(80 days)
The neria™ guard Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.
The neria™ guard Infusion Set manufactured by Unomedical is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication. The insertion needle and soft cannula of the neria™ guard Infusion Set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevents needle stick injuries as the device does not require loading with the needle is then automatically retracted after use.
This document describes the premarket notification (510(k)) for the neria™ guard Infusion Set. Since this is an infusion set and not an AI/ML powered device, several of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding AI/ML study design are not applicable.
Here's the information extracted from the provided text regarding the acceptance criteria and the studies conducted for the neria™ guard Infusion Set:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes various non-clinical performance tests conducted to demonstrate the safety and effectiveness of the neria™ guard Infusion Set and its substantial equivalence to the predicate device. The general acceptance criterion is that the device "meets all the requirements for overall design, sterilization, biocompatibility and usability confirming that the design inputs and specifications for the device." Specific quantitative acceptance criteria or precise performance metrics are not detailed in this summary for each functional test, but rather that the device "met the requirements" of the relevant standards and internal tests.
| Test Category | Specific Test / Standard | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11135:2014 (Ethylene Oxide Sterilization) | The sterility of the device is assured using a validated sterilization method in accordance with ISO 11135:2014. |
| Biocompatibility | ISO 10993-1:2009 (Biological Evaluation of Medical Devices) & FDA Guidance (June 16, 2016) | The biological safety was demonstrated through testing including: Cytotoxicity, Sensitization, Intracutaneous Reactivity/Irritation, Acute and 14-day Systemic toxicity, Material Mediated Pyrogenicity, Hemolysis, Particulate Testing, Chemical Characterization, Genotoxicity (AMES and MLA). The device complies with ISO 10993-1. |
| Shelf Life | ASTM F1980:2011 (Accelerated Aging of Sterile Barrier Systems) | A maximum shelf life of 3 years was determined. |
| Functional Testing | Placement Introducer Needle before and after activation, Tensile Test Base-Connector, Functional Test Adhesive Liner, Contents in Blister Package, Functional Test Serter, Tensile Test Needle Hub, Soft Cannula Tensile Test, Base-Adhesive Patch Peel Test, Packaging, Disassemble fluid part from base, Disassemble base from cylinder, Serter Activation Force, Leak Test, Flow Test, Distance Introducer Needle bevel to Soft Cannula tip, Distance Soft Cannula tip to bottom fluid part, Visual Test of IFU, Blister Lid and Inner and Outer box label, Disassemble Cylinder from Cover, Drug Compatibility Testing, Tensile Strength Packaging and Labelling tests. | The neria™ guard Infusion Set met the requirements for these internal performance tests. |
| Packaging | ISO 11607-1:2009, ISO 11607-2:2006, ASTM D4169-16 | Packaging tests were conducted and met requirements. |
| Risk Management | ISO 14971:2012 | Application of risk management principles per standard. |
2. Sample size used for the test set and the data provenance
The document indicates that "a number of non-clinical performance tests" were completed. However, specific sample sizes for each test are not provided in this summary. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but these were non-clinical, in-vitro/bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is an infusion set, not an AI/ML powered device requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests would be established by the physical and chemical properties of the materials and the functional performance against engineering specifications and international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the device is an infusion set, not an AI/ML powered device. Adjudication methods are typically relevant for human review of AI/ML performance.
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
This question is not applicable as the device is an infusion set, not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is an infusion set, not an AI/ML powered device. The "standalone" performance here refers to the device's functional performance as described in the non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this medical device (infusion set), the "ground truth" is established by:
- International Standards: e.g., ISO, ASTM standards for sterilization, biocompatibility, packaging, and functional performance.
- Engineering Specifications: Internal requirements that define the performance characteristics and design criteria of the device.
- Predetermined Benchmarks: Performance of the predicate device (Unomedical Inset™ Subcutaneous Infusion Set) serves as a benchmark for comparison.
It's not an expert consensus or pathology-based ground truth as would be used for diagnostic image analysis.
8. The sample size for the training set
This question is not applicable as the device is an infusion set, not an AI/ML powered device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as the device is an infusion set, not an AI/ML powered device that requires a training set and associated ground truth.
§ 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.