(63 days)
Hospira Administration Sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira Administration sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use. Hospira Administration sets are intended for the delivery of fluids, including blood and blood products where indicated, from a container to a patient's vascular system.
The subject of this Special 510(k): Device Modification is the addition of an alternate luer activated needleless valve to existing Hospira Administration sets cleared under the identified predicate 510(k)s. Hospira Administration Sets are comprised of components in various combinations of the following: male luer adapter with cap, female luer with cap, piercing pin connector, tubing, flow control device, filter, in-line adapter, injection site assembly, luer activated needleless valve Nuitiv™ Connector, check valve, burette chamber, and blood chamber.
This document describes the 510(k) premarket notification for Hospira Administration Sets, specifically addressing the addition of an alternate luer-activated needleless valve, the Nuitiv™ Connector, to existing administration sets. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from recognized international standards for medical devices, particularly those for intravascular administration sets and luer connectors. The reported performance demonstrates compliance with these standards.
| Characteristic / Test | Acceptance Criteria (Implicitly from Standards) | Reported Device Performance (Nuitiv™ Connector) |
|---|---|---|
| Biocompatibility | Meets applicable material test requirements for ISO 10993 | Meets applicable material test requirements for ISO 10993, specifically: |
- ISO 10993-4 Hemocompatibility
- ISO 10993-5 Cytotoxicity
- ISO 10993-10 Sensitization
- ISO 10993-11 Intracutaneous Irritation
- Systemic Toxicity
- Subacute Toxicity
- Subchronic Toxicity
- Pyrogenicity |
| Luer Connector Performance | Complies with ISO 594-1 and ISO 594-2 for conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment. | Complies with ISO 594-1 and ISO 594-2, specifically: - Section 4.1.1 Gauging (luer dimensions)
- Section 4.2.1 Liquid Leakage
- Section 4.2.2 Air Leakage
- Section 4.3 Separation Force
- Section 4.4 Unscrewing Torque
- Section 4.5 Ease of Assembly
- Section 4.6 Resistance to Overriding
- Section 4.7 Stress Cracking |
| Administration Set Performance (general) | Complies with ISO 8536-4 and ISO 1135-4 for infusion equipment. | Complies with ISO 8536-4 and ISO 1135-4, specifically: - Section 6.1 Particulate Matter
- Section 6.2 Air Leakage (for ISO 8536-4)
- Section 6.3 Tensile Strength (for ISO 8536-4)
- Section 5.1 Particulate Matter (for ISO 1135-4)
- Section 5.2 Air Leakage (for ISO 1135-4)
- Section 5.3 Tensile Strength (for ISO 1135-4) |
| Administration Set Performance (with pressure infusion equipment) | Complies with ISO 8536-8 for infusion equipment for use with pressure infusion equipment. | Complies with ISO 8536-8, specifically: - Section A.3.2 Air Leakage
- Section A.3.3 Air Leakage
- Section A.3.4 Liquid Leakage |
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 |
| Functional Claims & Intended Use | Meets functional claims and intended use as described in product labeling. | Meets functional claims and intended use as described in the product labeling. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes (number of units tested) for each individual non-clinical performance bench test. It uses the phrase "All testing is acceptable," implying that sufficient units were tested to demonstrate compliance with the specified standards.
The data provenance is from non-clinical bench testing conducted to evaluate the performance and material characteristics of the Nuitiv™ Connector and the administration sets incorporating it. This is prospective testing specifically performed for this 510(k) submission. The country of origin of the data is not explicitly stated, but it is implied to be internal testing by Hospira, Inc., a U.S.-based company.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (device modification for administration sets) does not involve expert-established ground truth in the way a diagnostic AI product would. The "ground truth" for these tests are the established international standards (ISO standards) themselves and the objective, measurable criteria they define. No human experts are used to establish "ground truth" for these mechanical and material tests; the tests evaluate direct physical properties and biological responses against predefined limits.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method like 2+1 or 3+1. The tests yield objective, quantitative results (e.g., force measurements, leak rates, chemical analyses) that are compared against predefined pass/fail criteria from the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is typically relevant for medical imaging AI devices where human readers interpret medical images with and without AI assistance. This submission is for a physical medical device (administration sets) and a component change, not an AI or diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, the "standalone" performance was evaluated. The performance bench tests described for the Nuitiv™ Connector are a standalone assessment of its properties and function without human interaction beyond its intended use. However, this is not an "algorithm-only" standalone performance as typically discussed in AI/software medical device contexts. It is a standalone evaluation of the physical device component.
7. The Type of Ground Truth Used
The ground truth used for this study is based on:
- Established International Standards: Specifically, various ISO standards for medical devices, infusion equipment, and luer connectors (e.g., ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4, ISO 8536-8, ISO 1135-4).
- Objective Engineering and Material Science Principles: The tests evaluate measurable physical properties and material characteristics against predefined limits identified in these standards.
It is not based on expert consensus, pathology, or outcomes data, as these are typically relevant for diagnostic or therapeutic efficacy studies.
8. The Sample Size for the Training Set
Not applicable. This is a submission for a physical medical device. There is no concept of a "training set" or "machine learning model" involved. The testing focuses on the performance of the manufactured device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device submission of this type.
§ 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.