XPLAN-1

{0}------------------------------------------------ ## Summary of Safety and Effectiveness K972905 # OCT 28 1997 | OCT 28 1997 | | |------------------------------------|----------------------------------------------------------------------------------| | General Information | | | Classification: | Class II | | Common Name: | Stereotactic Radiation Treatment Planning System | | Device Trade Name: | XPlan-1 | | Intended Uses: | Computer planned LINAC-based stereotactic<br>radiotherapy procedures | | Predicate Device: | RSA XKnife-3 System and CMS Focus System | | Establishment Name and Address: | Radionics Software Applications, Inc.<br>22 Terry Avenue<br>Burlington, MA 01803 | | Contact Name and Phone: | Renee J. Thibeault or Linda Jalbert, (617) 272-1233 | | Establishment Registration Number: | 1222895 | | Performance Standard: | None established under Section 514 | #### Substantial Equivalence Determination A summary of the information contained in this premarket notification that addresses safety and effectiveness follows. #### Safety Summary RSA XPlan-1 system testing verifies that the beam shaping function generated the correct aperture and that the dose displays in the Geometry Viewer and Dose Summary are correct. Further, it verifies that the PTV generation, Block and MLC generation, DRR display and other new features are accurate. #### General Safety and Effectiveness The device labeling contains instructions for use. It includes indications for use, cautions, warnings and user quality assurance procedures. The training and installation sessions provide assurance that the user understands all aspects of the XPlan-1 System; mechanical, computer and software, plus its intended functionality. This information promotes safe and effective use of the device. #### Description of the Device and the Basis for Substantial Equivalence The XPlan-1 system has the same intended use and similar technological characteristics as the commercially available XKnife-3 Stereotactic Radiation Treatment Planning System. Like XKnife-3, the XPlan-1 system includes the same image acquisition, localizing, contouring and beam planning techniques. In addition, XPlan-1 and XKnife-3 both contain methods of QA verification for targeting setup and delivery. XPlan-1 includes modifications of the XKnife-3 system, such as the ability to use conformal collimation devices and a modification to the dose algorithm to account for the use of conformal collimation devices. XPlan-1 also supports the use of the Laser Angio Target Localizer (LATL) as an additional QA check to verify the orientation and position of the LINAC jaws and gantry, the collimator and couch rotation. Like the XKnife-3 use of the Rectilinear Phantom Pointer (RLPP) and Laser Target Localizer Frame (LTLF), XPlan-1 supports the use of the LATL to confirm system alignment at isocenter and to position the patient at isocenter. XPlan-1 is also substantially equivalent to the commercially available Conformal Radiation Treatment Planning System, FOCUS. Like FOCUS, XPlan-1 supports the use of LINAC jaws, MLCs and wedges to modify the shape and attenuation of the beam. Both {1}------------------------------------------------ XPlan-1 and FOCUS also have the ability to model the total on the taget. volume and surrounding tissue via a 3D Beam's Eye View and 2D beam visualization. Both systems, also addition to the dose-volume histogram. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Renee J. Thibeault Radionics Software Applicants, Inc. 22 Terry Avenue Burlington, MA 01803-2516 Re: K972905 Xplan-1 Stereotactic Radiation Treatment Planning System Dated: August 5, 1997 Received: August 6, 1997 Regulatory class: II OCT 28 1997 21 CFR 892.5050/Procode: 90 IYE Dear Ms. Thibeault: We have reviewed your Section 510K) notification of intent to market the device and we have determined the device is substantially equivalent for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 and prohibitions against misbranding and adulteration. If your device is classified (see above) into either 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 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 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. 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) 594-4613. Additionally, for question 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. H. William Yu Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use The following are the indications for use of the XPlan-1 system: XPlan-1 is a stereotactic LINAC-based radiation treatment planning system. XPlan-1 A Flail-T IS a steleolacite Ell Tre Oase Tacianon Cleiting and digitized angiographic film. Iocalizes lesions to be treated using CT scans, MR scans and digitized angiographi XPlan-1 provides a stereotactic planning system, for treatment of turnors < 7 cm in XPlan-1 provides a stereotactic planning system, for treatment of turns of creation AF lan-1 provides a sices of skull and head. The conformal stereotactic chameler at sites Juen as on are delivered over multiple fractions. Givind A. Slegyson (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number . Prescription Use (Per 21 CFR 801.109)