(86 days)
The OmniPod Insulin Management System is 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) from the finger.
The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared.
Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.
The proposed device provides for the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. It is comprised of two primary components: the disposable insulin infusion pump (Pod) and an associated wireless remote controller referred to as the Personal Diabetes Manager (PDM) with an embedded blood glucose meter.
This document describes the 510(k) premarket notification for the Insulet OmniPod Insulin Management System (K160252). The notification details modifications made to the device and provides evidence of performance testing to support its substantial equivalence to a predicate device (K122953).
Here's the breakdown of the acceptance criteria and supporting studies based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Risk Management | Predetermined acceptance criteria were met, and the device is safe for use, as demonstrated by verification activities conducted in accordance with ISO 14971:2007. |
| Soft Cannula Depth and Angle | All Pod samples tested met the specified requirements for soft cannula insertion depth and angle. |
| Cam Finger Design | The cam finger design has been verified to perform as defined by its requirements. |
| Insertion Mechanism Release | Testing confirmed that the Release Bar design intent was met and it is capable of releasing the insertion mechanism. |
| Cannula Insertion Retention | Testing confirmed that the Catch Beam design intent was met and it is capable of retaining the Soft Cannula at the specified depth. |
| Cannula Insertion Indicator | An indicator has been provided and tested to confirm when the cannula is fully inserted. |
| Biocompatibility (Silicone Lubricant) | An assessment rationalized the additional silicone lubricant for human use as acceptable. The added silicone is not in contact with the fluid path. (Note: Predicate device testing per ISO 10993: Part 3, Part 5, Part 6, Part 10 is referenced for the same silicone at a different location on the predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test mentioned (e.g., number of Pods for cannula depth testing). It generally refers to "all Pod samples tested" or "testing was conducted."
The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated for these performance tests. The manufacturing site is listed as Flextronics Industrial (Shenzhen) Co., LTD. in Shenzhen, Guangdong, China. It is highly probable the performance testing was conducted at or in conjunction with the manufacturing site or the submitting company (Insulet Corporation, Billerica, MA, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the provided document. The performance data presented refers to engineering and bench testing of mechanical and material properties of the device, not clinical studies requiring expert interpretation of diagnostic output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. As stated above, these are engineering and bench tests, not clinical studies requiring human adjudication of ground truth.
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. The device described is an insulin management system with a built-in glucose meter, not an AI-based diagnostic imaging or interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device (infusion pump and glucose meter), not a standalone algorithm. The performance tests are for the physical components and their functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests described, the "ground truth" or reference standards are the device specifications and requirements established by the manufacturer and relevant industry standards (e.g., ISO 14971, ISO 10993). For example, for cannula depth, the ground truth is the specified depth. For biocompatibility, it's the acceptance criteria defined by ISO 10993.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. See point 8.
§ 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).