(89 days)
The AutoDose Infusion system is intended for sequential infusion of predetermined volumes of intravenous solutions including 0.9% Sodium Chloride Injection, (NaCl), and Heparin Lock Flush Solution, USP solutions.
The AutoDose Infusion System was designed to infuse Intravenous solutions of predetermined volumes in a predetermined order based on the configuration of the disposable bag. The system is capable of infusing Intravenous (IV) solutions of the following volumes in this order: Chamber 1
Here's an analysis of the provided text regarding the AutoDose™ Infusion System, focusing on acceptance criteria and the supporting study information:
Key Takeaways from the Document:
- This submission is a 510(k) for substantial equivalence, meaning the device is being compared to an existing, legally marketed predicate device (itself, but with a new "for use with" claim). This type of submission often relies on demonstrating that the new use doesn't introduce new safety or effectiveness concerns, rather than comprehensive standalone clinical trials or AI performance evaluations.
- The document describes a physical medical device (an infusion system) and its accessories, not an AI/software as a medical device (SaMD). Therefore, many of the typical AI-specific criteria (like expert consensus, adjudication, MRMC studies, training set details) are not applicable to this document.
- The performance criteria are related to the physical function of the infusion system, device compatibility, and solution stability.
Acceptance Criteria and Study Information for the AutoDose™ Infusion System
Given that this is a 510(k) for an infusion system and not an AI/software device, the request for AI-specific metrics (such as MRMC, standalone algorithm performance, number of experts, etc.) is not directly applicable. However, I will interpret the request in the context of the provided document by extracting the performance criteria and how the device met them.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion / Benchmark | Reported Device Performance |
|---|---|---|
| Solution Compatibility & Stability | Solutions (0.9% NaCl, Heparin Lock Flush) meet USP 24/NF 19 monographs requirements over storage periods and conditions when filled in AutoDose Bag/Restrictor Set. | Confirmed solutions meet all requirements over storage periods and conditions. |
| Solution Infusion Rate & Pressure | Consistent infusion rates and predetermined volumes. Infusion pressures no greater than 25 psi. | Verified consistent delivery in predetermined order and volumes, and generated infusion pressures no greater than 25 psi. |
| Biocompatibility | Fluid-contact materials (AutoDose Bag, Restrictor Set) are biocompatible. | Demonstrated biocompatible. |
| Hazards Analysis | No new or increased risk factors identified with Sodium Chloride and Heparin solutions. | Confirmed; compatibility and stability of solutions verified. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated as a numerical 'sample size' in the context of rigorous clinical trials. The document refers to "tests were performed" and "performance testing...verified." For a physical device like this, testing typically involves multiple units or cycles to demonstrate reliability and meet specifications. Specific numbers of units tested or cycles run are not provided.
- Data Provenance: Not applicable in the context of human data. The testing was performed on the device itself and the solutions in question (0.9% Sodium Chloride Injection and Heparin Lock Flush Solutions, USP). The "data" are results from physical and chemical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device, and "ground truth" as it applies to expert interpretation of medical images or patient data (which is relevant for AI devices) does not apply here. The "ground truth" is established through engineering and chemistry standards (e.g., USP monographs, pressure gauges, flow rate measurements).
4. Adjudication Method for the Test Set
- Not Applicable. As this is not an AI/software device, there is no expert adjudication process for image interpretation or clinical decision-making. Performance is determined by direct physical measurement and chemical analysis against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is designed to evaluate how human readers' diagnostic performance changes with and without AI assistance. This concept is not applicable to a physical IV infusion system.
6. Standalone (Algorithm Only) Performance
- Not Applicable. This device is hardware for infusion. There is no standalone "algorithm" in the sense of an AI model to evaluate without human-in-the-loop performance. Its "performance" is its physical ability to infuse fluids correctly.
7. Type of Ground Truth Used
- The "ground truth" for the performance claims in this document is based on:
- USP 24/NF 19 monographs: For demonstrating compatibility and stability of the solutions.
- Engineering specifications/measurements: For infusion flow rates, predetermined volumes, and pressures (e.g., pressure not exceeding 25 psi).
- Biocompatibility testing standards: For confirming material safety in contact with fluids.
8. Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI model requiring a "training set" of data. Device development and testing follow engineering design and validation processes, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI model, this question is not relevant to the provided information.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).