MITEK MICRO ANCHOR

{0}------------------------------------------------ 08/13/08 11:35 8781 461 9166 MITEK PRODUCTS K982 420 AUG 2 4 1998 **mitek** PRODUCTS ETHICON.INC. a Johnson Johnson company Page 1 of 2 WESTWOOD = MA = 02000 HONE (781) 281-2700 - TOLL-FRET (000) 330-4835 - FAX (781) 481-9100 510 (k) Summary For 8883440 SUBMITTER NAME ADDRESS 1'5', # CONTACT DATE Mitek Surgical Products, Inc. 60 Glacier Drive. Westwood, MA 02090 781-251-2700 Robert Zoletti, Manager, Regulatory Affairs August 13, 1998 ## NAME OF DEVICE CLASSIFICATION NAME COMMON NAME Staple, Fixalion, Bone Appliance for reconstruction 01 bone to soft tissue Mitek Micro Anchor PROPRIETARY NAME PREDICATE DEVICE Suturc DESCRIPTION OF DEVICE FUNCTION Fixation of USP #3/0 suture below bone surface. DEVICE DESIGN The Mitek Micro Anchor is 3 7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6AI 4V and uses a Nitinol arc. It is similar in design to the The same methods Mitek GII Mini Anchor. oi manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal anchors. The Mitek Mini anchor design was first cleared to market by US FDA in K915089 and K930892. MATERTAT S USED The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, a drill bit, and an Inserter. ### INTENDED USE The device is used to anchor suture into bone. The suture subsequently used by the surgeon to reartach the ມຸກ repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek for the lateral canthoplasty Micro -Anchor repair/reconstruction of collateral ligaments, flexor and extension tendons at the PTP (Proximal Tnterphalangeal)DTP MCB (Melacarpal (Distal Interphalangeal) , તાવે Interphalangeal) joints for all digits. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period ot rehabilitation. {1}------------------------------------------------ --------- #### SIU(k) SUMMARY FOR K982440 Page 2 of 2 COMPARISON TO PREDICATE DEVICE It has greater strength than IISP #3/0 suture, and is the same "design" as the Mitek Mini Anchor. DESCRIBLITOR OF NOW CRINICAT TESTS The Mitek Micro Anchor pull cests from cadaveric and porcine locations produced an average failure load (LBS) of: | 1) CADAVER HAND | 9.67 | SD 1.32 | |---------------------------|------|---------| | 2) CADAVER SKULL | 7.97 | SD 1.92 | | 3) FIG METACARPALS | 7.28 | SD 0.72 | | 4) SUTURE W/ BONE TUNNELS | 5.73 | SD 0.46 | USP Class I knot pull synthetic sterilized #3/0 suture, double strand, single knot, is 4.22 lb. Suture tissue failure for tendinous tissue is 15.75 lb., and capsular tissue is 21.00 lb. Reference: 3oft Tissue Fixation to Bone, Daniel B. Robertson, MD et al, The American Journal of Sports Medicine, Vol. 14, No. 5, 1986. . . # DESCRIPTION OF CLINICAL TESTS The clinical tests were done in accordance with IDE #G880026. Safety and effectiveness was based upon the results obtained in the clinical trials and their equivalence to historical data for the identical surgical procedure. #### CONCLUSIONS FROM TESTS The device met the design criteria. " {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 24 1998 Mr. Edward F. Kent Mitek Products 60 Glacier Drive 02090 Westwood, Massachusetts Re : K982420 Mitek Micro Anchor Trade Name: Regulatory Class: II Product Codes: JDR and HWC Dated: June 12, 1998 June 15, 1998 Received: Dear Mr. Kent: 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, Druq, 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, good manufacturing practice, labeling, and prohibitions aqainst 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. ਚੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set --forth in the Quality System Requlation (QS) 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ # Page 2 - Mr. Edward F. Kent 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) 594-4659. 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.qov/cdrh/dsmamain.html". Sincerely yours, Russell Sager Celia M. Witten, Ph.D. Kr 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 {4}------------------------------------------------ 510(k) Number (if known): K982420 流論となる。 MITEK HICRO ANCHOR Device Name: Indications For Use: 11:10 US: Lo: US REPAIR/RECONSTRUCTION OF COLLATERAL LIGATENTS, FLEXIA AND EXTENSION TENDONS AT THE PIP ( PROXIMAL INTERPRADANGEAL) , DIP ( DISTAL INTERPHALANCEAL), AND MCP ( METACARPAL INTERPHALANGEAL) JOINTS FOR ALL DIGITS 图 LEE ME MENNE SA SA SE LE LE PART PART PART POST POST POST POST POST POST POST TO (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Aun Paymer for IZD (Division Sign-Off) Division of General Restorative Devices 510(k) Number ________________________________________________________________________________________________________________________ X Prescription Use (Per 21 CFR 801.109) Ox Over-The-Counter Use_ (Optional Format 1-2-95)