PATLOG 2.0

{0}------------------------------------------------ ONCOlog Medical QA AB Image /page/0/Picture/1 description: The image contains a logo with the word "ONCOlog" in a sans-serif font, with the word "MEDICAL" underneath in a smaller font. Above the word "ONCOlog" is a circular symbol divided into four equal quadrants by a cross shape. The symbol is positioned directly above the text, creating a visual association between the symbol and the company name. 'ડે TO(k) Application PatLog 2.0 i Page: 34(46) Date: 2009-08-24 K092939 OCT - 9 2009 ONCOlog Medical QA AB Vallvägen 4B SE-756 \$1 Uppsala Sweden TEL +46 (0) 18-19 45 65 FAX +46 (0)18-30 06 85 www.oncologmedical.com > Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMA-TION ## as required by section 807.92(c) #### Submitter of 510(k): Company name: Registration number: Address: Phone: Fax: Correspondent ONCOlog Medical QA AB 10026961 Vallvägen 4B 756 51 Uppsala Sweden (011) 4618194565 (011) 461830685 Hans Dahlin and Jan Törnqvist #### New Device Name: Trade/Proprietary Name: Common/Usual Name: Classification Name: Classification: PatLog 2.0. Radiotherapy Patient Logistics System Medical charged-particle radiation therapy system 21 CFR 892.5050, Product Code IYE Class II ### Legally Marketed Device(s) Our new device is based on the legally marketed device cited in the table below: | Manufacturer | Device | 510(k) # | |---------------------------------------------------------|---------------------------------------------------------|----------| | ONCOlog medical QA AB | PatLog 1.0 | K090044 | | Precision Therapy International,<br>Precitron AB/Sweden | Hercules Radiation Therapy Couch and<br>ATLAS Couch Top | K950061 | {1}------------------------------------------------ # Device description The PatLog 2.0 Patient Logistics System is a combination of separate products that together form a complete patient logistics system for a radiation therapy department. The Loading Station facilitates loading and initial setup of the patient Table Plate, the Transport Trolley provides transport from the Loading Station to diagnostic devices like CT or MR, further to the Radiation therapy treatment room and back to the Loading Station for unloading after the treatment. The Patient Table Plate is docked on the patient table bases at each unit, CT, MR or Proton Gantry, and undocked for the transport between stations with the Transport Trolley. The system has the following components: - Patient Table Plates are manufactured from radiotranslucent, non-magnetic and non-. conductive composite material to be suitable both for CT, MR, X-ray and Proton therapy. They are extremely stiff and rigid and provide very precise patient positioning and reliable support during all the procedures. They have a docking mechanism for secure and precise connection to the Docking Units on all the table bases at the diagnostic and therapy units. They also have indexing features for accurate positioning and repositioning of patient immobilization devices. - . Transport Trolleys provide easy transport between the Patient Loading Station and the different patient table bases. The trolleys are designed to hold the Patient Table Plate securely during transport and easily disconnect and reconnect at Docking Stations. The Transport Trolleys are motorized and have a steering support system to make the transport safe and easy without twitches and jerks e.g. through narrow passages. - . Patient Loading Stations speed up the patient loading process and provides a reproducible transfer of the patient from standing up to horizontal position. - . Docking Units are mounted on each of the patient table bases at CT, MR, Simulator and Proton Therapy Units. They have features for quick and secure connection of the Patient Table Plates to each one of the patient table bases. The Docking Units are custom designed for each type of device, the Patient Positioning System (PPS) on the Proton Therapy Unit and the different table bases at the CT and MR units. ## Intended use System for patient positioning and fixation on the treatment couch, including transportation of the patient from preparation site and/or diagnostic surveys to the treatment unit Intended User: The PatLog Patient Handling System is intended to be used by qualified radiotherapy personnel trained in using the device. {2}------------------------------------------------ # Summary of Technological Characteristics and Intended Use r. The technological characteristics and the intended use are substantially the same for the new PatLog 2.0 Patient Logistics System as for PatLog 1.0 and Hercules. Name: Hans Dahlin Title: CEO ONCOlog Medical QA AB Uppsala, Sweden Date {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing-like shapes, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 # OCT - 9 2009 Oncolog Medical OA AB % Mr. Casev Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747 Re: K092939 Trade/Device Name: PatLog 2.0 Regulation Number: 21 CFR 892,5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 18, 2009 Received: September 24, 2009 #### Dear Mr. Conry: 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 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); medical device reporting of medical {4}------------------------------------------------ Page 2 – device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Janine M. Morris Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use Statement 510(k) Number Device Name Indications for Use PatLog 2.0. K092939 System for patient positioning and fixation on the treatment couch, including transportation of the patient from preparation site and/or diagnostic surveys to the treatment unit Intended User The PatLog Patient Handling System is intended to be used by qualified radiotherapy personnel trained in using the device. Prescription Use _ X (Part 21 CFR 801 subpart ID) AND/OR Over-The-Counter Use (Part 21 CFR 801 subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Hestelmann (Division Sign-Off) (Division Sign-Oil) Division of Reproductive, Abdominal, Divisioningical Devices 510(k) Number. Page 1 of 1