(84 days)
The Deltec Cozmo® Insulin Pump is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes.
The Deltec CoZmonitor™ Blood Glucose Monitor is available as an accessory to be used solely with the Deltec Cozmo® Insulin Pump. Because the monitor is powered by FreeStyle™, blood sampling can be performed using the finger, forearm, upper arm, thigh, calf or hand. All testing is performed outside of the body (in other words, in-vitro diagnostic use only with FreeStyle™ Test Strip and FreeStyle™ Control Solution, as other products can give inaccurate results.
The Deltec CoZmonitor™ Blood Glucose Monitoring System is designed to be used only with the Deltec Cozmo® Insulin Pump to help you and your healthcare provider monitor your diabetes management program. When used properly, the monitor provides a quantitative measurement of glucose (or sugar) in whole blood. Because the monitor is powered by FreeStyle™, blood sampling can be performed using the finger, forearm, upper arm, thigh, calf or hand. All testing is performed outside of the body (in other words, in-vitro diagnostic use only). Use only with FreeStyle™ Test Strip and FreeStyle™ Control Solution, as other products can give inaccurate results.
The Deltec Cozmo® Insulin Infusion Pump with CoZmonitor® Blood Glucose Module is lightweight and easy to use. The Deltec Cozmo® Insulin Pump incorporates a number of features to assist users in the management of their diabetes. Some of these features include a quick start program to allow users easy pump set-up and programming, enhancements to existing features, the addition of a food data base, user established blood glucose targets and alerts, insulin-on-board to alert the user of remaining active insulin following bolus administration, pump disconnect feature that allows the user to disconnect from the pump and allowing the pump to then keep track of insulin that would have been delivered during the disconnect period, Hypo Manager that alerts the patient of low BG levels and recommends carbohydrate units to ingest to elevate BG to patient specific specified levels, Therapy Summary Report to assist with diabetes management, weekly schedule to allow the user to set basal patterns to match activities of daily living. The Deltec Cozmo® Insulin Pump is used with the CoZmonitor® Blood Glucose Module
The CoZmanager® 2.0 is a PC based program that allows the user to download information from the pump and to program the pump via an IR connection between the pump and the PC. CoZmanager® 2.0 allows the user to customize names of features as well as establish meal selections based on individual needs. A number of reports are available from the program.
This document, K062323, is a 510(k) summary for the Deltec Cozmo® Insulin Infusion Pump Model 1800 with CoZmonitor® Blood Glucose Module. It focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting detailed acceptance criteria and a study to prove meeting those criteria for a novel device.
The provided text does not include acceptance criteria or a study designed to explicitly prove the device meets pre-defined acceptance criteria in the manner typically expected for a new or significantly modified medical device requiring such rigorous assessment.
Instead, the submission relies on the concept of "substantial equivalence" to predicate devices. Here's what we can extract and what's missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Software Functional Performance | Established specifications for proper pump operation (implied from "Verification and validation of software controlled programming functions related to proper pump operation"). | "Results of this testing showed the Deltec Cozmo® Insulin Pump Model 1800 met and performed to established specifications." |
| Clinical Effectiveness | Not explicitly defined as acceptance criteria for this 510(k) given its reliance on substantial equivalence. | "Clinical studies were not deemed necessary to establish effectiveness of the Deltec Cozmo® Insulin Pump Model 1800 as the pump is similar to other currently commercially available insulin pumps on the market today." (This indicates no clinical performance data was generated or reported for acceptance against specific criteria). |
| Safety | Not explicitly defined as acceptance criteria for this 510(k). | No specific safety performance metrics or data reported in this summary, relying on the safety profile of predicate devices. |
| Equivalence to Predicate Devices | Substantially equivalent to currently distributed Deltec Cozmo® Insulin Pump Model 1700 and Animas IR 1250. | "The Deltec Cozmo® Insulin Pump Model 1800 is substantially equivalent to other currently commercially available insulin infusion pumps on the market today." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable / Not reported. The document states "Verification and validation of software controlled programming functions related to proper pump operation were conducted," but it does not specify the sample size (e.g., number of test cases, number of devices tested) for this functional testing.
- Data Provenance: Not reported. The testing was internal to the manufacturer (Smiths Medical MD, Inc.) as part of their verification and validation process, but no details on the origin of data (e.g., country, retrospective/prospective) are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable / Not reported. The "ground truth" for functional software testing would typically be the expected output or behavior according to the design specifications. This doesn't involve external or clinical experts establishing ground truth in the way a diagnostic AI device would.
4. Adjudication Method for the Test Set
- Not applicable / Not reported. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation or clinical outcomes where discrepancies need resolution. This document describes functional and software verification, which generally follows pre-defined test protocols with expected pass/fail outcomes, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. A MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not deemed necessary to establish effectiveness of the Deltec Cozmo® Insulin Pump Model 1800 as the pump is similar to other currently commercially available insulin pumps on the market today." Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, implicitly for the software functionality. The "functional testing" described for "software controlled programming functions related to proper pump operation" would be a standalone evaluation of the algorithm's performance against specifications. However, specific performance metrics (e.g., accuracy, precision) for these algorithms (like insulin-on-board calculations, Hypo Manager recommendations) are not reported in this summary. The summary only states it "met and performed to established specifications."
7. The Type of Ground Truth Used
- For the reported "Functional Testing": The ground truth would be the engineering specifications and design requirements for the software and device functions. This is derived from product design documents, not external clinical data, pathology, or outcomes in this context.
8. The Sample Size for the Training Set
- Not applicable / Not reported. This device is an insulin pump, not an AI/ML-based diagnostic or prognostic algorithm that typically requires a distinct "training set" in the machine learning sense. The software functions were likely developed through traditional software engineering processes, not trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not reported. As this is not an AI/ML device in the modern sense requiring a training set, the concept of establishing ground truth for a training set does not apply.
Summary of Missing Information in the Context of Your Request for an Acceptance Criteria Study:
The provided 510(k) summary is for an insulin pump, which is a physical medical device with software, not a diagnostic AI algorithm. Consequently, many of the requested details such as sample sizes for test/training sets, data provenance, expert qualifications for ground truth, and MRMC studies, are either not applicable, not reported, or addressed through traditional device verification and validation (V&V) processes rather than a "study proving acceptance criteria" in the way one would for a novel AI diagnostic.
The key takeaway is that the device gained clearance based on substantial equivalence to predicate devices and internal functional testing demonstrating performance to established specifications, with no explicit clinical studies or external ground truth validation reported in this summary.
§ 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).