SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS

{0}------------------------------------------------ Kozlfls # 510(k) Summary Image Guided Surgical Instruments For Trauma Applications and Universal Accessories # OCT 1 7 2002 | Submitter's name: | Smith & Nephew, Inc., Orthopaedic Division | |-----------------------------------|----------------------------------------------------------------------------------------------------------| | Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 | | Submitter's telephone number: | 901-399-6707 | | Contact person: | Gino J. Rouss | | Date summary prepared: | May 30, 2002 | | Trade or proprietary device name: | Smith & Nephew Image Guided Surgical<br>Instruments for Trauma Applications and<br>Universal Accessories | | Common or usual name: | Stereotaxic Instrument | | Classification name: | Stereotaxic Instrument | | Device Class: | Class II | | Device Product Code: | HAW | | Panel Code: | Neurology/84 | # Subject device description: The Smith & Nephew Image Guided Instruments for Trauma Applications are instruments that have been modified to allow image-guided arrays (Fighters) to be fixed onto the instruments. The image-guided arrays can use either infrared LEDs (light emitting diodes) or universal accessories (passive spheres) to transmit or reflect the infrared LEDs (light emitting diodes) that are emitted by an IGS Platform System. Along with commercially available software, this will allow the instruments to be recognized and tracked in real time in the surgical field. The universal accessories (passive spheres) will be available as either sterile or non-sterile and are for single use only. Each package will contain a multiple number of spheres. The infrared LEDs (light emitting diodes) or universal accessories (passive spheres) do not come in contact with the open wound during surgical procedures. The image-guided arrays that are affixed to the instruments work in conjunction with reference frames that are rigidly attached to the anatomy. Each reference frame is also fitted with either infrared LEDs (light emitting diodes) or universal accessories (passive spheres) to transmit or reflect the infrared LEDs (light emitting diodes) that are emitted by the IGS Platform System. The reference frames will allow the IGS Platform System to continuously track the position of the anatomy during navigation. If any movement of the IGS Platform System or anatomy is detected, the system can compensate for it, thereby maintaining accurate navigation. {1}------------------------------------------------ K021f15 # A. Applicable 510(k)'s | Image Guided Instruments for Trauma Applications | | | | |--------------------------------------------------|---------------------------------------------------------|-------------|--------------------------| | Manufacturer | Submission Name | Exhibit No. | FDA<br>Clearance<br>Date | | Surgical Navigation<br>Technologies | StealthStation | 10 | 1-24-96 | | Surgical Navigation<br>Technologies | StealthStation™ System - ENT Application Addendum | 11 | 1-21-98 | | Surgical Navigation<br>Technologies | StealthStation® FluoroNav™ Module | 12 | 4-22-99 | | Surgical Navigation<br>Technologies | Indications Modifications for the StealthStation System | 13 | 2-22-00 | | Surgical Navigation<br>Technologies | StealthStation Generation 3 | 14 | 5-3-00 | | BrainLAB AG | VectorVision® Trauma | 15 | 3-14-02 | | BrainLAB AG | VectorVision2 | 16 | 5-19-99 | | Smith & Nephew, Inc. | Image Guided Surgical Instruments for Knees | 17 | 2-8-02 | | Surgical Navigation<br>Technologies | Knee Module For The StealthStation™ System | 18 | 1-25-02 | | Surgical Navigation<br>Technologies | StealthStation™ System Passive Instrument Option | 19 | 9-16-97 | # Subject device intended use: Image Guided Surgical Instruments for Trauma Applications are intended to be used with the Universal Accessories to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Trauma Applications are indicated for use in surgical trauma procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as a long bone (femur, tibia, humerus, radius, ulna, fibula), pelvic bone (including acetabular), calcaneus, and talus bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. # Example procedures include but are not limited to: Spinal procedures and spinal implant procedures such as pedicle screw placement Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation Fracture treatment procedures, such as intramedullary nailing or plating or screwing or external fixation procedures in the tubular bones Fracture reduction procedures High Tibia Osteotomy {2}------------------------------------------------ Kozifis # Technological Characteristics: Image Guided Surgical Instruments for Trauma Applications are similar to currently legally marketed Class II stereotactic instruments in that they incorporate infrared LED (light emitting diodes) or Universal Accessories (passive spheres) onto the instruments that allow the instruments to be recognized and tracked in real time in the surgical field. {3}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" 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 # OCT 1 7 2002 Mr. Gino J. Rouss Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 Re: K021815 Trade/Device Name: Smith & Nephew Image Surgical Instruments for Trauma Applications Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 18, 2002 Received: July 22, 2002 Dear Mr. Rouss: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ Page 2 -- Mr. Gino J. Rouss This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. uriam C. Provost for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### 510(k) Number (if known): K021815 ### Image Guided Surgical Instruments for Trauma Applications Device Name: and Universal Accessories ## Indications For Use: Smith & Nephew Image Guided Surgical Instruments for Trauma Applications are intended to be used with the Universal Accessories to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Trauma Applications are indicated for use in surgical trauma procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as a long bone (femur, tibia, humerus, radius, ulna, fibula), pelvic bone (including acetabular), calcaneus, and talus bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. ## Example procedures include, but are not limited to: Spinal procedures and spinal implant procedures such as pedicle screw placement Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation Fracture treatment procedures, such as intramedullary nailing or screwing or external fixation procedures in the tubular bones ## Additional procedures include: Fracture reduction procedures High Tibia Osteotomy (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 (Optional Format 1-2-96) Muriam C. Provost eral, Restorative and Neurological Dev 510(k) Number K621815