(220 days)
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! • the operating room or at the patient bedside. The device includes a microbial
A portable, AC powered suction pump
I am sorry, but the provided text from the FDA 510(k) letter for the Medco Aspirator IV, specifically from pages 0, 1, and 2, does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This document is a clearance letter stating that the device is substantially equivalent to a predicate device and outlining regulatory information. It does not include the detailed technical study information you are requesting.
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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page . I at 1
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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§ 878.4780 Powered suction pump.
(a)
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.(b)
Classification. Class II.