(108 days)
The Model SUA01 Suction unit is intended for professional use to remove infectious materials from wounds or fluids from a patients airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, or device performance metrics for the "Model SUA01 Suction Unit". The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device and allows the device to be marketed. It states the indications for use but does not contain a study report or technical specifications with performance data.
Therefore, I cannot provide the requested table and study details.
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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
DEC 1 6 2004
EMG Technology Company, Ltd. c/o Mr. Leonard Fryer MET Laboratories, Inc. 914 West Patapsco Avenue Baltimore, Maryland 21230
Re: K042349
Trade/Device Name: Model SUA01 Suction Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Unit Regulatory Class: II Product Code: JCX Dated: November 5, 2004 Received: November 9, 2004
Dear Mr. Fryer:
We have reviewed your Section 510(k) premarket notification of intent to market the device in die in die in We have reviewed your Section 3 ro(x) premained is substantially equivalent (for the indications felerenced above and nave determined the acted predicate devices marketed in interstate for use stated in the encrosuly manatinent date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food - France commerce prior to May 20, 1770, the enaochance with the provisions of the Federal Food. Drug, devices that have been icclassified in accessfited in a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can may be subject to such additional controliations, 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 r least of advised that I Dr o modalite or our device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must of any I cactar statutes and regulations and and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) certer and 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Leonard Fryer
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), please contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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 Statement
KO42349 510K number:
Device Name: Model SUA01 Suction Unit
Indications For Use: The Model SUA01 Suction unit is intended for professional use to remove infectious materials from wounds or fluids from a patients airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.
Prescription Use X (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative and Neurological Devices, Mirillandk) Numberovovat
Revised 11/5/04
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K042349
§ 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.