(89 days)
Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro).
The iXL-11 Diabetes Management System has two (2) components: a Remote Controller with integral blood glucose monitoring technology, and an insulin infusion Pod. Accessories include: Batteries and IFU packaged with the Remote Controller. A fill syringe and fill needle packaged with each Pod. Other accessories for use with the iXL-II Diabetes Management System will be available from Insulet Corporation. Accessories will include batteries, a Carry Case, a TheraSense FreeStyle Lancing Device, TheraSense FreeStyle lancets, TheraSense FreeStyle test strips, TheraSense FreeStyle Control Solution, commercially available site prep and adhesive removal wipes, etc. The IFU for the iXL-II Diabetes Management System will specify the use of only the TheraSense FreeStyle components for use with the iXL-II blood glucose measurement function. The Remote Controller is a hand held, battery-operated device, with 10 functional buttons, an electroluminescent (EL) backlit liquid crystal display (LCD) and BG Test Strip Reader. The device provides audio alarms, alerts and reminders. The Pod is activated and controlled exclusively through the use of the Remote Controller. The Pod and Remote Controller interact wirelessly using secure, bi-directional radio frequency (RF). The Pod is a microprocessor-controlled device worn directly on the same manner and general locations as a conventional insulin set. The Pod will deliver insulin based on the users custom programmed basal rate and bolus doses for up to 72 hours and provides audio alarms, alerts and reminders.
I apologize, but the provided text from the 510(k) submission for the iXL-II Diabetes Management System does not contain the detailed information required to describe specific acceptance criteria and a study proving device performance in the way you've requested.
Here's why and what information is missing:
- No Acceptance Criteria Table or Reported Performance: The document serves as a 510(k) summary, aiming to demonstrate substantial equivalence to predicate devices. It doesn't present a table of specific, quantifiable acceptance criteria (e.g., accuracy metrics, safety thresholds) for the iXL-II device, nor does it report the device's performance against such criteria.
- No Study Details: While it mentions that modifications raise "no new questions regarding the safety and effectiveness," it doesn't describe any specific clinical or non-clinical studies conducted to prove the performance of the new device itself. There are no details on sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods for any test or training sets.
- Focus on Substantial Equivalence: The core of this document is to argue that the iXL-II is "substantially equivalent" to existing, legally marketed devices (iXL Diabetes Management System and TheraSense FreeStyle Blood Glucose Monitor). This means the FDA is looking for evidence that the new device does not introduce new safety or efficacy concerns compared to the predicates, rather than a full, de novo validation of its performance against explicit criteria.
Therefore, I cannot populate the table or answer most of your questions based solely on the provided text.
The document does provide the following general information:
- Device Name: iXL-II Diabetes Management System with Blood Glucose Measurement
- Intended Use: "continuous, subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro)."
- Predicate Devices: iXL Diabetes Management System and TheraSense FreeStyle Blood Glucose Monitor.
- Conclusion: "The modifications discussed in this submission raise no new questions regarding the safety and effectiveness of the iXL-II Diabetes Management System with Blood Glucose Measurement as compared to the predicate devices."
To get the information you're asking for, one would typically need access to the full 510(k) submission, including any detailed performance testing reports, validation studies, and risk assessments that were submitted to the FDA. These documents would contain the specific acceptance criteria and the results of tests aimed at demonstrating performance.
§ 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).