(28 days)
LIFESHIELD™ VISION™ Infusion sets are intended for the delivery of fluids including but not limited to blood and blood products from a container into a patients vascular system.
The LIFESHIELD™ VISION™ infusion sets, are intended for use as gravity sets or with dedicated Hospira Infusion Pumps. These devices are obtainable in custom lengths and component options according to facility needs and physician preference, Hospira infusion sets are disposable devices for single patient use, which incorporate various set configurations and components. The components include Pre-pierced access ports (Pre-pierced Male Adapter Plug, Pre-pierced Y-site, and Pre-pierced T-connector) which are the subject of this submission, may be shared across Hospira set families may be used with sets for
The provided document is a 510(k) summary for a medical device called LIFESHIELD™ VISION™ Infusion sets with Pre-pierced Reseal Modification. This document describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test | Acceptance Criteria (Standard/Test Method) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5: 2009 | Pass |
| Sensitization | ISO 10993-10: 2010 | Pass |
| Irritation / Intracutaneous Reactivity | ISO 10993-10: 2010 | Pass |
| Systemic Toxicity (Acute) | ISO 10993-11: 2006 | Pass |
| Hemocompatibility | ISO 10993-4: 2006 | Pass |
| Sterility (SAL 10-6) | ISO 11137-2: 2006 | Pass |
| Dimensional Conformance and Connection Compatibility | ISO 594-2 1998 (Conical fittings with a 6% (LUER) taper for syringes, needles and certain other equipment) | Pass |
| Other Performance Characteristics | Not explicitly detailed as criteria, but mentioned as having met requirements | Particulate, Leakage, Tensile Strength, Filter characteristics: Met requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices or tests performed) for each specific test in the "Performance Test Summary-New Device" table. It generally states that "The LIFESHIELD™ VISION™ Infusion sets with Pre-pierced reseal access ports have passed all specified test requirements."
The data provenance is from non-clinical tests conducted by the manufacturer, Hospira, Incorporated, in the United States (based on the company's address). These tests are not human studies (clinical trials), so the concepts of retrospective or prospective human data do not apply directly. These are laboratory/bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The tests performed are non-clinical, bench testing (e.g., cytotoxicity, sterility, dimensional conformance) against established international standards (ISO). There is no "ground truth" derived from human expert consensus or interpretation of medical images/data in this context. The "ground truth" is adherence to the specified technical standards.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical data by multiple experts. For non-clinical bench testing, results are typically determined by adherence to pre-defined pass/fail criteria of the standard.
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
There was no MRMC comparative effectiveness study and no mention of AI assistance. This submission pertains to a modification of a physical medical device (infusion set), not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is based on:
- International Standards (ISO): Compliance with the specified parameters and methodologies outlined in standards like ISO 10993 (Biocompatibility), ISO 11137 (Sterility), and ISO 594-2 (Luer fittings).
- Pre-defined Pass/Fail Criteria: Each standard has specific criteria that must be met for a "Pass" result. The device's physical attributes and performance were confirmed to meet these requirements.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI algorithm. The device's design and manufacturing processes are validated against established engineering and quality control principles.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set.
§ 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.