BASIC, MEDIAN, DOMINANT, AND VARIO

K983552 · Medela, Inc. · BTA · Jan 7, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K983552
• Device Name: BASIC, MEDIAN, DOMINANT, AND VARIO
• Applicant: Medela, Inc.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Jan 7, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Suction pumps (Basic, Median, Dominant, Vario) provide vacuum-based aspiration; used for removal of surgical fluids, tissue, gases, and infectious materials from wounds or respiratory systems. Operated by clinicians in surgical or bedside settings. Device generates vacuum to facilitate fluid/tissue extraction; assists in maintaining clear surgical fields or patient airways. Benefits include effective debris/fluid clearance, supporting surgical procedures and respiratory care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrically powered suction pumps designed for vacuum generation. Includes multiple models (Basic, Median, Dominant, Vario) for fluid/tissue aspiration. Mechanical pump assembly; no software or algorithmic components described.

Indications for Use

Indicated for patients requiring vacuum extraction, aspiration, or removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious materials from wounds or airway/respiratory support systems. For use 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1999 JAN

Mr. Stephen D. Smith Medela, Inc. 4610 Prime Parkway McHenry, Illinois 60050-7005

K983552 Re:

Trade Name: Basic, Median, Dominant and Vario Suction Pumps Regulatory Class: II Product Code: BTA Dated: October 9, 1998 Received: October 9, 1998

Dear Mr. Smith:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 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.

{1}------------------------------------------------

## Page 2 - Mr. Stephen D. Smith

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,

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

Enclosure

{2}------------------------------------------------

## STATEMENT OF INDICATIONS FOR USE

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

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

(Division Sign-Off) Division of General Restorative Devic 510(k) Number.