(437 days)
The NiliMedix ADI insulin pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by the insulin pressure to deliver preset basal profiles and patient programmed bolus of insulin through FDA cleared infusion sets into subcutaneous tissue. The ADI pump is restricted to sale by, or on the order of a physician.
The provided document is a 510(k) summary for the NiliMedix ADI Insulin Pump, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results in the manner typically seen for novel devices.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with numerical targets and corresponding measured performance values. Instead, it states that the device was designed and tested in accordance with IEC 60601-2-24 and other relevant standards, and that performance tests showed the ADI's performance to be "substantially equivalent to the predicate device."
The types of tests conducted are listed, implying that the acceptance criteria would be derived from the requirements of the standards and the performance of the predicate device (Minimed Model 508, K990801).
Here's a conceptual representation based on the information, acknowledging that specific numerical criteria and results are not provided:
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Pump Flow rate Accuracy | Compliant with IEC 60601-2-24 and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Pump Bolus Accuracy | Compliant with IEC 60601-2-24 and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Battery Indication Performance | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Air In System Detection | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Valve leakage and Piston Leakage Alarm | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Valve blockage Alarm | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Cartridge depletion and Low insulin Alert | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Usability study | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Cartridge Performance validation | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Pump Operational Life validation | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Infusion set testing for compatibility | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Flow Rate Accuracy for Minimum Flow Rate | Compliant with IEC 60601-2-24 and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Flow Rate Accuracy after Change in infusion rate or Bolus Dose | Compliant with IEC 60601-2-24 and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Insulin Stability Study | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Spring Component validation | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Minimum Bolus Accuracy | Compliant with IEC 60601-2-24 and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Occlusion Alarm Test | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Free fall Test and Vibration tests | Compliant with relevant standards and equivalent to predicate device | ADI performance substantially equivalent to predicate device |
| Biocompatibility | Compliant with ISO 10993 | Tested according to relevant standards |
| Sterilization validation | Compliant with relevant standards | Tested according to relevant standards |
| Electrical safety | Compliant with IEC 60601-1 | Tested according to relevant standards |
| EMC | Compliant with IEC 60601-1-2, CISPR 11, IEC 61000-4-2/3/4/5, IEC 55011, IEC 801-2 | Tested according to relevant standards |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states that no animal or clinical studies were conducted for this 510(k) submission. All performance testing was non-clinical (bench testing). Therefore, there is no "test set" in the context of clinical data, sample size for patients, or data provenance from a specific country of origin (retrospective or prospective). The data provenance is entirely from laboratory bench testing performed by NiliMedix Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As no clinical studies were performed, there was no need for experts to establish ground truth from patient data. The ground truth for bench tests would be the established scientific and engineering principles, and the standards (e.g., IEC 60601-2-24) to which the device was tested.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication by experts was used.
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/imaging device. It is an insulin pump. No MRMC studies were conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is an insulin pump, not an algorithm. The device's performance was evaluated inherently as a standalone product during bench testing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical performance tests was based on:
- Requirements outlined in specified international standards (e.g., IEC 60601-2-24, ISO 13485, ISO 10993, IEC 60601-1, IEC 60601-1-2, CISPR 11, IEC 61000-4-2/3/4/5, IEC 55011, IEC 801-2).
- The performance characteristics of the legally marketed predicate device (Minimed Model 508). The submission's goal was to demonstrate that the ADI's performance was "as good as" the predicate device and met standard requirements.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, no training set was used.
§ 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).