(154 days)
The DrugBox MC-2000 is designed to maintain medications at their recommended storage temperature over a wide range of ambient temperatures.
The DrugBox MC-2000 is an insulated case with electronic temperature control. Heating or cooling is by means of a thermoelectric module, using the Peltier effect. The electronic control senses the temperature of air returning to the internal heat sink, compares it to the set point, and directs current to the thermoelectric array to heat or cool as necessary to maintain the set point. Depending upon the user's requirements, internal spacers or a rack are provided to ensure that air can be circulated around the drugs.
The provided document describes the acceptance criteria and the results of a study for the J.C.F. Electronics DRUGBOX MODEL MC-2000, a temperature-controlled drug case.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Internal Temperature Range) | Device Performance (Achieved Internal Temperature) | Ambient Temperature |
|---|---|---|
| 59-86°F (15-30°C) | Does not exceed 84°F (28.9°C) | 120°F (48.9°C) |
| 59-86°F (15-30°C) | Does not drop below 60°F (15.6°C) | 20°F (-6.7°C) |
| 59-86°F (15-30°C) | Can be maintained between 70-75°F (21.1-23.9°C) | 30-105°F (-1.1-40.6°C) |
Note: The reported device performance meets the stated acceptance criteria, as the internal temperatures remain within the 59-86°F (15-30°C) range even at extreme ambient temperatures. Specifically, 84°F is within range, and 60°F is within range. The 70-75°F range is also within acceptable limits.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of number of devices tested or the duration of each test. It refers to "manufacturer's tests."
The data provenance is from the manufacturer's tests, implying an internal, prospective study conducted by J.C.F. Electronics, Inc. The country of origin is implicitly the United States, given the company's address in Commack, NY, and the 510(k) submission context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a temperature-controlled case, and the ground truth for its performance is objective temperature measurements, not subjective interpretation by experts. Therefore, no experts were needed to establish the ground truth for the test.
4. Adjudication Method for the Test Set
Not applicable. The effectiveness evaluation involves objective temperature measurements and comparison to predefined thresholds, not subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic or interpretative devices where human readers assess cases. This device is a drug storage unit, and its effectiveness is determined by its ability to maintain a specific temperature range, not by human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the term "standalone" typically refers to algorithmic performance in AI/software, in the context of this device, the "standalone" performance refers to the device's ability to maintain the specified internal temperature range strictly based on its mechanical and electronic design, without human intervention or interpretation during its operation. The reported data in the "Effectiveness Information" section represents this standalone performance.
7. The Type of Ground Truth Used
The ground truth used is objective temperature measurements. The internal temperature of the device was measured and compared against the recommended storage temperature range for medications (59-86°F or 15-30°C).
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical/electronic temperature control unit, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of machine learning. The device's control system is designed and calibrated based on engineering principles, not through data training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The operating principles are based on established physics (Peltier effect, thermostatic control) and 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).