(211 days)
Quicknit Cord is unimpregnated cord for the temporary retraction of the gingival margin. The gingival retraction cord is placed in the sulcus (between the gum tissue and your tooth structure) to displace the gum tissue for a small period of time in dental procedures.
Professional use is recommended
Quicknit Cord is unimpregnated cord for the temporary retraction of the gingival margin.
This document is a 510(k) premarket notification decision letter from the FDA for a dental device called "Quicknit Cord." It is not a study report or technical document detailing acceptance criteria and performance data for an AI/ML-driven medical device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies cannot be extracted from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than presenting a performance study against specific acceptance criteria.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle or bird, with its wings outstretched.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2014
Microscopy, Division of Neo-Flo, Inc. Ms. Peggy Gober Quality Manager 3120 Moon Station Road, NW Kennesaw, GA 30144
Re: K131799
Trade/Device Name: Quicknit Regulation Number: None Regulation Name: Retraction Cord Regulatory Class: Unclassified Product Code: MVL Dated: November 12, 2013 Received: November 13, 2013
Dear Ms. Gober:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
{1}------------------------------------------------
Page 2 -Ms. Gober
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/7 description: The image shows the name "Kwame O. Ulmer-S" in a bold, sans-serif font. The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-S" on the bottom line. The letters are black, and the background is white.
for
Erin I. Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K 131 799
Device Name: Quicknit Cord Indications for Use:
Quicknit Cord is unimpregnated cord for the temporary retraction of the gingival margin. The gingival retraction cord is placed in the sulcus (between the gum tissue and your tooth structure) to displace the gum tissue for a small period of time in dental procedures.
Professional use is recommended
Prescription Use × (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -$
Susan Runner DOSPA 2014.01.09
14:23:33 -05'00'
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
N/A