(187 days)
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
The Hospira Extension 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, flow control device, in-line adapter, injection site assembly, and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Extension sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.
The provided text describes a 510(k) premarket notification for Hospira Extension Sets, which are intravascular administration sets. The document focuses on demonstrating substantial equivalence to predicate devices, primarily due to changes in tubing material and a needleless valve component.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from international standards for medical devices, specifically those relating to biocompatibility and mechanical/functional performance of IV administration sets. The reported device performance indicates that the new Hospira Extension Sets meet these standards.
| Acceptance Criteria (Standard & Section) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-4 Hemocompatibility | Acceptable |
| ISO 10993-5 Cytotoxicity | Acceptable |
| ISO 10993-10 Sensitization | Acceptable |
| ISO 10993-11 Intracutaneous Reactivity | Acceptable |
| Systemic Toxicity | Acceptable |
| Acute Toxicity | Acceptable |
| Subchronic Toxicity | Acceptable |
| Pyrogenicity | Acceptable |
| Mechanical/Functional Performance: | |
| ISO 594-1 (Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment): | |
| 4.1 Gauging | Acceptable |
| 4.2 Liquid Leakage | Acceptable |
| 4.3 Air Leakage | Acceptable |
| 4.4 Separation Force | Acceptable |
| 4.5 Stress Cracking | Acceptable |
| ISO 594-2 (Conical fittings with a 6% (Luer) taper - Part 2: Lock fittings): | |
| 4.1 Gauging | Acceptable |
| 4.2 Liquid Leakage | Acceptable |
| 4.3 Separation Force | Acceptable |
| 4.4 Unscrewing Torque | Acceptable |
| 4.5 Ease of Assembly | Acceptable |
| 4.6 Resistance to Overriding | Acceptable |
| 4.7 Stress Cracking | Acceptable |
| ISO 8536-4 (Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed): | |
| 6.1 Particulate Contamination | Acceptable |
| 6.2 Leakage | Acceptable |
| 6.3 Tensile Strength | Acceptable |
| 6.6 Tubing | Acceptable |
| 6.7 Fluid Filter | Acceptable |
| 6.9 Flow Regulator | Acceptable |
| 6.10 Flow Rate | Acceptable |
| 6.11 Injection Site | Acceptable |
| 6.12 Male Conical Fitting | Acceptable |
| 6.13 Protective Caps | Acceptable |
| Sterilization: | |
| Sterility Assurance Level (ANSI/AAMI/ISO 11137-1 and 11737-1) | 10^-6 |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of devices tested for liquid leakage, number of samples for cytotoxicity). It broadly states that "new data has been generated" and "all testing is acceptable."
The data provenance is not specified in terms of country of origin. The studies are non-clinical (laboratory testing) rather than studies on human subjects, so the retrospective or prospective nature isn't directly applicable in the same way it would be for clinical trials. The focus is on demonstrating compliance with recognized international standards for device performance and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" for non-clinical performance and biocompatibility testing is established by the specified standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4), rather than expert consensus on interpretive data. The tests themselves are objective measurements against defined parameters.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective assessment (e.g., image interpretation by multiple readers). For objective bench testing against defined standards, the outcome is determined by whether the device's performance falls within the specified acceptance limits for each test.
5. 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
No MRMC comparative effectiveness study was done. This type of study is not relevant for the evaluation of an invasive medical device like an extension set, which does not involve human interpretation of diagnostic data or AI assistance in a clinical workflow.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. This device is not an AI/ML-based diagnostic or therapeutic algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the device's performance is defined by adherence to objective, quantitative and qualitative criteria set forth in recognized international standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4, ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11737-1). For example, for "liquid leakage," the ground truth is whether the device leaks or not under specified test conditions, as defined by the ISO standard. For "cytotoxicity," it's whether the materials cause a cytotoxic reaction above a defined threshold.
8. The Sample Size for the Training Set
This information is not applicable. The development of this medical device (Hospira Extension Sets) does not involve a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles, materials science, and compliance with established performance standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.