(88 days)
The SoloPak® Sidekick Infusion Pump and Administration Set is intended to be used for the general use infusion of small volumes (50 - 100 ml) .
The SoloPak® Sidekick Infusion Pump is individually packaged and can be cleaned and reused for multiple infusions. The Administration Set is sterile, non-pyrogenic, and packaged in a tyvek/polyethylene pouch. It is a single use set. The materials used to manufacture the SoloPak Sidekick Infusion Pump and Administration Set are the same as those used in currently legally marketed products with the same intended uses.
This document pertains to the SoloPak® Sidekick Infusion Pump and Administration Set, a medical device for infusing small volumes (50-100 ml). The information provided is a 510(k) summary submitted in 1996, focusing on demonstrating substantial equivalence to a predicate device for safety and effectiveness.
Here's an analysis based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Infusion Accuracy | Accurately deliver medication within ±15% |
| Sterility Assurance Level (Administration Set) | Sterilized per AAMI guidelines to a 10⁻⁶ sterility assurance level |
| Pyrogenicity (Administration Set) | LAL tested per USP guidelines (non-pyrogenic implied by LAL testing) |
| Material Equivalence | Same materials as currently legally marketed products with the same intended uses; Same materials as the predicate device |
| Design Equivalence | Same design as the predicate device |
| Manufacturing Process Equivalence | Same manufacturing processes as the predicate device |
| Intended Use Equivalence | Same intended use as the predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for performance testing (e.g., infusion accuracy). It mentions "the infusion sets have been tested," but no numerical sample size is provided.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. Given the nature of a 510(k) submission, the data would likely be from laboratory testing and potentially some internal verification tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The document describes laboratory testing and comparisons to established guidelines (AAMI, USP) and a predicate device, rather than a process involving expert consensus on "ground truth" as might be seen for diagnostic algorithms.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication method" is typically relevant for studies involving human interpretation or subjective assessment where multiple experts' opinions need to be reconciled. This document describes performance testing against objective criteria (e.g., ±15% accuracy, sterility level).
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
Not applicable. This device is an infusion pump and administration set, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The SoloPak® Sidekick is a mechanical/electronic medical device, not an algorithm. Standalone performance for an algorithm is not relevant. The closest equivalent would be the "standalone" performance of the pump itself in delivering fluid accurately, which is addressed by the ±15% accuracy criterion.
7. The Type of Ground Truth Used
For the infusion accuracy, the "ground truth" would be the actual volume or rate of fluid delivered compared to the intended volume or rate. This would be established through precise measurement using calibrated equipment in a laboratory setting.
For sterility, the ground truth is established by the AAMI 10⁻⁶ sterility assurance level and USP guidelines for LAL testing, which are objective, scientifically defined standards.
For material, design, and manufacturing process equivalence, the ground truth is the documented specifications and processes of the predicate device and other legally marketed products.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as point 8.
§ 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).