(70 days)
The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in a vial.
The proposed device, Vented Vial Adapter Transfer Device - 13mm, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The proposed device consists of two integrated parts, the 13mm vial adapter body intended to be attached to a standard 13 mm drug vial. The other end is intended to be connected to a Female Luer connection. The vial adapter body contains the dual lumen piercing spike and the second part of the device is an assembled 0.2um hydrophobic air path filter (100% expanded PTFE membrane over Non-woven polyester membrane support). This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/ released air through 0.2um air filter. The proposed device does not contain any medicinal substances.
The provided text describes a 510(k) premarket notification for a medical device called the "Vented Vial Adapter Transfer Device - 13mm". The document focuses on demonstrating substantial equivalence to a predicate device (Vented Vial Adapter Transfer Device, K062482) through design comparisons and performance testing.
Here's an analysis of the acceptance criteria and the study as described in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that all testing met the required acceptance criteria, but it does not explicitly list specific numerical or qualitative acceptance criteria for each test. Instead, it lists the types of tests performed and generally states that the results met internal performance standards.
| Test Name | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Product Functionality Performance test according to IFU | "Required acceptance criteria" (Internal standards) | Met "internal performance standards" |
| Filter Bursting Pressure | "Required acceptance criteria" (Internal standards) | Met "internal performance standards" |
| Flow Rate Testing | "Required acceptance criteria" (Internal standards) | Met "internal performance standards" |
| Cap/valve-housing detachment from body Test | "Required acceptance criteria" (Internal standards) | Met "internal performance standards" |
| Internal stress level for assembled product | "Required acceptance criteria" (Internal standards) | Met "internal performance standards" |
| Biocompatibility | Harmonized standard (ISO 10993-1) | Met "required acceptance criteria" (Tested per ISO 10993-1) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the performance tests. It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective); it's implied the testing was conducted internally by Medimop Medical Projects Ltd. as part of their design control.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The testing described is strictly focused on the physical and functional performance of a medical device (vial adapter), not on clinical diagnostic accuracy or interpretation by experts. Ground truth, in this context, refers to objective measurements and adherence to engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert reviews or clinical outcomes where there might be disagreements in interpretation. The performance tests for this device involve objective measurements against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to assess diagnostic performance. The device here is a physical product for drug transfer, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical, mechanical medical device and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for the performance testing is based on internal performance standards and harmonized international standards (e.g., ISO 10993-1 for biocompatibility). For physical and functional tests, the ground truth would be precise measurements and observations confirming adherence to specified design parameters and functional requirements. For biocompatibility, the ground truth is conformance to the criteria outlined in ISO 10993-1.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As stated above, the device does not involve 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.