CONTROLLED TEMPERATURE CABINET SYSTEM

K973747 · Smith · LDQ · May 7, 1998 · SU

Device Facts

• Record ID: K973747
• Device Name: CONTROLLED TEMPERATURE CABINET SYSTEM
• Applicant: Smith
• Product Code: LDQ · SU
• Decision Date: May 7, 1998
• Decision: SESE
• Submission Type: Traditional

Indications for Use

The Medical Products, Inc. Controlled Temperature Cabiner Systems are designed to store and maintain the temperature of drugs and I.V. solutions within the ambulance or mobile vehicle environment to temperatures between 21º to 26ºC or 35º to 40ºC. The Controlled Temperature Cabinet Systems must be ordered by temperature range. For drugs the range is 210 to 26°C and for I.V. solutions the temperature range is 35°co 40°C. Warning: The owner of the ambulance or mobile vehicle should contact the manufacturer of the products to be placed inside the cabinets and obtain guidelines for exposing their product to temperatures other than those stated on the I.V. solution bag/bottle or drug container.

Device Story

Controlled Temperature Cabinet System designed for mobile/ambulance use; maintains specific temperature ranges for drugs (21-26°C) or I.V. solutions (35-40°C). Device operates as a thermal storage unit to prevent temperature excursions for medical supplies during transport. Operated by ambulance personnel/EMS staff. Output is a temperature-controlled environment for stored contents. Benefits include preservation of drug/solution integrity during transit. Users must verify compatibility with product manufacturers' storage guidelines.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Thermal cabinet system for mobile vehicle installation. Configured for specific temperature ranges (21-26°C or 35-40°C). Mechanical/electrical temperature control system.

Indications for Use

Indicated for storage and temperature maintenance of drugs (21-26°C) and I.V. solutions (35-40°C) within ambulance or mobile vehicle environments.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1998 MAY

Medical Products, Incorporated C/O Mr. E.J Smith President Smith Associates P.O. Box 4341 Crofton, Maryland 2114-4341

Re : K973747 Controlled Temperature Cabinet System Trade Name: Unclassified Requlatory Class: Product Code: LDQ Dated: March 24, 1998 Received: March 26, 1998

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A - 1. substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Smith

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberibod in your bio (i) providence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Controlled Temperature Cabinet System

Classification Panel: 80LGZ, General Hospital

Indications for Use:

The Medical Products, Inc. Controlled Temperature Cabiner Systems are designed to store and I he Moutan's roducts, the. Comrowin the ambulance or mobile vehicle environment to temperatures between 21º to 26ºC or 35º to 40ºC.

The Controlled Temperature Cabinet Systems must be ordered by temperature range. For drugs the range is 210 to 26°C and for I.V. solutions the temperature range is 35°co 40°C.

Warning: The owner of the ambulance or mobile vehicle should contact the manufacturer of the products to be placed inside the cabinets and obtain guidelines for exposing their product to temperatures other than those stated on the I.V. solution bag/bottle or drug container.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use | | or | Over-the-Counter Use |
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| | <div><i>(Division Sign-Off)</i></div> <div>Patricia Cucerda</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> |
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| 510(k) Number | K973747 |