(154 days)
For percutaneous drainage of abscess, nephrostomy and other fluids.
Not Found
I am sorry, but the provided text from the FDA 510(k) K981344 approval letter and "ATTACHMENT D" does not contain information about the acceptance criteria or a study proving that the device meets such criteria.
The documents primarily focus on the regulatory approval process for the Uresil Percutaneous Drainage Catheters with Hydrophilic Coating, stating that the device is substantially equivalent to legally marketed predicate devices. They outline the general controls provisions of the Federal Food, Drug, and Cosmetic Act, regulatory responsibilities, and the indications for use.
There is no mention of specific performance metrics, clinical or non-clinical study design, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1998
Mr. Lev Melinyshyn Director of Operations Uresil, L.P. 5418 W. Touhy Avenue Skokie, IL 60077
Re: K981344
Uresil® Percutaneous Drainage Catheters with Hydrophilic Coating Dated: July 24, 1998 Received: July 29, 1998 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE 21 CFR 878.4200/Procodes: 79 GBO, 79 GBX Unclassified/Procode: 78 LJE
Dear Mr. Melinyshyn:
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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/cdrbdsmamain.html".
Sincerely your
Lillian Yin, Ph.D.
Director. Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT D
Page 1 of 5
510(k) Number (if known): unknown
Device Name: Uresil General Purpose Drainage Catheter
Indications For Use:
For percutaneous drainage of abscess, nephrostomy and other fluids.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
f/n: intenus
David L. Ayres
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number .
N/A