Mr. Matt Longson
Vice President Research and Development
NeoSci Medical, Incorporated
1192 E. Draper Parkway
Draper, Utah 84020
Re: K030400
Trade/Device Name: NeoSci Medical Endoluminal Brush
Regulation Number: 880.5970
Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter
Regulatory Class: II
Product Code: LJS
Dated: December 8, 2004
Received: December 9, 2004
Dear Mr. Longson:
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
your 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.
Page 2 - Mr. Triolo
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.
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);
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" (21 CFR 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.htrnl
Sincerely yours,
Chiu Lin, Ph.D.
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
