RESOLVE QUICKANCHOR

{0}------------------------------------------------ DEC 2 9 1999 Mitek Products ReSolve™ QuickAnchor® Cranio/Maxillofacial Image /page/0/Picture/2 description: The image shows a handwritten text string that appears to be a code or identifier. The string is "K993575" with a horizontal line above the last digit. The text is written in a cursive style, and the image is a close-up of the text. 510(k) Premarket Notification October 20, 1999 | Trade Name: | ReSolve™ QuickAnchor | |----------------------|--------------------------------------------------------------------------------------------------------------| | Sponsor: | Mitek Products | | | 60 Glacier Drive | | | Westwood, MA 02090 | | | Registration #1221934 | | Contact: | Paula E. Bulger | | | Regulatory Affairs Project Manager | | | Mitek Products | | | 60 Glacier Drive | | | Westwood, MA 02090 | | | Phone: (781) 251-2700 | | | Fax: (781) 461-9166 | | Device Generic Name: | Staple, Fixation, Bone | | Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. | | Product Code: | JDR (21 CFR 888.3030) | | Predicate Devices: | K970896 - Mitek Panalok Anchor | | | K962511, K982420 - Mitek Micro Anchor | | | K992611 - Mitek Rotator Cuff QuickAnchor Plus | Product Description: The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone. ## Indications for Use: The ReSolve™ QuickAnchor is used for the fixation of absorbable monofilament surgical suture to bone. This product is intended for the following indications: Cranio/Maxillofacial: Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull. ## Safety and Performance: The following safety and performance data has been provided to support substantial equivalence of ReSolve™ QuickAnchor: | Performance testing: | Pullout force (preserved human cadaver skull) | |----------------------|-----------------------------------------------------| | | Strength comparison (ReSolve vs. Mitek Micro Anchor | | | Skull thickness measurements | ## Conclusion: Based on safety and performance data, similarities in design, operating principle, materials, biocompatibility and sterilization method, the ReSolve™ QuickAnchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. {1}------------------------------------------------ Image /page/1/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 image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in all caps and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 9 1999 Ms. Paula E. Bulger Requlatory Affairs Project Manager Mitek Products Ethicon, Inc. 60 Glacier Drive Westwood, MA 02090 K993575 Re : Resolve™ QuickAnchor (Cranio/Maxillofacial) Trade Name: Regulatory Class: II Product Code: DZL October 20, 1999 Dated: Received: October 21, 1999 Dear Ms. Bulger: 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 {2}------------------------------------------------ Page 2 - Ms. Bulger 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. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sit with puivalence of your device to a legally marketed predicate device results in a classification for your markets processor mits 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) 594-4692. 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, Gerald W. Sheppan for Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Premarket Notification October 20, 1999 Page 1 of of 510(k) Number (if known): K993575 Device Name: ReSolve™ QuickAnchor Indications for Use: The ReSolve ™ QuickAnchor is used for the fixation of absorbable monofilament polydioxanone surgical suture to bone. This product is intended for the following indications: Cranio/Maxillofacial: Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-the -Counter Use (Division Sign-Off) 4 and Division of Dental, Infection and General Hospital Devic 510(k) Number_K993 000000