(154 days)
Not Found
No
The description details a standard electronic temperature control system using a thermoelectric module and feedback loop, with no mention of AI or ML terms or concepts.
No
Explanation: The device is designed to maintain the temperature of medications, not to directly treat or diagnose a patient's medical condition. It's an environmental control device for drugs.
No
The device is designed to maintain the temperature of medications, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components like an insulated case, electronic temperature control, a thermoelectric module, and internal spacers or a rack, indicating it is a hardware device with integrated software for control.
Based on the provided information, the DrugBox MC-2000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to maintain medications at their recommended storage temperature. This is a function related to the storage and preservation of medical products, not the testing of biological samples or the diagnosis of diseases.
- Device Description: The description details a temperature-controlled case. This aligns with a storage device, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Predicate Device: The predicate device (K922786; C.F. Electronics Therm-O-Drug) is also described as a temperature-controlled storage device for drugs, further supporting that this class of device is not an IVD.
In summary, the DrugBox MC-2000 is a medical device used for the storage and preservation of medications, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The DrugBox MC-2000 is designed to maintain medications at their recommended storage temperature
§ 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).
0
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 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
2
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 at | |
| 59-86 °F/15-30°C | Store drugs above | |
| 59°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 cooling |
| capability | ||
| Usable Capacity | 1,050 in³/17.2L | 800 in³/13.2L |
| (Approx.) | ||
| Thermal device | Thermoelectric | |
| heater-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 module
with heat sinks and
circulating fan. |
|---------------------------|----------------------------------------------------------------------|
| Power source | 12VDC @ 4 amperes. This
voltage is not hazardous
to personnel. |
3
| Power adapter | 115VAC input, 12VDC output @
4.5 amperes max. UL & CSA
listed. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Power consumption | 48 watts |
| Control means | Solid-state electronics
sensing interior air tem-
perature. Adjustable
set-point |
| Out-of-tolerance indicators | Digital temperature display
Red LED indicator |
| Electrical protection | Fuse |
| Patient shock hazard | None; voltage used is not
hazardous, and patient does
not contact device. Optional
power adapter isolates device
from AC lines. |
| Sterility | Not involved; drugs are
contained 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) .