TaiChiB

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Our United Corporation Ms. Qi Liu Regulatory Affairs Engineer Room 10301, 3rd Floor, Unit 1, Block 28 ShouChuang International Business Center, No.66 Xi'an, Shaanxi 710018 China Re: K210921 Trade/Device Name: TaiChiB Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE, IWB Dated: March 26, 2021 Received: March 29, 2021 Dear Ms. Qi Liu: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Thalia T. Mills, PhD. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210921 ### Device Name TaiChiB Digital Radiotherapy System ### Indications for Use (Describe) TaiChiB Digital Radiotherapy System is a teletherapy device equipped with two radiation beam delivery units within an enclosed gantry. (1) The electron linear accelerator producing 6MV photon beam is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. (2) The rotating focused gamma beam emitting unit with multiple Cobalt-60 sources is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated. Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Premarket Notification [510(k)] Summary OUR UNITED CORPORATION TaiChiB Digital Radiotherapy System The following information is provided following the format of 21 CFR 807.92. # I. GENERAL INFORMATION - OUR UNITED CORPORATION Submitter's Name: Room 10301, 3rd Floor, Unit 1, Block 28, Shou Chuang International Business Center, No.66 Fengcheng 12 Road, Xi'an Economic & Technological Development Zone, 710018, Shaanxi, China. - Contact Person: Qi Liu Phone: +86 15389012257 Email: qi.liu@ourunited.com Sep. 27thth2021 Date Prepared: # II. DEVICE INFORMATION | Proprietary Name: | TaiChiB | |----------------------|--------------------------------------------------------------------------------------------| | Common/Usual Name: | TaiChiB Digital Radiotherapy System | | Classification Name: | Medical charged-particle radiation therapy system<br>Radionuclide radiation therapy system | | Device Regulation: | 21 CFR 892.5050; 21 CFR 892.5750 | | Regulatory Class: | II | | Product Code: | IYE; IWB | #### III. PREDICATE DEVICE | Primary Device | TaiChiA Medical Linear Accelerator (K193207) | |----------------------|---------------------------------------------------| | Classification Name: | Medical charged-particle radiation therapy system | | Device Regulation: | 21 CFR 892.5050 | {4}------------------------------------------------ | Regulatory Class: | II | |--------------------------------------------|----------------------------------------------------------| | Product Code: | IYE | | Reference Device | TaiChiC Rotating Gamma System (K203250) | | Classification Name:<br>Device Regulation: | Radionuclide radiation therapy system<br>21 CFR 892.5750 | | Regulatory Class: | II | | Product Code: | IWB | #### Device Description: IV. TaiChiB Digital Radiotherapy System integrates medical linear accelerator technology and rotating gamma technology for precision radiotherapy and stereotactic radiosurgery. TaiChiB contains a gantry with a slip ring, 6 MV X-ray Beam Generation Module (BGM), Beam Shaping Module (BSM), Rotating Gamma Subsystem (RGS), Image Guidance System (IGS), Patient Support System (PSS), Treatment Control System (TCS). # V. Intended Use: TaiChiB Digital Radiotherapy System is a teletherapy device equipped with two radiation beam delivery units within an enclosed gantry. (1) The electron linear accelerator producing 6MV photon beam is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. (2) The rotating focused gamma beam emitting unit with multiple Cobalt-60 sources is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated. ### VI. Indications for Use: TaiChiB Digital Radiotherapy System is a teletherapy device equipped with two radiation beam delivery units within an enclosed gantry. (1) The electron linear accelerator producing 6MV photon beam is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. (2) The rotating focused gamma beam emitting unit with multiple Cobalt-60 sources is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated. ## VII. Comparison of the Technological Characteristics with the Predicate Device {5}------------------------------------------------ TaiChiB is a comprehensive radiotherapy system including a medical linear accelerator system and a rotating gamma focusing system (RGS). TaiChiB integrates the rotating gamma focusing system from TaiChiC Rotating Gamma System(K203250) into the TaiChiA Medical Linear Accelerator System (K193207). There are ONLY two treatment modes in TaiChiB, Linac mode and Gamma mode, and these two modes are activated independently through a hardwired interlock, i.e. when one mode is activated another is prohibited. Beams from two subsystems are delivered independently. TaiChiB system enables the accelerator-based radiation therapy and RGS-based stereotactic radiosurgery to be completed in one device and one treatment room. TaiChiA (K193207) from OUR UNITED CORPORATION