(90 days)
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.
| Characteristic | Acceptance Criteria (Predicate's Performance) | Reported Device Performance (Amigo Insulin Pump) |
|---|---|---|
| Intended Use | Subcutaneous infusion of insulin | Subcutaneous infusion of insulin |
| Pump Type | Linear Piston | Linear Piston |
| Control Technology | Microprocessor | Microprocessor |
| Insulin Reservoir | 3 mL (300 Units) | 3 mL (300 Units) |
| Insulin Type | U-100 | U-100 |
| Power Source | One 3 Volt lithium battery | One 3 Volt lithium battery |
| Programmable Basal Delivery | Yes | Yes |
| Programmable Bolus Delivery | Yes | Yes |
| User Notification | Audible, visual, and vibration | Audible, visual, and vibration |
| Visual Display | LCD | LCD |
| Insulin Syringe / reservoir | Nipro GlucoPro | Nipro GlucoPro |
| Infusion Set Connector | Standard luer lock | Standard luer lock |
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.
§ 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).