MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01

{0}------------------------------------------------ Ko41897 Summary of Safety and Effectiveness Mayfield® ACCISS™ II Image Guided Surgery System Pursuant to Section 513(I) of the Federal Food, Drug and Cosmetics Act. ### 1. General Information: | Classification Name: | Stereotactic instrumentation | |-------------------------------|----------------------------------------------------------------------------------------------| | Common/Usual Name: | Image Guided Surgery System | | Proprietary Name: | Mayfield® ACCISS™ II Image Guided Surgery System | | Applicant's Name and Address: | Teck W. Awa<br>Schaerer Mayfield USA, Inc.<br>4900 Charlemar Drive<br>Cincinnati, Ohio 45227 | ### 2. Name of predicate device(s): Mayfield® ACCISS™ Operating Arm System and Mayfield® Optical ACCISS™ System (K013428) Nicolet Biomedical Electromagnetic Navigational System (K013419) #### 3. Classification: Neurosurgical stereotactic instruments and accessories are Class II (21CFR 882.4800). ### 4. Performance Standards: No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act. ### 5. Intended Use and Device Description: Intended Use: Mayfield® ACCISS™ II Image Guided Surgery System is indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure such as the skull, a long bone, or vertebra can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures. {1}------------------------------------------------ ## Summary of Safety and Effectiveness Mayfield® ACCISS™ II Image Guided Surgery System ## 5. Intended Use and Device Description: - continued #### Device Description: The Mayfield® A CCISS™ II I mage Guided Surgery System comprises a cart, power supplies The Maylield ACCIDS - Frinage Career & argust to and tracking devices. The Mayfield® ACCISS™ II Image Guided Surgery System supports two different tracking The Mayneld " Nechob " In mage "Sacking devices. The tracking devices track the position and orientation of surgical probes and other instruments. The computer is loaded with the and offentialion of 'or 'surgious' are correlated to the patient by physically matching points, such as scanned fiducial markers and anatomical landmarks. In the optical tracking method, the configuration of infrared light points is detected by two In the optical tracking memor, the coning of to calculate the spatial position of the point configuration. With this method, the cameras must constantly maintain a line of sight with the contriguration: "With this meanse, the eliminated by the use of measuring ectromagnetic fields mistians. This moonvenie transmitter can be placed underneath the operating table and covered. An image guidance procedure can be performed based on pre-operative (CT/MRI) or intraoperative acquired diagnostic images, like intra-operative MRI, CT or Fluoroscopy. The operative acquired thagles, intages, System must first establish a correlation Mayleld " ACCIOD" " "It anage "Stat" end world" of the operating room so that the position of special surgical instruments, such as a pointer or surgical tool, can be portrayed within the special surgical morrained cash alled i mage data registration. Clearly and easily identified scanned in both the "real world" and the "image world" are used. These markers can be markers in ooth the "rear work" and "will be attached to the patient before image acquisition. The artificial markers (fiducials) have a defined shape and contrast medium appropriate for the imaging procedures. The Mayfield® ACCISS™ II Image Guided Surgery System uses a two-component marker system. The markers with contrast medium are attached to a self-adhesive pad before they are affixed to the prepared skin of the patient. These markers to a sen admost of par ocanning procedure, but the adhesive pads must remain on the patient with oc removed and the counting prss will be automatically identified and located within the image data by the Mayfield® ACCISS™ II Image Guided Surgery System during the data preparation. The images from the scanner are archived in a specific data format and stored in a specific data medium, or transmitted directly to the Mayfield® ACCISS™ II Image Guided Surgery System modiatin, or wallentified water supports the DICOM data format and the DICOM data transfer. Over the formats and transfer protocols are supported by customer specifications. {2}------------------------------------------------ ## Summary of Safety and Effectiveness Mayfield® ACCISS™ II Image Guided Surgery System ### 5. Intended Use and Device Description: - continued After successful review the transferred data for quality and consistency, the i mages s lices a re there combined in a three-dimensional volume and viewed on the monitor screen as axial, sagittal then coronal orthogonal images. The user can now manually check for image quality, image orientation and patient identification. Artifacts can be sliced off (at least at the screen border) without changing the image content. The brain, lesions or special access paths and landmarks can be segmented and displayed as three-dimensional objects which can be useful during planning and navigation process. In the operating room, measuring aids (i.e., registration markers) will be attached to the adhesive pads. After selection of the tracking system (optical/electromagnetic), the markers positions puds: Titler belowing on on marks) are repeatedly measured by pressing the function button on the pointer. This measurement routine creates a correlation between the data and the "real world. During this procedure, the number of measured points and the number of clusters found are Darling and A cluster describes the position of one unique marker point. The Mayfield® ACCISS™ II Image Guided Surgery System assigns a cluster to a correct image point automatically. At least four cluster pairs are required to establish an image registration. The system shows the fiducial registration error (FRE) and presents a prediction of the target registration error (TRE) to provide the surgeon with a rough quality gauge of the image accuracy. However, even a good error prediction cannot replace surgeon expertise. That's why the surgeon is responsible to verify the given information by proofing the markers position as well as well-defined anatomical landmarks close to the region of interest. Once the registration is completed, the pointer's position to the patient's head is displayed in the scanned images. The marker pads can be removed once the registration quality satisfies the surgical needs and requirements. The surgical area can be cleaned and draped. The pointer used for image registration is replaced with a sterile instrument and cranial navigation can begin. The system automatically recognizes this new instrument. In case of using surgical tools with an intra-operatively mounted position sensor an instrument calibration has to be performed first. The surgeon can define a reachable area near the operating field, in which he or she is able to control the Mayfield® ACCISS™ II Image Guided Surgery System via the pointer device. If the instrument reaches this defined area, the system switches from navigation mode to control mode. Through spatial movement within the defined area, the surgeon can control all essential guidance functions by pressing the function key on the instrument. {3}------------------------------------------------ ## Summary of Safety and Effectiveness Mayfield® ACCISS™ II Image Guided Surgery Svstem ### 6. Summary of Substantial Equivalence: - Indications: Mayfield® ACCISS™ II Image Guided Surgery System is intended to be used in an identical manner as the predicate devices that is used to interactively provide image guidance during cranial, ENT and spinal procedures. - Design: The Mayfield® ACCISS™ II Image Guided Surgery System is designed to u tilize an optical tracking device that is similar to those used in the predicate device and an electromagnetic tracking device that is similar to those used in the predicate device as a 3-D digitizer to interface with the computer workstation to provide image guided surgery using a CT or MR based model or fluoroscopy images of the anatomy. - Materials: The materials used in the manufacture of the Mayfield® ACCISS™ II Image Guided Surgery System are similar to those used in the predicate devices. - Manufacturing: The manufacturing processes used in the Mayfield® ACCISS™ II Image Guided Surgery System are similar to those used in the predicate devices. - Specifications: The specifications of the Mayfield® ACCISS™ II Image Guided Surgery System are similar to those of the predicate devices. - Conclusions: The indications, design, materials, manufacturing, and specifications of the Mayfield® ACCISS™ II Image Guided Surgery System do not raise any new unresolved issues relating to safety and effectiveness. Schaerer Mayfield USA, Inc. thus considers the Mayfield® ACCISS™ II Image Guided Surgery System to be substantially equivalent to the predicate devices. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles facing to the right. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 - 2005 Mr. Teck Awa Product Manager Schaerer Mayfield USA Incorporated 4900 Charlemar Drive Cincinnati. Ohio 45227 Re: K041897 K041877 Trade/Device Name: Mayfield® Acciss™ II Image Guided Surgery System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 25, 2005 Received: April 26, 2005 Dear Mr. Awa: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave decemblicate devices marketed predicate devices marketed in interstate 10 use Stated in the encreate) to tegans the Medical Device Amendments, or to conimeres phor to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, de vices that have occh receasing t require approval of a premarket approval application (PMA). and Cosmetic 7107 (1107 that do nevice, subject to the general controls provisions of the Act. The I ou may, dierelore, market of the Act include requirements for annual registration, listing of general controlly provisions of wactice, 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 your device is classified (controls. Existing major regulations affecting your device it may be subject to saan as Electral Regulations, Title 21, Parts 800 to 898. In addition, FDA ean be found in the Over ments concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe awnsoed a determination that your device complies with other requirements of the Act that I Dr Has made a assoc regulations administered by other Federal agencies. You must of any I cacial statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K ratt 077); adoling (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quanty byections (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ Page 2 - Mr. Teck Awa This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manceing your articlequivalence of your device to a legally premarket notification. "The I DTF Intentig cification 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), please If you desire specific advice for your acon of the other and one the regulation entitled, Contact the Office of Compulation (21 the Part 807.97). You may obtain " Misofallaning by relective to premainst noullivan in the Act from the Division of Small other general information on your responsibilities at its toll-free number (800) 638-2041 or Manufacturers, international and Consultin'invow.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Miriam C. Provo Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: ## MAYFIELD® ACCISS™ II IMAGE GUIDED SURGERY SYSTEM Indications For Use: MAYFIELD® ACCISS™ II IMAGE GUIDED SURGERY SYSTEM is indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure such as the skull, a long bone, or vertebra can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures. AND/OR Prescription Use ____x________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Ech por of General, Restorative - Neurological Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .