(91 days)
The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyroqenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Insed to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The Cequr Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
The provided document does not contain specific acceptance criteria or details of a study proving the device meets said criteria.
Instead, it describes the CeQur Simplicity™ On-Demand Insulin Delivery System and its substantial equivalence determination by the FDA based on modifications to labeling allowing for extended wear time (up to 4 days/96 hours, compared to 3 days/72 hours for the predicate device).
Here's a breakdown of the information that is and is not present, with regards to your request:
1. A table of acceptance criteria and the reported device performance:
* Not provided. The document states that "Verfication and validation data reported in this 510(k), including those assessing biocompatibility, and human factors, demonstrate that the proposed change in labeling does not raise different questions of safety and effectiveness than those for the predicate device, and that the subject device is as safe and effective as the predicate device." However, it does not specify what those acceptance criteria were or what performance metrics were achieved.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not provided. The document mentions "Verfication and validation data" but does not detail the sample sizes, data provenance, or whether the studies were retrospective or prospective.
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):
* Not applicable/Not provided. This device is an insulin delivery system, not an AI or diagnostic imaging device that typically requires expert-established ground truth for a test set in the way you describe. The "ground truth" for its performance would likely relate to objective measurements of insulin delivery accuracy, biocompatibility, and user-factor performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not provided. As with point 3, adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective expert review (e.g., radiology image interpretation) to establish a consensus ground truth. This is not directly relevant to the testing of an insulin delivery device's technical specifications or user experience.
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. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic systems where human readers interpret cases. This device is an insulin delivery system, not an AI diagnostic tool, so such a study would not be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is a manual, user-filled, positive volume displacement bolus dosing pump, not an algorithm. Therefore, "standalone" algorithm performance testing is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* Not explicitly stated in detail. For a medical device like this, the "ground truth" for performance would generally involve:
* Objective measurements: E.g., insulin delivery accuracy (volume delivered vs. intended), flow rates, mechanical integrity, battery life (if applicable).
* Biocompatibility testing: In vitro and in vivo tests to ensure the materials are safe for contact with the body.
* Human factors validation: User studies to ensure safe and effective operation by typical users.
* The document generally refers to "biocompatibility, and human factors" data.
8. The sample size for the training set:
* Not applicable/Not provided. This device is an electro-mechanical system, not an AI/machine learning model that undergoes "training."
9. How the ground truth for the training set was established:
* Not applicable. As above, there is no "training set" for this type of device.
In summary: The provided FDA 510(k) clearance letter and summary are focused on establishing substantial equivalence to existing predicate devices for an insulin delivery system, primarily based on a labeling change (extended wear time). It asserts that "Verfication and validation data" were submitted for biocompatibility and human factors, demonstrating that the change does not raise new safety or effectiveness concerns, but it does not provide the specific details of these studies, including acceptance criteria, sample sizes, or performance metrics.
§ 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).