MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057

K021368 · Medela AG · BTA · May 15, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021368
• Device Name: MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
• Applicant: Medela AG
• Product Code: BTA · General, Plastic Surgery
• Decision Date: May 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Basic 30 and Dominant 50 Suction Pumps are indicated for vacuum extraction, aspiration an removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from removal or from a patient's airway or respiratory support system, either during surgery or at the patients bedside.

Device Story

Basic 30 and Dominant 50 are powered suction pumps; used for vacuum extraction and aspiration of surgical fluids, tissue, gases, and infectious materials; operated in surgical or bedside settings by healthcare professionals; device generates vacuum to remove materials from patient airways or respiratory support systems; provides clinical utility by clearing obstructions or fluids to maintain patient respiratory function or surgical site visibility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered suction pump; electrical energy source; intended for fluid/tissue aspiration; Class II device (Product Code BTA).

Indications for Use

Indicated for vacuum extraction, aspiration, and removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious materials from a patient's airway or respiratory support system in surgical or bedside settings.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 5 2002

Medela AG c/o Mr. Mark Job TÜV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K021368

Trade/Device Name: Basic 30, Dominant 50 Regulation Number: 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: April 24, 2002 Received: April 30, 2002

Dear Mr. Job:

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. Mark Job

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

for 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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Page of of 1

510(k) Number (if known); KO21368

Basic 30, Dominant 50 Device Name:_

Indications For Use:

The Basic 30 and Dominant 50 Suction Pumps are indicated for vacuum extraction, aspiration an removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from removal or from a patient's airway or respiratory support system, either during surgery or at the patients bedside.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Optional Format 3-10-98)

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

510(k) Number K021368