(112 days)
The sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
These neria™ multi sets are intended to be used by patients of all ages who have been prescribed subcutaneous infusion of immunoglobulin (IgG) for the treatment of Primary Immunodeficiency Disease (PID).
The neria™ multi product is a multisite infusion catheter. The product has a luer lock connector that is designed to be attached to an infusion pump reservoir. The tubing from the luer connector is attached to a furcation or splitter block, which splits the fluid flow into two, three or four subcutaneous Infusion catheters. Each tube that exits the splitter terminates in a subcutaneous catheter with a stainless steel infusion needle set at 90 degrees from an adhesive pad.
The neria™ multi line will include three different needle lengths of 8, 10 and 12 mm. The product is provided with a separate tubing clamp or clamps to enable the user to selectively stop infusion to one or more sites as necessary. The sets are packaged in custom formed blisters sealed with a Sterikraft paper lid and sterilized in a validated EO gas cycle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the neria™ multi Subcutaneous Infusion Set:
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed report of a stand-alone clinical study with comprehensive performance metrics. As such, information regarding ground truth establishment, expert qualifications, and specific multi-reader multi-case studies is not present. The "study" here refers to a series of performance tests.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Reported Device Performance/Conformity |
|---|---|---|
| Dimensional Tests | Needle length | Conforms to predefined criteria. |
| Tubing Length | Conforms to predefined criteria. | |
| Functional Tests | Leak test | Conforms to predefined criteria. |
| Flow test | Conforms to predefined criteria. | |
| Pull (Tension) Tests | Furcator - tubing | Conforms to predefined criteria. |
| Set base tubing | Conforms to predefined criteria. | |
| Luer tubing | Conforms to predefined criteria. | |
| Set base adhesive | Conforms to predefined criteria. | |
| Biological Tests | Biocompatibility Test | Meets the requirements of ISO 10993-1, Biological evaluation of Medical Devices. |
| Chemical Testing | Drug/Device compatibility test (with Hizentra®) | Conforms to predefined criteria. |
Study Details
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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 specify the sample sizes used for each of the performance tests. It states "The devices were tested for the following attributes and conform to all predefined criteria," implying a sample was used, but the quantity is not provided.
- Data Provenance: Not specified. The tests would likely have been conducted in a lab setting by Unomedical A/S (Denmark, given their address). The nature of these tests (dimensional, functional, biological, chemical) inherently makes them lab-based rather than from patient data. Therefore, the concepts of "country of origin of the data" or "retrospective/prospective" as applied to clinical data are not directly applicable here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. For these types of engineering and material performance tests, "ground truth" is typically established by objective measurements against engineering specifications and industry standards (e.g., ISO for biocompatibility). There is no mention of human expert consensus for these specific tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 are typically used for subjective clinical interpretations by experts. The described tests are objective measurements against predefined criteria.
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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. This device is a subcutaneous infusion set, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the described performance tests, the "ground truth" is based on:
- Defined Engineering Specifications: For dimensional (needle/tubing length), functional (leak/flow), and pull tests, the acceptance criteria are based on pre-established engineering parameters specific to the device's design and intended function.
- Industry Standards: For biocompatibility, the ground truth is conformity to ISO 10993-1.
- Predefined Chemical Compatibility Criteria: For drug compatibility, the ground truth relies on the set's ability to maintain integrity and function when exposed to the specified drug (Hizentra®), likely against pre-established chemical and physical stability criteria.
- For the described performance tests, the "ground truth" is based on:
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The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, this question is not relevant.
Overall Conclusion from the document:
The provided 510(k) summary focuses on demonstrating that the neria™ multi Subcutaneous Infusion Set is substantially equivalent to existing legally marketed predicate devices (Unomedical Contact™ and MarCal Medical Sub Q Needle infusion set) by showing it shares similar technological characteristics and meets various performance criteria (dimensional, functional, pull, biological, and chemical). The "study" consists of these performance tests, confirming the device's adherence to predefined engineering specifications and relevant industry standards.
§ 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.