(265 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 capillary whole blood (in vitro) from the fingertip.
The glucose measurements should not be used for the diagnosis of or screening for diabetes or for neonatal use. The PDM glucose meter is intended for single-patient use and should not be shared.
OneTouch® Verio™ Test Strips are used with the built-in blood glucose meter with One Touch Verio technology for the quantitative measurement of blood glucose in fresh capillary whole blood drawn from the fingertips.
OneTouch Verio Control Solutions are used to check that the meter and test strips are working together properly and that the test is performing correctly.
The OmniPod® Insulin Management System is a tubeless insulin pump 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 capillary whole blood (in vitro) from the fingertip. This System is comprised of two primary components, the insulin pump (Pod) and the remote controller (Personal Diabetes Manager). The Personal Diabetes Manager incorporates LifeScan OneTouch Verio blood glucose measurement capability through a built in blood glucose meter. The blood glucose meter uses One Touch Verio Test Strips. OneTouch Verio Level 3 (Mid) and OneTouch Verio Level 4 (High) Control Solutions are used to check that the meter and test strips are working together properly. OneTouch Verio Test Strips are included in the Starter Kit. OneTouch Verio Control Solutions are not included in the Starter Kit and must be purchased separately.
Here's a breakdown of the acceptance criteria and study information for the OmniPod Insulin Management System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on demonstrating substantial equivalence to a predicate device (OmniPod Insulin Management System K122953). Therefore, the "acceptance criteria" are generally that the new device meets the performance and safety standards established for the predicate and relevant industry guidance/standards (e.g., ISO, IEC). The reported performance is that the device met these criteria.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance* |
|---|---|---|
| Physical Characteristics | Met physical dimension and weight requirements. | Met |
| Drop and Vibration | Met all relevant requirements for drop and vibration testing per IEC 60601-2-24. | Met |
| Hardware | Meets all associated hardware specifications. | Met |
| Software | Documentation prepared and submitted for a MAJOR level of concern device in accordance with FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. | Met |
| Electrical Safety | Successfully passed all relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety. | Met |
| RF Wireless Safety & Perf | Verified to ensure proper wireless communication between the Pod and PDM. | Met |
| Electromagnetic Interfer. | Successfully met all relevant sections (Radiated emissions, Electrostatic discharge immunity, electromagnetic field immunity, and Power frequency magnetic field immunity test) to satisfy compliance. | Met |
| Alarm Sound Level | Successfully met requirements for sound pressure level. | Met |
| Environmental | Successfully met IEC 60601-2-24 requirements for temperature, humidity and atmospheric pressure. | Met |
| Battery Life | Successfully met the requirement of sufficient battery power for expected use. | Met |
| Shipping | Successfully met requirements for aesthetic and functional integrity after shipping. | Met |
| BGM Performance (General) | Repeatability, Precision, Intermediate Precision, Method Comparison (System Accuracy Capillary Sample), Device Comparison (Accuracy Equivalence), Linearity, Effect of Temperature and Relative Humidity, Hematocrit, Sample Identification, Sample Volume, Interferences (Exogenous and Endogenous), Altitude, Pre and Post Cleaning and Disinfection (System Accuracy). Specific values for these are not provided in this document, only that the predicate manufacturer (LifeScan) completed appropriate testing to verify product design and performance accuracy. | Completed testing, verified accurate |
| BGM Operating Cond. | Operating temperature: 50°F to 104°F (10°C to 40°C), Operating relative humidity range: 20% to 90%. | Met |
| Clinical Study (BGM) | Fulfillment of the requirements of ISO 15197:2003 (E) – Section 8 User Performance Evaluation. | Fulfilled |
Note: The document consistently states that the device "met" or "successfully met" these requirements, or that testing was "completed" and "confirmed" the device to be substantially equivalent. Specific quantitative performance figures are generally not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for any of the individual tests. The document mentions "LifeScan completed appropriate testing" and "LifeScan completed a clinical study," suggesting the test sets were those used in LifeScan's validation of the integrated OneTouch Verio technology.
- Data Provenance: Not explicitly stated. The manufacturer (Insulet) is based in the USA. LifeScan, the developer of the integrated blood glucose meter technology, is also a US-based company generally. The clinical study for the BGM fulfilled requirements of ISO 15197:2003 (E), which is an international standard. It is most likely US-based data, but not definitively stated.
- Retrospective or Prospective: Not explicitly stated. Clinical studies are typically prospective, but this is not confirmed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. For the blood glucose measurement component, the "ground truth" would typically come from laboratory reference methods, but the number and qualifications of technicians/experts are not mentioned. For the overall system, the ground truth is established by meeting the specified performance and safety standards.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
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. This device is an insulin management system with an integrated blood glucose meter, not an AI-powered diagnostic imaging device that would typically involve human readers. Therefore, an MRMC study and AI assistance effect size are not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- For the blood glucose meter component, the accuracy studies (e.g., repeatability, precision, method comparison) represent the "standalone" performance of the algorithm and sensor. The document states LifeScan completed these evaluations and they "confirmed the proposed device to be substantially equivalent to the predicate device."
- For the insulin pump component, the various engineering and safety tests (e.g., physical characteristics, software, electrical safety, battery life) represent its standalone performance without a human in the loop affecting its core function.
7. The Type of Ground Truth Used
- For the insulin pump components: The ground truth is established by adherence to recognized medical device standards (e.g., IEC 60601-2-24, IEC 60601-1), industry guidance from the FDA, and meeting self-defined hardware and software specifications. This is a mix of engineered specifications and regulatory compliance.
- For the blood glucose meter component: The ground truth for accuracy and performance parameters (e.g., repeatability, linearity) is typically established by laboratory reference methods (e.g., YSI analyzer for glucose concentration). For the clinical user performance, it would be a comparison to a "validated method" as stated, which likely refers to these laboratory reference methods performed by trained personnel.
8. The Sample Size for the Training Set
- This information is not applicable and therefore not provided. The OmniPod Insulin Management System, as described in this 2014 510(k) summary, does not appear to use machine learning algorithms that require a "training set" in the modern sense. It's a hardware-based electromechanical device with embedded software.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no mention of a training set for machine learning.
§ 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).