(165 days)
The Vented Vial Transfer Pin is intended for the transfer and mixing of drugs contained in a vial.
The proposed device consists of five components: (1) Protective cap, (2) Piercing spike, (3) Filter medium, (4) Filter shell, (5) Luer connector cap. The piercing spike contains the dual lumen channel for liquid and air. A 0.2um hydrophobic air filter medium is assembled to the end of air channel. This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/released air through filter medium. There is a female Luer lock connector in the end of liquid channel, it can be attached a device with a male Luer connector (e.g., standard syringe). The proposed device is available 2 specifications according to design, with security clip and without security clip. The Vented Vial Transfer Pin with Security Clip designed which can be fixed to a 13mm drug vial to prevent accidental separation. The proposed device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 106 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years. No DEHP, BPA and Natural Rubber Latex are added in the proposed device.
This document is a 510(k) Summary for a medical device called the "Vented Vial Transfer Pin." It mostly focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria for the new device as an AI or diagnostic tool.
However, it does list several non-clinical tests that were performed to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These tests, along with comments on the differences between the proposed and predicate devices, indirectly describe acceptance criteria and how the device met them.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside reported performance in the general sense of a diagnostic or AI device. Instead, it lists standards with which non-clinical tests complied and states that the proposed device "met all design specifications" and "complies with the following standards." The comments section addresses differences between the proposed and predicate device and assures that these differences do not affect substantial equivalence on safety and effectiveness.
Here's an interpretation based on the provided text, focusing on the non-clinical tests:
| Acceptance Criteria (Inferred from Standards & Test Objectives) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility | |
| No cytotoxicity (per ISO 10993-5:2009) | Achieved: "no cytotoxicity per ISO 10993-5" |
| No irritation (per ISO 10993-10:2010) | Achieved: "no irritation per ISO 10993-10" |
| No sensitization (per ISO 10993-10:2010) | Achieved: "no sensitization per ISO 10993-10" |
| No acute systemic toxicity (per ISO 10993-11:2017) | Achieved: "no acute systemic per ISO 10993-11" |
| No pyrogenicity (per USP ) | Achieved: "no pyrogen per USP" |
| No hemolysis (per ASTM F756-17) | Achieved: "no hemolysis per ASTM F756" |
| Sterility & Shelf Life | |
| Sterility Assurance Level (SAL) of 10-6 | Achieved: "Sterility Assurance Level (SAL) of 10-6" |
| Ethylene Oxide Sterilization Residuals within limits (per ISO 10993-7:2008 AMD.1:2019) | Achieved: "Examination of the Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals have met with ISO 10993-7AMD1:2019" |
| Maintenance of sterility for 5 years (packaging integrity per ISO 11607 and ISTA 3A) | Achieved: "demonstrated that the aged samples also complied with the requirements of ISO 8536-4 and ISO 80369-7. The ability of immediate package of the proposed device to maintain the device in a sterile state for a period of 5 years has been validated in accordance with ISO 11607 and ISTA 3A." |
| Packaging Integrity | |
| No seal leaks (per ASTM F1929-15) | Not explicitly stated "achieved," but compliance with standard for packaging integrity is implied by being listed. |
| Seal strength (per ASTM F88/F88M-15) | Not explicitly stated "achieved," but compliance with standard for packaging integrity is implied. |
| Seal integrity (visual inspection per ASTM F1886/F1886M-16) | Not explicitly stated "achieved," but compliance with standard for packaging integrity is implied. |
| Bacterial Endotoxins | |
| Within limits (per USP ) | Not explicitly stated "achieved," but compliance with standard is implied by being listed. |
| Performance Testing | |
| Product Functionality Performance (ISO 8536-4, 7.4 and ISO 80369-7) | Achieved: "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and "complies with the following standards". |
| Filter Bursting Pressure (ISO 8536-4, 7.5) | Achieved generally as part of "met all design specifications" and compliance. |
| Flow Rate Testing (ISO 8536-4, 7.10) | Achieved generally as part of "met all design specifications" and compliance. |
| Cap/valve-housing detachment from body Test (ISO 8536-4, 7.3) | Achieved generally as part of "met all design specifications" and compliance. |
| Internal stress level for assembled product (ISO 8536-4, 7.13) | Achieved generally as part of "met all design specifications" and compliance. |
| Small-bore connectors compliance (ISO 80369-7:2021) | Achieved: "demonstrated that the aged samples also complied with the requirements of ISO 8536-4 and ISO 80369-7" |
| Mechanical Strength (Cap Assembly) | |
| Tensile strength of parts 15N for 15s | Achieved: "The tensile strength of parts have been tested at 15N for 15s. Both of them meet acceptable criteria." |
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 relates to a physical medical device (Vented Vial Transfer Pin), not an AI/diagnostic software. Therefore, there is no "test set" in the context of data for an algorithm. The non-clinical tests would have involved physical samples of the device. The document does not specify the number of units tested for each non-clinical test.
Data provenance is not applicable here as it refers to typical AI/diagnostic data (e.g., patient images, medical records).
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. This device is a physical medical device, not an AI or diagnostic tool that requires ground truth established by medical experts for performance evaluation. The "ground truth" for this device's performance would be derived from the physical and chemical properties and test outcomes according to the cited standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/diagnostic software study involving human readers or adjudication of results.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" is established by:
- Compliance with international and national standards (e.g., ISO, ASTM, USP) for materials, sterility, packaging, and functional performance.
- Material properties and test results from laboratory analyses (e.g., cytotoxicity, hemolytic properties, tensile strength).
- Physical measurements and functional tests directly assessing the device's ability to perform its intended function (e.g., flow rate, filter bursting pressure).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI/ML algorithm.
§ 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.