METACARPAL FIXATION SYSTEM

{0}------------------------------------------------ ## JUN 23 1999 # Summary of Safety and Effectiveness for the Metacarpal Fixation System Submitted by K991064 Medcanica, Inc. 8308 NW 74th Avenue Miami, FL 33166 Phone: (305) 863-1603 ## Identification of a Legally Marketed Predicate Device The Medcanica, Inc. Metacarpal Fixation System (MFS) is substantially equivalent to the K-wire implantable pin that is manufactured and marketed by MicroAire Surgical Equipment, Inc. ## Device Description The MFS is a sterile, single use, disposable device that is delivered non-toxic. The MFS consists of the Cannulated Awl Assembly, the Implantable Pin Handle Assembly, and Exchange Guide and Bend Tube. A typical MFS is shown in Figure 1, MFS Assembled Implantable Pin Handle and Cannulated Awl Assemblies. Figure 2, Implantable pin and Awl Assemblies shows the assemblies separately. Image /page/0/Figure/10 description: The image shows a technical drawing of a medical instrument. The instrument has two main parts: an implantable pin and a cannulated awl. The implantable pin is a thin, pointed rod, while the cannulated awl is a hollow tube with a sharp tip. The drawing also labels the implantable pin handle and the cannulated awl handle. #### Figure 1, MFS Assembled Implantable Pin Handle and Cannulated Awl Assemblies {1}------------------------------------------------ Image /page/1/Figure/2 description: This image shows two different medical tools. The tool on the left is labeled as an "Implantable Pin Handle" and an "Implantable Pin". The tool on the right is labeled as a "Cannulated Awl Handle" and a "Cannulated Awl". Figure 2, Implantable Pin and Awl Assemblies Prior to use the implantable pin assembly is nested in the cannulated awl assembly. The cannulated awl assembly has a trocar point. The implantable pin has a blunt point that is positioned just behind the trocar point of the cannulated awl. The sharp point of the cannulated awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the cannulated awl handle is held stationary while the implantable pin is then advanced distally from the base of the metacarpal bone. See Figure 3, MFS Partially Deployed. The awl handle is then withdrawn and removed for advancement of the implantable pin. The implantable pin is then cut adjacent to the pin handle. Using the bending tube end of the exchange guide and bend tube pictured in Figure 4, Exchange Guide and Bend Tube, the implantable pin is bent to 90° with the apex of the implantable pin insertion site. The pin is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable pin subsequent to healing. The implantable pin will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable pin is percutaneously removed. In the event that it is desired to reform the implantable pin or implant a smaller pin, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable pin into the medullar space. Once the medullar space is accessed, the pin is removed. Another pin may be placed into the medulla by inserting it into the groove of the exchange guide. After the pin has been inserted into the medullar space, remove the exchange guide. {2}------------------------------------------------ Image /page/2/Figure/2 description: The image shows a medical tool with several labeled parts. The top part is labeled as the implantable pin handle. The bottom part is labeled as the cannulated awl and cannulated awl handle. #### Figure 3, MFS Partially Deployed Image /page/2/Figure/4 description: The image shows a technical drawing of a tool with labels pointing to different parts. The tool has a handle with a button on it, and a tube extending from each end. One tube is labeled "Bend Tube" and the other is labeled "Exchange Guide". Figure 4, Exchange Guide and Bend Tube ## Intended Use The Metacarpal Fixation System is indicated for the fixation of transverse or short oblique fractures of the diaphysis or diaphyseal junction of metacarpal bones. {3}------------------------------------------------ # Summary of Technological Characteristics The table below compares the technological characteristics of the MFS to the predicate device. | Feature | MFS | Predicate Device | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Manufacturer | Medcanica, Inc. | MicroAire | | Sterile packaging | Tray, Mylar®/Tyvek® Pouch | Polymeric Pouch | | Sterilization method | Gamma radiation | Gamma radiation | | Shelf life | 3 years | 3 years | | Intended use | The Metacarpal Fixation System is<br>indicated for the fixation of transverse<br>or short oblique fractures of the dia-<br>physis or diaphyseal-metaphyseal<br>junction of metacarpal bones. | Used in a variety of surgical applica-<br>tions including metacarpal fixation. | | Implant Period | Approximately 6 weeks | Various including permanent | | Drill geometry† | | | | Facets | 3 | 3 | | Edge Angle | 23.5° | 19.0° | | Facet Angle | 13.7° | 10.4° | | Working length* | 3.5 inches | 6.0 inches | | Available Sizes | 0.062 | 0.062 | | Implantable pin mate-<br>rial | 316LVM, ASTM F138-97 | 316LVM, ASTM F138-97 | | Placement Method‡ | Cannulated Awl | Powered Drill | ⁺ The Metacarpal Fixation System has a different drill geometry than the predicate because it is designed to be compliant with the trocar point requirements of ISO 5838-3, Implants for Surgery - Skeletal Pins and Wires - Part 3: Kirschner Skeletal Wires. ^* Working length of the Metacarpal Fixation System has a shorter working than the predicate device because it is not a multi-purpose device. It needs only to accommodate the length of metacarpal bones. ^* Placement of implantable pins in the metacarpal bone does not require the use of a powered drill. Because the Metacarpal Fixation System is restricted to metacarpal use it is not designed for use with a powered drill. {4}------------------------------------------------ #### Summary of Performance Data The MFS meets the requirements of the following recognized consensus standards. - ASTM F138 97, Standard Specification for Wrought 18 Chromium-14 Nickel-. 2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) - ASTM F899 95, Standard Specification for Stainless Steel Billet, Bar and Wire . for Surgical Instruments - ASTM F86 91, Standard Practice for Surface Preparation and Marking of Me-. tallic Surgical Implants - ASTM F366 82 (Reapproved 1993), Standard Specification for Fixation Pins . and Wires The MFS is substantially equivalent to the K-wire manufactured by MicroAire Surgical Equipment, Inc. Extensive bench testing of both devices has demonstrated this. Testing includes stiffness/yield, cutting geometry comparison, and drilling test. The tissue/bone contact materials of the device have been carefully selected for their long history of biocompatibility. The materials meet the requirements of the previously referenced recognized consensus standards. Since the MFS meets the requirements of the stated standards and embodies technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The MFS was designed utilizing design controls compliant with the Ouality System Regulation. The MFS will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use. {5}------------------------------------------------ Image /page/5/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 three lines representing its wings. The eagle's head is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 23 1999 Mr. Matthew A. Palmer President Medcanica, Inc. 8308 NW 74th Avenue Miami, Florida 33166 K991064 Re: Metacarpal Fixation System Trade Name: Regulatory Class: II HTY Product Code: Dated: March 30, 1999 March 31, 1999 Received: #### Dear Mr. Palmer: 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 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. A 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 requlation 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. {6}------------------------------------------------ Page 2 - Mr. Matthew A. Palmer 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.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Whitton, Ph.D., M Ph.D., M.D. -Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use Page 1 of 1 510(k) Number (if known): K991064 Metacarpal Fixation System Device Name: Indications for Use: Fixation System is indicated for The Metacarpal the fixation of transverse or short oblique fractures of the diaphysis or diaphyseal-metaphyseal junction of metacarpal bones. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE Evaluation (ODE) vision Sign-Off (Divisio eral Restorative Devices Division of G 510(k) Numb X Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)