MICROFUSE DUAL RATE INFUSER

K091386 · Numia Medical Technology, LLC · FRN · Oct 2, 2009 · General Hospital

Device Facts

• Record ID: K091386
• Device Name: MICROFUSE DUAL RATE INFUSER
• Applicant: Numia Medical Technology, LLC
• Product Code: FRN · General Hospital
• Decision Date: Oct 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroFuse Dual Rate infuser is intended to be used for the intermittent administration of I.V. medication.

Device Story

MicroFuse Dual Rate Infuser is a battery-powered, portable syringe infusion pump; automates injection of syringe contents into patient. Device operates by depressing syringe plunger at controlled, factory-preset rates. Offered in three models (standard, dual rate, extended infusion) differing only by software-programmed infusion rates. Used with sterile, disposable administration sets and syringes; no patient-contact materials in pump itself. Operated by clinicians or patients to deliver medication over extended periods. Output is controlled fluid delivery; assists in clinical medication management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-powered portable syringe pump. Mechanical plunger actuation. No patient-contact materials. Software-controlled infusion rates (factory-preset, non-modifiable). Non-sterile device.

Indications for Use

Indicated for intermittent I.V. medication administration. Prescription use only.

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

• MicroFuse Dual Rate Infuser (K983321)

Submission Summary (Full Text)

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# Attachment 4

091386

# 510(K) SUMMARY

Numia Medical Technology, LLC 230 Main Street PO Box 236 Lyndonville, Vermont 05851

### Contact Person:

Eric J Flachbart President Numia Medical Technology, LLC 230 Main Street PO Box 236 Lyndonville, Vermont 05851 802-284-4105 802-284-4104 facimile 508-397-1248 mobile [e-mail] www.numiamedical.com

Date Prepared: April 1, 2009

Trade Name: MicroFuse Dual Rate Infuser Common Name: Syringe Infusion Pump Classification Name: Infusion Pump

Predicate Devices MicroFuse Dual Rate Infuser

### Intended Use

The MicroFuse Dual Rate infuser is intended to be used for the intermittent administration of I.V. medication.

## Device Description:

The Numia Medical Technology Dual Rate Infuser, or MicroFuse, is a battery powered, portable device that automates the injection of the contents of a syringe into a patient. The MicroFuse was originally developed and cleared through FDA by Baxa Corporation of Englewood Colorado under K983321. Each MicroFuse has two predetermined rates that are preset at the manufacturing facility. These preset

MicroFuse Special 510k - April 1, 2009 Page 12 OCT - 2 2009

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rates cannot be modified by the user or patient. The MicroFuse is used in conjunction with a sterile faces Cambo be modified by the acer or paterile administration set for injecting the medication into a syinge, the contents of meaned of the syringe at a controlled, pre-determined rate, delivering the dose in patient it depresses the praiger of the MicroFuse is offered in thee models a standard dual the synnge over an extended ported on extended infuse model. The only difference between these being the prodet, and infusion rates programmed into the device's software.

The MicroFuse System consists of the MicroFuse Dual Rate Infuser and a syringe and administration I he Microruse and administration sets are sterile and disposable. Since only the accessory syringes and administration sets are in the fluid path, the MicroFuse has no patient contact materials. This also means the device is not provided sterile, nor is it sterilized in the field.

Cof c

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Mr. Eric J. Flachbart President Numia Medical Technology, L.L.C. 230 Main Street P.O. Box 236 Lyndonville, Vermont 05851

OCT - 2 2009

Re: K091386

Trade/Device Name: MicroFuse Dual Rate Infuser Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 15, 2009 Received: September 24, 2009

Dear Mr. Flachbart:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2- Mr. Flachbart

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Runner

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use Statement

# 510(k) Number: K091386

Device Name: MicroFuse Dual Rate Infuser

## Indications for Use:

The MicroFuse Dual Rate infuser is intended to be used for the intermittent administration of I.V. medication.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use_ Prescription Use X ___________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Susan Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KONZEL 510(k) Number: