(76 days)
The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
The ACCU-CHEK Spirit Insulin Infusion Pump is an ambulatory, battery operated insulin pump designed for continuous delivery of insulin. The design allows for delivery of 0.0 to 25.0 units of U100 insulin per hour in basal rates and up to 25.0 units of U100 insulin per meal or meal bolus. The pump is made of impact resistant plastic. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. The ACCU-CHEK Spirit Insulin Infusion Pump is equipped with an IR-Interface in order to enable data transmission between the pump and a personal computer. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
This 510(k) submission (K060876) for the ACCU-CHEK® Spirit Insulin Infusion Pump is a Special 510(k) for a modification to an already cleared device (K042887). The modification primarily concerns the addition of the "ACCU-CHEK Insulin Pump Configuration Software" which facilitates monitoring and programming of pump settings.
The document states that the software has been verified and validated and that no new issues were raised regarding safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format. However, the core acceptance criterion for this Special 510(k) is substantial equivalence to the predicate device (K042887).
| Acceptance Criteria (Implicit for Special 510(k)) | Reported Device Performance |
|---|---|
| Maintain the same intended use. | Same intended use. |
| Maintain the same technological characteristics (or demonstrate safety/effectiveness if different). | Same features, with the addition of software for monitoring/programming. |
| Not raise new questions of safety or effectiveness. | Software has been verified and validated; no new issues identified regarding safety and effectiveness. |
| Software performs as intended. | Software facilitates monitoring and programming of pump settings. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "software testing performed" and that the software "has been verified and validated." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used to establish ground truth or their qualifications. The testing approach appears to be focused on software verification and validation rather than clinical performance adjudicated by medical experts.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method as it primarily concerns software verification and validation, not a clinical study involving human judgment on cases.
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 MRMC comparative effectiveness study was mentioned. The device is an insulin pump and software, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
The "ACCU-CHEK Insulin Pump Configuration Software" itself would be considered a standalone component, as it performs its functions independent of direct human intervention in the data processing, although it facilitates monitoring and programming by a human. The verification and validation of this software would essentially be demonstrating its standalone performance against its specifications. However, the document does not explicitly describe this as a "standalone study" in the context of typical AI/CAD device evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):
For the "software testing," the ground truth would likely be defined by the software requirements and design specifications. This would involve verifying that the software functions correctly, calculates values accurately, and displays information as intended, rather than clinical ground truth like pathology or expert consensus on a medical diagnosis.
8. The Sample Size for the Training Set:
The document does not mention a training set sample size. This is expected as the software likely follows traditional software development and testing methodologies (verification and validation) rather than machine learning or AI paradigms that require distinct training sets.
9. How the Ground Truth for the Training Set was Established:
As no training set is mentioned or implied, this information is not applicable/provided.
§ 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).