Accu-Chek Solo Micropump System with Interoperable Technology
by Roche Diabetes Care GmbH Germany EUDAMED510(k)
510(k) K213134 Product code QFG
Overview
The Accu-Chek Solo Micropump System with Interoperable Technology is an Alternate Controller Enabled Insulin Infusion Pump, designed for continuous subcutaneous insulin delivery. It integrates with external controllers to automate insulin dosing based on real-time glucose monitoring data, supporting precise glycemic management for individuals with diabetes.
This system is intended for in-vitro diagnostic use in clinical chemistry settings, as classified under Device Class II (FDA regulation 880.5730). Supplied as a reusable medical device, it requires proper sterilization and maintenance per manufacturer guidelines. The system operates within MRI-safe parameters for specified components and is authorized under FDA 510(k) clearance and MDD compliance. Multiple model references are listed for regulatory tracking, ensuring traceability and adherence to regulatory standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK213134 | Date10 Aug 2023 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- QFG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5730
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Roche Diabetes Care GmbH
Questions
What is the primary purpose of the Accu-Chek Solo micropump system with interoperable technology, and how does it differ from traditional insulin pumps?
The Accu-Chek Solo micropump system is designed for continuous subcutaneous insulin delivery and integrates with external controllers to automate insulin dosing. Unlike traditional pumps, it uses real-time glucose monitoring data to adjust insulin delivery precisely, helping users achieve better glycemic control. It’s classified as an Alternate Controller Enabled Insulin Infusion Pump, meaning it relies on external devices for decision-making rather than standalone programming.
Is the Accu-Chek Solo micropump system single-use or reusable, and what sterilization requirements apply?
The system is reusable and requires proper sterilization and maintenance as outlined by the manufacturer. Since it’s classified under FDA regulation 880.5730 (Clinical Chemistry), it must adhere to sterilization protocols to ensure safety and functionality for repeated use in clinical settings.
How many model references are associated with this device, and why are they important?
The device has multiple model references (listed under `openfda` and `registration_number` fields), totaling over 30 unique identifiers. These references are critical for regulatory traceability, ensuring compliance with FDA and MDD requirements, and allowing healthcare providers to verify the specific version in use for maintenance or recalls.
Can this device be used safely in an MRI environment, and if so, which components are MRI-safe?
The system is designed with MRI-safe parameters for specified components, though the exact details (e.g., field strength limits or safe zones) aren’t provided in the data. Clinicians should consult the manufacturer’s guidelines or device labeling to confirm compatibility with their MRI facility’s protocols before use.
What regulatory pathways does the Accu-Chek Solo micropump system follow, and how does that affect its availability?
The device follows FDA 510(k) clearance (traditional pathway, classified as Substantially Equivalent) and MDD compliance, meaning it’s authorized for sale in the U.S. and EU markets under these frameworks. The Clinical Chemistry advisory committee classification reflects its regulatory filing route, not its clinical indication. Availability depends on local regulatory approvals and healthcare provider adoption.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K213134
- EUDAMED