(218 days)
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.
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).
The provide text is a 510(k) summary for the TaiChiB Digital Radiotherapy System. This document focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study designed to meet pre-defined acceptance criteria for the new device's performance.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a specific performance evaluation is not available within this document.
The document primarily highlights the device's technical specifications and compares them to predicate devices, stating that "The TaiChiB system is as safe and effective as the predicate device and reference device." and "The verification and validation testing demonstrated that TaiChiB has met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use."
The "PERFORMANCE DATA" section lists various electrical safety, EMC, and bench tests conducted according to relevant IEC and ISO standards. It also mentions "Hardware and Software Verification and Validation Testing" where test results showed TaiChiB conforms to applicable requirements and assures hazard safeguards functioned properly. However, these are general compliance statements and not specific performance metrics with acceptance criteria for the device's clinical efficacy or accuracy in the context of diagnostic or treatment capabilities. No clinical or animal studies were performed.
Summary of available information from the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the format of acceptance criteria for clinical performance and device performance results. The document instead presents a table comparing the new device's features and specifications to those of its predicate and reference devices, implying that matching or being similar to these established devices constitutes acceptable performance.
Excerpts from the "Detailed Comparisons" table representing device specifications that could be considered performance characteristics:
| Feature | New Device (K210921) | Predicate Device (K193207) | Reference Device (K203250) | Analysis of Differences |
|---|---|---|---|---|
| Initial Dose rate at the focal spot¹ | ≥3.5Gy / min | NA | ≥3.5Gy / min | Same as the reference device. |
| Radiologic accuracy | <0.5mm | NA | <0.5mm | Same as the reference device. |
| Beam energy (MV) | 6MV, FFF | 6MV, FFF | NA | Same as the Predicate device. |
| Maximum dose rate (cGy/min) | Up to 1400 | Up to 1400 | NA | Same as the Predicate device. |
| Maximum treatment field (cm) | 40×40 | 40×40 | NA | Same as the Predicate device. |
| Dmax (cm) | 1.5±0.2 cm | 1.5±0.2 cm | NA | Same as the Predicate device. |
| Percentage dose at 10 cm depth (%) | 65.0±2.0 | 65.0±2.0 | NA | Same as the Predicate device. |
| Shift positioning accuracy (cm) | ≤0.05 | ≤0.05 | ≤0.05 | Same design as the Predicate device and reference device. |
These are technical specifications and not acceptance criteria from a clinical performance study. The "Analysis of Differences" column indicates that if the new device's specification is the "Same as" the predicate or reference device, it is considered acceptable for substantial equivalence.
2. Sample size used for the test set and the data provenance:
Not applicable, as no clinical or animal test performance study is reported. The document states "Animal or clinical test: Not applicable for TaiChiB". The listed "Bench Test" and "Hardware and Software Verification and Validation Testing" are conducted in accordance with specified standards and internal procedures, but detailed sample sizes of data used for these engineering tests are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no study involving human expert ground truth for clinical cases is reported.
4. Adjudication method for the test set:
Not applicable, as no study involving human adjudication is reported.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable, as no MRMC study or AI component requiring human reader interaction is discussed. The device is a radiation therapy system, not an AI-assisted diagnostic or intervention system in the context of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as the document does not describe a standalone algorithm performance study for clinical efficacy or accuracy in diagnosis/treatment planning beyond the general verification and validation of software and hardware.
7. The type of ground truth used:
For the engineering and software validation, the "ground truth" would be the predefined functional and performance requirements derived from the device's design specifications and compliance with international standards (e.g., IEC, ISO). No clinical ground truth (e.g., pathology, outcomes data) is mentioned as it's not a clinical performance study.
8. The sample size for the training set:
Not applicable, as this document does not describe a machine learning model requiring a training set for clinical performance.
9. How the ground truth for the training set was established:
Not applicable.
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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 systemRadionuclide 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 system21 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 < 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.
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| Detailed Comparisons of TaiChiA with TaiChiA (Predicate Device) and TaiChiC (Reference Device) | ||
|---|---|---|
| ------------------------------------------------------------------------------------------------ | -- | -- |
| NO. | Feature | New Device(K210921) | Predicate Device(K193207) | Reference Device(K203250) | Analysis ofDifferences |
|---|---|---|---|---|---|
| General Information | |||||
| 1. | Product Name | TaiChiB DigitalRadiotherapy System | TaiChiA Medical LinearAccelerator | TaiChiC Rotating GammaSystem. | |
