(50 days)
The ACCU-CHEK Pocket Compass Diabetes Management Software is a single user system indicated for use as an accessory to compatible Disetronic insulin pumps and a number of commercially available Accu-Chek blood glucose meters to download data from these devices to a personal digital assistant (PDA) where it may be saved, displayed, reviewed, analyzed, and evaluated to support effective diabetes management. The Accu-Chek Pocket Compass Software is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on user entered data. The device is indicated for over-the-counter sale.
An accessory software that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results and insulin infusion pump data to support effective diabetes management, including calculating an insulin or carbohydrate dose based on user entered data. The device is not intended to provide any diagnosis based upon patient results.
This medical device submission for the ACCU-CHEK® Pocket Compass Diabetes Management Software (K082595) primarily establishes substantial equivalence to a previously cleared device of the same name. As such, the submission does not contain detailed information on acceptance criteria for novel performance claims or a dedicated study proving device performance against such criteria. Instead, it relies on the similarity of features and functionality to the predicate.
Given the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria or quantifiable performance metrics are directly stated for this 510(k) submission. The submission focuses on demonstrating that the new version of the software is substantially equivalent to the predicate by having the "Same" or "Similar" features and intended use.
| Feature/Claim | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Meter / pump data download | Must allow download of historical data from compatible devices | Yes. Both products allow for the download of historical data stored in the compatible devices. |
| Pump data upload | Must not send programming or parameter information to pumps | No. Neither product sends programming or parameter information to the compatible pumps. |
| Support | Must provide support | Yes; through call center support, labeling and health care professionals. |
| Data storage | Must store data | On computer media. |
| Reports and graphs | Must generate reports and graphs | Similar graphs and reports can be generated for viewing on a display screen, and hard copy printout. |
| Manual Data Entry | Must allow manual data entry | Same. |
| Delete Data | Must allow data deletion | Same. |
| Track non-blood glucose data | Must track non-blood glucose data | Same. |
| Intended use | Must have the same intended use without new risks | Same. |
| Fundamental scientific technology | Must use the same fundamental scientific technology | Same. |
| Security of Bolus Calculator | Must require communication with a supported insulin pump before activation | Same; requires user to communicate to the software with a supported insulin pump before the bolus calculator is active. |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not detail a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a primary performance study. The assessment is primarily against the predicate device's existing clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Since the submission focuses on substantial equivalence to an existing cleared device of the same name, a de novo ground truth establishment study for performance is not explicitly described.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of an MRMC comparative effectiveness study, or effect size improvements with AI assistance, is found in the provided text. This is a software accessory without "AI" in the modern sense of interpreting complex clinical data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study is described. The device is a "single user system" and the purpose of the software is to facilitate review, analysis, and evaluation by the user and healthcare professionals, and to calculate an insulin or carbohydrate dose based on user-entered data. It is inherently "human-in-the-loop."
7. Type of Ground Truth Used
The ground truth, in this context, is implicitly defined by the performance and safety characteristics of the legally cleared predicate device. The submission aims to demonstrate that the new version maintains these characteristics.
8. Sample Size for the Training Set
No training set or its sample size is mentioned. This type of software, designed to manage and display user-entered and device-downloaded data, and perform calculations based on established formulas (e.g., insulin/carbohydrate dose), generally does not involve machine learning algorithms that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is described. The calculations performed by the bolus calculator would be based on established medical formulas and parameters configured by the user/healthcare professional, rather than learned patterns from a training set.
§ 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).