(106 days)
Omnipod Insulin Management 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 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.
Omnipod DASH Insulin Management System
The Omnipod DASH 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.
Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.
The subject devices provide for the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. They are each 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). The PDMs incorporate a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading, programmable correction factor, insulin to carbohydrate ratio, target blood glucose value, and Insulin on Board (IoB).
The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or 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 PDM is a handheld device that controls the Pod. The user interfaces with the device system through the PDM, where they control basal and bolus delivery and various insulin program settings and calculations. The PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The Omnipod Insulin Management System PDM has an integrated blood glucose meter and communicates with the Pod using wirelessly using secure, low power, bi-directional radio frequency (RF) communications at 433.92MHz. The Omnipod DASH Insulin Management System PDM does not have an integrated blood glucose meter, but is interoperable with a compatible blood glucose meter to receive and display glucose measurements. The Omnipod DASH PDM communicates to the Pod and a compatible blood glucose meter using Bluetooth Low Energy.
Both systems are for prescription use only.
The provided document is a 510(k) summary for the Omnipod Insulin Management System and Omnipod DASH Insulin Management System. It describes modifications to an existing device rather than a new device and thus does not contain the specific information requested in the prompt regarding a study that proves the device meets specific acceptance criteria with detailed statistical analysis.
However, based on the Performance Data and Standards Compliance section, I can extract information about the types of testing performed and the general conclusions, even if the detailed acceptance criteria and study designs are not fully elaborated.
Here's an attempt to answer using the available information, noting where specific details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary from Document) |
|---|---|
| Drug Stability and Compatibility | In-use stability and leachables testing with Admelog U100 insulin verified and validated that the systems do not adversely affect the insulin. |
| Soft Cannula Design | Testing was conducted to verify that the modified soft cannula design met the insertion depth and new insulin infusion depth specifications. |
| Safety and Effectiveness | A real-world data analysis of post-market data gathered from devices with the modified soft cannula concluded that the modification did not raise any new questions of safety and effectiveness. Safety Assurance Cases for both Omnipod and Omnipod DASH systems with the modified cannula and Admelog were provided, with the stated goal that the systems are "acceptably safe for the infusion of U100 insulin...for use in the home setting by people with diabetes mellitus who require insulin on a daily basis." |
| Sterilization | A sterilization product adoption was conducted in accordance with AAMI TIR28:2016, and bioburden testing was conducted in accordance with ISO 11737-1 for the modified soft cannula design. |
| Risk Management | Risk management was completed in accordance with ISO 14971:2007. Verification activities demonstrated that the predetermined acceptance criteria were met and the devices are safe for use. |
| Other Standards Compliance | The devices comply with ISO 10993-1 (biological evaluation), ISO 14971 (risk management), ISO 11737-1 (sterilization - microbiological methods), and ISO 11135 (sterilization - ethylene oxide). |
Missing Information: The document does not provide the specific numerical acceptance criteria (e.g., specific thresholds for leachables, precise depth specifications, or quantitative results from the stability/compatibility testing). It states that criteria were "met" or "verified" or "validated."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Real-world data analysis: An analysis of post-market data gathered from devices with the modified soft cannula was conducted..."
- Sample Size: Not specified.
- Data Provenance: Retrospective, post-market data. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable as this was not a diagnostic image-based AI study relying on expert ground truth. The "ground truth" for cannula performance or insulin stability would be derived from laboratory measurements and clinical outcomes, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable for this type of device modification study. Adjudication methods like 2+1 or 3+1 typically refer to reconciliation of discrepancies among multiple expert readers in diagnostic studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not mentioned. This type of study is more common for diagnostic imaging AI. The document focuses on performance testing of the device's physical and chemical properties and post-market safety.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
The device is an insulin pump system with a bolus calculator, not a standalone AI algorithm for diagnosis. Therefore, this question isn't directly applicable in the typical sense of AI standalone performance. The "algorithm" for dose calculation is part of the system's intended function, and its overall safety and effectiveness were assessed as part of the system.
7. The Type of Ground Truth Used
- For Drug Stability and Compatibility: Laboratory analytical results for insulin integrity (e.g., potency, purity, presence of leachables).
- For Soft Cannula Studies: Engineering measurements and specifications for insertion depth and insulin infusion depth.
- For Safety and Effectiveness (Real-world data): Clinical outcomes, adverse event reports, and other post-market surveillance data.
- For Sterilization: Microbiological test results (bioburden) and compliance with sterilization standards.
- For Risk Management: Verification activities demonstrating that risks identified were mitigated to an acceptable level as defined by ISO 14971.
8. The Sample Size for the Training Set
Not applicable. This document describes a modification to an existing device, and the "real-world data analysis" was for post-market validation, not for training a machine learning model in the context of an AI device. The bolus calculator is rule-based and user-programmed, not an AI model requiring a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there's no mention of a traditional "training set" for an AI model.
§ 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).