C-LEG (3C100)

{0}------------------------------------------------ JUL 8 1999 ------- Image /page/0/Picture/1 description: The image shows the logo for Otto Bock. The logo is in a cursive font and is underlined. The text below the line says "ORTHOPEDIC INDUSTRY INC." ORTHOPEDIC INDUSTRY, INC Kq91590 # 510(k) SUMMARY of SAFETY and EFFECTIVENESS ## A. General Information | 1. | Submitter's Name: | Otto Bock Orthopedic Industry, Inc. | |------------------|----------------------|-------------------------------------------------| | 2. | Address: | 3000 Xenium Lane North<br>Minneapolis, MN 55441 | | 3. | Telephone: | 612-553-9464 | | 4. | Contact Person: | John Hendrickson | | 5. | Date Prepared: | May 6, 1999 | | 6. | Registration Number: | 2182293 | | <b>B. Device</b> | | | | 1. | Name: | C-LEG (3C100) | | 2. | Trade Name: | C-LEG (3C100) | | 3. | Common Name: | External Limb Prosthetic Component (Knee) | | 4. | Classification Name: | External Limb Prosthetic Component (Knee) | | 5. | Product Code: | 89 ISY | | 6. | Class: | I, Exempt | | 7. | Regulation Number: | 890.3240 | A COMPANY OF THE OTTO BOCK GROUP {1}------------------------------------------------ ### C. Identification of Legally Marketed Devices - 3C1 1. Name: - Exempt 2. K Number: - Exempt 3. Date Cleared: #### D. Description of the Device C-LEG (3C100) is a microprocessor-controlled knee joint system with hydraulic stance and swing phase control. The C-LEG immediately adapts to different walking speeds and provides knee stability. The C-LEG (3C100) is recommended for lower limb amputees weighing up to 110 kg (220 pounds) who have a moderate (level 2 or 3) functional level. It is a monocentric knee joint composed of: - Carbon Fiber Frame ● - Hydraulics with Servo Motor ● - Electronics . - Distal Tube Clamp ● - . Upper Joint - Shin Tube Adapter � Components of the C-LEG (3C100) are the following: - Electronic Knee Joint 3C87 ● - 2R90 Tube Adapter or . - Tube Adapter with Torsion Adapter 2R91 . - Rotation Adapter 4R57 . Accessories are the following: | • 757L17 | Charging Device | |----------|-----------------| |----------|-----------------| - Power Unit ● 757L16 - Prosthetic Foot 1D10, 1D25, 1A30 . - Foam Cover ● 3826 - . 4X70 Slider Software - Extension Cable . 4X72 - 4X71 PC Interface . - 4R302 Transportation Case ● {2}------------------------------------------------ ### E. Intended Use Statement The C-LEG (3C100) is intended for use in the fitting of lower limb prostheses. It can be used by highly mobile individuals as well as those who need additional stance stability. ## F. Technological Characteristics Summary The C-LEG (3C100) is substantially equivalent to Otto Bock's 3C1, a Class I Exempt Device according to 21 CFR Part 890.3420. Differences that exist between these devices, relating to technical specifications, physical appearance and design, do not affect the relative safety and effectiveness of the C-LEG (3C100). {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Public Health Service JUL 8 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. John Hendrickson President Otto Bock Orthopedic Industry, Inc. 3000 Xenium Lane North Minneapolis, Minnesota 55441 Re: K991590 Trade Name: C-LEG (3C100) Regulatory Class: II Product Code: ISW and KFX Dated: May 6, 1999 Received: May 7, 1999 Dear Mr. Hendrickson: 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 Regulations, 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 Regulation (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. {4}------------------------------------------------ Page 2 - Mr. John Hendrickson 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a black and white picture that appears to be a map. The map shows a cluster of islands in the ocean. The islands are small and scattered, and the ocean is a vast expanse of white. 510(k) Number: K99 เร90 Device Name: C-LEG (3C100) #### Indications for Use: - Fitting of lower limb prosthesis . - Highly mobile individuals and/or individuals who need stance stability . #### PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X OR OVER-THE-COUNTER USE (optional Form 1-2-96) Dalee (Division Sign-Off) Division of General Restorative Devices 510(k) Number _