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The Abbott Plum A+3 infusion pump consists of three independent Plum A+ pumping units each identical to each other, housed in a single enclosure. It is an electromechanical infusion pump which uses a stepper motor in conjunction with an n-line cassette to meter IV fluids through a dedicated intravenous administration set that is also manufactured and distributed by Abbott Laboratories. The user interface of the infusion pump allows the user to program fluid delivery through a variety of weight and medication based units such as micrograms/kg/hour, grams/hr and other delivery specifications. An individual pump can accurately control the delivery of fluid from two input sources out to a single infusion line. The Abbott Plum A+3 infusion pump allows for six lines in and three lines out. While identical, each pump operates independently from the others and must be programmed separately. Each pump is uniquely labeled and numbered and differentiated by color of the center unit. The proposed device includes a nurse call function that provides for remote monitoring in the case of alarm activation. A computer data port is provided that allows for an exchange of data from the pump to host computers in the healthcare facility. The display on each pump provides visible indication of several functions including active pump operations, alarm and program status and the parameters of fluid flow. Each pump can be used for standard, piggyback, or concurrent fluid delivery.

AI/ML Overview

The Abbott Plum A+3 Multichannel Infusion Pump is a Class II electromechanical infusion pump. It consists of three independent Plum A+ pumping units, each capable of controlling fluid delivery from two input sources to a single infusion line. The device is intended for administering fluids, whole blood, and blood products in parenteral, enteral, and epidural therapies.

The provided document, K021350, is a 510(k) summary for a Special 510(k) submission, indicating a modification to an already legally marketed predicate device (Abbott Plum A+™ Single Channel Infusion Pump). The modification involves housing three identical Plum A+ pumping units into a single enclosure, utilizing a single bar code wand, and a single AC power source.

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary states: "Data regarding the functional performance of the proposed Abbott Plum A+3 Multichannel Infusion Pump has been generated and reviewed. The results of testing conducted to verify and validate the design modifications demonstrate acceptable performance of the device."

However, the specific acceptance criteria (e.g., flow rate accuracy tolerance, alarm response times, occlusion pressure thresholds, battery life, electromagnetic compatibility limits, etc.) and the detailed quantitative reported device performance against these criteria are not provided in the excerpt. The document only offers a general statement of acceptable performance. For a medical device of this nature, industry standards (e.g., IEC 60601 series, ISO 14971) and FDA guidance documents would typically define the performance criteria.

Acceptance Criteria Category	Specific Criteria (Example - Not provided in document)	Reported Device Performance (Example - Not provided in document)
Flow Rate Accuracy	e.g., ±5% for flow rates > 1 mL/hr	e.g., Achieved ±3% for flow rates > 1 mL/hr
Occlusion Detection Pressure	e.g., Detect occlusion within X psi	e.g., Detected occlusion within Y psi
Alarm Response Time	e.g., Audible/visual alarm within Z seconds	e.g., Alarm activated within W seconds
Battery Operation Duration	e.g., Operate for A hours on full charge	e.g., Operated for B hours on full charge
EMC Compliance	e.g., Meets limits of IEC 60601-1-2	e.g., Compliant with IEC 60601-1-2
Software Validation	e.g., No critical defects identified	e.g., All software tests passed with no critical defects

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Data regarding the functional performance... has been generated and reviewed." For infusion pump testing, this would typically involve various types of units tested under a range of operating conditions (e.g., different flow rates, fluid viscosities, temperatures, pressures, and alarm conditions) to ensure robust performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this type of device submission. The Abbott Plum A+3 Multichannel Infusion Pump is a hardware device where "ground truth" for performance is established through objective engineering tests against predefined specifications and regulatory standards, not through clinical expert consensus on complex diagnostic interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable as it pertains to expert consensus on interpretation, which is not relevant for the functional performance testing of an infusion pump.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study is not applicable for this device. This type of study is typically used for diagnostic or screening devices (e.g., AI algorithms for medical imaging) where human readers (e.g., radiologists) interpret cases, and their performance with and without AI assistance is compared. The Abbott Plum A+3 is an infusion pump, and its effectiveness is measured by its mechanical and software performance in fluid delivery, not by human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept is not applicable to the Abbott Plum A+3 Multichannel Infusion Pump. "Standalone" performance usually refers to the performance of an AI algorithm without human intervention. While the pump has embedded software and "intelligence," its primary function is mechanical fluid delivery guided by programmed parameters. Its "performance" is inherently a standalone measurement against engineering specifications, but it's not an AI-driven interpretive algorithm in the typical sense of standalone AI studies. The "functional performance" mentioned in the document would represent this standalone performance.

7. Type of Ground Truth Used:

The ground truth for the functional performance testing of the Abbott Plum A+3 Multichannel Infusion Pump would be based on objective engineering measurements and predefined technical specifications derived from regulatory standards (e.g., IEC 60601 series for medical electrical equipment, specific infusion pump standards). For example:

Flow Rate: Measured actual fluid volume delivered compared to programmed volume using calibrated flow meters or gravimetric methods.
Occlusion Pressure: Measurement of pressure required to trigger an occlusion alarm using calibrated pressure sensors.
Alarm Functionality: Verification that alarms (audible, visual) activate correctly under specified fault conditions (e.g., air in line, low battery, completion of infusion).
Electrical Safety: Measurements against electrical safety standards.
EMC: Measurements against electromagnetic compatibility standards.

8. Sample Size for the Training Set:

This information is not applicable as the Abbott Plum A+3 Multichannel Infusion Pump is a hardware device with embedded software for control, not a machine learning model that requires a "training set" of data in the AI sense to learn patterns. The software development lifecycle would involve verification and validation activities, but not "training" data.

9. How Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated in point 8.

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