(268 days)
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Hospira Primary sets are indicated for the delivery of fluids from a container to a patient's vascular system.
The Hospira Extension Sets and the Hospira Primary Sets are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, , in-line adapter, injection site assembly, and Dial-A-Flo. Hospira Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with a spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, Dial-A-Flo assembly and tubing. Extension sets and Primary Sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.
The provided document (K161036) is a 510(k) summary for medical devices (Hospira Extension Set and Hospira Primary Set), which are intravenous administration sets. It describes the device, its intended use, and the technological characteristics compared to predicate devices. The primary change addressed in this submission is the replacement of the current Dial-A-Flo flow control device with a new one from a different manufacturer.
The document does not contain information about acceptance criteria or performance from a study in the context of an Artificial Intelligence/Machine Learning (AI/ML) device. The acceptance criteria and performance data presented here are for a traditional medical device (IV administration sets) undergoing a change in a component.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device meeting them as if it were an AI/ML device.
However, I can extract the acceptance criteria and reported device performance for the Hospira Extension Set and Hospira Primary Set as described in the document, which are related to non-clinical and performance testing of the physical medical device.
Acceptance Criteria and Reported Device Performance (as related to the physical medical device):
The acceptance criteria are generally implied by meeting applicable standards.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Biocompatibility | All materials of construction meet applicable material test requirements for ISO 10993. | New data generated showing all materials of construction meet applicable material test requirements for ISO 10993. Tested ISO 10993-4 (Hemocompatibility), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-11 (Intracutaneous Irritation), Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Pyrogenicity. |
| Performance Testing | Device performs as intended in accordance with applicable standards, specifically ISO 8536-4. Compliance with ISO 594-1 and ISO 594-2 (covered by predicate). All testing is acceptable. | New performance data generated ensuring the device performs as intended in accordance with ISO 8536-4. Tested sections: 6.1 Particulate Contamination, 6.2 Leakage, 6.3 Tensile Strength, 6.6 Tubing, 6.7 Fluid Filter, 6.9 Flow Regulator, 6.10 Flow Rate, 6.11 Injection Site, 6.12 Male Conical Fitting, 6.13 Protective Caps. All testing reported as acceptable. |
| Sterility | Product Sterility Assurance Level (SAL) is 10-6. | The product Sterility Assurance Level is 10-6. |
| Functional Equivalence | Meet the functional claims and intended use as described in the product labeling. Substantially equivalent to predicate devices. | Hospira Extension Sets and Hospira Primary Sets meet the functional claims and intended use. Found substantially equivalent to K142974 and K143015. |
Information Not Applicable to this Document (as it's not an AI/ML device study):
- Sample sized used for the test set and the data provenance: Not applicable for this type of device submission. Performance testing is typically done on physical samples, and the number of samples is not detailed in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing is based on objective measurements against engineering specifications and standards.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For this device, ground truth is based on established ISO standards, engineering specifications, and validated test methods (e.g., flow rate measurement, leak detection, material compatibility assays).
- The sample size for the training set: Not applicable (no "training set" in the AI/ML sense).
- 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.