(302 days)
Transfer of drugs contained in a vial.
The Vented Vial Adapter HU, is a single use, sterile, non-pyrogenic medical device intended for the transfer of drugs contained in a vial. The device is intended for use in the preparation of drugs for home use, in hospitals, or outpatient nursing units as used/administered by the patient, caregiver, or Healthcare Professionals (HPCs). The subject device is by prescription use only and does not have contraindications. The device does not contain any medicinal substances and there are no additional accessories provided for use with the product. The device has a 3-year shelf life.
The Vented Vial Adapter HU allows for the connection of a standard accessory with a female Luer lock to be connected to a vial. The vial adapter body with tight grip hold ("wings") is intended to be attached to a standard drug vial with a neck diameter of 20mm. The device contains a piercing spike, cap with air filter, vent and a female Luer lock connector for attachment to a standard accessory. This dual lumen spike design facilitates rapid withdrawal of the drug/solution without pressurizing the vial by allowing inbound air aspiration through the air filter.
The materials of construction of the VVA HU body and cap are polycarbonate, with a 0.2um hydrophobic air filter comprised of 100% expanded PTFE membrane over non-woven polyester membrane support.
The provided document is a 510(k) premarket notification for a medical device called the "Vented Vial Adapter 20mm". This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than requiring a full clinical trial for safety and efficacy. Therefore, the information typically found in a study proving acceptance criteria for AI/ML devices, such as sample sizes for test sets, expert consensus, and comparative effectiveness studies, is not present here.
Instead, the document focuses on non-clinical performance data and biocompatibility testing to demonstrate that the new device meets relevant standards and is substantially equivalent to a previously cleared predicate device.
Here's an analysis of the provided information within the context of your request:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly provide a table of acceptance criteria alongside reported device performance in the typical sense of a clinical study measuring a specific outcome (e.g., sensitivity, specificity for an AI diagnostic). Instead, it lists various performance tests conducted and indicates that the device "met the applicable design and performance requirements" and that "all product design requirements are verified."
Below is a table summarizing the types of tests conducted, which implicitly serve as criteria for performance, and the general statement of their success:
| Test Category | Specific Tests / Standards | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | Fragmentation Test (ISO 8536-2:2010 section 6.2.2) | Met applicable design and performance requirements; all product design requirements verified. |
| Detachment of Cap (BS EN ISO 80369-7:2016 Section 6.4) | Met applicable design and performance requirements; all product design requirements verified. | |
| Internal Diameter Upper Skirt (ISO 8362-6:2010 Section 4.2) | Met applicable design and performance requirements; all product design requirements verified. | |
| Luer Gauging Test (ISO 594-1:1986 and ISO 594-2:1998) | Met applicable design and performance requirements; all product design requirements verified. | |
| Luer Stability and compliance to ISO 80369-7:2016 (various annexes of BS EN ISO 80369-20:2015 for leakage, stress cracking, axial load, resistance separation, overriding, and dimensions) | Met applicable design and performance requirements; all product design requirements verified. | |
| Residual Volume (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Device Leakage (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Device Total Penetration Force (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Vial Adapter Detachment Force (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Product Retention in Blister (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Filter Clogging (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Device Skirt ("wings") Position on standard 20mm Vial (ISO 8362-6:2010) | Met applicable design and performance requirements; all product design requirements verified. | |
| Flow Rate (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Device Removal Force from Blister (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Tyvek Total Peel Test Force (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Air Filter Bursting Pressure (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Internal Diameter Dimensional Measurements Upper Skirt (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Functionality according to IFU (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Injection Force (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Aspiration Force (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Label Legibility (In-house test method) | Met applicable design and performance requirements; all product design requirements verified. | |
| Biological Safety | Cytotoxicity (ISO 10993-5:2009) | Successfully conducted; materials considered biocompatible. |
| Sensitization (ISO 10993-10:2010) | Successfully conducted; materials considered biocompatible. | |
| Intracutaneous Reactivity (ISO 10993-10:2010) | Successfully conducted; materials considered biocompatible. | |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Successfully conducted; materials considered biocompatible. | |
| Material Mediated Pyrogenicity (ISO 10993-11:2017) | Successfully conducted; materials considered biocompatible. | |
| Systemic (Subacute) Toxicity (ISO 10993-11: 2017) | Successfully conducted; materials considered biocompatible. | |
| ASTM Hemolysis (ISO 10993-4: 2017) | Successfully conducted; materials considered biocompatible. | |
| Sterilization | Sterility (BS EN ISO 11137-1:2015 & A2:2019, BS EN ISO 11137-2:2015, AAMI TIR 33) | Sterility Assurance Level (SAL) of $10^{-6}$ achieved. |
| Bacterial Endotoxin Testing (limulus amebocyte lysate - LAL) | Passed with acceptable levels. |
Regarding the other requested information:
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2. Sample sizes 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 sample sizes for each non-clinical performance test. It mentions that an "in-house test method" was often used.
- The data provenance is not explicitly stated in terms of country of origin for the non-clinical tests. The manufacturer is West Pharma. Services IL, Ltd. in Ra'anana, Israel. The tests are non-clinical bench tests, not involving human data.
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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 question is not applicable to a device submission of this nature. The "ground truth" for these tests are objective measurements against defined standards or specified functional parameters, not subjective expert interpretations.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. The performance testing is based on objective measurements against engineering and biological standards, not on human adjudication of subjective findings.
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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 MRMC or comparative effectiveness study was done. This device is a passive medical device (a vial adapter), not an AI/ML diagnostic or assistive technology.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/ML algorithm or software device.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For performance testing, the "ground truth" refers to the established specifications, international standards (e.g., ISO, BS EN ISO), or in-house defined criteria for mechanical properties, fluid dynamics, and biological safety. For biocompatibility and sterilization, the ground truth is defined by specific ISO standards and their associated pass/fail criteria (e.g., for cytotoxicity, sensitization, sterility assurance level).
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8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device that requires training data.
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9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device that requires a training set or associated ground truth.
§ 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.