Search Results

The Amigo® Insulin Pump is intended for the subcutaneous infusion of insulin.

The proposed Amigo® Insulin Pump is a small, lightweight, battery-operated programmable insulin infusion pump. The pump houses a replaceable single-use insulin syringe containing up to 300 units (3mL) of U-100 insulin. Programming is accomplished via a keypad and LCD display. A microcomputer controls the rotation of a stepper-motor which is connected to a gear reduction assembly. The output of the reduction assembly turns a lead-screw which moves a linear piston. The piston mechanically engages the plunger of the insulin syringe, and the programmed amount of insulin is dispensed through an external seal and luer lock connector to an infusion set. Various hardware and software systems monitor the pump's operation and provide a method of control and monitor function to keep the pump within safe parameters. A hierarchy of alarms based on IEC 60601-1-8 criteria and priorities notifies the user to possible error conditions. Notifications are via visual, audible, and vibration means through the use of the LCD backlight, the audio speaker, and a vibrator motor, respectively. If the alarm priority warrants, the system is put into a safe state with infusion stopped. Power is provided by a user-replaceable primary battery (CR2), allowing for a minimum of 22 days of typical usage. An internal, rechargeable backup battery is used for primary battery end-of-life alarms and for operating redundancy. Provision is made for an infrared communications port, which is accessible only to Nipro for manufacturing use.

The Nipro Amigo® Insulin Pump's acceptance criteria and performance are detailed in the provided 510(k) summary. The submission argues for substantial equivalence to predicate devices based on non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it compares the proposed Amigo® Insulin Pump's performance characteristics directly against three predicate devices. The implicit acceptance criterion is that the new device performs "similarly" or "favorably" compared to the predicate devices, with noted minor differences not being clinically significant.

The table below summarizes key relevant performance characteristics from the comparison table (Table 2 in the original document) that relate to device functionality and safety. The values for the "New Amigo® Insulin Pump (This Submission)" column indicate the reported device performance.

The study supporting these claims is described under "NON-CLINICAL PERFORMANCE DATA" and involved testing against various IEC and ISO standards.

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

The document describes non-clinical performance data based on engineering tests, not human subject testing. Therefore, there is no "test set" in the context of patient data or clinical trials, nor is there data provenance (e.g., country of origin, retrospective/prospective). The tests were conducted on the device itself.

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

Not applicable. This was a non-clinical, engineering-based performance assessment against established standards, not a ground truth established by experts for a test set.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical, engineering-based performance assessment, not requiring adjudication of human expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical specifications and non-clinical performance testing of the device itself, not on human-in-the-loop performance or reader improvement.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance assessment was done. The "NON-CLINICAL PERFORMANCE DATA" section describes the testing of the Amigo® Insulin Pump for its electrical safety and infusion pump performance and safety according to various international standards (IEC and ISO). This testing evaluates the device's inherent functional characteristics without human intervention beyond setting up the tests.

7. The type of ground truth used

The "ground truth" for this submission are the performance specifications and safety requirements defined by international standards (IEC 60601-1, IEC 60601-2-24, IEC 60601-1-2, IEC 60601-1-4, ISO 14971) and the performance characteristics of legally marketed predicate devices. The new device's performance was measured against these established benchmarks.

8. The sample size for the training set

Not applicable. This is a medical device submission based on product engineering and testing, not an AI/algorithm submission that would involve a "training set" of data for machine learning.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set."

Ask a specific question about this device

The Amigo Insulin Pump is intended for the subcutaneous infusion of insulin.

The Amigo Insulin Pump is a small, lightweight, battery-operated programmable Insulin infusion pump. The pump houses a replaceable Nipro GlucoPro™ single-use insulin syringe containing up to 300 units of U-100 insulin. Programming is accomplished via a keypad and LCD display. A microcomputer controls the rotation of a stepper-motor which is connected to a gear reduction assembly. The output of the reduction assembly turns a lead-screw which moves a linear piston. The piston mechanically engages the plunger of the insulin syringe, and the programmed amount of insulin is dispensed through an external seal and luer lock connector to an infusion set.

This document is a 510(k) summary for the Amigo Insulin Pump. It describes the device and its intended use, and argues for its substantial equivalence to a previously cleared device, the GlucoPro EVA Pump (K013309).

Based on the provided information, the following answers can be given:

1. A table of acceptance criteria and the reported device performance

The document does not provide acceptance criteria or detailed device performance metrics in the way one would typically find for an AI/software device undergoing validation studies with specific performance targets (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GlucoPro EVA Pump K013309) by comparing key characteristics. The "performance" in this context refers to the functional equivalence of the Amigo Insulin Pump to the predicate device.

Study Proving Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, which argues for substantial equivalence. It does so by directly comparing the Amigo Insulin Pump's specifications and features to those of the legally marketed predicate device, the GlucoPro EVA Pump (K013309). The FDA's letter (K050312) confirms that based on this comparison, the device is deemed substantially equivalent. This is not a clinical study in the traditional sense, but rather a regulatory comparison.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/not provided in the given document. The submission is for a physical medical device (an insulin pump), not an AI/software device that would typically rely on a "test set" of data for performance evaluation in the context of AI. The "test" here is the comparison of device specifications to a 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)

This information is not applicable/not provided. As above, this is a physical device submission, not an AI/software validation involving expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided.

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

This information is not applicable/not provided. This type of study is relevant for AI-assisted diagnostic or decision-making tools, not for an insulin pump.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. The device is an insulin pump; it does not perform an "algorithm only" function in the way an AI diagnostic tool would. It is inherently a "human-in-the-loop" device in that a patient or caregiver programs and uses it.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not provided. In the context of "substantial equivalence" for a physical device, the "ground truth" is established by the predicate device's cleared specifications and performance, which the new device aims to match. There isn't an external "ground truth" in the AI sense.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical insulin pump, not an AI model that undergoes training on a dataset.

9. How the ground truth for the training set was established

This information is not applicable/not provided.

Ask a specific question about this device