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510(k) Data Aggregation
(119 days)
The Omnipod 5 ACE Pump (Pod) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Omnipod 5 ACE Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Omnipod 5 ACE Pump is intended for single patient, home use and requires a prescription.
The Omnipod 5 ACE Pump is intended to deliver insulin via a tubeless insulin pump (the Pod) that wirelessly connects to and receives insulin delivery commands from the Omnipod 5 App, which is installed on a locked-down Android controller device or a user's personal smartphone device. The predicate device allowed the user to download the Omnipod 5 App to an Android compatible phone. This submission includes an iOS compatible Omnipod 5 App to allow users to download it to a compatible iPhone.
The Omnipod 5 ACE Pump is part of the Omnipod 5 Automated Insulin Delivery System, which also includes SmartAdjust Technology (iAGC), and the SmartBolus Calculator. SmartAdjust Technology and the SmartBolus Calculator functionally independent from the Omnipod 5 ACE Pump. The Omnipod 5 ACE Pump is intended to be digitally connected to a third party iCGM, SmartAdjust Technology, and the SmartBolus Calculator.
The Omnipod 5 ACE Pump can operate in Manual Mode, delivering insulin based on userprogrammed basal rates, or in Automated Mode, where insulin is automatically delivered based on the calculations and command of a compatible iAGC. Currently, the Omnipod 5 ACE Pump is compatible with SmartAdjust Technology, the software which is pre-installed on the Pod and the App. Future alternate controllers may be established for use with the Pod, in which case the software modules of the SmartAdjust Technology would be disabled. The Pod is a bodywearable insulin pump that affixes to the user on the back of the arm, the lower back, the abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The Omnipod 5 App is a software application installed on a handheld touchscreen device (Android and iOS) that connects to the Pod via Bluetooth Low Energy (BLE) and serves as the user interface of the system. In addition to programmed basal delivery and automated insulin delivery, the Omnipod 5 ACE Pump allows users to deliver bolus doses at values that are either inputted manually or calculated by the SmartBolus Calculator based on the user's settings and user-entered parameters. The Pod has the ability to connect to a compatible iCGM through BLE and receive data for use with SmartAdiust Technology and the SmartBolus Calculator.
The Omnipod 5 App has the ability to wirelessly connect to the Insulet Cloud which it utilizes for registering new devices, authenticating users, ensuring hardware devices and host operating systems are compatible, and completing over the air software (OTA) and firmware (FOTA) updates.
The provided text is a 510(k) summary for the Omnipod 5 ACE Pump, which describes the addition of an iOS compatible mobile application. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K203768).
Based on the provided text, the acceptance criteria and study details are primarily related to software verification and validation, interoperability, cybersecurity, electrical safety and EMC, and human factors validation for the new iOS application, rather than clinical performance of the insulin delivery itself (as the Pod itself was not modified).
Here's an attempt to structure the information based on your request, highlighting what is and isn't explicitly stated in the document:
Device: Omnipod 5 ACE Pump (with added iOS compatible Omnipod 5 App)
Purpose of Submission: To add a new mobile application compatible with iOS mobile devices. The Omnipod 5 App (iOS) is the new configuration being added to the previously cleared Omnipod 5 ACE Pump.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several types of performance testing and their adherence to standards and regulations. It doesn't present specific quantitative acceptance criteria or detailed performance metrics in a tabular format that is typically seen for accuracy, sensitivity, or specificity in AI/ML medical devices. Instead, it states that tests were performed and demonstrated that predetermined acceptance criteria were met and the device is safe and effective for use.
