MEDCO ASPIRATOR IV

K982371 · Medco Mfg. · BTA · Feb 12, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K982371
• Device Name: MEDCO ASPIRATOR IV
• Applicant: Medco Mfg.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A portable, AC powered suction pump to be used to remove infectious materials from wounds or fluids from a patients airway or respiratory support system. The pump may be used during surgery in the operating room or at the patients bedside. The device includes a microbial

Device Story

Medco Aspirator IV is a portable, AC-powered suction pump. Device removes infectious materials from wounds or fluids from patient airways/respiratory support systems. Used in operating rooms or at patient bedside by clinicians. Includes microbial filter. Provides suction to assist in clearing obstructions or drainage; aids in patient respiratory management and wound care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable AC-powered suction pump. Includes microbial filter. Class II device (Product Code BTA).

Indications for Use

Indicated for removal of infectious materials from wounds or fluids from airway/respiratory support systems 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Medco Manufacturing c/o E.J. Smith Smith Associates Medical Marketing & Research P.O. Box 4341 Crofton, Maryland 21114

K982371 Re: Trade Name: Medco Aspirator IV Regulatory Class: II Product Code: BTA Dated: January 19, 1999 Received: January 20, 1999

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.

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Page 2 - Mr. E.J. 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 vour 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

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K9823'11',

510(k) Number (ii known) K982371 Device Name -Spirator IV Indications For Use

A portable, AC powered suction pum
to be used to remove infectious
materials from wounds or fluids
from a patients airway or.
respiratory Support system. The
pump may be used during Surgery!
• the operating room or at the patien
bedside. The device includes a microbial
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Concurrence of CDRH, Office of Device Evaluation (ODE)

ence of CDRH, Office of Device Evaluation (ODE)

Prescription Us (Per 21 CFR 801.

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