(67 days)
Hospira infusion sets are intended for use in parenteral, enteral and epidural therapies and the administration of fluids, medications, nutritional fluids, blood and blood products. Safety features on these devices aid in prevention of needle-stick injuries.
Indications for use may include hospital and other medical settings, ambulatory and home use,
The Hospira infusion sets, previously cleared in K052052 (Hospira Plum A+,A+3) and K060806 (Gemstar infusion sets) are intended for use with dedicated Hospira Infusion Pumps. Hospira infusion sets are disposable devices for single patient use, which incorporate various set configurations and components which may be shared across Hospira set families.
These administration set families include primary sets, secondary sets, extension sets, piggyback sets, gravity sets, microbore sets, macrobore sets, and sets which allow concurrent delivery. These sets provide a range of physical characteristics such as priming volume, length, diameter, materials etc.
This submission describes modifications to existing Hospira Infusion Sets (K052052 and K060806), primarily involving a change in the bonding process and the conversion of tubing material from DEHP to Non-DEHP PVC. The study presented focuses on demonstrating that the modified devices maintain the same safety and effectiveness as the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (ISO 10993-5: 2009) | Pass | Pass |
| Sensitization (ISO 10993-10: 2002) | Pass | Pass |
| Irritation / Intracutaneous Reactivity (ISO 10993-10: 2002) | Pass | Pass |
| Systemic Toxicity (Acute) (ISO 10993-11: 2006) | Pass | Pass |
| Hemocompatibility (ISO 10993-4: 2002) | Pass | Pass |
| Sterility | ||
| SAL 10-6 (ISO 11137-2: 2006) | Pass | Pass |
| Dimensional Conformance and Connection Compatibility | ||
| Conical Fittings (Luer Taper) (ISO 594-2) | Pass | Pass |
| Functional Performance (General) | Meet design inputs, and requirements of standards for sterility, particulate, leakage, tensile strength, and filter characteristics. | Passed all specified test requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for each test. However, it indicates that "Hospira Infusion sets with laser welded access device" and "Hospira Infusion sets with Non-DEHP PVC yellow striped tubing" were tested. This implies that representative samples of the modified devices were used for testing.
The data provenance is not specified in terms of country of origin, but it is retrospective in the sense that it relies on bench testing and comparisons to existing predicate devices, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve "ground truth" established by human experts in the way an imaging diagnostic device might. The "ground truth" for these tests are the established and recognized international standards (e.g., ISO standards) and the specifications derived from the design inputs for an infusion set. Compliance with these standards is objectively measured through defined test methods rather than expert consensus.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, the evaluation is based on objective conformance to established standards and physical/functional specifications, not on subjective expert interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typical for diagnostic imaging devices where human interpretation plays a significant role. The current submission pertains to physical and chemical modifications of a medical device, which are assessed through bench testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is not an AI algorithm. The performance evaluation is for the physical medical device itself.
7. The Type of Ground Truth Used
The "ground truth" in this context is the fulfillment of established engineering design requirements, compliance with international ISO standards (e.g., for biocompatibility, sterility, dimensional conformance), and the functional claims and intended use of an infusion set. These are objective, measurable criteria.
8. The Sample Size for the Training Set
Not applicable. This study does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.