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510(k) Data Aggregation
(73 days)
OMNIPOD INSULIN MANAGMENT SYSTEM
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 OmniPod Insulin Management System 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.
The provided document (K122953) describes the OmniPod Insulin Management System, but it does not contain acceptance criteria or study results for a device that uses Artificial Intelligence (AI). The submission focuses on the mechanical, electrical, and biocompatibility aspects of an insulin pump system with an integrated blood glucose meter, and its substantial equivalence to predicate devices. There is no mention of AI, machine learning, or complex algorithms that would require a study proving the device meets AI-specific acceptance criteria.
Therefore, I cannot fulfill your request for the specific information regarding AI acceptance criteria and studies from this document.
However, I can extract the general performance criteria and test results for various components of the OmniPod Insulin Management System as described in the submission, which are analogous to acceptance criteria in a non-AI context.
General Performance Criteria and Reported Device Performance (Non-AI)
Since the document does not relate to an AI device, the table below reflects the described performance and verification activities for the OmniPod Insulin Management System, which are general device performance criteria rather than AI-specific acceptance criteria.
| Acceptance Criteria (General Device Performance) | Reported Device Performance (Study Results) |
|---|---|
| Usability | Device usability has been fully validated in accordance with IEC 62366:2007, AAMI HE75, and FDA's Medical Device Use-Safety guidance. |
| Risk Management | Verification activities, required by ISO 14971:2007, demonstrated that predetermined acceptance criteria were met and the device is safe for use. |
| Fluid Path Integrity | Testing verified that the fluid path within the Pod can withstand required internal pressures. |
| PDM Environmental Performance | The PDM met environmental testing requirements (temperature, humidity, pressure per IEC 60601-2-24) and passed all functional tests. |
| Soft Cannula Depth and Angle | All Pod samples tested met the requirements for soft cannula insertion depth and angle. |
| Priming Volume | The Pod met the priming volume requirements after soft cannula deployment as part of the activation sequence, verifying appropriate insertion mechanism release and priming. |
| Rotational Sensor Functionality | Testing confirmed that the rotational sensor meets its design intent and is capable of making and maintaining electrical contact in all installed positions. |
| Reliability and Useful Life (PDM) | Testing verified that the PDM met the reliability and useful life requirements, confirming mechanical and functional integrity of common use features over the labeled warranty life. |
| Basal Flow Accuracy | Accuracy of +/- 5% at rates of 0.05 U/hr – 30.00 U/hr was met as per IEC 60601-2-24. |
| Bolus Flow Accuracy | Bolus accuracy of +/- 5% for all set values of 0.05 – 30.00 units was confirmed as per IEC 60601-2-24. |
| Basal Accuracy at Max/Min Temperature | The Pod passed basal flow rates at the minimum and maximum operational temperatures. |
| Nominal Flow Basal with Vacuum Transition | The proposed Pod was developed and confirmed to provide a nominal flow basal with vacuum transition at nominal temperature. |
| Power Interruptions (Pod Battery) | The proposed Pod battery connections were tested and determined to perform as intended. |
| Cam Finger Functionality | The cam finger design has been verified to perform as defined by its requirements. |
| Cannula Insertion Indicator | An indicator has been provided and tested to confirm when the cannula is fully inserted. |
| Pod Temperature Operation | The Pod has been tested and confirmed to operate at a temperature range of 40°F to 98.6°F. |
| Biocompatibility | Assessment consistent with FDA's Blue Book Memorandum G95-1 showed fluid path components and surface pad/adhesive pose no concerns for human use due to biocompatibility, toxicity, or dermal sensitization. Tested under GLP conditions. |
| Insulin Compatibility | The system has been tested and is considered compatible with NovoLog®, HumaLog®, and Apidra® U-100 insulin. |
| Sterilization | The proposed device (Pod) and disposable set have been tested and will be sterilized by 100% ethylene oxide. |
| Software | Documentation was prepared and submitted for a MAJOR level of concern device in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. (Note: No specifics on performance of software beyond documentation compliance are given.) |
| Electrical Safety | The system successfully passed all relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety. |
| RF Wireless Safety and Performance | The system has been tested and verified to ensure proper wireless communication between the Pod and PDM. |
| Electromagnetic Interference (EMI) | The system successfully met all relevant sections for EMI compliance, including Radiated emissions, Electrostatic discharge immunity test, radiated radio frequency, electromagnetic field immunity, and Power frequency magnetic field immunity test. |
Inability to provide certain information for AI/ML aspects:
As this device predates widespread AI/ML integration in medical devices and the submission does not mention AI, the following specific questions cannot be answered from the provided text:
- Sample sized used for the test set and the data provenance: Not applicable for an AI test set. This document describes bench testing and verification activities on device components.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no AI model for which ground truth would be established by experts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as no AI is involved.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as no algorithm-only performance study is mentioned for AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for AI. The "ground truth" for the tests described are engineering specifications, industry standards (e.g., IEC standards), and documented design requirements.
- The sample size for the training set: Not applicable, as there is no mention of an AI training set.
- How the ground truth for the training set was established: Not applicable, as there is no mention of an AI training set.
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