30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU

K991363 · Sorenson Medical, Inc. · FRN · May 13, 1999 · General Hospital

Device Facts

• Record ID: K991363
• Device Name: 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
• Applicant: Sorenson Medical, Inc.
• Product Code: FRN · General Hospital
• Decision Date: May 13, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

All Pumps are for the infusion of fluids and medications into a body. The 30 Pump is for infusion at a continuous low flow rate. The 200 Pump is for intermittent doses with a keep vein open (KVO) rate between doses, as well as continuous or KVO only capabilities. The PCA Pump is for pain management by intravenous and epidural infusion of fluids and medications. The PCEA Pump is marketed for epidural infusion of fluids and medication for pain management; but the PCEA model can also be used for intravenous infusion as well.

Device Story

Infusion pumps (Models 30, 200, PCA-1) deliver fluids and medications into body. Model 30 provides continuous low-flow infusion. Model 200 provides intermittent dosing with keep-vein-open (KVO) rate between doses, or continuous infusion. PCA/PCEA models support intravenous and epidural pain management. Used in clinical settings by healthcare professionals. Output is controlled fluid delivery; affects clinical decision-making by automating medication administration. Benefits include precise dosing and pain management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infusion pump system. Mechanical/electromechanical fluid delivery. Models support continuous, intermittent, and KVO flow rates. Intended for intravenous and epidural administration.

Indications for Use

Indicated for infusion of fluids and medications into the body. Model 30 for continuous low flow; Model 200 for intermittent doses with KVO rate or continuous/KVO; PCA/PCEA models for intravenous and epidural 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.

Predicate Devices

• MicroJect® Model 200 (K941595)
• MicroJect® Model 30 (K941595)
• MicroJect® Model TPN-5 (K941595)
• MicroJect® Model PCA-1 (K965222)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1999

Mr. R. Douglas Jacob Director, Regulatory Affairs Sorenson Medical, Incorporated 1375 West 8040 South West Jordan, Utah 84088-8320

Re : K991363 30 Pump, Continuous Low Flow, 200 Pump, Trade Name: Intermittent with KVO or Continuous Requlatory Class: II Product Code: FRN April 16, 1999 Dated: April 20, 1999 Received:

Dear Mr. Jacob:

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) 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 requlation 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 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.

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Page 2 - Mr. Jacob

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 reguladiagnostic 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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## INDICATIONS FOR USE STATEMENT

## MicroJect® Model 200, Model 30 and Model TPN-5 K941595 510(k) Numbers MicroJect® Model PCA-1 K965222

- All Pumps are for the infusion of fluids and medications into a body. The 30 Indications for Pump is for infusion at a continuous low flow rate. The 200 Pump is for intermittent doses with a keep vein open (KVO) rate between doses, as well as continuous or KVO only capabilities. The PCA Pump is for pain management by intravenous and epidural infusion of fluids and medications. The PCEA Pump is marketed for epidural infusion of fluids and medication for pain management; but the PCEA model can also be used for intravenous infusion as well.
Rihace Cucenit
Division Supt. O.R.

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

510(k) Number K991363

**Prescription Use**
(Per 21 CFR 801.109)