DRUGBOX

K955659 · C.F. Electronics, Inc. · LGZ · May 14, 1996 · General Hospital

Device Facts

• Record ID: K955659
• Device Name: DRUGBOX
• Applicant: C.F. Electronics, Inc.
• Product Code: LGZ · General Hospital
• Decision Date: May 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Indications for Use

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 will maintain the drugs in the correct temperature range; heating or cooling automatically, as required.

Device Story

DrugBox MC-2000 is an insulated, temperature-controlled storage case for emergency medications. It utilizes a thermoelectric module (Peltier effect) with a circulating fan to heat or cool the internal compartment. A solid-state controller senses internal air temperature, compares it to an adjustable set point, and regulates current to the thermoelectric array. The device operates on 12VDC or 115VAC (via adapter). It features a digital temperature display and LED indicators for in-tolerance/out-of-tolerance status. Used in emergency vehicles or clinical settings, the device ensures drugs remain within manufacturer-specified storage ranges (59-86°F) despite extreme ambient conditions (20°F to 120°F). Healthcare providers (EMTs) transfer drugs from the MC-2000 to portable kits for patient administration. The device prevents drug potency loss due to thermal exposure, benefiting patients by ensuring medication efficacy.

Clinical Evidence

Bench testing only. Performance was validated by measuring internal temperature stability against ambient temperature extremes. Results: At 120°F ambient, internal temperature remained ≤84°F. At 20°F ambient, internal temperature remained ≥60°F. Between 30°F and 105°F ambient, internal temperature was maintained between 70°F and 75°F.

Technological Characteristics

Polypropylene inner/outer shells with polyurethane foam insulation. Active element: Thermoelectric module (Peltier effect) with circulating fan. Solid-state electronic controller with adjustable set-point. Power: 12VDC (4A max) or 115VAC via UL/CSA listed adapter. Dimensions: 15.5"H x 17.5"W x 16"D (outside). Displays: Digital temperature, in-tolerance/out-of-tolerance LEDs. Electrical protection: Fuse.

Indications for Use

Indicated for the storage of medications requiring a temperature range of 59-86°F (15-30°C) for use by emergency medical services in ambulances or indoor environments.

Regulatory Classification

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.

Predicate Devices

• Therm-O-Drug (K922786)

Submission Summary (Full Text)

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C.F. ELECTRONICS
MEDICAL TECHNOLOGY DIVISION
MAY 14 1996
K955659

ELECTRONICS, INC. • 5 Brayton Court • Commack, NY 11725 • Tel: [phone] • Fax: [phone]

## 510(k) SUMMARY

## 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 Notification information required by 21 CFR 807.87 is as follows:

a. Classification Name: Drug case, Temperature controlled Common/Usual Name: Temperature controlled drug box Proprietary Name: DRUG BOX MC-2000 (Part Number 203045)

b. Establishment Registration Number: 2435731

c. Classification: Not determined. Manufacturer believes 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-Drug [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 7, 1995

## DESCRIPTION OF DEVICE

Purpose:

The DrugBox MC-2000 is designed to maintain medications at their recommended storage temperature over 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 after 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 (15-30° 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 drug box for use. The DrugBox 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
12.5/317.5 H, 12/3.5 W, 12/305 D
15.5/394 H, 17.5/445 W, 16/406 D |
| --- | --- |
| Weight | 12 lb/5.4 kg |
| Case construction | Polypropylene inner and outer shells, polyurethane foam insulation |
| Temperature controller | Solid-state with adjustable set-point and out-of-tolerance detection |
| Set-point adjustment | Recessed screwdriver slot |
| Active element | Thermoelectric module with circulating fan |
| Displays | Inside temperature (digital)
In-tolerance LED
Out-of-tolerance LED |

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Power requirement 12VDC @ 3-4 amperes

Power adapter (Part No. 203046) 115VAC input, 12VDC @ 4.5 amperes max. (UL and CSA listed)

Ambient temperature range 20°F to 120°F (-6.7 to 48.9°C)

(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. |

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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 temperature. 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 packaging.

## EFFECTIVENESS INFORMATION

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 range 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).