(194 days)
The t:slim™ Insulin Delivery System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater.
The t:slim™ Insulin Delivery System ("t:slim System") consists of the following components and accessories:
- a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump").
- a dedicated, disposable 3mL (300 unit) insulin cartridge ("cartridge");
- an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
- accessories, including a Becton Dickenson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pump's internal battery, cartridge Instructions for Use, and User's Guide.
The t:slim Pump is a battery operated infusion pump capable of both basal and bolus delivery of insulin. It utilizes a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient's subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the end user (i.e., the patient). The graphical user interface on the t:slim Pump is a capacitive touch screen that is overlaid on an organic light emitting diode ("OLED") screen that displays information used to control the t:slim System. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge.
Cartridges are individually packaged and sealed, and provided sterile. The cartridge attaches to the t:slim Pump and is designed to hold up to 3 mL, or 300 units, of insulin. The cartridge has been tested for insulin compatibility with two types of rapid-acting U-100 insulin (Humalog® and NovoLog®) and determined to be insulin compatible as demonstrated by the performance data submitted in this 510(k) application.
The provided text describes the t:slim™ Insulin Delivery System and its path to 510(k) clearance. Here's a breakdown of the acceptance criteria and study details based on the input:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria or performance metrics for each test, but it broadly claims the device "functioned as intended and testing results observed were as expected." The performance data is presented as a list of validated and verified activities.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| System Performance | The t:slim System meets its intended requirements. |
| User Interface (Human Factors) | Can be used without critical errors that could lead to user harm. Satisfies all functional performance, safety requirements, and meets its intended use, and is safe for the intended user population. |
| Pump Performance | Pump Flow Rate Accuracy, Pump Bolus Accuracy, Battery Indication Performance, Cartridge Depletion and Low Insulin Alert, Flow Rate Accuracy for Minimum Flow Rate, Flow Rate Accuracy after Change in the Infusion Rate or Bolus Dose, Minimum Bolus Accuracy, Occlusion Alarm Test, Free Fall Test and Vibration Tests – functioned as intended and testing results observed were as expected. |
| Cartridge Performance | Cartridge Performance Validation, Insulin Stability Study, Biocompatibility, Insulin Compatibility Testing – functioned as intended and testing results observed were as expected; determined to be insulin compatible with Humalog® and NovoLog®. |
| Environmental & Operational Life | Pump Environmental and Operational Life Validation – functioned as intended and testing results observed were as expected. |
| Software, Hardware, Mechanical, Electrical Safety, EMC | Completed validation and verification activities, functioning as intended. |
| Water Ingress, Simulated Aging | Completed validation and verification activities, functioning as intended. |
2. Sample Size Used for the Test Set and Data Provenance:
-
Human Factors Summative Study:
- Sample Size: 53 patients
- Data Provenance: Prospective, non-randomized, multicenter study. (Country of origin is not specified, but typically for 510(k) in the US, it would be within the US.)
-
For other performance tests (e.g., pump flow rate, bolus accuracy, cartridge performance), the document does not specify sample sizes for individual tests. It broadly mentions "appropriate validation and verification activities."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for any of the tests. The Human Factors study involved patients, and the assessment of whether "critical errors" occurred was likely based on pre-defined criteria associated with potential harm, but expert involvement for ground truth establishment beyond this is not detailed.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or evaluating the results of the performance studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This device is an insulin pump, and the studies described are related to its functional performance, safety, and user interface, not comparative effectiveness with human readers using an AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
The "standalone" concept, as typically applied to AI algorithms, doesn't directly apply here since the t:slim system is a physical device that requires human interaction for its intended use (programming insulin delivery). However, the document does describe extensive device-centric standalone testing for various components and functions of the pump and cartridge (e.g., Pump Flow Rate Accuracy, Bolus Accuracy, Cartridge Performance Validation, Occlusion Alarm Test). These tests evaluate the device's inherent performance characteristics independent of a human user's specific performance in a clinical setting, although they are part of a system intended for human use.
7. The Type of Ground Truth Used:
- Human Factors Study: The ground truth for this study was established against pre-defined safety criteria and the absence of "critical errors that could lead to user harm" during patient tasks. This is essentially ground truth based on safety and functional criteria defined by experts/engineers in the context of user interaction.
- Other Performance Tests (e.g., flow rate, bolus accuracy): The ground truth would have been established against engineered specifications and established physical/chemical principles. For example, a flow rate test would compare the delivered insulin volume against a precisely measured or expected volume based on pump programming. Insulin compatibility would be measured against pre-defined chemical stability parameters.
8. The Sample Size for the Training Set:
The document does not explicitly mention a "training set" in the context of machine learning. The studies described are verification and validation activities for a medical device's physical and software performance. Therefore, there is no direct equivalent of a "training set" as understood in AI/ML development.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the AI/ML sense, this question is not applicable. The device's design and functionality would be based on engineering principles and regulatory requirements, and its performance verified and validated through the studies described.
§ 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).