(63 days)
The nextaro® va. 15mm, 5um is indicated for the transfer and mixing of drugs contained in vials.
The nextaro® va, 15mm, 5μm is a sterile packaged vial adapter for single withdrawal of drug solutions with a single-use syringe via Luer adapter from drug vials or for one-time injection of a low-particle and sterile solution with immediate withdrawal of the prepared drug solution with a single-use syringe via Luer adapter from drug vials.
The provided text describes a 510(k) premarket notification for a medical device called nextaro® va, 15mm, 5µm. This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to a legally marketed predicate device (nextaro® va, K183187).
This type of submission focuses on demonstrating substantial equivalence rather than proving device performance against specific clinical acceptance criteria in the way an AI-powered diagnostic device would. Therefore, the information typically requested in your prompt regarding AI/machine learning device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document. This document describes a physical medical device (an intravascular administration set) and changes to its physical characteristics, not an AI or software device.
However, I can extract the information that is relevant to the "acceptance criteria" and "proof" provided within this regulatory context.
Acceptance Criteria and Study for nextaro® va, 15mm, 5µm
The "acceptance criteria" in this context refer to the performance standards and regulatory requirements that the modified device must meet to demonstrate its substantial equivalence to the predicate device and ensure its safety and effectiveness for its intended use. The "study that proves" the device meets these criteria is the performance testing conducted.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of a typical AI performance table (e.g., sensitivity, specificity), the "acceptance criteria" here are defined by various testing standards and the "reported device performance" is a general statement of compliance with those standards.
| Test Name | Testing Standard | Acceptance Criteria Implicitly Met | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Asssessment (e.g., Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Hemocompatibility, EO Residues) | ISO 10993 Series, ASTM F756, USP | Device materials must be safe for patient contact and not cause adverse biological reactions (e.g., toxicity, irritation, sensitization, fever, hemolysis). EO residues must be within acceptable limits. Implicitly, the proposed device must show biocompatibility equivalent or superior to the predicate and meet the specific criteria outlined in the referenced standards for each test (e.g., no significant cytotoxicity, no sensitization, etc.). | "Pass," "Pass," "Pass," "Pass," "Pass," "Pass," "Pass" (from table, indicating compliance with the respective standards). Also, "The biocompatibility tests show that the subject device is biocompatible and can be regarded as substantially equivalent regarding biocompatibility." |
| Chemical Characterization (Leachables/Extractables) | ISO 10993-18 | Leachables and extractables from the device materials must be within safe limits and not pose a toxicological risk. | Not explicitly stated as "Pass" but implied by passing biocompatibility and risk assessment. |
| Reducing (oxidizable) ingredients | ISO 8536-4 | The device must not release substances that would act as reducing agents in the drug solution beyond acceptable limits. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Titration acidity or alkalinity | ISO 8536-4 | The device must not significantly alter the pH of the drug solution. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Residue on Evaporation | ISO 8536-4 | The device must not release an unacceptable amount of non-volatile residue into the drug solution. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| UV absorption of the extract | ISO 8536-4 | Extracts from the device should not show unacceptable UV absorption, indicating the presence of harmful or undesirable substances. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Detection of metal ions | ISO 8536-4 | The device must not release an unacceptable amount of metal ions into the drug solution. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Particulate contamination | ISO 8536-4 and USP | The device must not shed an unacceptable number of particulate contaminants into the drug solution during use. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Filter Retention Rate | ISO 8536-4 | The filter must retain a specified percentage of particles of a given size. Specifically, "A retention rate of ≥80 % of particles with a size of ≥ 20 µm was confirmed for the subject device." This is compared to the predicate device, also meeting this criterion. | "Confirmed" to meet the ≥80% retention rate for ≥20µm particles. "The performance of the filters (retention) of the subject and predicate devices has been shown to be substantially equivalent." |
| Leakage / Tightness of the system | ISO 8536-4 / ISO 22413 | The device must maintain its integrity and not leak during use. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Tensile strength | ISO 8536-4 / ISO 22413 | The device components must withstand specified tensile forces without breaking. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Penetration Force | ISO 22413 (using a test procedure outlined in Annex B of ISO 8536-2) | The force required to penetrate the vial stopper must be within acceptable limits for user ease and safety. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Fragmentation Test | ISO 22413 | The device must not cause excessive fragmentation of the vial stopper during penetration. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Verification of the design specification for Transfer devices with housing | ISO 22413 | The physical design and dimensions must conform to specified requirements for safe and effective use. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Luer connector testing | ISO 80369-7 (test methods according to ISO 80369-20) | The Luer connector must meet international standards for secure and leak-free connection to syringes. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Retention Force | Internal performance standard | The device must securely attach to the vial and retain the syringe, preventing accidental detachment. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Transfer performance (practical transfer and residual volume) | Internal performance standard | The device must allow for efficient transfer of liquid with minimal residual volume. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Conformity of the packaging / packaging process validation (e.g., seal width, peel feature, seal strength, dye penetration, transport test, bubble test, visual inspection, burst testing) | ISO 11607-1 / ISO 11607-2, DIN EN 868-5, ASTM F1929, ASTM D4169, ASTM F2096, ASTM F1886/1886M, ASTM F2054/F2054M | The sterile barrier system must maintain sterility and product integrity until the point of use. Packaging must withstand handling (transport test) and maintain seals (seal strength, dye penetration, bubble test, burst testing), and be easily opened (peel feature). | "Packaging testing has been shown that the packaging of the subject and the predicate device are substantially equivalent." Implied passage of all listed tests. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (N) for each of the performance tests. Regulatory submissions often report that tests were conducted according to the relevant standards, which themselves may define minimum sample sizes for specific tests.
- Data Provenance: The tests were conducted by the manufacturer, SFM Medical Devices GmbH, located in Waechtersbach, Hessen, Germany. The data is prospective, as it was generated specifically for this 510(k) submission to demonstrate the performance of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This is not applicable. For a physical medical device like an intravascular administration set, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM, DIN, USP) and by direct physical and chemical testing, not by expert human interpretation of data in the way a diagnostic AI device would require (e.g., radiologists reviewing images). The acceptance criteria are objective measurements against these standards.
4. Adjudication Method for the Test Set:
- This is not applicable as the tests are objective physical and chemical analyses based on established standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- This is not applicable. MRMC studies are relevant for diagnostic devices where human readers interpret data, often with or without AI assistance, to assess diagnostic performance. This device is an intravenous fluid transfer set, not a diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is not an AI/software algorithm. Its "performance" is determined by its physical and chemical properties and functionality, not by an algorithm's output.
7. The Type of Ground Truth Used:
- For this device, the "ground truth" is established through objective measurements and analyses against pre-defined engineering, chemical, and biological performance specifications derived from international and national standards (e.g., ISO 10993 for biocompatibility, ISO 8536-4 for infusions sets, ISO 22413 for vial adapters, ISO 80369-7 for Luer connectors, ISO 11607 for packaging). These standards represent the accepted scientific and engineering consensus for safe and effective device performance.
8. The Sample Size for the Training Set:
- This is not applicable. This is a physical device, not an AI/machine learning model that undergoes "training" on a dataset. The device design and manufacturing processes are developed through engineering and quality management systems, not through machine learning.
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable for the reasons stated above.
§ 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.