(106 days)
The ACCU-CHEK® 360° Diabetes Management System is indicated for use by individuals or healthcare professionals in the home or health care facilities to support effective diabetes management. The software also allows for entry of other healthcare parameters with or without diabetes related information, which can be shown in report and graphical format. This device is indicated for professional use and over-the-counter sale.
Software accessory to ACCU-CHEK® brand meters and/or Disetronic/ACCU-CHEK insulin infusion pumps.
This K080227 submission for the ACCU-CHEK® 360° Diabetes Management System is a 510(k) summary and not a detailed study report. Therefore, it does not contain the specific information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or comparative effectiveness studies.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (Camit Diabetes Management Software and Smart Pix Device Reader) rather than presenting a performance study against predefined acceptance criteria. This type of submission relies on showing that the new device has the same intended use and technological characteristics as a legally marketed device, or that any differences do not raise new questions of safety and effectiveness.
Here's a breakdown of why the requested information is absent:
- Acceptance Criteria and Reported Device Performance (Table): Not provided. The submission’s core is a comparison of features and functionalities with predicate devices, not performance metrics against criteria.
- Sample Size and Data Provenance (Test Set): Not applicable as a formal performance test set with a specific sample size for evaluating accuracy or specific performance metrics is not detailed. The "study" here is a comparison of features.
- Number of Experts and Qualifications (Ground Truth): Not applicable for this type of submission. There's no clinical "ground truth" establishment described in the context of device performance evaluation.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned or applicable. This is not a study assessing human reader improvement with AI assistance.
- Standalone Performance Study: Not explicitly described with performance metrics. The submission focuses on functional equivalence.
- Type of Ground Truth Used: Not applicable in the context of device performance. The "truth" in this submission relates to the functional attributes and capabilities of the software.
- Sample Size for Training Set: Not applicable. This software is a diabetes management system, not an AI/ML model that would typically have a "training set" in the conventional sense of machine learning.
- How Ground Truth for Training Set was Established: Not applicable.
Summary of what the document does provide:
- Device Name: ACCU-CHEK® 360° Diabetes Management System
- Indications for Use: For individuals or healthcare professionals to support effective diabetes management, allowing entry of healthcare parameters and report/graphical output. Indicated for professional use and over-the-counter sale.
- Predicate Devices: Camit Diabetes Management Software (K001907) and Smart Pix Device Reader (K062395).
- Similarities and Differences Table: This table compares features of the ACCU-CHEK® 360° with the predicate devices, covering aspects like device memory downloading, report generation, compatibility, data storage, and security. This is the primary "evidence" for substantial equivalence.
Without a detailed performance study, which is often not required for this type of software a 510(k) submission, the specific information requested cannot be extracted from the provided text.
§ 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).