(373 days)
Advcare Vial Direct to Bag (VDB) Needle-free Admixture devices are intended for drug reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution and attaching an IV set to administer influsion liquid to patient. The devices are provided as single-use, sterile, and non-pyrogenic products. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag. The devices are intended for use in healthcare environments by clinically trained healthcare professional providers to aid and support prescribed treatment and therapy.
Advcare IV fluid transfer Vial Direct to Bag (VDB) VDB-13 & 20 Needle-free Admixture Devices are designed for drug reconstitution and transfer of fluids from drug vials into IV bag containing infusion solution. The VDB-13 & 20 serve as a fluid pathway for standard IV set to administer fluid to patient while minimizing exposure to drug aerosols and spills. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag. Both IV fluid transfer system designs consist of a body, piercing spike, spike cover, IV port, and twist-off for the IV administration set. The VDB 13mm and 20mm has an integrated Vial Adaptor for access to the drug/solution vial. Both system transfer drug into an IV bag and to an external IV administration set to administer fluid to patient. The products do not contain any medicinal substances, and can be used with standard drug vials. It is intended for use in healthcare facilities by care-giver to aid and support prescribed treatment and therapy.
The provided text describes the Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices (K212525). 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
The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it lists the performance tests conducted, implying that the device was deemed acceptable if it successfully passed these tests. The "reported device performance" is essentially that the device met these requirements.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Functionality & Design | - Product Functionality According to IFU |
- Cap Detachment Force
- Spike Penetration Force
- Air Leakage Test
- Vial Adaptor Tensile Detachment Force From Drug Vial
- Vial Adaptor Torsional Breakage Test
- Spike to IV Bag Port Tensile Detachment Force
- IV Admin Spike to VDB-IV Port Attachment Force
- Vial Attachment Force
- Vial Detachment Force
- Flange Breakage
- Flow Rate
- Coring of IV Bag Port
- Coring and Fragmentation of Vial Stopper
- Twist-Off Bonding To IV Spike
- Leakage After Removal of Twist OFF
- Leakage at VDB-IV Spike to IV Bag port following assembly of components
- Leakage at VDB-IV Port to IV Admin Spike following assembly of components
- Dimensional Measurements of the IV spike lumens
- Dimensional Measurements of the Vial Adaptor Retention Feature | "Testing was conducted to validate that the Advcare IV fluid transfer Vial Direct to Bag (VDB) VDB-13 & 20 Needle-free Admixture Devices met the applicable design and performance requirements." (Implies successful completion of all listed tests.) |
| Material Safety | - Chemical Compatibility Testing | "Biocompatibility testing demonstrated the materials are biocompatible." |
| Biocompatibility | - Cytotoxicity - Sensitization
- Intracutaneous Reactivity
- Acute System Toxicity
- Subacute System Toxicity
- Pyrogenicity
- Hemolysis
- Particulate Test
- Bacterial Endotoxin | "The following biocompatibility tests has been successfully conducted." |
| Sterilization | - Validation in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10-6 | "The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014... The sterilization method provides a sterility assurance level (SAL) of 10-6." |
| Dose Accuracy | - Dose Concentration Study - Dose Accuracy (Transfer of vial contents to the IV bag & to the administration set) | Implied successful completion as part of "Performance Testing." |
2. Sample size 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 sample sizes used for each individual test. It mentions "Testing was conducted to validate..." globally. The data provenance (country of origin, retrospective/prospective) is not explicitly stated for the performance testing. However, the manufacturer is Advcare Medical from New Taipei, Taiwan, suggesting the testing was likely conducted by or sponsored by the manufacturer.
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 is a medical device for drug administration, not an AI or diagnostic imaging device. Therefore, the concept of "experts used to establish groundwork" for a test set in the way a diagnostic algorithm requires (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for this device would be established by engineering specifications, material standards, and regulatory requirements, rather than expert interpretation of a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study requiring human adjudication for diagnostic discrepancies. The tests conducted are objective, primarily engineering and performance-based.
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
Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards for sterilization, biocompatibility, and general medical device performance). For instance, for "Air Leakage Test," the ground truth would be a defined permissible leakage rate, not an expert consensus on a diagnosis.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI-driven system requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical 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.