WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS

K991275 · Mckinley, Inc. · FRN · Jul 1, 1999 · General Hospital

Device Facts

• Record ID: K991275
• Device Name: WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
• Applicant: Mckinley, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jul 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The pump is indicated for intravenous, subcutaneous, arterial, enteral, and epidural infusion of antibiotics, analgesics, chemotherapeutic agents and other medications or fluids requiring precisely-controlled infusion rates.

Device Story

WalkMed series (300, 350, IC, PCA, Plus) are infusion pumps designed for delivery of medications/fluids via intravenous, subcutaneous, arterial, enteral, or epidural routes. Devices provide precisely-controlled infusion rates for antibiotics, analgesics, and chemotherapeutic agents. Operated by healthcare professionals in clinical settings; pumps manage fluid delivery to patients requiring controlled therapy. Output consists of mechanical fluid infusion; clinical decision-making relies on pump settings for rate and volume. Benefits include accurate, consistent medication administration.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Infusion pump system; electromechanical fluid delivery; supports multiple infusion routes (IV, subcutaneous, arterial, enteral, epidural).

Indications for Use

Indicated for patients requiring intravenous, subcutaneous, arterial, enteral, or epidural infusion of medications or fluids, including antibiotics, analgesics, and chemotherapeutic agents, where precise infusion rate control is necessary.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 1999

Mr. John McInroy Manager Regulatory Affairs and Quality Assurance McKinley Medical LLLP 4080 Youngfield Street Wheat Ridge, Colorado 80033 USA

Re: K991275 Trade Name: WalkMed® 300, WalkMed® 350, WalkMed® IC, WalkMed® PCA, WalkMed® Plus Requlatory Class: II Product Code: FRN Dated: April 8, 1999 Received: April 14, 1999

Dear Mr. McInroy:

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, Druq, 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 aqainst 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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 Register.

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Page 2 - Mr. McInroy

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of 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 findinq 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 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,

Susan Kump

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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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: WalkMed XXX Infusion Pump

Indications for Use:

The pump is indicated for intravenous, subcutaneous, arterial, enteral, and epidural infusion of antibiotics, analgesics, chemotherapeutic agents and other medications or fluids requiring precisely-controlled infusion rates.

here Nereau for ACC

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ ﺃﻧﺴﻄ or

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

McKinley Medical