← Product Code LDQ · K981032 # PIV SYSTEM (K981032) _Medical Solutions, Inc. · LDQ · Sep 2, 1998 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K981032 ## Device Facts - **Applicant:** Medical Solutions, Inc. - **Product Code:** LDQ - **Decision Date:** Sep 2, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Review Panel:** SU - **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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol is a representation of a human figure in profile, with three figures overlapping to create a sense of depth and connection. The figures are rendered in a dark color, contrasting with the white background. 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 {1}------------------------------------------------ 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 {2}------------------------------------------------ Page 1 of 1 510(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 --- **Source:** [https://fda.innolitics.com/device/K981032](https://fda.innolitics.com/device/K981032) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com