(184 days)
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.
| Characteristic | New Amigo® Insulin Pump (This Submission) | Predicate Device (Animas IR1250) (for comparison) | Predicate Device (Amigo® Insulin Pump K050312) | Predicate Device (Smiths Medical Deltec Cozmo®) | Discussion/Implicit Acceptance |
|---|---|---|---|---|---|
| Flow Rate Accuracy Bolus | +/- 5% | +/- 5% | +/- 5% | +/- 15% at 0.1 U, +/- 1.5% at 25 U | Similar to Animas & Amigo, favorable vs. Cozmo (at low U) |
| Flow Rate Accuracy Basal | +/- 5% (0.5 U/hr or greater) | +/- 5% (0.1 U/hr or greater) | +/- 5% (0.1 U/hr or greater) | +/-2% (nominal) except at low delivery rates | Considered similar, with Animas being slightly better at lower flow rates, and Deltec's nominal % not directly comparable. |
| Basal Rate Adjustment Range | 0.00 - 30.00 U/hr in .05 U/hr steps | 0.025 - 25U/hr in .025 U/hr steps | 0.00 - 30.00U/hr in .05U/hr steps | 0.00 - 35.00 U/hr in 0.05 U/hr steps | Similar range to predicate devices. |
| Bolus Adjustment Range | 0.05 to 30.00U in 0.05U steps | 0.05U - 35 U in 0.05U steps | 0.05 to 30.00U in 0.05U steps | 0.00 - 75.00 U in 0.05 to 5.00 U steps | Similar range to predicate devices. |
| Delivery Rates - Bolus | 0.2 U/sec | 0.2 U/sec to 2.2 U/sec | 0.07 U/sec to 0.2 U/sec | 0.01 U / sec to 2.5 U/sec | Fixed rate matches an allowed rate within predicate device ranges. |
| Max. Volume infused under single fault conditions | Max 1.5 U | Max 2.0U | Not available | Less than 2 units | Compares favorably with predicate devices. |
| Occlusion Pressure Threshold | Low (15 psi nominal), High (35 psi maximum) (104 kPa, 241.5 kPa) | 75 kPa – 241kPa | 15 psi, 25 psi, 35 psi (104 kPa, 172.5 kPa, 241.5 kPa) | 18 psi +/- 5 psi (13 psi to 23 psi) | Similar to Animas and previous Amigo (two settings), maximum below 35 psi. |
| Bolus Volume after Occlusion Release | 0.65 U (low pressure), 0.79 U (high pressure) (1.0U/hr basal) | 1.0 U (high sens), 3.0 U (low sens) (1.0U/hr basal) | Not available | Approx. 4 U | Compares favorably with predicate devices (lower volume released). |
| Battery capacity | Minimum of 22 days based on typical use | 6-8 week life | Not available | Up to 30 days | Shorter battery life, but not clinically significant due to user-replaceable battery and multiple warnings. |
| Environmental (IPX8) | Yes | Yes | Yes | Yes | Meets IPX8 standard, similar to predicates. |
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."
§ 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).