(183 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 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 OmniPod Insulin Management system consists of two main components:
- . The Personal Diabetes Manager (PDM)
- The OmniPod (Pod) .
The Personal Diabetes Manager (PDM) handles all processes for the operation of the OmniPod System. The display uses full text language to prompt the user through the set up process. It is also utilized to initialize and program the Pod with the user's custom based insulin profile, to check the pod status, and initiate a bolus dose of insulin. Using the PDM the user can also make temporary changes to the insulin delivery profile. After set-up and initiation, the Pod will run independently of the PDM.
The PDM device incorporates the Freestyle glucose meter. The PDM receives blood glucose readings that are measured using the Freestyle blood glucose meter via an internal serial interface. The blood glucose data is stored and can be displayed by the PDM. The integrated glucose test meter is intended to be used with Abbott Freestyle test strips.
The Pod is the disposable component of the system. The Pod is intended to be filled with rapid acting insulin U-100. The brands of insulin that can be utilized with the Pod are as follows: Novolog@/NovoRapid®, Humalog®, or Apidra®.
Once the Pod has been filled with a minimum volume of insulin the tubing in the pump is primed. Once primed the user is instructed to remove the adhesive backing and place the Pod adhesive side down on the body. Once in place, the needle punctures the injection site and the cannula is deployed for insulin delivery.
The provided text describes the OmniPod Insulin Management System and studies conducted to support its safety and effectiveness, particularly concerning the integrated glucose meter's performance.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for the glucose meter's performance in terms of accuracy metrics (e.g., specific percentage deviation from reference, MARD scores). Instead, it states that "Verification of meter functionality was completed in accordance with ISO 15917:2003." This ISO standard would contain the specific performance requirements for blood glucose monitoring systems.
For the purpose of this summary, the reported performance is the successful verification against that standard and the clinical study results.
Table 1: Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Implied) | Reported Device Performance | Study Reference |
|---|---|---|---|
| Glucose Meter Accuracy | Compliance with ISO 15917:2003 for meter functionality. | "Verification of meter functionality was completed in accordance with ISO 15917:2003." | TP/TR09-217 |
| Clinical Performance (Comparison to Reference) | Blood glucose measurements by the device should be comparable to a glucose reference sample (YSI 2300 Stat Plus). | Whole capillary blood samples measured by subjects and trained users showed results comparable to a YSI 2300 Stat Plus reference. | TP/TR10-067 |
| Cleaning/Disinfection | Device remains functional after multiple cycles of cleaning/disinfection. | Demonstrated that the device could be disinfected appropriately and remain functional after multiple cycles. | TP/TR10-326 |
| Software Functionality | Software functions as intended with no defects. | Software verification, unit testing, code reviews completed. | TP/TR08-078, TP/TR08-233, TP/TR09-21 |
| Electromagnetic Compatibility (EMC) | Compliance with 60601-1-2 standard. | EMC testing completed to demonstrate compliance. | TP/TR07-273 |
| Hardware Functionality | Hardware performs as intended. | Hardware verification testing completed. | TP/TR07-176, TP/TR07-177, TP/TR07-178, TP/TR07-179 |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Clinical (TP/TR10-067): 75 subjects.
- Data Provenance: The document states "75 subjects at two sites were evaluated." It does not explicitly state the country of origin, but given the submitter (Insulet Corporation, Bedford, MA) and the FDA submission, it's highly probable the study was conducted in the United States. The study is prospective, as it involved collecting blood from subjects and measuring it.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For study TP/TR10-067:
- Number of Experts: The document mentions "trained user" but does not specify the number of such users. It also mentions a "glucose reference sample measured with the YSI 2300 Stat Plus device" which would serve as the primary ground truth. The operation of a YSI 2300 Stat Plus requires trained personnel, which could be considered the "experts" in establishing the reference values.
- Qualifications of Experts: Not specified beyond "trained user" for administering the device, and implicitly, trained personnel for operating the YSI 2300 Stat Plus.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. For the clinical study (TP/TR10-067), the comparison was made between the device readings (by subjects and trained users) and the YSI 2300 Stat Plus reference. This implies a direct comparison rather than a consensus-based adjudication process.
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
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.
- The device being described is an insulin management system with an integrated glucose meter, not an AI-powered diagnostic imaging system requiring human "readers" or showing "improvement with AI vs. without AI assistance." The studies focus on the glucose meter's accuracy and the system's functionality.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, a standalone performance assessment was done for the glucose meter. Study TP/TR09-217 confirms "Verification of meter functionality was completed in accordance with ISO 15917:2003." This often involves testing the device's accuracy with spiked samples or reference materials in a lab setting, which is a form of standalone performance.
- Additionally, in study TP/TR10-067, the reference measurement from the YSI 2300 Stat Plus served as the independent "standalone" ground truth against which both subject and trained user device measurements were compared.
7. The Type of Ground Truth Used
- The primary ground truth for the glucose meter accuracy study (TP/TR10-067) was a glucose reference sample measured with the YSI 2300 Stat Plus device. This is considered a highly accurate laboratory reference method for glucose measurement.
8. The Sample Size for the Training Set
- The document does not provide information on a "training set" or its sample size. The studies described are verification and clinical performance validation studies for a medical device, not a machine learning model that typically requires a separate training set. If the device's internal algorithms involve machine learning, information on its training would not typically be found in this type of 510(k) summary.
9. How the Ground Truth for the Training Set was Established
- As no "training set" is explicitly mentioned for a machine learning context, this question is not applicable based on the provided document. The ground truth for the validation test set was established by the YSI 2300 Stat Plus device.
§ 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).