(300 days)
The freetlex@+ Transfer Adapter is indicated for reconstituting a drug in a vial with a 20mm closure and the transfer of the drug into the freeflex®+ IV Bag prior to administration to the patient. The device may be used for pediatric (newborn to 21 years) and adult populations.
The freeflex®+ Transfer Adapter is a single use, fluid transfer device that allows for the reconstitution and transfer of powdered or liquid drugs from drug vials into the freeflex + IV Bag (NDA BN070012) through the IV bag medication port. The device consists of a body, male Luer lock and a safety ring. The device is provided as a sterile, non-pyrogenicproduct. The device is intended to be used with standard drug vials with a seal diameter of 20mm. with an elastomeric membrane. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the freeflex®+ Transfer Adapter for the device to meet its intended purpose.
The Fresenius Kabi AG freeflex®+ Transfer Adapter (K212445) is a single-use fluid transfer device intended for reconstituting drugs in a vial with a 20mm closure and transferring them into a freeflex®+ IV Bag prior to administration.
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Test | Reported Device Performance |
|---|---|
| ISO 22413:2013 Transfer sets for pharmaceutical preparations | Successfully passed. |
| Fragmentation | Successfully passed. |
| USP Particulate Matter in Injections Test method 1 | Successfully passed. |
| Particulate Testing | Successfully passed. |
| ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods | Successfully passed. |
| Luer Connector Leakage | Successfully passed. |
| Stress Cracking Resistance Testing | Successfully passed. |
| ISO 11607-1 (2019-02) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems | Successfully passed. |
| Sterile Barrier Systems Validation | Successfully passed. |
| Internal device performance test methods | Successfully passed. |
| Visual Inspection | Successfully passed. |
| Penetration Force | Successfully passed. |
| Force to Remove Safety Ring | Successfully passed. |
| Separation under Tensile Force | Successfully passed. |
| Residual Volume in Adapter-Vial-System | Successfully passed. |
| Biocompatibility Testing | Successfully passed. |
| Hemolysis | Successfully passed. |
| Cytotoxicity | Successfully passed. |
| Irritation | Successfully passed. |
| Skin Sensitization | Successfully passed. |
| Acute Systemic Toxicity | Successfully passed. |
| Chemical Characterization | Successfully passed. |
| Material Mediated Pyrogenicity | Successfully passed. |
| Particulate Testing (re-listed, but part of biocompatibility section) | Successfully passed. |
| Sterilization Validation | Successfully passed. |
| Ethylene oxide sterilization (DIN EN ISO 11135:2014) | Achieved a Sterilization Assurance Level (SAL) of 10-6. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). It generally mentions "functional performance bench testing was conducted." Without specific numbers, it's impossible to provide these details accurately.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical medical device, not an AI/ML algorithm requiring expert human interpretation for ground truth establishment. The performance testing is based on objective, quantifiable measurements according to established international and internal standards.
4. Adjudication Method for the Test Set
Not applicable, for the same reason as point 3.
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/ML device that involves human reader interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance testing is based on the objective criteria defined by the cited international standards (e.g., ISO 22413, USP , ISO 80369-20, ISO 11607-1) and internal test methods. These standards define measurable thresholds for attributes like leakage, fragmentation, particulate matter, etc. For biocompatibility, the ground truth is the absence of adverse biological reactions as defined by ISO 10993-1.
8. The Sample Size for the Training Set
Not applicable. This is a physical device and presumably does not involve a "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as point 8.
Study Proving Acceptance Criteria are Met:
The study proving the device meets the acceptance criteria is a series of bench testing and biocompatibility testing as detailed in Section 9 of the 510(k) Summary.
- Bench Performance Testing: The device was subjected to various functional tests based on international standards (ISO 22413, USP , ISO 80369-20, ISO 11607-1) and internal test methods. These tests evaluated properties such as freedom from fragmentation, particulate matter, Luer connector leakage, stress cracking resistance, sterile barrier integrity, visual inspection, penetration force, force to remove the safety ring, separation under tensile force, and residual volume.
- Biocompatibility Testing: Following FDA guidance (ISO 10993-1), a comprehensive suite of biocompatibility tests was performed, including hemolysis, cytotoxicity, irritation, skin sensitization, acute systemic toxicity, chemical characterization, material mediated pyrogenicity, and particulate testing.
- Sterilization Validation: Ethylene oxide sterilization was validated to meet DIN EN ISO 11135:2014, achieving an SAL of 10-6.
All these tests were successfully conducted, and their aggregated results are deemed to demonstrate that the freeflex®+ Transfer Adapter performs as intended and supports a substantial equivalence determination to the predicate device (Vial2Bag Advanced™ 20mm Admixture Device, K201415). The conclusion explicitly states: "The freeflex®+ Transfer Adapter, has met all established acceptance criteria for performance testing and design verification testing. Results of functional performance and biocompatibility testing conducted with the freeflex + Transfer Adapter, demonstratethat the subject device supports a substantial equivalence determination to the predicate 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.