(116 days)
The nextaro® Transfer System and nextaro® va is indicated for the transfer and mixing of drugs contained in vials.
The nextaro® Transfer System and nextaro® va is practically one system with two variants which are to be used independently.
The nextaro® Transfer System consists of two components already assembled (screwed together) in the delivery condition. Each of the components has a plastic spike which is used to perforate the seals of a solvent vial, or lyophilizated pharmaceutical vial, respectively. The components have a male and female Luer adapter to create an air-tight inner media-carrying system with open ends for fluid transfer. Both components are equipped with a filter element to prevent particles (fragments of vial seals, undissolved pharmaceutical) from being administered into the patient's circulatory system.
To be used as intended, the spike of the blue ("upper") part of the nextaro® Transfer System is used to perforate the seal of the solvent vial. The assembly is flipped vertically and the spike of the white ("lower") part of the device is used to perforate the seal of the pharmaceutical vial. The solvent transfer process starts immediately due to the vacuum in the pharmaceutical vial.
After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, the blue component of the device is removed from the white part by unscrewing, a standard syringe with a male Luer is attached to the exposed female Luer of the device to aspirate the ready-to-use solution.
The nextaro® va is a standalone device. Basically, it is the lower part of the nextaro® Transfer System, but without the thread which the latter has to connect the upper part. After connecting the nextaro® va to a pharmaceutical vial by pushing it downwards, a solvent can be transferred by a syringe via the female Luer. After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, a standard syringe with a male Luer is attached to the female Luer of the device to aspirate the ready-to-use solution.
The provided document is a 510(k) summary for the nextaro® Transfer System and nextaro® va, which are drug transfer devices. It does not describe a study involving human readers or AI. Therefore, I cannot provide details on sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies.
Here's the information regarding acceptance criteria and device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by meeting various international and ASTM standards. The reported device performance is indicated by "Pass" or "Equivalent" to the predicate device, or by specific measured values where stated.
| Standard / Test Performed | Acceptance Criteria (Implied by Standard) | Reported Device Performance |
|---|---|---|
| ISO 22413 | ||
| Fragmentation | Meets standard requirements for limiting fragmentation. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." (Implies meeting the standard's criteria) |
| Penetration Force | Meets standard requirements for penetration force. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Piercing | Meets standard requirements for piercing. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Verification of Design Specifications for Transfer Devices with Housing | Meets specified design requirements. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ISO 594-2 | ||
| Male Conical Fitting / Luer Connector | Meets standard requirements for Luer fittings (e.g., leakage, security). | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ISO 8536-4 | ||
| Flow Rate of Infusion Fluid | Meets standard requirements for flow rate. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Fluid Filter (Retention Rate) | Retains particles as specified by the standard. | "A retention rate of > 95 % of particles sized ≥ 15 um has been confirmed by testing." "The performance of the filters (retention) of the subject and predicate devices has been shown to be substantially equivalent." (Note: The filter mesh traps particles ≥ 11 µm, but retention rate is reported for ≥ 15 µm). |
| Leakage (Aging/ Submersion Test) | No leakage after aging and submersion. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Metal Ions | Below specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Particulate Contamination | Below specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Penetration Force (also under ISO 22413) | Meets standard requirements. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Reduction of Oxidizable Matter | Within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Residue on Evaporation | Within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Tensile Strength | Meets standard requirements. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Titration Acidity or Alkalinity | Within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| UV Absorption of Extract Solution | Within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ISO 11607 | ||
| Sterile Barrier and Packaging Systems | Meets standard requirements for maintaining sterility of the product until point of use. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ASTM D3078 | ||
| Bubble Emissions | No unacceptable bubble emissions, indicating seal integrity. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ASTM F 1886 | ||
| Integrity of Seals | Seals maintain integrity. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ASTM F 1929-12 | ||
| Seal Leakage | No unacceptable seal leakage. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ASTM F 1980-07 | ||
| Accelerated Aging | Performance maintained after accelerated aging, correlating to shelf-life. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." Also implies devices meet 5-year shelf-life claim. |
| ASTM F 2054-07, EN 868-5 | ||
| Seal Strength | Seals meet required strength for packaging. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ISTA 2A | ||
| Transport Testing | Device integrity and functionality maintained after transport simulation. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| **USP , USP ** | ||
| Bacterial Endotoxin | Endotoxin levels below specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Biocompatibility (ISO 10993-1) | All biocompatibility tests (e.g., cytotoxicity, sensitization, irritation, material mediated pyrogenicity, LAL Testing) pass for patient contact type. | "Tests were conducted to show that the nextaro® Transfer System and the nextaro® va were evaluated for biocompatibility in accordance with ISO 10993-1." "The biocompatibility tests show that the subject devices are biocompatible and can therefore be regarded as substantially equivalent in regard to biocompatibility." (Pass) |
| Material Mediated Pyrogenicity, LAL Testing | Materials are non-pyrogenic. | "Material Mediated Pyrogenicity LAL Testing" (Implies pass, as part of biocompatibility.) |
| Sterility (ISO 11135:2014) | Sterility Assurance Level (SAL) of 10-6 achieved. Residual EtO and ECH within ISO 10993-7 guidelines. | "The sterility... were validated in accordance with ISO 11135:2014... SAL 10-6." "The maximum levels of ethylene oxide (EtO) and ethylene chlorohydrin (ECH) residuals remaining on the products were within the guidelines for... ISO 10993-7:2008." |
| N/A - Roll Inhibition (to design specification) | Meets specific design requirements for roll inhibition. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." (Implies meeting the design specification) |
| N/A - Transfer performance for residual volume (to design specification) | Residual volume after transfer is within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." (Implies meeting the design specification) |
| N/A - Opening torque (to design specification) | Opening torque is within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." (Implies meeting the design specification) |
| Shelf Life | At least 3 years (predicate) / 5 years (proposed device). | Predicate: > 3 years. Proposed Device: 5 years. "The subject devices are substantially equivalent with regard to their shelf-life." |
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 does not explicitly state the sample sizes for the various tests performed. The testing was conducted by sfm medical devices GmbH, which is located in Waechtersbach Hessen, Germany, suggesting the data provenance is likely Germany. The tests appear to be prospective, laboratory-based engineering and performance tests on the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a physical medical device (fluid transfer set), not an AI/imaging diagnostic device that would require expert-established ground truth for a test set. Its performance relies on objective measurements against engineering and biocompatibility standards.
4. Adjudication method for the test set
This information is not applicable for this type of device and testing. The tests are based on objective pass/fail criteria from recognized standards, not on subjective expert evaluations requiring adjudication.
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
No, an MRMC comparative effectiveness study was not done. This device is a physical drug transfer system, not an AI or imaging system designed to be used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this question is not applicable to the device described. This is a physical, manually operated medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for evaluating the nextaro® Transfer System and nextaro® va is based on:
- Compliance with established international and national standards (ISO, ASTM, USP).
- Meeting pre-defined engineering design specifications (e.g., residual volume, roll inhibition, opening torque).
- Laboratory testing results (e.g., retention rate, biocompatibility, sterility) against specified acceptance limits derived from these standards.
8. The sample size for the training set
This information is not applicable. The nextaro® Transfer System and nextaro® va are physical devices, not AI/machine learning models that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a physical medical 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.