(210 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 safe 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 components of the previously cleared TEVADAPTOR® system are:
- . Vial Adaptor 20 mm with 13 mm Vial Converter
- . Vial Adaptor 28 mm
- . Syringe Adaptor
- Spike Port Adaptor .
- . Connecting Set
- . Luer Lock Adaptor
- . Syringe Adaptor Lock
Each of the above component parts is available separately.
The purpose of this 510(k) is to add an additional component to the TEVADAPTOR® system already cleared for sale in the US, the description of which is:
- New component: TEVADAPTOR® Catheter Adaptor
The Catheter Adaptor provides closed system protection and disconnection of the fluid path between the Syringe Adaptor of the TEVADAPTOR® system and a bladder catheter (not supplied), while allowing safe administration of cytotoxic drugs to the bladder.
The Catheter Adaptor connects to the TEVADAPTOR® Syringe Adaptor, the short length of polymeric tubing of the adaptor is connected to the adaptor main body, which in turn is connected to the universal bladder catheter connector. A vented cap is supplied over the universal connector. The universal bladder catheter connector connects to a bladder catheter (not supplied).
The provided text describes the TEVADAPTOR® Closed Drug Reconstitution and Transfer System, specifically focusing on the addition of a new component: the TEVADAPTOR® Catheter Adaptor. The document details performance tests conducted to demonstrate the safety and effectiveness of this new component and its substantial equivalence to a previously cleared predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Test | Criterion | Reported Device Performance (T0 and T12mo) |
|---|---|---|
| Air leakage test | No leakage between the connections of the Catheter Adaptor components under an air pressure of 0.7 bar for at least 15 min. | No failures observed |
| Catheter Adaptor component disconnection force test | Disconnection force between component connections shall not be less than 3.00 kgf at a speed of 500 mm/min and shall have a gluing depth of 8.0 mm. | No failures observed |
| Catheter Adaptor component unclogged device test | Air bubbles appear in the water bath for at least 15 min. | No failures observed |
| Non-Luer universal connector to a bladder catheter seal | The connection between the non-Luer universal connector of the Catheter Adaptor and the bladder catheter is sealed to prevent user exposure to hazardous drugs. Testing in accordance with ISO 8536-4:2010, section 6.11. | Demonstrated successful sealing |
| Chemical resistance test | Device is compatible with cytotoxic drugs. | Device demonstrated compatibility |
| Sterility Assurance Level (SAL) | SAL of 10-6 | Met (Ethylene Oxide sterilization) |
| Biocompatibility | Meet requirements of ISO 10993 and FDA guidance for new materials based on patient contact and duration. | New materials met requirements |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document repeatedly mentions "no failures observed at T0 and T12mo" for several tests, indicating a sample of devices were tested both at initial production (T0) and after accelerated aging equivalent to 12 months (T12mo). However, the specific number of samples tested for each criterion is not provided.
- Data Provenance: The manufacturer is Teva Medical Ltd. from Israel. The testing was described as "Performance tests have been conducted," implying prospective testing within a laboratory setting. Details about the specific test facilities or country of origin for the data are not explicitly stated, but are presumably conducted by or on behalf of Teva Medical Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a medical accessory (Closed System Drug Transfer Device), not an AI/imaging device requiring expert interpretation for ground truth. Therefore, this information is not applicable and not provided in the context of this 510(k) submission. The ground truth for performance relied on objective measurements and adherence to engineering and sterility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided for this type of device and testing. Adjudication methods are typically used in clinical trials or studies involving subjective human interpretation, which is not the primary focus for evaluating the mechanical performance and safety of a CSTD.
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
As noted previously, this is a medical device for drug transfer, not an AI or imaging diagnostic tool. Therefore, MRMC comparative effectiveness studies involving human readers and AI assistance are not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Again, this is a hardware device. No standalone algorithm performance study was conducted or is relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests was based on:
- Objective Measurements: E.g., pressure readings for air leakage, force measurements for disconnection, observation of air bubbles for unclogged device.
- Adherence to Standards: Compliance with ISO 8536-4:2010 for connector sealing, ISO 10993 and FDA guidance for biocompatibility, and an SAL of 10-6 for sterility.
- Chemical Compatibility: Direct observation or analytical testing to confirm the device's compatibility with cytotoxic drugs.
8. The sample size for the training set
This device did not involve machine learning or AI, so there was no training set. The testing involved physical samples of the manufactured device.
9. How the ground truth for the training set was established
Since there was no training set, this question is not applicable. The "ground truth" for the device's performance was established through rigorous bench testing against predefined engineering specifications and regulatory standards.
§ 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.