(122 days)
The t:slim™ Insulin Delivery System is indicated 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 is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The scope of this Special 510(k) is limited to changes to the cartridge configuration of the t:slim System.
The t:slim System with the modified cartridge, like the predicate device, consists of the following components and accessories:
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- a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump"),
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- a dedicated, disposable 3mL (300 unit) insulin cartridge ("cartridge");
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- an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
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- 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 user (i.e., the patient). The graphical user interface (GUI) of the t:slim Pump is a capacitive touch 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.
The t:slim cartridge is a single-use device, 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 delivery of insulin is accomplished through a micro-syringe within the head of the cartridge. The Pump has a pressure measurement sensor to estimate the volume of insulin in the insulin reservoir by measuring air pressure in the cartridge. This information is used to provide feedback to the software to determine the insulin volume, detect occlusions and cartridge removal.
- 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.
This 510(k) submission (K133593) is for a Special 510(k) notice regarding changes to the cartridge of the t:slim™ Insulin Delivery System. The primary focus of the performance data and acceptance criteria is to ensure that the modifications to the cartridge materials do not negatively impact the device's safety and effectiveness compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance / Evaluation Method |
|---|---|---|
| Material Safety & Compatibility | Biocompatibility with human tissue | Confirmation of biocompatibility testing per ISO 10993-1, repeated cytotoxicity testing. |
| Insulin compatibility (no degradation or interaction with insulin) | Insulin Compatibility testing. | |
| Extractables and Leachables within acceptable limits | Extractable and Leachables testing. | |
| Chemical composition of new materials matches specifications (or is acceptable) | Chemical composition comparison (FTIR). | |
| Cartridge Structural Integrity | Patient line bond strength sufficient | Patient line bond strength testing. |
| Cartridge integrity (no leaks under pressure) | Cartridge Pressure/leak testing. | |
| Package seal integrity maintained | Package seal integrity testing. | |
| Functional Performance (Delivery) | Infusion flow accuracy meets specifications | Infusion flow accuracy testing. |
| Fill volume accuracy meets specifications | Fill volume accuracy testing. | |
| Manufacturing Process & Quality | Production processes validated (Installation, Operational, Performance) | Production IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification). |
| Product inspection and release testing standards met | Product inspection and release testing. | |
| Risk Mitigation | All identified risks mitigated, no new risks introduced | Evaluation of risks for the type of change involved, confirmation that all changes made to the cartridge were assessed to make sure all the risks were mitigated (e.g., infusion flow accuracy, fill volume accuracy, leakage, bond strength and tubing integrity, shelf life, biocompatibility, insulin compatibility) and that no new risks were introduced as a result of these modifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each test mentioned (e.g., for bond strength, leak testing, flow accuracy, etc.). It refers generally to "testing" and "evaluation". Given the nature of a Special 510(k) for material and supplier changes, the testing would typically involve a statistically relevant number of units to demonstrate equivalence to the previously cleared predicate device.
The data provenance is not explicitly stated as country of origin but is implicitly domestic, as the submitter, Tandem Diabetes Care, Inc., is based in San Diego, CA, USA, and the submission is to the U.S. FDA. The data is retrospective in the sense that it's based on internal verification and qualification testing performed by the manufacturer to support the safety and effectiveness of the modified device before market introduction. It is not clinical trial data involving patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (Special 510(k) for material changes) does not typically involve a "test set" with "ground truth" established by external experts in the same way clinical studies for diagnostic devices might. The "ground truth" here is adherence to pre-defined engineering specifications, regulatory standards (like ISO 10993-1), and the performance characteristics of the predicate device. The experts involved would be the manufacturer's internal R&D, engineering, quality, and regulatory personnel responsible for designing, testing, and verifying the changes, along with potentially external lab specialists for specific tests like biocompatibility or extractables/leachables. Their qualifications would be relevant scientific and engineering degrees and experience in medical device development and testing. The document does not specify the number or detailed qualifications of these individuals.
4. Adjudication Method for the Test Set
Not applicable in the context of this Special 510(k). Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image-based diagnostic device evaluations where multiple human readers interpret data to establish a consensus ground truth. Here, the "ground truth" is defined by established engineering specifications and compliance with validated test methods.
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
Not applicable. This submission is for modifications to an insulin pump cartridge, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an insulin pump, not an algorithm. Performance is tested for the physical device components and their functionality.
7. The Type of Ground Truth Used
The ground truth used in this context is primarily:
- Engineering Specifications and Design Requirements: The performance of the modified cartridge must meet or exceed the original design specifications for the predicate device.
- Regulatory Standards: Compliance with relevant international standards, e.g., ISO 10993-1 for biocompatibility.
- Predicate Device Performance: The modified device must demonstrate substantial equivalence to the predicate device, meaning its performance, safety, and effectiveness are comparable.
- Validated Test Methods: The results are derived from validated test methods and protocols.
8. The Sample Size for the Training Set
Not applicable. This device does not have an "algorithm" in the sense of a machine learning model that requires a training set. The "training" here refers to the development and manufacturing processes which are subject to qualification (IQ/OQ/PQ) and ongoing quality control.
9. How the Ground Truth for the Training Set was Established
Not applicable for the reasons stated in point 8.
§ 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).