MCKINLEY OUTBOUND-2 SYSTEM

K971844 · Mckinley, Inc. · FPA · Jan 23, 1998 · General Hospital

Device Facts

• Record ID: K971844
• Device Name: MCKINLEY OUTBOUND-2 SYSTEM
• Applicant: Mckinley, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The McKinley OUTBOUND-2 is indicated for patients requiring intravenous, interarterial, subcutaneous, or enteral administration of medication. It is convenient for use by ambulatory patients.

Device Story

McKinley Outbound-2 is an infusion pump system designed for delivery of medication via intravenous, interarterial, subcutaneous, or enteral routes. Device facilitates ambulatory patient care by allowing medication administration outside of traditional clinical settings. System operates as a portable infusion pump; provides controlled delivery of fluids/medications to patients. Healthcare providers program the device for specific infusion parameters; patients use the device for ongoing therapy. Output consists of controlled fluid delivery; assists in clinical management of patients requiring continuous or intermittent medication administration. Benefits include increased patient mobility and convenience during therapy.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Portable infusion pump system for intravenous, interarterial, subcutaneous, or enteral administration. Designed for ambulatory use.

Indications for Use

Indicated for patients requiring intravenous, interarterial, subcutaneous, or enteral medication administration. Suitable for ambulatory patients.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 23 1998

Mr. Brian D. Zdeb Chief Technical Engineer McKinley, Incorporated 4080 Youngfield Street Wheat Rdge, Colorado 80033

Re : K971844 Trade Name: McKinley Outbound-2 System Requlatory Class: II Product Code: FPA Dated: October 18, 1997 Received: October 27, 1997

Dear Mr. Zdeb: ... . .

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 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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 Register. 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

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Page 2 - Mr. Zdeb

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 leqally 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 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,

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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510(k) Number (if known): K971844

Device Name: McKinley Outbound-2

Indications For Use: ( As stated in our Instructions for Use, page 5 of our submission. )

The McKinley OUTBOUND-2 is indicated for patients requiring intravenous, interarterial, subcutaneous, or enteral administration of medication. It is convenient for use by ambulatory patients.

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Concurrence of CDRH, office of Device Evaluation (ODE)

Patricio Crescenti

510(k) Nu

Prescription Use 1 (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)