IRRIGATION OR INFUSION PUMP K PUMP

K991203 · Kmi Kolster Methods, Inc. · FRN · Oct 15, 1999 · General Hospital

Device Facts

• Record ID: K991203
• Device Name: IRRIGATION OR INFUSION PUMP K PUMP
• Applicant: Kmi Kolster Methods, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Oct 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The K.M.I. Irrigation or Infusion pump "K" Pump is intended for the administration of sterile solutions drawn from containers using standard sterile administration sets with a 3/8 diameter silicone peristaltic section. The "K" Pump is intended for the rapid introduction of sterile fluids into the wound site for wound irrigation. The "K" pump may also be used with K.M.I.'s DIK Irrigation System.

Device Story

The K.M.I. "K" Pump is a peristaltic infusion/irrigation pump designed for clinical use. It utilizes a 3/8-inch diameter silicone peristaltic tubing section within a standard sterile administration set to draw sterile fluids from containers. The device operates by mechanically compressing the silicone tubing to propel fluid, facilitating the rapid delivery of sterile solutions directly to a wound site. It is compatible with the K.M.I. DIK Irrigation System. The pump is operated by healthcare professionals to manage wound irrigation, assisting in clinical procedures where controlled, rapid fluid delivery is required to maintain site cleanliness or facilitate treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Peristaltic pump mechanism; utilizes 3/8-inch diameter silicone tubing for fluid transport; electromechanical energy source; designed for use with standard sterile administration sets.

Indications for Use

Indicated for the administration of sterile solutions for wound irrigation in clinical settings requiring rapid fluid introduction.

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

OCT 1 5 1999

Mr. Alwin H. Kolster K.M.I. Kolster Methods, Inc. 708 N. Valley Street, Unit N Anaheim, CA 92801

Re : K991203 Trade Name: Irrigation or Infusion Pump "K" Pump Regulatory Class: II Product Code: FRN Dated: August 11, 1999 Received: August 19, 1999

Dear Mr. Kolster:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: a 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. Please note: this response to your premarket notification submission does not affect any

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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 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,

Susx Junge

A

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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Image /page/2/Picture/10 description: The image shows a diagram of a medical instrument. The instrument has a cylindrical body with the letters "K.M.I." printed on it. The instrument has a long, thin tube extending from one end. The other end has a black piece attached to it.

KOLSTER METHODS, II 708 N. VALLEY ST UNI

Anaheim 4-9-99

## 14991203

Section 4

## Intended use

The K.M.I. Irrigation or Infusion pump "K" Pump is intended for the administration of sterile solutions drawn from containers using standard sterile administration sets with a 3/8 diameter silicone peristaltic section. The "K" Pump is intended for the rapid introduction of sterile fluids into the wound site for wound irrigation. The "K" pump may also be used with K.M.I.'s DIK Irrigation System.

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Patricia Cassanete

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