(89 days)
The neria™ soft 90 infusion set is Indicated for subcutaneous infusion of medication administered by an external pump.
The neria™ soft 90 subcutaneous infusion set is a new product designed by Unomedical based on the Unomedical Inset™ Subcutaneous Infusion Set and Unomedical Quick-Set® Subcutaneous Infusion Set.
The neria™ soft 90 is a 90 degree soft cannula infusion set with a standard luer-lock connection. The neria™ soft 90 subcutaneous infusion set consists of an introducer needle/insertion handle that inserts the soft cannula into the skin and is removed immediately after insertion, a cannula housing that rests upon the skin with adhesive tape, securing the soft cannula in place under the skin, tubing with disconnect option and a reservoir connector (standard luer lock) and disconnect cover for the tubing and cannula housing.
The proposed configurations are:
- includes tubing and cannula . Infusion Set
- Tubing Only ●
- . Cannula only
Acceptance Criteria and Device Performance for neria™ soft 90 Infusion Set
This document details the acceptance criteria and study information for the neria™ soft 90 Infusion Set, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the device as being substantially equivalent to its predicate devices based on non-clinical performance data. Therefore, the "acceptance criteria" are implied by the successful execution of these tests and compliance with relevant standards. The "reported device performance" is that the device passed all tests.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance (Target/Outcome) |
|---|---|---|
| Functional Performance | Leak/Tightness Test | Passed (Meets requirements) |
| Flow (Occlusion) Test | Passed (Meets requirements) | |
| Tensile Test (introducer needle, tubing connections, soft cannula, adhesive tape, connector from cannula housing, connector needle) | Passed (Meets requirements for overall design) | |
| Packaging Integrity | Dynamic Peel Test | Passed (Meets requirements) |
| Visual Peel Test | Passed (Meets requirements) | |
| Print on Packaging and Labeling Inspection | Passed (Meets requirements) | |
| Transportation Durability | Transportation Tests (General) | Passed (Meets requirements) |
| Drop Test | Passed (Meets requirements) | |
| Dimensional Accuracy | Distance soft cannula to set | Passed (Meets requirements) |
| Distance of introducer needle bevel to soft cannula | Passed (Meets requirements) | |
| Length of tubes | Passed (Meets requirements) | |
| Biocompatibility | Biocompatibility Testing (in accordance with ISO 10993-1) | Passed (Complies with ISO 10993-1) |
| Sterilization & Residuals | EO/ECH residuals Testing | Passed (Meets requirements) |
| Pyrogen/Endotoxin Testing | Passed (Meets requirements) | |
| Sterilization Testing | Passed (Complies with applicable standards) | |
| Shelf Life | Shelf Life Testing | Passed (Results demonstrate 3 years shelf life) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the non-clinical tests. It only indicates that "a number of tests" were completed. Given that this is a 510(k) submission for substantial equivalence based on non-clinical data, it is highly likely that standard testing protocols and sample sizes specified by relevant national and international standards (e.g., ISO, ASTM) were followed.
The data provenance is from Unomedical A/S (the manufacturer) and is retrospective in the sense that these tests were performed on the device prototypes and finalized designs prior to submission. The country of origin of the data is Denmark (where Unomedical A/S is located), as well as any external testing facilities used for specific tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation relies on non-clinical performance data (functional, mechanical, material, and sterilization tests) rather than human interpretation of medical images or clinical outcomes requiring clinical ground truth establishment. These tests are assessed against predefined specifications and industry standards by qualified laboratory personnel and engineers.
4. Adjudication Method for the Test Set
This information is not applicable for the non-clinical performance data presented. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human readers/interpreters where there is an element of subjective judgment, and discrepancies need to be resolved. The non-clinical tests involve objective measurements and pass/fail criteria based on established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." Therefore, there is no effect size related to human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, there was no standalone algorithm performance study conducted. The neria™ soft 90 Infusion Set is a physical medical device, not an AI/software-as-a-medical-device (SaMD) or an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on pre-established physical, chemical, and biological specifications and standards. For example:
- Engineering specifications: Tensile strength limits, flow rates, dimensional tolerances.
- Material standards: Biocompatibility according to ISO 10993 standards.
- Sterilization standards: Assurance of sterility.
- Packaging standards: Peel strength, integrity.
These standards and specifications serve as the "ground truth" against which the device's performance is measured.
8. The Sample Size for the Training Set
This information is not applicable. The neria™ soft 90 Infusion Set is a physical medical device. It does not employ machine learning or AI algorithms 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 this 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.