(77 days)
Symbiq™ Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. They are intended primarily for use in the hospital setting and can be used in other acute and nonacute care areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Sub acute Facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.
List Number 16120 is a Primary Symbiq™ set that includes MICRODRIP™ Drop Former, Sight Chamber, Backcheck Valve, 2 CLAVE™ Y-Sites, Distal Microbore Tubing, 0.2 Micron Filter, 105 Inch and is non-DEHP . It is designed specifically for use with the Symbiq™ Infusion Pump and is used to administer fluids from a container to a patient's vascular system though a needle or catheter. The set has a sterile fluid pathway and is for single patient use.
This document describes a Special 510(k) submission for a labeling update to an existing medical device, the Primary Symbiq™ Set. It is not a study proving the device meets acceptance criteria through rigorous clinical trials or AI performance evaluations as would be typical for a new diagnostic or prognostic device. Instead, it demonstrates continued performance for an expanded use case compared to a previously cleared version of the same device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Delivery accuracy at flow rates between 100 ml/hr and 500 ml/hr under standard conditions | ±10% (Implicitly met as the device passed System Accuracy Performance for 500 ml/hr and a general statement of meeting all acceptance criteria and accuracy performance claims is made.) |
| Delivery Accuracy at Flow Rate of 500 ml/hr | Pass (tested under "System Verification" method with "System Accuracy Performance" title) |
| Meet all acceptance criteria and accuracy performance claims under standard conditions as described in product labeling. | Met all acceptance criteria and accuracy performance claims. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used for the "Delivery Accuracy at Flow Rate of 500ml/hr" test. It only mentions the test method ("System Verification") and title ("System Accuracy Performance").
The data provenance is not specified beyond being "Non-Clinical Tests Conducted." Given the nature of a 510(k) submission for a label update on an existing device, these would likely be internal lab tests performed by Hospira (the manufacturer), and thus retrospective from the perspective of the submission, but the tests themselves are performed on manufactured units.
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 type of submission. The "ground truth" here is the physical performance of the infusion set, measured by engineering and quality control tests, not by human expert interpretation of data or images.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically relevant for human interpretation or consensus-based ground truth establishment, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
This information is not applicable. The device is an infusion set, not an AI-powered diagnostic or therapeutic tool that involves human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
This information is not applicable. The device is an infusion set, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is the physical measurement of fluid delivery accuracy under controlled laboratory conditions, against predefined engineering specifications.
8. The Sample Size for the Training Set
This information is not applicable. The device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this type of medical device.
§ 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.