(139 days)
For use in transferring IV fluids/medication from a 20 mm drug vial to an IV fluid administration device.
The 20 mm Vial Fluid Transfer Adapter is a sterile, single use fluid transfer device. The 20 mm Vial Fluid Transfer Adapter is composed of a flexible PVC twist-off cap, PVC tubing, a polycarbonate large bore male luer lock, polycarbonate/LDPE piercing pin, and an inline air filter assembly. The PVC components do not contain DEHP. Components will be solvent bonded to assemble the device. The finished device will be packed and sterilized.
The provided text describes the 510(k) summary for the "20 mm Vial Fluid Transfer Adapter". It focuses on the device's substantial equivalence to a predicate device and its functional performance and material safety, rather than providing details of a study with acceptance criteria in the typical format of an AI/algorithm-based diagnostic device (which would include metrics like sensitivity, specificity, AUC).
This device is a physical medical device (a fluid transfer adapter), not an AI/algorithm. Therefore, many of the requested categories related to AI/algorithm performance studies (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance with metrics like sensitivity/specificity) are not applicable.
Here's an attempt to extract and reframe the information based on the provided text, focusing on the available details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Functional Performance | - Pass visual inspection | "All functional performance testing...met the acceptance criteria." "This testing demonstrates that the 20 mm Vial Fluid Transfer Adapter functions as intended." "Functional performance testing...demonstrate that the 20 mm Vial Fluid Transfer Adapter is both safe and effective and performs similarly to the predicate device." |
| - Meet occlusion requirements | ||
| - Meet pressure requirements | ||
| - Meet pull requirements | ||
| - Meet insertion requirements | ||
| - Meet retention requirements | ||
| Biocompatibility | - Material safety demonstrated through biocompatibility testing | "The safety of the subject device materials of composition was verified through biocompatibility and chemical testing. All functional performance testing, biological and chemical testing of the materials met the acceptance criteria." "Material biocompatibility and chemical testing demonstrate that the 20 mm Vial Fluid Transfer Adapter is both safe and effective and performs similarly to the predicate device." |
| Chemical Safety | - Material safety demonstrated through chemical testing | "The safety of the subject device materials of composition was verified through biocompatibility and chemical testing. All functional performance testing, biological and chemical testing of the materials met the acceptance criteria." "Material biocompatibility and chemical testing demonstrate that the 20 mm Vial Fluid Transfer Adapter is both safe and effective and performs similarly to the predicate device." The PVC components do not contain DEHP. |
| Substantial Equivalence | - No new issues of safety or effectiveness compared to the predicate device (IV Fluid Transfer Pin, B. Braun Medical Inc, K925401) through biocompatibility, chemical, and functional testing. | "The 20 mm Vial Fluid Transfer Adapter has a similar intended use and is comprised of components similar to the IV Fluid Transfer Pin (K925401). Both products have a plastic spike used to access the source container and withdraw IV fluid. Biocompatibility, chemical and functional testing have been completed to verify that there are no differences between the proposed device and the predicate device which raise new issues of safety or effectiveness." "...performs similarly to the predicate device." |
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 does not specify the sample size for the functional, biocompatibility, or chemical testing. It only states that "testing has been executed in the test laboratory."
- Data Provenance: Not specified, but implied to be from internal laboratory testing ("in the test laboratory"). This would be prospective for the purpose of the submission.
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)
- Not applicable/mentioned. This is for a physical device, and the "ground truth" for functional tests would be based on engineering specifications and direct measurement, not expert medical opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/mentioned. This concept is for diagnostic interpretation, not functional testing of a physical device.
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 for a physical medical device, not an AI/algorithm or diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for a physical medical device, not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this physical device would be based on engineering specifications, physical/mechanical standards (e.g., for pressure, pull force), and established methods for biocompatibility and chemical safety testing. It's not based on medical pathology or expert consensus on diagnosis.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical device, not an AI/algorithm that requires a training set.
§ 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.