MCKINLEY SP DISPOSABLE INFUSION PUMP

K990461 · Mckinley, Inc. · MEB · Jun 30, 1999 · General Hospital

Device Facts

• Record ID: K990461
• Device Name: MCKINLEY SP DISPOSABLE INFUSION PUMP
• Applicant: Mckinley, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Jun 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The McKinley SP is indicated for intravenous, intra-arterial, enteral, subcutaneous and epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. The McKinley SP is also intended to provide continuous infusion of a local anaesthetic directly into the intraoperative site for postoperative pain management.

Device Story

McKinley SP is a disposable infusion pump designed for continuous delivery of fluids or medications at controlled rates. Used in clinical settings for intravenous, intra-arterial, enteral, subcutaneous, and epidural administration, as well as postoperative pain management via local anesthetic infusion at intraoperative sites. Device operates as a mechanical infusion system; provides controlled flow rates for therapeutic delivery. Healthcare providers manage pump setup and rate settings to ensure accurate medication administration. Benefits include consistent, reliable delivery of prescribed therapies, reducing manual intervention requirements for continuous infusion needs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable infusion pump; mechanical delivery system for continuous fluid/medication infusion. Designed for intravenous, intra-arterial, enteral, subcutaneous, and epidural use. No electronic or software components described.

Indications for Use

Indicated for patients requiring continuous infusion of medications or fluids via intravenous, intra-arterial, enteral, subcutaneous, or epidural routes. Also indicated for continuous local anesthetic infusion at intraoperative sites for postoperative pain management.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 1999

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

Re: K990461 McKinley SP Disposable Infusion Pump Trade Name: Requlatory Class: II Product Code: MEB May 10, 1999 Dated: May 13, 1999 Received:

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, 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, qood 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. A 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.

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Page 2 - Mr. McInroy

Please note: this response to your premarket notification 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 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 ene regaración Chorolog (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 Runner

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): __

Device Name: McKinley SP Disposable Infusion Pump

Indications for Use:

The McKinley SP is indicated for intravenous, intra-arterial, enteral, subcutaneous and epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates.

McKinley SPA

- O The McKinley SP is also intended to provide continuous infusion of a local anaesthetic directly into the intraoperative site for postoperative pain management.
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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | or | Over-The-Counter Use |
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Palacia Curate

| (Division Sign-Off) | |
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| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K 990461 |