(55 days)
The DAHEDI Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin dependent diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis, as well as adhere to a proper diet and exercise regiment. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.
The DAHED! Insulin Infusion Pump is a very small, ambulatory, battery operated portable pump that is designed for the treatment of Insulin Dependent Diabetes Mellitus. The DAHEDI Insulin Infusion Pump infuses small amounts of insulin through a catheter into the patient via subcutaneous administration twenty-four hours a day. It is compact, watertight and shock resistant to maximize patient convenience. The pump uses a commercially available insulin reservoir that holds reqular insulin into which the pump drives a piston rod that displaces precise amounts of insulin at exact times throughout the day. Insulin is delivered from the insulin reservoir of the pump to the body through a thin, plastic tube called an "infusion set." The infusion set has a small needle or flexible catheter that the user inserts under the skin (most commonly in the subcutaneous tissue of the abdomen). Insulin passes through the infusion set into a needle or a soft Teflon cannula into the body. The pump is compatible with all commercially available subcutaneous insulin infusion sets with female luer lock connectors. The insulin reservoirs and catheters are sterile and single use (disposable). The pump itself is not sterile as it does not come in contact with the insulin. Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a motor driving a piston forward into the cartridge. The frequency of the motor revolution is controlled by the pump according to the information entered into the pump by the user or his care provider. The rate of the basal infusion, initiation of boluses, any dosage limitations or modifications can be simply entered using the buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to the proper monitoring of the pump and the therapy. An optional IR adapter allows the user to send 42 days of history into a standard IBM compatible Personal computer.
The provided text describes a 510(k) submission for the DAHEDI Insulin Infusion Pump, asserting its substantial equivalence to a predicate device based on functional comparison and performance and safety testing. However, it does not contain the specific details required to populate a table of acceptance criteria and reported device performance in the way typically expected for a detailed study.
Here's an attempt to answer your request based on the available information, with important caveats highlighting what is not present in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "All test results demonstrate that the system specifications and functional requirements were met." and "The DAHEDI Insulin Infusion Pump has been designed and tested in accordance with IEC 601-2-24...". However, it does not provide a specific table of quantitative acceptance criteria or the numerical results of the performance tests.
| Performance Metric/Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Requirements | Met |
| System Specifications | Met |
| Safety Requirements (IEC 601-2-24) | Met |
| Electromagnetic Interference (EMI) | Met (per IEC 601-1-2) |
| Precision of Insulin Delivery | Not explicitly quantified, but implied to be "precise amounts" and "controlled delivery" and comparable to predicate. |
| Accuracy of Insulin Delivery | Not explicitly quantified. |
| Reliability/Durability | Not explicitly quantified. |
| Battery Life | Not explicitly quantified. |
| Watertightness | Confirmed as "watertight". |
| Shock Resistance | Confirmed as "shock resistant". |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size (number of pumps or test runs) used for the performance and safety testing. It also does not explicitly state the provenance of any data (e.g., country of origin, retrospective or prospective). The testing appears to be part of the product development and regulatory submission process, implying prospective testing specific to the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the document describes performance and safety testing against engineering standards (IEC 601-2-24) and functional specifications, not a clinical study involving ground truth established by medical experts for diagnostic purposes.
4. Adjudication method for the test set
Not applicable, as ground truth establishment by experts for a test set is not described. The testing involves engineering and regulatory compliance, likely with internal quality control and verification procedures.
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
Not applicable. This is not an AI/diagnostic device. It is an insulin infusion pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is framed for AI algorithms. For a device like an insulin pump, standalone performance refers to the device's ability to operate according to its specifications independently. The document implies that the device's functional and safety performance was tested in a standalone manner to ensure it met "system specifications and functional requirements."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance and safety testing, the "ground truth" would be the established engineering standards and specifications (e.g., IEC 601-2-24) to which the device was designed and tested. Compliance with these quantitative and qualitative standards serves as the benchmark.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set" in the conventional sense. The "proprietary digital control chip" has "hardwired" operations rather than being "trained."
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is mentioned or implied. The device's control parameters are "hardwired" and based on engineering design.
§ 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).