(108 days)
UniCryl M is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery but not for use in cardiovascular, neurological procedures, or microsurgery.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "UniCryl M," which is an absorbable polydioxanone surgical suture. It is a regulatory document and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other technical details requested in your prompt.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on the regulatory approval process and the determination of substantial equivalence to a predicate device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that form the body and wings of the bird, and a wavy line that forms the tail.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Mr. Mohammed Azeez M.Sc. Quality Assurance Manager United Medical Industries Co., Ltd. P.O. Box-51871, Riyadh-11553 Kingdom of Saudi Arabia
Re: K042285
Trade/Device Name: UniCryl M Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical (POS) suture Regulatory Class: II Product Code: NEW Dated: November 27, 2004 Received: November 30, 2004
Dear Mr. Azeez:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) premium is substantially equivalent (for the indications ferenced adove and nave determined by marketed predicate devices marketed in interstate for use stated in the enclosure) to regars manatinent date of the Medical Device American processed to commerce prior to May 20, 1976, the eccordance with the provisions of the Federal Food, Drug, devices martials act (Act) that do not require approval of a premarket approval application (PMA). and Cosment Act (Feel) that to not require appt o the general controls provisions of the Act. The r ou may, morelore, mains of 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 craisonical (600 as 970) ols. Existing major regulations affecting your device can Inay be subject to sable additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dri bristian that your device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any I cacial statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI I ratt 0077, laboring (21 CFR Part 820); and if applicable, the electronic form in the quality by over of sions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
Page 2 - Mr. Mohammed Azeez M.Sc.
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,
Miriam 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
{2}------------------------------------------------
042285/5002
Indications for Use
510(k) Number (if known):
KD42285/5002
Device Name:
UniCryl M
Indications for Use:
UniCryl M is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery but not for use in cardiovascular, neurological procedures, or microsurgery.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General. Restorative. and Neurological Devices
510(k) Number K042285
Page / of /
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.