(63 days)
JoAn II ™ is designed for external application for use in absorbing fluids.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device named "JoAn II™," which is described as being "designed for external application for use in absorbing fluids." This document does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth establishment, expert qualifications, or sample sizes for training or testing.
Therefore, I cannot provide the requested information. The letter only confirms that the device has been found substantially equivalent to a pre-amendment device and can be legally marketed.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Mr. William C. Thomas, Ph.D.,DABT,CIH Manager, Toxicology and Product Safety Celanese Acetate Company P.O. Box 32414 Charlotte, North Carolina 28232-2414
Re: K982648 JoAn II™` Trade Name: Requlatory Class: Unclassified Product Code: EFO July 24, 1998 Dated: Received: July 29, 1998
Dear Dr. Thomas:
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. ਕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 - Dr. William C. Thomas
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 your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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.
-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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SEP 3 0 1998
Form B
Indications for Use Form
510(k) Number (if known): K982648
Device Name: JoAn II TM
Indications for Use: JoAn II ™ is designed for external application for use in absorbing fluids.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or Over-the-Counter Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 1498264
7
N/A