is included as the primary predicate device, because TaiChiB and TaiChiA have same intended use, indications for use and same medical linear accelerator performance specifications for Linac mode. TaiChiB is designed on the same platform as TaiChiA with only adding the gamma focusing subsystem on the gantry. It keeps the same system architecture design as TaiChiA including the gantry, the linear accelerator, the couch, the image guidance system. The medical linear accelerator system used in both devices have the same FFF beam with energy of 6MV, Maximum dose rate of up to 1400cCy/min, and Maximum treatment field of 40×40cm. Since TaiChiB has an extra rotating gamma focusing system compared with the predicate device TaiChiA Medical Linear Accelerator System(K193207), TaiChiC Rotating Gamma System (K203250) from OUR UNITED CORPORATION is included as the reference device, because the rotating gamma focusing system from TaiChiB is the same as rotating gamma focusing system used in TaiChiC for Gamma mode. They have same intended use, indications for use, structural design, and dosimetry specifications. The rotating gamma focusing system used in both devices are teletherapy devices intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation is indicated. The two rotating gamma focusing systems utilize rotational circular cone to collimate and deliver the treatment. Both rotating gamma focusing systems have the same initial dose rate as ≥3.5Gy/min and radiological accuracy < 0.5mm at the focal point. The above-mentioned differences between TaiChiA have been verified and validated. The verification and validation test results proved that these differences will not affect the safety and effectiveness of TaiChiB in treating patients. The TaiChiB system is as safe and effective as the predicate device and reference device. Detailed comparisons among TaiChiA (the predicate device), and TaiChiC (the reference device) are provided in the following tables respectively. {6}------------------------------------------------ | Detailed Comparisons of TaiChiA with TaiChiA (Predicate Device) and TaiChiC (Reference Device) | | | |------------------------------------------------------------------------------------------------|--|--| |------------------------------------------------------------------------------------------------|--|--| | NO. | Feature | New Device<br>(K210921) | Predicate Device<br>(K193207) | Reference Device<br>(K203250) | Analysis of<br>Differences | 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| General Information | | | | | | | 1. | Product Name | TaiChiB Digital<br>Radiotherapy System | TaiChiA Medical Linear<br>Accelerator | TaiChiC Rotating Gamma<br>System. | | | 2. | Indications for Use | TaiChiB Digital Radiotherapy<br>System is a teletherapy device<br>equipped with two radiation<br>beam delivery units within an<br>enclosed gantry.<br>(1) The electron linear<br>accelerator producing 6MV<br>photon beam is indicated to<br>provide stereotactic<br>radiosurgery and precision<br>radiotherapy for lesions,<br>tumors, and conditions<br>anywhere in the body where<br>radiation treatment is<br>indicated.<br>(2) The rotating focused<br>gamma beam emitting unit<br>with multiple Cobalt-60<br>sources is indicated to provide<br>stereotactic radiosurgery and<br>precision radiotherapy for<br>lesions, tumors, and<br>conditions in the brain and<br>head where radiation<br>treatment is indicated. | TaiChiA, is a Medical<br>Linear Accelerator,<br>intended to provide<br>stereotactic radiosurgery<br>and precision radiotherapy<br>for lesions, tumors, and<br>conditions anywhere in<br>the body where radiation<br>treatment is indicated. | TaiChiC is a teletherapy<br>device intended to provide<br>stereotactic radiosurgery and<br>precision radiotherapy for<br>lesions, tumors, and<br>conditions in the brain, and<br>head, where radiation<br>treatment is indicated. | When use linac treatment in<br>the body, the Indications for<br>Use is as same as the Predicate<br>device due to the functionality,<br>performance and workflow is<br>as same as the Predicate device<br>(K193207).<br>When use Rotating Gamma<br>System treatment in the brain<br>and head, the Indications for<br>Use is as same as the reference<br>device due to the functionality,<br>performance and workflow is<br>as same as the reference device<br>(K203250). | | 3. | Treatment delivery<br>techniques | 3DCRT, IMRT, VMAT,<br>stereotactic radiosurgery | 3DCRT, IMRT, VMAT | Stereotactic radiosurgery,<br>precision radiotherapy | 3DCRT, IMRT, VMAT are<br>same as the predicate device | | | | Precision radiotherapy | | | Stereotactic radiosurgery and<br>precision radiotherapy are<br>same as the reference device<br>for head. | | 4. | Radiation source | Cobalt 60 | NA | Cobalt 60 | Same as the reference device. | | 5. | Quantity of<br>radiation sources | 18 | NA | 18 | Same as the reference device. | | 6. | Distance from<br>source to focal