(128 days)
Hospira Primary sets are indicated for the delivery of fluids from a container to a patient's vascular system.
The Hospira Primary Sets with Secure Lock are intended for use as gravity sets. Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, dial-a-flo assembly and tubing. In addition to these components, a set may contain one or more of the following components: flow control device, drip chamber assembly and air inlet. Hospira Primary sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira infusion sets are disposable devices for single patient use.
The provided text describes a 510(k) premarket notification for a medical device, specifically Hospira Primary Sets. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Hospira Primary Sets - K142367).
Based on the information provided, it's clear this document is for a physical medical device (intravascular administration sets) and not an AI/ML-driven diagnostic or image analysis software. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.
The "acceptance criteria" for a physical device like this typically revolve around compliance with relevant engineering standards, material biocompatibility, and functional performance tests rather than diagnostic accuracy metrics.
Here's a breakdown of the applicable information:
Acceptance Criteria and Device Performance for Hospira Primary Sets (K143015)
The device in question, Hospira Primary Sets, is an intravascular administration set. The criteria for its acceptance are based on its functional performance, material safety, and compliance with established international standards for such medical devices, demonstrating substantial equivalence to a previously cleared predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance (as reported) |
|---|---|
| Indications for Use | "Hospira Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular system." (Matches predicate) |
| Design and Materials of Construction | "The design and materials of construction remain the same as the predicate product." (Meets predicate design/materials) |
| Material Biocompatibility | "All materials of construction for Hospira Primary Sets meet the applicable material test requirements for ISO 10993." (Meets ISO 10993) |
| Functional Performance | "New performance data has been generated to ensure the device performs as intended in accordance with ISO 594-1, ISO 594-2 and ISO 8536-4. All testing is acceptable." (Meets specified ISO standards and performs as intended) |
| Sterility Assurance Level (SAL) | "The product Sterility Assurance Level is 10-6." (Meets acceptable SAL) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly detailed in the provided document. For physical device performance testing, sample sizes are typically determined by statistical methods to achieve a certain confidence level for the specific tests performed (e.g., tensile strength, leak tests). The data provenance is generally from internal lab testing by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable as the device is a physical product, not an AI/ML diagnostic. Ground truth for its performance is established through engineering and laboratory testing against defined standards.
4. Adjudication Method for the Test Set
This is not applicable for a physical device. Performance is objectively measured against engineering specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
This is not applicable. MRMC studies are relevant for diagnostic devices involving human interpretation, especially with AI assistance. This device is an intravenous fluid delivery set.
6. If Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" is defined by:
- Compliance with international standards such as ISO 10993 (biocompatibility), ISO 594-1 (luer fittings), ISO 594-2 (luer fittings), and ISO 8536-4 (infusion sets).
- Demonstrated functional performance through engineering tests that confirm safe and effective fluid delivery.
- Material properties meeting specified requirements.
- Achieving a sterility assurance level of 10-6.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical product and does not involve AI/ML training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason mentioned 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.