Search Results

The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body. They are also intended for use in administering intravenous fluids to a dialysis set in conjunction with hemodialysis.

Intravascular administration sets are described in 21 CFR §880.5440. The Disposable Solution Infusion Sets that we intend to market include 4 types of designs. The sets consist of a length of polyvinylchloride tubing with a clamp roller along it and a male luer lock at one end and a nonvented infusion subassembly without filter at the other end. Model number NNC-3L has a male luer-lock conector (without injection site) and NNC-3CL has the male luer-lock connector and Y-connector with injection site. Model NNC-3CS has the cone luer slip and Y-connector with injection site and NNC-3C has the cone slip connector (without injection site). The materials used for the components include polyethylene (PE), polyvinylchloride (PVC) (contains DEHP), polypropylene (PP) and acrylonitrile butadiene styrene (ABS). Cyclohexanone and adhesive bond are used and are present in trace amounts.

The provided document is a 510(k) summary for the Nipro Disposable Solution Infusion Set. This type of submission is for demonstrating substantial equivalence to a legally marketed device, rather than proving device performance against specific acceptance criteria through a clinical study in the way typically seen for novel or high-risk devices.

Therefore, many of the requested elements (e.g., acceptance criteria, detailed study results, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for AI/ML) are not applicable or not provided in this type of regulatory submission because the device is a standard, well-understood medical product that has a predicate.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent due to the nature of the submission:

Acceptance Criteria and Device Performance Study for Nipro® Disposable Solution Infusion Set

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify quantitative or qualitative acceptance criteria typical of performance studies (e.g., specific flow rates, burst pressures, material biocompatibility thresholds) because it relies on the predicate device's established safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. There was no specific "test set" in the context of a prospective performance study as would be conducted for an AI/ML device. The claim of equivalence is based on the technical characteristics being identical to the predicate device and historical clinical use.
• Data Provenance: The "data" provenance refers to "years of clinical use" of similar devices, implying real-world usage data, likely from various geographies where such devices are used. The specific country of origin or whether it was retrospective/prospective is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. There was no "ground truth" establishment in the context of expert review for a performance study. Clinical experience with the predicate device and similar infusion sets forms the basis of the safety and effectiveness claim.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method was described as there was no test set requiring expert consensus.

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

• Not applicable. This device is a disposable solution infusion set, not an AI/ML diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical medical device, not an algorithm, so standalone performance in that context is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Historical Clinical Outcomes: The "ground truth" for the safety and effectiveness claim relies on "years of clinical use" and the absence of reported problems for similar, legally marketed devices. This implicitly refers to real-world outcomes and user experience, rather than specific diagnostic ground truth like pathology or expert consensus on individual cases.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model, so the concept of a "training set" is not relevant.

9. How the ground truth for the training set was established

• Not applicable. See #8.

Ask a specific question about this device