UNIVERSAL DRIVE SYSTEM

{0}------------------------------------------------ 981/269 # JUN 24 1998 Image /page/0/Picture/2 description: The image shows the logo for Linvatec. To the left of the company name is a geometric shape that looks like three arrows pointing to the left. The company name is in bold, black font. 11311 Concept Boulevard Largo, Florida 33773 813 399-5334 Fax 813 399-5264 Carol A. Weideman, Ph.D. Compliance and Regulatory Affairs ### April 6, 1998 ### 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is Safety the 510(k) Summary of and hereby submittinq Effectiveness for the Universal Drive System, 510(k) Number #### A. Submitter Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 #### Company Contact B. Carol A. Weideman, Ph.D. Director, Regulatory and Clinical Affairs #### c. Device Name Trade Name: Common Name Classification Name Universal Drive System : Drive System . Instrument, Surgical, . . Powered Motor Orthopedic, AC cessory/Attachment #### Predicate/Legally Marketed Devices D. Universal Drive System Linvatec Corporation Hall® Versipower® Plus Large Bone Instrument System Linvatec Corporation ЗМТМ Maxi-Driver™ Electric Powered Instrument System 3M Health Care {1}------------------------------------------------ Summary of Safety and Effectiveness Universal Drive System 510 (k) # April 6, 1998 Page 2 of 4 #### Device Description E . System is a modification of the Universal Drive The Linvatec Universal Drive System with the addition of three new handpieces used in large bone orthopedic procedures. The Universal Drive System was cleared under #K971059 on 6/18/97 for the following intended 510 (k) Cutting of soft tissue and bone in Orthopedic, uses: Oral/Maxillofacial, Otolaryngological, Arthroscopic, Foot, Neuro, and Plastic/Reconstructive surgical Hand, procedures. Universal Drive System consists of an AC powered The drive console, a sterilizable handpiece cord, various motorized handpieces, various shavers, blades, burrs, drills, routers, and a foot switch. The modification will take place within the Universal drive console power unit. A software computer chip will be upgrade to allow the use of additional motorized handpieces for large in order to have more available current to drive the large bone handpieces. Three handpieces used in large bone orthopedic procedures will be added to the system. The new handpieces include single trigger modular, dual trigger modular handpiece and an oscillating saw. These handpieces are similar in design to the Hall® Versipower® Plus handpieces. The handpieces will be sold with a detachable handpiece cord. The detachable handpiece cord will allow the handpieces run on the same console. The new handpieces will to perform as the Versipower® Plus handpieces described in the predicate information. accessories used with the system include shavers, The as described in blades, burrs, drills, and routers 510(k)# K971059. {2}------------------------------------------------ Summary of Safety and Effectiveness Universal Drive System 510(k) # April 6, 1998 Page 3 of 4 #### Intended Use r. System functions as a powered Drive The Universal system consisting of drills, saws, and instrument associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Oral/Maxillofacial, Otolaryngological, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures. #### Substantial Equivalence G. The Universal Drive System is substantially equivalent in design, function and intended use to the Universal Drive System (Linvatec Corporation), Hall® Versipower® Plus Large Bone Instrument System (Linvatec Corporation), and the 3M™ Maxi-Driver™ Eyectmin Powered Instrument System (3M Health Care) . Testing has been done to prove safety and effectiveness of the devices. The similarities/dissimilarities to the predicates are shown in the attached table. {3}------------------------------------------------ ### Summary of Safety and Effectiveness Universal Drive System 510 (k) # April 6, 1998 Page 4 of 4 ## CHART OF SIMILARITIES AND DISSIMILARITIES | Company | Device Name | Intended Use | System Components and Design | |------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | NEW<br>PRODUCT<br>Linvatec | Universal Drive<br>System | Cut Soft Tissue & Bone during<br>Large Bone Orthopedic<br>Procedures. | System consists of: Universal Controller, Single Trigger<br>Modular Handpiece, Dual Trigger Modular Handpiece, Oscillating<br>Saw, Power Cord and Handpiece Cord. | | PREDICATE<br>Linvatec<br>510 (k)<br>#K971059 | Universal Drive<br>System | Cut Soft Tissue & Bone during<br>Orthopedic,<br>Oral/Maxillofacial, Hand, Foot,<br>Neuro and<br>Plastic/Reconstructive surgical<br>procedures. | System consists of: Universal Controller, Foot Control,<br>Sagittal Saw, Oscillating Saw, Reciprocating Saw, High Speed<br>Drill, Medium Speed Drill, Low Speed Drill,<br>Wiredriver/Fixation Drill and associated attachments, blades,<br>and burs. | | | | To perform cutting of soft<br>tissue and bone in the<br>applications of :<br>Arthroscopic/Orthopedic,<br>Otolaryngological and<br>Reconstructive Surgery. | System consists of: Universal Controller, Foot Control, "Apex<br>style" Handpieces and associated attachments, blades, and<br>burrs.<br>Shaver blades & burrs: length 75-200mm, diameter 2.0-6.0mm. | | PREDICATE<br>Linvatec<br>510 (k)<br>#K895198 | Hall®<br>Versipower® Plus<br>Large Bone<br>Instrument<br>System | Drill, Ream, and Cut large bone<br>during Orthopedic Procedures. | System consists of: drills and saws which are powered either<br>by battery or electric console. | | PREDICATE<br>3M Health<br>Care<br>510 (k)<br>K951118 | 3M Maxi-Driver<br>Electric Powered<br>Instrument<br>System | Drill, Ream, and Cut large bone<br>during Orthopedic Procedures | System consists of: Controller, handpiece, and interchangeable<br>attachments. | 7 Comments of the {4}------------------------------------------------ Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 4 1998 Carol A. Weideman, Ph.D. ·Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773 Re: K981269 Trade Name: Universal Drive System Regulatory Class: II Product Code: HRX Dated: April 6, 1998 Received: April 7, 1998 Dear Dr. Weideman: 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. 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. {5}------------------------------------------------ Page 2 - Carol Weideman, Ph.D. 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) 594-4595. 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, Colin M. Witwer, Ph.D., M.D. 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is made up of three nested chevrons, with the innermost chevron being a solid black diamond. The word "Linvatec" is written in a bold, sans-serif font. 11311 Concept Boulevard Largo, Florida 33773-4908 813 392-6464 April 6, 1998 Page 1 of 1 510 (k) Number (if known) : Universal Drive System Device Name: Indications for Use: The Universal Drive System functions as a powered instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of Orthopedic, Arthroscopic, include: application Otolaryngological, Oral/Maxillofacial, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <center>Proleps</center> | |---------------|-----------------------------------------| | | (Division Sign-Off) | | | Division of General Restorative Devices | | 510(k) Number | K981269 | Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use (Optional Format 1-2-96)