MHI-TM2000 Linear Accelerator System, VERO, Imavis

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 21, 2015 Mitsubishi Heavy Industries, Ltd. % Mr. Katsuhisa Toyama Senior Administrator, Business Development Department 4-6-22 Kan-on-shin-machi, Nishi-ku Hiroshima-shi, Hiroshima-ken 733-8553 JAPAN Re: K152867 Trade/Device Name: MHI-TM2000 Linear Accelerator System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 28, 2015 Received: September 30, 2015 Dear Mr. Toyama: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 (reporting of medical 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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Sincerely yours, Robert Ochs Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152867 Device Name MHI-TM2000 Linear Accelerator System #### Indications for Use (Describe) MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Type of Use (Select one or both, as applicable) | <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |---------------------------------------------------------------------------------------------------------| | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below the logo, the text reads "MITSUBISHI HEAVY INDUSTRIES, LTD." followed by "MACHINERY, EQUIPMENT & INFRASTRUCTURE" and the address "6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN". # 510(k) Summary MHI-TM2000 Linear Accelerator System The following information is provided following the format of 21 CFR 807.92 for the MHI-TM2000 Linear Accelerator System. Date prepared: September 17, 2015 - 1. Submitter: Mitsubishi Heavy Industries, Ltd. Machinery, Equipment & Infrastructure 4-6-22 Kan-on-shin-machi, Nishi-ku, Hiroshima 733-8553 Japan Establishment Registration Number: 3006942329 Contact person: Shuji Kaneko Manager, Medical System Engineering Section Phone: +81-82-291-2146 Fax: +81-82-294-9888 ## 2. Name of the Device: | Trade Name: | MHI-TM2000 Linear Accelerator System/ Vero/ Imavis | |-----------------------|----------------------------------------------------| | Common or Usual name: | Clinical Linear Accelerator | | Classification Name: | Medical Charged Particle Radiation Therapy System | | | 21CFR §892.5050, Class II | | | Product Code: IYE | ## 3. Predicate devices to claim substantial equivalence: MHI-TM2000 Linear Accelerator System: K122450 ## 4. Description of the Device: The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (Ver. 3.5)") is an Image-Guided Radiation Therapy device generating 6MV high energy X-ray for precision radiation therapy of tumors and conditions, where radiation treatment is indicated. It includes a linear accelerator, multi-leaf collimator, electric portal imaging device and couch. It also includes O-ring-type gantry platform, X-ray-head-mounted gimbals, Built-in Imaging System, and function to continuously align treatment beam with moving target for precise radiotherapy of {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo and address of Mitsubishi Heavy Industries, LTD. The logo is a red emblem consisting of three diamond shapes arranged in a triangular formation. Below the logo is the company name in bold, followed by the description "MACHINERY, EQUIPMENT & INFRASTRUCTURE". The address is listed as 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN. moving targets, as notable characteristics. The MHI-TM2000 (Ver. 3.5) has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K122450 (hereinafter called "MHI-TM2000 (K122450)''). Modification was made for introducing a method of radiation therapy called "Dynamic WaveArc" ("DWA") that delivers radiation while rotating both O-ring-shaped gantry (Gantry rotation) and rotational floor of the gantry that moves entire gantry (Ring rotation), or rotating the Ring rotation only. Radiation type, energy, and the method of generating radiation are identical between MHI-TM2000 (Ver. 3.5) and MHI-TM2000 (K122450) # 5. Intended Use Statement: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. # Indications for Use Statement: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. ## 6. Technological Characteristics: Comparison to the predicate device is listed below: | Feature | MHI-TM2000 (Ver. 3.5) | MHI-TM2000 (K122450) | |-----------------------------------------------|-----------------------|----------------------| | "Dynamic WaveArc" radiation<br>therapy method | Yes | No | This is the only modification and all other technological characteristics are identical between MHI-TM2000 (Ver. 3.5) and MHI-TM2000 (K122450), such as Indications for use, Operation principles and Method of operation. # 7. Summary of Performance Testing: The design control procedures applied to the development of MHI-TM2000 (Ver. 3.5) includes requirements reviews, risk analysis, and verification and validation testing according to:. -ISO14971: Risk Management Standard -FDA Quality System regulation (21 CFR 820) and ISO13485: Quality Management System Standard {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo and address of Mitsubishi Heavy Industries, LTD. The logo is a red, three-diamond shape. Below the logo is the company name, followed by the description "MACHINERY, EQUIPMENT & INFRASTRUCTURE". The address is listed as 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN. -Other international standards listed in "8. Standards conformance" below in 8. Result of verification testing, including regression testing, showed conformance to applicable requirements specifications, assured hazard safeguards functioned properly. Result of validation testing showed conformance to customer needs and intended use of the MHI-TM2000 (Ver. 3.5). ### 8. Standards conformance: The MHI-TM2000 (Ver. 3.5) conforms with the FDA recognized consensus standards and other international standards listed below. IEC 60601-1, IEC 60601-1-2, IEC 60601-2-28, IEC 60825-1, IEC 60976, IEC 62304 ISO13845, ISO13845, ISO14971 ### 9. Conclusion: The verification and validation testing results from bench testing, including regression testing, support the substantial equivalence of the MHI-TM2000 (Ver. 3.5) with MHI-TM2000 (K122450) A special 510(k) is applicable to this application due to the following reasons: -Change/ modification does not significantly affect safety and effectiveness of MHI-TM2000 (K122450); -There is no change in basic design control activities specified in 21CFR 820.30; -There is no change in the medical device information specified in 21CFR 807.87; -There is no change in all Labeling including Indications for Use; -There is no change in fundamental scientific technologies; and -There is no change in material used.