DISPENSER DP 20

K071588 · NOUVAG AG · FRN · Nov 26, 2007 · General Hospital

Device Facts

• Record ID: K071588
• Device Name: DISPENSER DP 20
• Applicant: NOUVAG AG
• Product Code: FRN · General Hospital
• Decision Date: Nov 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.

Device Story

Dispenser DP 20 is a peristaltic irrigation pump; moves fluid through tubing via mechanical roller squeezing. Device contacts only tubing; maintains fluid sterility. Used in surgical settings under physician control for fluid irrigation and infiltration. Not for intravascular use. Provides controlled fluid delivery to surgical site; benefits patient by facilitating irrigation during procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Peristaltic pump mechanism; roller-based fluid delivery. Disposable sterile tubing set with plug-in cannula (4m length). Non-patient contacting pump housing. No software or electronic algorithm described.

Indications for Use

Indicated for general surgical fluid irrigation and infiltration under physician control. Not for intravascular infusion. Patient population not specified.

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

• PSI-TEC Peristaltic Infiltration Pump (K040149)
• Wells Johnson Infusion System, Model 20-6000-00 (K991437)

Submission Summary (Full Text)

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K071588

# 510(k) Summary

NDV 2 6 2007

| Submitter: | NOUVAG AG<br>St. Gallerstrasse 23-25<br>CH-9403 Goldach<br>Switzerland |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Benno Frei<br>Technical Director, New Product Development<br>Phone [phone]<br>Fax [phone] |
| Date Summary Prepared: | May 31, 2007 |
| Device Name: | |
| Proprietary Name | Dispenser DP 20 |
| Common Name | Infiltration Pump |
| Classification Name | Infusion Pump<br>(per 21 CFR section 880.5725) |

Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

| Product: | PSI-TEC Peristaltic Infiltration Pump |
|---------------|-------------------------------------------------|
| Manufacturer | Byron Medical, Incorporated |
| 510(k) Number | K040149 |
| Product: | Wells Johnson Infusion System, Model 20-6000-00 |
| Manufacturer | Wells Johnson |
| 510(k) Number | K991437 |

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### Device Description:

The principle of operation and technology incorporated in the Dispenser DP 20 are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller.

As with all peristaltic pumps, the Dispenser DP 20 contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

Sterility: Tubing set; disposable with plug-in cannula, sterile, length 4 m

#### Intended use of the Devices:

The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.

Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:

The principle of operation and technology incorporated in the NOUVAG Dispenser DP 20 are similar to other irrigation devices with the function to deliver fluid with a roller, which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined above.

## Brief summary of nonclinical tests and results:

The Dispenser DP 20 has been designed and tested to applicable safety standards. The Dispenser DP 20 does not raise any new issues of safety, effectiveness, or nerformance of the product

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2007

NOUVAG AG. C/O Mr. Erich Forster Regulatory Consultant INTRATest Systems GmbH Reusswehrstrasse 1 CH-5412 Gebenstorf SWITZERLAND

Re: K071588

> Trade/Device Name: Dispenser DP 20 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 15, 2007 Received: November 19, 2007

Dear Mr. Forster:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Forster

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: K071588

Device Name: Dispenser DP 20

Indications for Use:

The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.

x_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anting Dr-m

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

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