(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.
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Image /page/0/Picture/0 description: The image shows the logo for J.C.F. Electronics Medical Technology Division. The logo is in black and white and features a stylized image on the left. The text "J.C.F. ELECTRONICS" is in a bold, blocky font with horizontal lines running through the letters. Below the company name, the text "MEDICAL TECHNOLOGY DIVISION" is printed in a smaller, less bold font.
Image /page/0/Picture/2 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '955659'. The numbers are written in a bold, slightly irregular style, giving them a distinct, handwritten appearance. The contrast between the dark ink and the white background makes the characters stand out.
ELECTRONICS, INC. · 5 Brayton Court · Commack, NY 11725 · Tel: 516-499-8085 · Fax: 516-499-8657
510 (k) SUMMAR!
DRUGBOX MODEL MC 2000
C.F. Electronics, Inc. is requesting marketing clearance for its Temperature-controlled drug case, which will be manufactured by Koolatron Division of Urus Industrial Corporation and marketed by C.F. Electronics, Inc. The Premarket Notif.cation information required by 21 CFR 807.87 is as follows:
- Classification Name: Drug case, Temperature controlled a. Common/Usual Name: Temperature controlled drug box Proprietary Name: DRUG BOX MC-2000 (Part Number 203045)
- b. Establishment Registration Number: 2435731
- Classification: Not determined. Manufacturer believes C. device should be exempt or Class I
- d . Performance standards: Not applicable
- e. Substantial equivalence: The MC-2000 is similar to the C.F. Electronics Therm-O-Druq [510(k) No. K922786]. That device uses low intensity, low voltage resistance heaters with thermostatic control to warm drugs in an insulated enclosure.
Contact person:
Robert P. Freedman
Date summary prepared:
December 27, 1995
DESCRIPTION OF DEVICE
Purpose :
The DrugBox MC-2000 is designed to maintain medications at their recommended storage temperature <ver a wide range of ambient temperatures. Recent publications (see citations) have shown that several of the drugs commonly used in emergency medical service lose potency or even are totally unusable atter exposure to temperatures outside the recommended storage range.
Since ambulances and back-up vehicles are frequently exposed to extreme ambient temperatures for extended periods, it is necessary to take precautions to keep the drug case and its contents within the correct storage temperature range.
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In checking the labeling of every drug listed by a typical ambulance service for their drug box, we found the recommended storage temperature range to be 59-86° F (15-3(19 C) in every instance. The DrugBox MC-2000 will maintain the drugs in the correct temperature range; heating or cooling automatically, as required.
General description of the device:
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.
In typical use, the DrugBox MC-2000 would be carried in the emergency vehicle and powered at all times. One or more complete kits of drugs will be kept in the DrugBox MC-2000 in soft cases and moved to the EMT's regular portable druq box for use. The DruqBox MC-2000 may also be used indoors or in any situation where 12VDC or 115VAC (power adapter required) is available
Detailed description:
Dimensions [Inches/mm]
Inside Outside
Weight
Case construction
Temperature controller
Set-point adjustment
Active element
Displays
12.5/317.5 H, 12/3.5 W, 12/305 D 15.5/394 H, 17.5/445 W, 16/406 D
12 lb/5.4 kg
Polypropylene inner and outer shells, polyurethane foam insulation
Solid-state with adjustable setpoint and out-of -tolerance detection
Recessed screwdriver slot
Thermoelectric module with circulating fan
Inside temperature (digital) In-tolerance LED Out-of-tolerance LED
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12VDC @ 3-4 amperes Power requirement Power adapter (Part No. 203046) 115VAC input, 12VDC @ 4.5 amperes
Ambient temperature range (for interior temperature of 60°F to 84°F (15.5-28.9°C))
SUBSTANTIAL EQUIVALENCE COMPARISON
| MC-2000 | THERM-O-DRUG | |
|---|---|---|
| ================================================== | ||
| Function | Store drugs at59-86 °F/15-30°C | Store drugs above59°F/15°C min. |
| Protect against low ambients | to 20°F/-6.7°C | to 10°F/-12.2°C |
| Protect against high ambients | to 120°F/48.9°C | 86°F-no coolingcapability |
| Usable Capacity | 1,050 in³/17.2L | 800 in³/13.2L(Approx.) |
| Thermal device | Thermoelectricheater-cooler | Resistance heater |
| Control method | Solid-state | Thermostats |
| Adjustments | Set point pot. | None |
| Power source | 12VDC | 12V DC or AC |
| Current | 4 Amp max | 2.3 Amp |
| Displays | Temperature (digital)LEDs (2) | None |
SAFETY INFORMATION
| Method of heating/cooling | Thermoelectric modulewith heat sinks andcirculating fan. |
|---|---|
| Power source | 12VDC @ 4 amperes. Thisvoltage is not hazardousto personnel. |
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| Power adapter | 115VAC input, 12VDC output @4.5 amperes max. UL & CSAlisted. |
|---|---|
| Power consumption | 48 watts |
| Control means | Solid-state electronicssensing interior air tem-perature. Adjustableset-point |
| Out-of-tolerance indicators | Digital temperature displayRed LED indicator |
| Electrical protection | Fuse |
| Patient shock hazard | None; voltage used is nothazardous, and patient doesnot contact device. Optionalpower adapter isolates devicefrom AC lines. |
| Sterility | Not involved; drugs arecontained in their own |
EFFECTIVENESS INFORMATION
packaging.
Because the drugs typically used by emergency medical services are labelled for storage at 59-86°F (15-30°C), and this device is intended to keep drugs within that range over a ranqe of ambient temperatures, effectiveness is a function of the ambient temperature extremes which can be withstood without allowing the drugs to leave the specified temperature range.
BASED ON THE MANUFACTURER'S TESTS....
At an ambient temperature of 120°F/48.9°C, the internal temperature will not exceed 84°F/28.9°C.
At an ambient temperature of 20°F/-6.7°C, the internal temperature will not drop below 60°F/15.6°C.
Between 30°F and 105°F (-1.1 to 40.6°C), the internal temperature can be maintained between 70° and 75°F (21.1 to 23.9°C) .
§ 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).