(56 days)
The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.
The proposed device, Vial2Bag Direct Connect, 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. Vial2Bag Direct Connect is available with 13mm Vial Adapter or 20mm Vial Adapter. The device consists of the Vial2Bag piercing spike and cover, the twist-off connector and an integrated Vial Adapter (13mm or 20mm) for access to the drug/solution vial.
Up to 3 Vial2Bag Direct Connect can be consecutively connected by inserting the spike of one device into the twist off connector of the previous device.
The device does not contain any medicinal substances, and can be used with standard drug vials.
This is a 510(k) premarket notification for a medical device (Vial2Bag™ Direct Connect), not an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria and study details is not applicable to this document. The document describes modifications to an existing device and the performance testing conducted to ensure substantial equivalence to a predicate device.
However, I can extract information related to the device's performance testing and general characteristics from the provided text.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests conducted, but it does not explicitly define specific numerical acceptance criteria for each test. Instead, it states for all tests: "All testing met the required acceptance criteria." This implies that internal, pre-defined acceptance criteria were used and successfully achieved.
| Performance Test Name | Reported Device Performance |
|---|---|
| Product Functionality According to IFU | Met internal performance standards |
| Total Penetration Force | Met internal performance standards |
| Cap Detachment Force | Met internal performance standards |
| Vial Adapter Detachment Force from Drug Vial | Met internal performance standards |
| Breaking Torque Test | Met internal performance standards |
| Spike Tip Ductility Test | Met internal performance standards |
| Air Leakage Test | Met internal performance standards |
| Packaging | Tested per ISO 11607-1; Met required acceptance criteria |
| Sterilization (SAL) | Met minimum SAL 10^-6 |
| Residuals of ETO and ECH | Met requirements of ISO 10993-7:2008 for prolonged exposure |
| Bacterial Endotoxin (LAL method) | Acceptable Endotoxin level 0.5 EU/ml or 20 EU/device; sensitivity of 0.005 EU/ml achieved |
| Cytotoxicity (ISO 10993-5) | Successfully completed biocompatibility testing |
| Sensitization (ISO 10993-10) | Successfully completed biocompatibility testing |
| ASTM Hemolysis (ASTM F756 and ISO 10993-4) | Successfully completed biocompatibility testing |
| Intracutaneous Reactivity (ISO 10993-10) | Successfully completed biocompatibility testing |
| Systemic Toxicity (Acute Systemic Injection, ISO 10993-11) | Successfully completed biocompatibility testing |
| USP Rabbit Pyrogen (USP 151) | Successfully completed biocompatibility testing |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each performance test. It only states that "The modifications to the proposed device were evaluated within the Medimop design control system." The data provenance is internal to Medimop Medical Project Ltd., based in Israel. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission to evaluate the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The device is a physical medical device, not an AI/ML product that requires expert-established ground truth for performance evaluation in the context of image interpretation or diagnosis. The "ground truth" for the performance tests would be defined by engineering specifications and relevant regulatory standards.
4. Adjudication Method for the Test Set:
Not applicable for a physical device's performance testing. The tests are typically objective measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a physical device, not an AI/ML diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical device, not an AI/ML algorithm.
7. Type of Ground Truth Used:
For the performance tests, the "ground truth" is a combination of:
- Internal performance standards: Defined by the manufacturer (Medimop) for functionality, penetration force, detachment forces, torque, ductility, and air leakage.
- International Standards: e.g., ISO 11607-1 for packaging, ISO 11135-1:2007 for sterilization, ISO 10993-7:2008 for ETO and ECH residuals, ISO 10993-1 and G95-1 for biocompatibility assessment, and specific ISO 10993 sub-standards, ASTM F756, and USP 151 for various biocompatibility tests.
- Regulatory requirements: e.g., acceptable Endotoxin levels.
8. Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 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.