ACCUSOFT

{0}------------------------------------------------ JUN 2 3 2004 # 510(K) Summary # AccuSoft 510(k) Number K (40474 # Applicant's Name: Direx Systems Corp. 11 Mercer Road, Natick Business park Natick, MA 01760 United States of America # Contact Person: Larisa Gershtein Direx Systems Corp. 11 Mercer Road Natick, MA 01760 Tel: (888) 874 7837 Fax: (508) 651-8125 E-mail: lgershtein@direxusa.com # Trade Name: AccuSoft # Model: AccuSoft # Classification Name: System, Planning, Radiation Therapy Treatment # Classification: The FDA has classified this type of devices as class II (product code 90 IYE, Regulation No. 892.5050); they are reviewed by the Radiology Panel. # Applicable Standards: No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, AccuSoft complies with the following consensus standards: - > IEC 60812 (1985) Failure Mode and Effects Analysis. > IEC 60601-1-4 - Consol. Ed. 1.1 (2000-04) Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral Standard: Programmable electrical medical systems. - IEEE Std 829 (1998) Standard for Software Test Documentation A - IEEE Std 830 (1998) Recommended Practice for Software Requirements Specifications A - ISO 14971 (2000) Medical devices Application of risk management to medical devices A - Guidance on Medical Device Patient Labeling; Final Guidance for Industry and {1}------------------------------------------------ FDA Reviewers, April 19, 2001 - > An Introduction to Human Factors in Medical Devices, December 1996 - > An ma oduction is = " = " = " = " = " = " = " = " = " = " = " = " = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = > Guidance for FDA Keviewers and Industry, Cartical Devices May 29, 1998 - Chiarter Buonnestone Software Validation; Final Guidance for Industry and FDA A Staff January 11, 2002 - Start July 21, 2017 11:41 > Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices September 9, 1999 #### Intended Use: AccuSoft is intended to be used for the computation, display, evaluation, Accusoft is intended to be accurion dose estimations including and output documentation of radiation Treatment (IMRT) that thise for Thrensity arounded and clinical review and verification by a physicist or physician prior to use. The application provides output data in the form of displays or The application provides output a physician in selecting the bound by natucopy printouts to garao a personal provide a report to be used by patient treathent professional such as a radiation oncologist, a comportist, radiation therapist or dosimetrist. # Device Description: AccuSoft is a radiation treatment planning system. It consists of a AccuSoft is a factation treatment proxected algorithmic approaches to Soltware package that aloous and of extensive verification and produce radiation dose coundations to enable the proper system and patient setup and adequate radiation delivery. It includes the image, delineation and beam planning techniques. The it includes the miage, delineation beam enables the user to treat irregularly shaped lesions, maximizing the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures. # Predicate Devices: Based on validations and performance testing results, Direx Systems Corp. Dascu on valuations and pubstantially equivalent to the following belleves that hecabor is backening new safety and/or effectiveness issues. - AccuSoft, v2.02., radiation treatment planning system cleared on . Accurson, V2.02., Facking number K032171), manufacturer Direx Systems Corp. - DMLC IV ERGO cleared on October 23, 2000 (Tracking number . K001163). Manufacturer 3D Line {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 3 2004 Ms. Larisa Gershtein QA Manager Direx Systems Corp. 11 Mercer Road NATICK MA 01760 Re: K040474 Trade/Device Name: AccuSoft Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: May 18, 2004 Received: May 21, 2004 Dear Ms. Gershtein: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bection 310(t) promotion is substantially equivalent (for the indications felerenced above and nave coloring to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manated posice Americal Device Americal processor of Coast Drug commerce prior to May 20, 1970, the excordance with the provisions of the Federal Food, DNA devices that have been recuassincs in accordance wal of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosment Act (Act) that do not require apper o the general controls provisions of the Act. The You may, therefore, thanker the device, only of equirements for annual registration, listing of general Controls provisions of the rice, 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 If your device is classince (see above) nits. Existing major regulations affecting your device can may be subject to sach additional ochilonial official of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouchar Eng 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 that FDA has made a determination that your device complies with one waters and that FDA has made a Gecermanation that Jointer Federal agencies. You must comply of CCP Post or any Federal statutes and regulations administry of the orders and listing (2) CFR Part with all the Act \$ requirements, moractice requirements as set forth in the 807), labeling (21 CFR Part 820), and if applicable, the electronic product quality systems (QB) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin hanceling your ever of your device of your device to a legally premarket notification. The PDA miding of bactiation 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 dones on our of the following numbers, based on the regulation number at the top of the letter: | 8xx. 1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Adultionally, for questions on the promotions. Also, please note the regulation entitled, "Misbranding Othece of Compliance at (301) 59 1-100 (21CFR Part 807.97) you may obtain. Other general by reletence to premarket notified.com (Dr of Act may be obtained from the Division of Strail information on your responsionalism 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 yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # INDICATIONS FOR USE STATEMENT # 510(k) Number (if known): k040474 Device Name: AccuSoft Indications for Use: AccuSoft is to be used for the computation, display, evaluation, and output Accumentation of radiation dose estimations including those for Intensity Modulated Radiation Treatment (IMRT), to be submitted for independent clinical review and judgment by a physicist or physician much to use. The device provides output data in the form of displays or prior to abores. hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a tratifies professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist. (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) y Prescription Use _____________________________________________________________________________________________________________________________________________________________ Daniel A. Sprem (Division Sign-Off) Division of Reproductive, Abdon ann Radiological Devices 51(Jik) Number _