(25 days)
Infusion sets are intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. These sets are intended for use primarily in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient / Surgical Centers, Long Term Care, Urgent Care, Transport and in Physician offices.
Hospira infusion sets are intended for use as gravity sets or with dedicated Hospira Infusion Pumps. Hospira infusion sets are disposable devices for single patient use, which incorporate various set configurations and components. These components including the back check valve which is the subject of this submission may be shared across Hospira set families and used with sets designed for gravity or other pump platforms.
The acceptance criteria and the study proving the device meets these criteria are detailed below, based on the provided document.
Acceptance Criteria and Device Performance
The Hospira Infusion Sets with an alternate fixed diaphragm Back Check Valve were evaluated against various performance characteristics, primarily focusing on biocompatibility and sterility. The acceptance criteria are implicitly defined by the successful "Pass" result for each test.
| Characteristic | Acceptance Criteria (Standard/Test Method) | Reported Device Performance |
|---|---|---|
| Biocompatibility: Cytotoxicity | ISO 10993-5: 2009 | Pass |
| Biocompatibility: Sensitization | ISO 10993-10: 2002 | Pass |
| Biocompatibility: Irritation / Intracutaneous Reactivity | ISO 10993-10: 2002 | Pass |
| Biocompatibility: Systemic Toxicity (Acute) | ISO 10993-11:2006 | Pass |
| Biocompatibility: Hemocompatibility | ISO 10993-4:2002 | Pass |
| Sterility | ISO 11137-2:2006 (SAL 10-6) | Pass |
| Set Functionality | Meets all performance V&V testing | Same (as predicate device) |
| Back Check Valve Performance | Reduction of backflow | Demonstrated excellent |
Study Details
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Sample Size used for the test set and the data provenance:
The document does not specify the exact sample sizes used for each individual test (e.g., number of devices tested for cytotoxicity, sensitization, etc.). It only states that the "Hospira Infusion sets with an alternate Back Check Valve passed all specified test requirements."
The data provenance is not explicitly stated as country of origin, nor is it explicitly mentioned whether the data is retrospective or prospective. However, given this is a 510(k) submission for a modified device, the testing would typically be prospective for the modified component. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are laboratory-based performance and safety tests, not clinical evaluations requiring expert consensus on a 'ground truth' in the context of diagnostic algorithms. -
Adjudication method for the test set:
Not applicable, as the tests are laboratory-based performance and safety tests with objective pass/fail criteria according to international standards. -
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 submission is for a physical medical device (infusion set) and not an AI/software as a medical device (SaMD) that involves human readers or AI assistance. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device. -
The type of ground truth used:
The ground truth for the device's performance is established by the specified international standards (ISO series) for biocompatibility and sterility. For the back check valve performance, it's assessed against "reduction of backflow" and "user needs and design inputs for an Infusion set." These are objective, measurable criteria defined by regulatory and engineering standards. -
The sample size for the training set:
Not applicable, as this is a physical medical device and not an AI/machine learning algorithm that requires a training set. -
How the ground truth for the training set was established:
Not applicable, for the same reason as above.
§ 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.