(218 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on hardware components and standard radiotherapy technologies.
Yes
Explanation: The device is indicated for providing stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions, which are therapeutic interventions.
No
Explanation: The device is a radiotherapy system indicated for providing stereotactic radiosurgery and precision radiotherapy, which are treatment modalities. It does not mention diagnosing conditions.
No
The device description explicitly lists multiple hardware components (gantry, slip ring, BGM, BSM, RGS, IGS, PSS, TCS) and the performance studies include hardware verification and validation testing, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The TaiChiB Digital Radiotherapy System is a therapeutic device. It delivers radiation (photon and gamma beams) to treat lesions, tumors, and conditions within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states that the device is used to "provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated." This is a treatment function, not a diagnostic one.
Therefore, the TaiChiB Digital Radiotherapy System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IYE, IWB
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
kV, CBCT
Anatomical Site
Body (general), brain and head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence:
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on this medical device. The system complies with the IEC 60601-1: 2012 standard for safety and the IEC 60601-1-2:2014 standard for EMC.
Bench Test
Successful testing was performed in accordance with following standards:
IEC60976:2007, Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
IEC 60601-2-1: 2014, Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
IEC 60601-2-11: 2013, particular requirements for the basic safety and essential performance of gamma beam therapy equipment
IEC60601-1-3:2013, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC60601-2-68:2014, Medical electrical equipment - Part 2-68: particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
IEC61217:2011, Radiotherapy equipment - Coordinates, movements and scales
IEC62274 :2005, Medical electrical equipment - Safety of radiotherapy record and verify systems
IEC62366-1:2015, Medical devices - Part 1: Application of usability engineering to medical devices
IEC60601-1-6:2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
RT2:2017 Radiation therapy readiness check
ISO 15223-1: 2016, Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
ISO10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Hardware and Software Verification and Validation Testing
Hardware and software verification and validation process were conducted according to the FDA Quality System Regulation (21 CFR Section 820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards.
Test results showed TaiChiB conforms to applicable requirements specifications and assures hazard safeguards functioned properly. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
Animal or clinical test
Not applicable for TaiChiB
Summary
The verification and validation testing demonstrated that TaiChiB has met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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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
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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
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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)
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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 |
| 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 |
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| Regulatory Class: | II |
|---|---|
| Product Code: | IYE |
| Reference Device | TaiChiC Rotating Gamma System (K203250) |
| Classification Name: | |
| Device Regulation: | Radionuclide radiation therapy system |
| 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
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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