NOUVAG AG - VACUSON 40 AND VACUSON 60

K042943 · NOUVAG AG · BTA · Dec 17, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042943
• Device Name: NOUVAG AG - VACUSON 40 AND VACUSON 60
• Applicant: NOUVAG AG
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vacuson 40 and Vacuson 60 are intended as extraction suction units for vacuum extraction, aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient 's bedside.

Device Story

Vacuson 40 and 60 are powered suction pumps for fluid/infectious material removal. Devices consist of a piston pump (P40 for Vacuson 40; P70 for Vacuson 60), suction jar with overflow safety, bacterial filter, and optional trolley. Operation involves manual regulation of suction flow via valve, monitored by a manometer; optional foot switch activation. Used by clinicians in surgical or bedside settings. Output is mechanical suction force. Benefits include efficient fluid extraction during procedures or patient care.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Powered suction pump; piston pump mechanism (P40 or P70); includes suction jar, overflow safety device, bacterial filter, manometer, and optional foot switch. Flow rates: 40 L/min (Vacuson 40) and 60 L/min (Vacuson 60). Sterilization: User-performed heat sterilization up to 134°C for tubes and jars. Mechanical operation; no software or electronic control algorithms.

Indications for Use

Indicated for vacuum extraction, aspiration, and removal of fluids and infectious material from wounds or tissue in surgical settings or at the patient's bedside.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• Medela AG Medela "Basic 30" and "Dominant 50" Suction Pumps (K021368)

Submission Summary (Full Text)

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K042943

NOUVAG AG Vacuson 40 and Vacuson 60

DEC 17 2004

510(k) Notification October 22, 2004

# SECTION 5

# 510(k) SUMMARY

| 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: | October 22, 2004 |
| Device Name: | |
| Proprietary Name | Vacuson 40 and Vacuson 60 |
| Common Name | Powered suction pump |
| Classification Name | Pump, Portable, Aspiration (Manual or Powered)<br>(per 21 CFR section 878.4780) |

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

Medela AG Medela "Basic 30" and "Dominant 50" Suction Pumps K021368, Cleared on 05/15/2002

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### Device Description:

Every model has at least one suction jar with overflow safety device, bacterial filter and optional a castered troiley. The optional foot switch can be used to activate the suction opinonal a castered a most can be continuously regulated by a valve and monitored through the manometer.

Vacuson 40 and Vacuson 60 are different in the maximum suction flow rate.

The Vacuson 40 has a built-in piston pump with the name "P40". The maximum suction flow rate for the Vacuson 40 Device is specified with 40 litres/min.

The Vacuson 60 has a built-in piston pump with the name "P70". The maximum suction flow rate for the Vacuson 60 Device is specified with 60 litres/min.

#### Sterility:

Suction tube, Suction jars with jar lids: Sterility by user up to 134°C.

#### Intended use of the Devices:

The Vacuson 40 and Vacuson 60 are intended as extraction suction units for vacuum extraction, aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient 's bedside.

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

The Vacuson 40 and Vacuson 60 are substantially equivalent to other legally marketed devices in the United States. The Vacuson 40 and Vacuson 60 function in a manner similar and are intended for the same use as the Devices designed by Medela AG.

## Brief summary of nonclinical tests and results:

The Vacuson 40 and Vacuson 60 have been designed and tested to applicable safety standards. The Vacuson 40 and Vacuson 60 do not raise any new issues of safety, effectivness, or performance of the product.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling an eagle or bird in flight, positioned above a wavy line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Nouvag AG c/o Mr. Erich Forster INTRATest Systems GmbH St. Gallerstrasse 23-25 CH-9403 Goldach Switzerland

Re: K042943

Trade/Device Name: Vacuson 40 and Vacuson 60 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: October 22, 2004 Received: October 25, 2004

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.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Erich Forster

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours ough finding of substantial equivalence of your device to a legally promation in a classification for your device and thus, permits 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 in you deall 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 other general micromation and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K042943

Device Name: Vacuson 40 and Vacuson 60

Indications For Use:

The Vacuson 40 and Vacuson 60 are intended as extraction suction units for vacuum The vacuson 40 and Vacuson of fluids, and infectious material from wounds or Extraction, dopiration argery or at the patient's bedside.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

iriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_Ko42943_________________________________________________________________________________________________________________________________________________________