| Category | Acceptance Criteria / Standard Compliance | Reported Device Performance |
|---|---|---|
| Risk Management | Compliance with ISO 14971:2019. | "Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the device is safe for use." |
| Software Validation | Compliance with IEC 62304:2015-06 and FDA’s guidance “General Principles of Software Validation – Issued January 11, 2002,” and “Content of Premarket Submissions for Device Software Functions - Issued June 2023.” | "Software verification and validation testing were performed..." "Software documentation was provided..." "Software verification testing has demonstrated the device records timestamped critical events, including information related to its state, user inputs, and device settings, as required by the ACE Pump special controls." (for Data Logging) |
| Interoperability | Adherence to FDA Guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff - Issued September 6, 2017.” Specifies validated interface specifications, partnership agreements, and post-market reporting. | "Interoperability documentation was provided as is relates to changes due to the Omnipod 5 App (iOS) according to the FDA Guidance..." |
| Cybersecurity | Compliance with various FDA cybersecurity guidances (2014, 2016, March 2023, April 2022 draft). | "a cybersecurity analysis was performed for the OP5 ACE Pump with the Omnipod 5 App (iOS)... In addition, Insulet has provided a software bill of materials and penetration testing." |
| Electrical Safety & EMC | Compliance with IEC 60601-1:2020-08 and IEC 60601-1-2:2020-9, and FDA guidances on Electromagnetic Compatibility and Radio Frequency Wireless Technology. | "testing was performed to verify that the Omnipod 5 ACE Pump with the Omnipod 5 App (iOS) meets its requirement to comply with IEC 60601-1:2020-08... and IEC 60601-1-2:2020-9..." |
| Human Factors Validation | Compliance with IEC 62366:2015-06, HE75:2009(R)2018, and FDA’s guidance “Applying Human Factors and Usability Engineering to Medical Devices - Issued February 3, 2016.” | "A robust validation evaluation was performed to demonstrate safe and effective use of the Omnipod 5 App (iOS) with intended users in the expected use environments, including associated training and accompanying documentation. The results of the validation demonstrate that the device has been found to be safe and effective for the intended users, uses, and use environments." |
| Special Controls (21 CFR 880.5730) | Evaluation supports safety and effectiveness. | "evaluation of the Special Controls for this device (regulation 21 CFR 880.5730) supports the safety and effectiveness of the device." "Through performance testing, the Subject device has been shown to meet the Alternate Controller Enabled Insulin Pump special controls..." |
Note on Insulin Delivery Accuracy: The document states that the "Pod Delivery Accuracy (tested per IEC 60601-2-24)" for basal and bolus rates is a characteristic of the predicate device and is unchanged for the subject device. It is listed as:
- Basal: ± 5% at rates ≥ 0.05 U/hr
- Bolus: ± 5% for all set values ≥ 1.0 unit, ± 0.05 unit for set values < 1.0 unit
However, the current submission focuses on the new mobile app, not the Pod's fundamental insulin delivery mechanism.
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify quantitative sample sizes for the various testing protocols (e.g., software validation, human factors validation). It broadly refers to "performance testing" being completed.
- Data Provenance: Not explicitly stated as retrospective or prospective data in the context of clinical studies for direct performance evaluation. The testing described is primarily non-clinical, involving software validation, cybersecurity analysis, and human factors validation. The device is a pump with an app, not an AI/ML algorithm that analyzes patient data to provide a diagnosis or risk assessment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This submission is for an Alternate Controller Enabled Pump (ACE Pump) with a new mobile application. It's not an AI/ML diagnostic or prognostic device where expert ground truth interpretation of images or other clinical data would be required. The "ground truth" for this device's validation is adherence to engineering and usability standards and ensuring the software functions as intended and securely.
4. Adjudication Method for the Test Set
N/A. Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 typically apply to the establishment of ground truth in image-based diagnostic AI/ML models.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study focuses on how AI assistance impacts human reader performance, typically in diagnostic tasks. The Omnipod 5 ACE Pump with its iOS app is an insulin delivery system and its controlling interface, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "algorithm only" performance for an insulin pump would refer to its ability to accurately deliver insulin based on programmed rates or commands. The document states that the Omnipod 5 ACE Pump's Pod (insulin pump itself) has not been modified, and therefore, performance testing applicable only to the Pod was not completed for this submission. The original validation of the Pod's insulin delivery accuracy (referenced in the table) would be considered its standalone performance. The new submission focuses on the software application for iOS as the controller. The software's performance is validated through various non-clinical tests (software validation, interoperability, cybersecurity, human factors) to ensure it reliably sends commands to the Pod.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the established technical standards, regulatory guidelines, and functional requirements for medical device software, cybersecurity, electrical safety, and human factors. For instance:
- Software Validation: Ground truth is defined by the functional specifications and requirements of the software.
- Cybersecurity: Ground truth is defined by cybersecurity best practices and regulatory guidance.
- Human Factors Validation: Ground truth is defined by usability engineering principles and standards, demonstrated by the device being "safe and effective for the intended users, uses, and use environments" after testing.
8. The Sample Size for the Training Set
N/A. The Omnipod 5 ACE Pump and its associated app are not explicitly described as an AI/ML device that uses a "training set" in the context of supervised learning for a diagnostic or prognostic task. The software development process would involve iterative testing and debugging, but this is distinct from training a machine learning model on a labeled dataset.
9. How the Ground Truth for the Training Set Was Established
N/A, as there is no mention of an AI/ML training set in the context of this device and its submission.
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