PIV SYSTEM

K981032 · Medical Solutions, Inc. · LDQ · Sep 2, 1998 · SU

Device Facts

• Record ID: K981032
• Device Name: PIV SYSTEM
• Applicant: Medical Solutions, Inc.
• Product Code: LDQ · SU
• Decision Date: Sep 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Attributes: Therapeutic

Intended Use

The Medical Solutions PIV IV Bag Warmer and Pressure Infusor is designed to hold and heat IV fluid bags and maintain temperatures to 980 F ( 3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Device Story

PIV System functions as an IV bag warmer and pressure infusor; holds IV fluid bags; heats fluid to 980 F (±3°F); utilizes inflation mechanism to apply pressure to IV bag; assists fluid infusion. Used in clinical settings; operated by healthcare professionals. Benefits patient by providing warmed fluids and facilitating controlled infusion rates.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Device consists of a heating element and an inflatable pressure cuff. Maintains temperature at 980 F (±3°F). Mechanical pressure infusion mechanism.

Indications for Use

Indicated for patients requiring IV fluid administration where warming and/or pressurized infusion is clinically necessary. Restricted to prescription use by or on the order of a physician.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1998

Medical Solutions, Incorporated C/O Mr. E.J. Smith Smith Associates P.O. Box 4343 Crofton, Maryland 21114

- Re : K981032 PIV System Trade Name: Requlatory Class: I Product Code: LDQ Dated: June 17, 1998 Received: June 19, 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 legally marketed predicate 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 of the Act. The general controls provisions 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. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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

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Page 2 - Mr. Smith

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence 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 requlation (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"(21CFR 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/dsma/dsmamain.html".

Sincerely yours,

S. Dutman for

Timothy A. Ulatowski Director 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: PIV System

Classification Panel: LDQ

Indications for Use:

The Medical Solutions PIV IV Bag Warmer and Pressure Infusor is designed to hold and heat IV fluid bags and maintain temperatures to 980 F ( 3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid.

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use

or

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

Patricea Cuccurullo
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital, Infection
and General Hospital Devices

510(k) Number K981052