(60 days)
The ADD-Vantage ADDaptor™20 mm binary connector is a double ended for use in a pharmacy setting or patient care area, by trained clinicians, to connect an ADD Vantage diluent solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
ADD-Vantage ADDaptor™ vial adapter transfer device is a double ended vial transfer device which allows the use of a 20mm single dose standard drug vial, to be connected to an ADD-Vantage diluent container bag.
The information below is extracted from the provided text, primarily sections {2} and {3}. Please note that the document is a 510(k) submission for a medical device (vial adapter transfer device), which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy trials. Therefore, much of the requested information, particularly around human reader studies or sophisticated ground truth establishment, is not present for this type of device.
1. Table of acceptance criteria and the reported device performance
| Characteristic | Standard/Test Method | Standard / Test Title | Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 : 2009/ | ||
| AC 2010 | Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process | Pass | |
| Biocompatibility | ISO 10993-5: 2009 | Biological evaluation of medical devices- Part 5: Cytotoxicity | Pass |
| Biocompatibility | ISO 10993-10: 2010 | Biological evaluation of medical devices- Part 10: Sensitization/ Irritation / Intracutaneous Reactivity | Pass |
| Biocompatibility | ISO 10993-11:2006 | Biological evaluation of medical devices- Part 11: Systemic Toxicity (Acute) | Pass |
| Biocompatibility | ISO 10993-4: 2002 AC: 2006 | Biological evaluation of medical devices- Part 4: Hemocompatibility | Pass |
| Sterilization | ANSI/AAMI/ISO 11137-2:2012 | Sterilization of health care product-Radiation- Establishing the sterilization dose | Pass |
| Sterilization | ANSI/AAMI/ISO 11737-1:2006 | Sterilization of medical devices- Microbiological methods- Part1: Estimation of population of microorganisms on products. | Pass |
| Sterilization | ANSI/AAMI/ISO 11737-2:2009 | Sterilization of medical devices-Microbiological methods- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | Pass |
| Performance | ISO 8536-4 :2010 | Infusion Equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Performance | ISO 8536-6: 2009 | Infusion equipment for medical use - Part 6:Freeze drying closures for infusion bottles | Pass |
The summary states: "The ADD-Vantage ADDaptor™ vial adapter transfer device has passed all specified test requirements. The validation and verification testing have confirmed these devices meet user needs and design inputs for a vial adapter. Testing also confirmed physical attributes and device performance meets requirements of the standards listed in the Performance Test Summary-New Devices table above. These standards address sterility, biocompatibility, and particulate."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each test listed. The tests are non-clinical (bench testing for performance, biocompatibility, and sterilization) rather than clinical studies on humans. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective, as these are typically not applicable to laboratory-based non-clinical testing.
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 information is not applicable to the type of device and testing described. The "ground truth" for non-clinical performance and safety tests is typically established by fulfilling the requirements of the specified ISO or ANSI/AAMI standards, which are laboratory benchmarks and protocols, not expert consensus on medical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device underwent bench testing against established standards, not a diagnostic or interpretative study 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
No. This is a non-AI medical device (a vial adapter transfer device). MRMC studies are not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is adherence to the specified international and national standards for device performance, biocompatibility, and sterility (e.g., ISO 10993 series and ANSI/AAMI/ISO 11137/11737 series). These standards define acceptable limits and methodologies, and passing these tests constitutes meeting the "ground truth" for the device's characteristics.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. 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.