retrospective in the sense that it's a submission for clearance of a modified device, and the testing was performed to demonstrate equivalence to a previously cleared predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a Closed System Drug Transfer Device, and the performance evaluation relies on objective physical and mechanical tests (e.g., flow rates, leakage, disconnection forces, ISO compliance) rather than expert interpretation of medical images or clinical outcomes. The "ground truth" for these tests is defined by established engineering standards and specifications.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective measurements and compliance with engineering standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is not an AI-powered diagnostic tool, but rather a medical device for drug transfer. Therefore, no MRMC study or AI-related effectiveness assessment was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is not an algorithm or software; it is a physical medical device.
7. The Type of Ground Truth Used
The ground truth used for this evaluation consists of:
- Established engineering specifications and standards, particularly ISO 594/1 & 2 for Luer fittings.
- The performance characteristics of the predicate device (TEVADAPTOR® Syringe Adaptor cleared under K141448), as the goal was to demonstrate equivalence.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of 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.