(15 days)
Abbott Plum A+® Infusion Pump with a HPL/RS plug and play module has the following indications for use: Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
The Abbott Plum A+ Infusion Pump is an electromechanical infusion pump that uses a stepper motor in coniunction with an in-line cassette to meter IV fluids through a dedicated intravenous administration set that is also manufactured and distributed by Abbott Laboratories.
The subject and predicate devices have identical indications for use. Abbott proposes to modify the plug-and-play module of the predicate device to provide a medication error management alert feature through software changes and increasing the memory capacity of the module. The plug-and-play module will be available as a kit. In addition, there will be a separate kit that contains the software on a CD-ROM to develop the library as well as connectors to download the library from the Personal Computer (PC) to the pump. In addition, a confirmation step is being added after programming of simple delivery. These proposed changes are intended to aid in medication error reduction.
The user interface of the infusion pump allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units such as micrograms/kg/hour, grams/hr and other delivery specifications.
Like the predicate device, the display on the pump provides visible indication of several functions including active pump operations, alarm and program status and the parameters of fluid flow for one or both incoming fluid lines.
Both the predicate and the proposed devices can be used for standard, piggyback, or concurrent fluid delivery.
This submission describes a modification to an existing infusion pump, the Abbott Plum A+ Infusion Pump, to include a medication error management alert feature through software changes and increased memory capacity in the plug-and-play module. The documentation provided does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel medical device AI would.
Instead, this 510(k) submission, K031185, relies on establishing substantial equivalence to a predicate device (Abbott Plum A+ Infusion Pump, K011442 and K024084). The core argument is that the proposed device is so similar to the predicate device that it does not raise new issues of safety or effectiveness.
Therefore, the requested information elements related to acceptance criteria, specific device performance, sample sizes, expert ground truth, adjudication methods, and AI-specific studies (MRMC, standalone) are not applicable in the context of this 510(k) submission as no such detailed studies are presented.
The documentation focuses on demonstrating that the modifications do not fundamentally alter the device's mechanism of action, intended use, or safety profile compared to the lawfully marketed predicate device.
Here's how the provided document addresses "acceptance criteria" and "proof" in the context of a 510(k) for substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: In a 510(k) for substantial equivalence, the "acceptance criteria" is primarily that the modified device remains as safe and effective as the predicate device, and that the modifications do not raise new questions of safety or effectiveness. Specific performance criteria would be related to the new feature (medication error management) and would typically reference industry standards or internal validation testing. The provided summary does not explicitly list quantitative acceptance criteria for the software changes.
- Reported Device Performance: The document states, "The proposed Abbott Plum A+® Infusion Pump with HPL/RS with the plug-and-play Module and the marketed Abbott Plum A+® Infusion Pump are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. Therefore, the Abbott Plum A+® Infusion Pump with HPL/RS with the plug-and-play Module and the Abbott Plum A+ Infusion Pump are substantially equivalent. The modifications do not raise new issues of safety and effectiveness." This is the reported performance in the context of substantial equivalence – that the changes do not degrade performance or safety.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This document does not describe a clinical study or a performance test set with a sample size for a new device's performance evaluation. The evaluation is based on comparing the modified device's characteristics to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No ground truth establishment by external experts for a test set is described, as it's not a clinical performance study. The expertise is internal to the manufacturer for design, risk assessment, and regulatory submission, and then the FDA's reviewers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
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 is not an AI-assisted device, and no MRMC study or human reader improvement with AI is mentioned. The device is an electromechanical infusion pump with software enhancements for error management.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. While the device has software, it's not an "algorithm only" device in the sense of AI or diagnostic software. Its function is to manage infusion, and the new feature provides alerts to a human operator. No standalone algorithm performance is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No explicit "ground truth" for evaluating performance in a clinical or diagnostic sense is discussed. "Ground truth" in this context would be the successful operation of the predicate device and the manufacturer's validation that the new features function as intended and do not introduce new risks.
8. The sample size for the training set:
- Not Applicable. This submission does not describe a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no machine learning algorithm, there is no training set or associated ground truth.
In summary, for this specific 510(k) submission (K031185):
The acceptance criteria are implicitly that the modified device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness. The "study that proves" this is the 510(k) submission itself, which provides a comparison to the predicate device and the manufacturer's assertion (backed by internal testing, not detailed here) that the modifications do not negatively impact safety or effectiveness. The FDA's letter of April 30, 2003, confirms their agreement with this substantial equivalence claim.
§ 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).