(70 days)
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The Disetronic D-TRON Insulin Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and fulfills the requirements for IP X7 to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, adapter and custom reservoir kit. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a stepper motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or their care provider. The rate of the basal infusion each hour for twenty four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the four buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump. Two separate 24-hour profiles for the delivery of insulin can be programmed independently for each hour of the day. The hourly dose can be incremented to a maximum of 25 I.U. per hour. The basal delivery can be supplemented by a bolus up to 25 I.U. The D-TRON Insulin Infusion pump is equipped with an IR-Interface in order to enable data transmissions between the pump and a personal computer. The DiaLog PC-Software facilitates the monitoring and programming of the pump settings. Current pump settings can be displayed on the computer monitor, adjustments can be made and re-stored into the pump.
The Disetronic D-TRON Insulin Infusion Pump (K021225) was deemed substantially equivalent to the currently marketed D-TRON Pump (K994186) based on design equivalency and performance and safety testing.
Here's a breakdown of the available information:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Performance Standards: Adherence to IEC 60601-2-24 (Particular requirements for safety of infusion pumps and controllers), which incorporates IEC 60601-1 (General safety requirements) and IEC 60601-1-2 (Electromagnetic compatibility - requirements and tests). | The device's modifications are stated to be "consistent with the requirements of these standards." The electronic and mechanical design is described as "not unique and therefore the specifications fully address pump performance." |
| Substantial Equivalence: To the predicate device, D-TRON Pump K994186. | The submission concludes "the implementation of the DiaLog PC software for the Disetronic D-TRON Insulin Infusion Pump is substantially equivalent to the devices currently marketed in the United States." |
2. Sample Size and Data Provenance
The provided document does not specify a separate "test set" in the context of a clinical study with a defined sample size for evaluating the device's performance against specific clinical endpoints. The evaluation appears to be based on engineering and design verification against established international standards.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth, in this context, refers to the established safety and performance standards for infusion pumps (IEC 60601 series). These standards are developed by consensus of international experts in the field of medical device safety and functionality. However, the document does not detail specific experts involved in the K021225 submission for establishing a ground truth for a test set.
4. Adjudication Method
Not applicable, as there is no mention of a test set requiring adjudication in the context of clinical or diagnostic performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was mentioned or performed. This is not a diagnostic imaging device where human readers would interpret results.
6. Standalone Performance (Algorithm Only)
The device is an insulin infusion pump with associated software (DiaLog PC-Software). Its "standalone performance" refers to its ability to deliver insulin according to programmed settings and to operate safely. The submission states that "The electronic and mechanical design is not unique and therefore the specifications fully address pump performance," implying that its functionality was assessed against engineering specifications and international standards rather than a clinical standalone study in typical diagnostic AI context.
7. Type of Ground Truth Used
The "ground truth" for demonstrating the device's acceptability relies on its adherence to established international safety and performance standards for infusion pumps (IEC 60601-2-24, IEC 60601-1, and IEC 60601-1-2) and design equivalency to a legally marketed predicate device (K994186). There is no mention of pathology, outcomes data, or expert consensus in the conventional sense of establishing ground truth for a diagnostic device.
8. Sample Size for the Training Set
Not applicable. This device is an insulin infusion pump with software, not an AI/ML algorithm that requires a "training set" in the machine learning sense. The "training" for such devices typically involves engineering design, development, and testing processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned in the context of machine learning. The device's design and functionality were developed and verified against engineering specifications derived from relevant medical device standards.
§ 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).