| 2. | Indications for Use | TaiChiB Digital RadiotherapySystem is a teletherapy deviceequipped with two radiationbeam delivery units within anenclosed gantry.(1) The electron linearaccelerator producing 6MVphoton beam is indicated toprovide stereotacticradiosurgery and precisionradiotherapy for lesions,tumors, and conditionsanywhere in the body whereradiation treatment isindicated.(2) The rotating focusedgamma beam emitting unitwith multiple Cobalt-60sources is indicated to providestereotactic radiosurgery andprecision radiotherapy forlesions, tumors, andconditions in the brain andhead where radiationtreatment is indicated. | TaiChiA, is a MedicalLinear Accelerator,intended to providestereotactic radiosurgeryand precision radiotherapyfor lesions, tumors, andconditions anywhere inthe body where radiationtreatment is indicated. | TaiChiC is a teletherapydevice intended to providestereotactic radiosurgery andprecision radiotherapy forlesions, tumors, andconditions in the brain, andhead, where radiationtreatment is indicated. | When use linac treatment inthe body, the Indications forUse is as same as the Predicatedevice due to the functionality,performance and workflow isas same as the Predicate device(K193207).When use Rotating GammaSystem treatment in the brainand head, the Indications forUse is as same as the referencedevice due to the functionality,performance and workflow isas same as the reference device(K203250). |
| 3. | Treatment deliverytechniques | 3DCRT, IMRT, VMAT,stereotactic radiosurgery | 3DCRT, IMRT, VMAT | Stereotactic radiosurgery,precision radiotherapy | 3DCRT, IMRT, VMAT aresame as the predicate device |
| Precision radiotherapy | Stereotactic radiosurgery andprecision radiotherapy aresame as the reference devicefor head. | ||||
| 4. | Radiation source | Cobalt 60 | NA | Cobalt 60 | Same as the reference device. |
| 5. | Quantity ofradiation sources | 18 | NA | 18 | Same as the reference device. |
| 6. | Distance fromsource to focal spot(cm) | 75 | NA | 75 | Same as the reference device. |
| 7. | Initial Dose rate atthe focal spot¹ | ≥3.5Gy / min | NA | ≥3.5Gy / min | Same as the reference device. |
| 8. | Quantity ofcollimatorand nominalaperture size | 7:φ6mm, φ9mm,φ12mm, φ16mm, φ20mm,φ25mmand φ35mm | NA | 7:φ6mm, φ9mm,φ12mm, φ16mm,φ20mm, φ25mmand 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(cGy/min) | Up to 1400 | Up to 1400 | NA | Same as the Predicate device. |
| 13. | Maximum treatmentfield (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 at10 cm depth (%) | 65.0±2.0 | 65.0±2.0 | NA | Same as the Predicate device. |
| 16. | Source to axisdistance(cm) | 100 | 100 | NA | Same as the Predicate device |
| 17. | Collimator rotationrange(degrees) | + 90 | + 90 | NA | Same as the Predicate device. |
| 18. | Number of MLCleaves | 120 | 120 | NA | Same as the Predicate device. |
| 19. | Leaf resolution atisoplane(cm) | 0.5 and 1 | 0.5 and 1 | NA | Same as the Predicate device |
| 20. | Average leaftransmission (%) | ≤1.0 | ≤1.0 | NA | Same as the Predicate device |
| 21. | Gantry rotationrange (degrees) | No limit (continuousrotation) | No limit (continuousrotation) | No limit (continuousrotation) | Same design with differentload installed as the Predicatedevice and reference device. |
| 22. | Isocenter heightrelative to the floor(cm) | 95 | 95 | 95 | Same design with differentload installed as the Predicatedevice and reference device. |
| 23. | Bore Diameter (cm) | 95 | 95 | 95 | Same design with differentload installed as the Predicatedevice and reference device. |
| 24. | Gantry maximumrotational speed(RPM) | Up to 1.0 | Up to 1.0 | Up to 1.0 | Same design with differentload installed as the Predicatedevice and reference device. |
| 25. | Shift positioningaccuracy (cm) | ≤0.05 | ≤0.05 | ≤0.05 | Same design as the Predicatedevice and reference device. |
| 26. | Degrees of freedom | 3 | 3 | 3 | Same design as the Predicatedevice and reference device. |
| 27. | Lateral travel range(cm) | ±15.0 | ±15.0 | ±15.0 | Same design as the Predicatedevice and reference device. |
| 28. | Vertical travelrange (cm) | -28.0 to 5.0 | -28.0 to 10.0 | -28.0 to 5.0 | Similar as the predicatedevice,same as the reference device.This difference does not affectthe safety and effectiveness ofthe device.Mechanical hardware designof three products are same.The vertical travel range ofpredicate device, referencedevice and new device are setby an electrical limit switchand software. |
| The new device and referencedevice have same electricallimit switch installation andsoftware parameters setting ofvertical travel range, so theVertical travel range are same.The new device and predicatedevice have differentelectrical limit switchinstallation and softwareparameters setting of verticaltravel range, so the Verticaltravel range are different. | |||||
| 29. | Longitudinal travelrange (cm) | 180.0 | 180.0 | 180.0 | Same design as the Predicatedevice and reference device. |
| 30. | Imaging beam | kV | kV | kV | Same design as the Predicatedevice and reference device. |
| 31. | Imaging techniques | CBCT, kV/kV | CBCT, kV/kV | CBCT, kV/kV | Same design as the Predicatedevice and reference device. |
| 32. | Imaging field ofview (cm) | φ25.0 for head scanφ44.5 for body scan | φ25.0 for head scanφ44.5 for body scan | φ25.0 for head scan | same as the predicate device,same as the reference deviceof head scan.Hardware design of threeproducts is same.The functionality of imagingfield of view is configurable.The new device and predicatedevice have sameconfiguration of imaging fieldof view.The new device and referencedevice have different softwareconfiguration of imaging fieldof view due to the referencedevice is used on brain andhead. |
| 33. | CBCT acquisitionMode(pixels/degrees) | 512x512 reconstructionmatrix/200 (head) or 360(body) | 512x512 reconstructionmatrix/200 (head) or 360(body) | 512x512 reconstructionmatrix/200 (head) | same as the predicate devicesame as the reference deviceat head |
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V. PERFORMANCE DATA
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
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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 $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.
VI. CONCLUSIONS
The TaiChiB has the same intended use, indications for use and fundamental scientific technology as the predicate device and reference device.
The differences among TaiChiB and predicate have been verified and validated and do not raise any new safety or effectiveness issues.
The Verification and Validation demonstrate that the device is as safe and effective as the predicate and reference device.
Based on the comparison and analysis above, OUR therefore believes that TaiChiB is substantially equivalent to the predicate device.
§ 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.