WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00

K991437 · Wells Johnson Co. · FRN · Aug 30, 1999 · General Hospital

Device Facts

• Record ID: K991437
• Device Name: WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
• Applicant: Wells Johnson Co.
• Product Code: FRN · General Hospital
• Decision Date: Aug 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

General surgical fluid irrigation and infiltration.

Device Story

Wells Johnson Infusion System (Model 20-6000-00) is a device for general surgical fluid irrigation and infiltration. It is used in clinical settings by healthcare professionals to deliver fluids during surgical procedures. The device functions by facilitating the controlled infusion of irrigation fluids into the surgical site. It is a prescription-only device.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Indications for Use

Indicated for general surgical fluid irrigation and infiltration. 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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 30 1999

Mr. Ken Rodenburg Technical Manager Wells Johnson Company P.O. Box 18230 85731-8230 Tucson, Arizona

Re : K991437 Wells Johnson Infusion System, Trade Name: Model 20-6000-00 Regulatory Class: II Product Code: FRN June 9, 1999 Dated: Received: June 10, 1999

## Dear Mr. Rodenburg:

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 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

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## Page 2 - Mr. Rodenburg

verify such assumptions. Failure to comply with the GMP vertif back abbampenin regulatory action. In addition, FDA regulation may rebarannouncements concerning your device in may pabilon Farenter. Please note: this response to your che read in the submission does not affect any premarker nocerright have under sections 531 through 542 of obligation you magis the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as first receir wir as 0 k) premarket notification. The FDA described in your sion, promalence of your device to a legally Finding of bubbeanstation a classification for your marketed predicate actes 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 regaradiagnostic 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 Radioloqical Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

Indications for use are: General surgical fluid irrigation and infiltration.

Rahaux Cussente

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

PRESCRIPTION DEVICE

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