(63 days)
The Micromedics FibriJet Aerosol Applicator is intended for use in applying two non-homogeneous fluids to a treatment site.
Not Found
This is a PMA (Premarket Approval) letter and does not contain the information requested. There are no acceptance criteria, device performance, or study details included in this document. This letter primarily focuses on the FDA's decision regarding the substantial equivalence of the Micromedics FibriJet Aerosol Applicator to legally marketed predicate devices and outlines regulatory compliance requirements.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2001
Mr. Charles Grote Manager of Quality Assurance Micromedics, Incorporated 1285 Corporate Center Drive Suite 150 Eagan, Minnesota 55121
Re: K012868
Trade/Device Name: Micromedics FibriJet Aerosol Applicator Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 24, 2001 Received: August 27, 2001
Dear Mr. Grote:
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 vour 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.
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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.
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 (301) 594-4618. 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" (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): _ _ _ _ 012868
Device Name: Micromedics, Inc. FibriJet Aerosol Applicator
Indications for use:
The Micromedics FibriJet Aerosol Applicator is intended for use in applying two non-homogeneous fluids to a treatment site.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Palacios Cussenitt
(Division Sign-Off)
Division Sign-Off) Division of Dental. Infection Control. and General Hospital Devices 510(k) Number .
Prescription Use: (Per 21 CFT 801.109) OR
Over-The-Counter
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).