← Product Code [MEB](/productcode/MEB) · K983634 # PREPARE HOME INFUSION PUMP (K983634) _Medical Infusion Technologies, Inc. · MEB · Feb 24, 1999 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K983634 ## Device Facts - **Applicant:** Medical Infusion Technologies, Inc. - **Product Code:** [MEB](/productcode/MEB.md) - **Decision Date:** Feb 24, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5725 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use Provide controlled, continuous, intravenous fluid therapy for ambulatory patients. ## Device Story The Prepare™ Home Infusion Pump is an elastomeric infusion pump designed for ambulatory patients. It functions by delivering intravenous fluids in a controlled, continuous manner. The device is intended for use in home or clinical settings to facilitate patient mobility during therapy. It operates as a passive delivery system, utilizing elastomeric technology to maintain flow rates without the need for external power or complex electronic controls. Healthcare providers prescribe the device to manage fluid therapy, allowing patients to receive treatment outside of a hospital environment, thereby improving patient convenience and quality of life. ## Clinical Evidence Bench testing only. Functional testing was performed to confirm performance specifications and demonstrate substantial equivalence to the predicate device. ## Technological Characteristics Elastomeric infusion pump; passive fluid delivery mechanism; intended for continuous intravenous administration. Design and materials are equivalent to the predicate device. ## Regulatory 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 - Homepump, Block Medical, Inc. ## 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}------------------------------------------------ K9836634 ## MEDICAL INFUSION TECHNOLOGY, INC. がなくなっています。 【 # PREPARE™ HOME INFUSION PUMP #### 510(k) SUMMARY | Submitter Name: | Medical Infusion Technology, Inc. | |----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Address: | 6576 E. Quaker Street
Orchard Park, NY 14127 | | Contact Person: | John Wynne, President | | Phone Number: | 716-667-3318 | | Facsimile Number: | 716-667-3319 | | Date Prepared: | October 9, 1998 | | Device Trade Name: | Prepare™ Home Infusion Pump | | Device Common Name: | Elastomeric Infusion Pump | | Classification Name: | Infusion Pump, 21 CFR 880.5725 | | Predicate Device: | Homepump, Block Medical, Inc. | | Device Description: | An infusion pump used to pump fluids into a patient in
a controlled manner. | | Intended Use: | Provide controlled, continuous, intravenous fluid therapy
for ambulatory patients. | | Technological Characteristics
and Comparison to Predicate
Device(s). | Both the Block Medical Homepump and the Prepare™
Home Infusion Pump are equivalent in design, material,
intended use and function. | | Performance Data: | The Prepare™ Home Infusion Pump has been functionally
tested to confirm documented performance which demon-
strates substantial equivalence to the predicate device. | | Conclusion: | The Prepare™ Home Infusion Pump is safe and effective
for its intended use and meets all regulatory requirements
to be found substantially equivalent to the predicate device. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines that resemble a person. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 4 1999 Thomas L. Parker Mr. Medical Infusion Technologies, Incorporated 6576 East Quaker Street Orchard Park, New York 14127-2593 K983634 Re : Prepare Home Infusion Pump Trade Name: Requlatory Class: II Product Code: MEB February 5, 1999 Dated: February 8, 1999 Received: Dear Mr. Parker 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. ಗ್ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {2}------------------------------------------------ Page 2 - Mr. Parker 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 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaffgov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {3}------------------------------------------------ Page 10 #### SECTION 5 ## INDICATIONS FOR USE ## PREPARE™ HOME INFUSION PUMP "Provide controlled, continuous, intravenous fluid therapy for ambulatory patients." (Division Sign-Off) General Hospital and General Use Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Prescription Use 21 CFR 801.109 : Petricia Cuzzortle (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda-staging.innolitics.com/device/K983634](https://fda-staging.innolitics.com/device/K983634) **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