spot<br>(cm) | 75 | NA | 75 | Same as the reference device. | | 7. | Initial Dose rate at<br>the focal spot¹ | ≥3.5Gy / min | NA | ≥3.5Gy / min | Same as the reference device. | | 8. | Quantity of<br>collimator<br>and nominal<br>aperture size | 7:<br>φ6mm, φ9mm,<br>φ12mm, φ16mm, φ20mm,<br>φ25mm<br>and φ35mm | NA | 7:<br>φ6mm, φ9mm,<br>φ12mm, φ16mm,<br>φ20mm, φ25mm<br>and φ35mm | Same as the reference device. | | 9. | Collimator selection | Automatically | NA | Automatically | Same as the reference device. | | 10. | Radiologic accuracy | <0.5mm | NA | <0.5mm | Same as the reference device. | | 11. | Beam energy (MV) | 6MV, FFF | 6MV, FFF | NA | Same as the Predicate device. | | 12. | Maximum dose rate<br>(cGy/min) | Up to 1400 | Up to 1400 | NA | Same as the Predicate device. | | 13. | Maximum treatment<br>field (cm) | 40×40 | 40×40 | NA | Same as the Predicate device. | | 14. | Dmax (cm) | 1.5±0.2 cm | 1.5±0.2 cm | NA | Same as the Predicate device. | | 15. | Percentage dose at<br>10 cm depth (%) | 65.0±2.0 | 65.0±2.0 | NA | Same as the Predicate device. | | 16. | Source to axis<br>distance(cm) | 100 | 100 | NA | Same as the Predicate device | | 17. | Collimator rotation<br>range(degrees) | + 90 | + 90 | NA | Same as the Predicate device. | | 18. | Number of MLC<br>leaves | 120 | 120 | NA | Same as the Predicate device. | | 19. | Leaf resolution at<br>isoplane(cm) | 0.5 and 1 | 0.5 and 1 | NA | Same as the Predicate device | | 20. | Average leaf<br>transmission (%) | ≤1.0 | ≤1.0 | NA | Same as the Predicate device | | 21. | Gantry rotation<br>range (degrees) | No limit (continuous<br>rotation) | No limit (continuous<br>rotation) | No limit (continuous<br>rotation) | Same design with different<br>load installed as the Predicate<br>device and reference device. | | 22. | Isocenter height<br>relative to the floor<br>(cm) | 95 | 95 | 95 | Same design with different<br>load installed as the Predicate<br>device and reference device. | | 23. | Bore Diameter (cm) | 95 | 95 | 95 | Same design with different<br>load installed as the Predicate<br>device and reference device. | | 24. | Gantry maximum<br>rotational speed<br>(RPM) | Up to 1.0 | Up to 1.0 | Up to 1.0 | Same design with different<br>load installed as the Predicate<br>device and reference device. | | 25. | Shift positioning<br>accuracy (cm) | ≤0.05 | ≤0.05 | ≤0.05 | Same design as the Predicate<br>device and reference device. | | 26. | Degrees of freedom | 3 | 3 | 3 | Same design as the Predicate<br>device and reference device. | | 27. | Lateral travel range<br>(cm) | ±15.0 | ±15.0 | ±15.0 | Same design as the Predicate<br>device and reference device. | | 28. | Vertical travel<br>range (cm) | -28.0 to 5.0 | -28.0 to 10.0 | -28.0 to 5.0 | Similar as the predicate<br>device,<br>same as the reference device.<br>This difference does not affect<br>the safety and effectiveness of<br>the device.<br>Mechanical hardware design<br>of three products are same.<br>The vertical travel range of<br>predicate device, reference<br>device and new device are set<br>by an electrical limit switch<br>and software. | | | | | | | The new device and reference<br>device have same electrical<br>limit switch installation and<br>software parameters setting of<br>vertical travel range, so the<br>Vertical travel range are same.<br>The new device and predicate<br>device have different<br>electrical limit switch<br>installation and software<br>parameters setting of vertical<br>travel range, so the Vertical<br>travel range are different. | | 29. | Longitudinal travel<br>range (cm) | 180.0 | 180.0 | 180.0 | Same design as the Predicate<br>device and reference device. | | 30. | Imaging beam | kV | kV | kV | Same design as the Predicate<br>device and reference device. | | 31. | Imaging techniques | CBCT, kV/kV | CBCT, kV/kV | CBCT, kV/kV | Same design as the Predicate<br>device and reference device. | | 32. | Imaging field of<br>view (cm) | φ25.0 for head scan<br>φ44.5 for body scan | φ25.0 for head scan<br>φ44.5 for body scan | φ25.0 for head scan | same as the predicate device,<br>same as the reference device<br>of head scan.<br>Hardware design of three<br>products is same.<br>The functionality of imaging<br>field of view is configurable.<br>The new device and predicate<br>device have same<br>configuration of imaging field<br>of view.<br>The new device and reference<br>device have different software<br>configuration of imaging field<br>of view due to the reference<br>device is used on brain and<br>head. | | 33. | CBCT acquisition<br>Mode<br>(pixels/degrees) | 512x512 reconstruction<br>matrix/<br>200 (head) or 360<br>(body) | 512x512 reconstruction<br>matrix/<br>200 (head) or 360<br>(body) | 512x512 reconstruction<br>matrix/<br>200 (head) | same as the predicate device<br>same as the reference device<br>at head | {7}------------------------------------------------ {8}------------------------------------------------ {9}----------------------------------…