(261 days)
No
The 510(k) summary does not mention AI, ML, or related terms, and the device description focuses on traditional linear accelerator technology and image guidance.
Yes
The device is a Medical Linear Accelerator intended to provide radiation treatment for lesions, tumors, and conditions anywhere in the body, which is a therapeutic intervention.
No
This device is a therapeutic device (Medical Linear Accelerator) that delivers radiation treatment. While it uses image guidance, its primary purpose is treatment delivery, not diagnosis.
No
The device description clearly states it is a Medical Linear Accelerator system consisting of hardware components like an accelerator, patient support, and control console, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide radiation treatment for lesions, tumors, and conditions anywhere in the body. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a Medical Linear Accelerator designed to deliver radiation therapy. It uses imaging for guidance during treatment, but its primary function is delivering radiation, not performing diagnostic tests on samples from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such examinations.
In summary, the TaiChiA Medical Linear Accelerator is a therapeutic device used for delivering radiation treatment, not a diagnostic device used for testing samples from the body.
N/A
Intended Use / Indications for Use
TaiChiA, is a Medical Linear Accelerator intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors,and conditions anywhere in the body where radiation treatment is indicated.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
TaiChiA Medical Linear Accelerator, has been designed to deliver radiation treatment in accordance with a prescribed plan. This system utilizes kV image guidance technology (IGRT) to deliver photon based radiation therapy treatments, using an integrated rotating linear accelerator system. TaiChiA is a single energy medical linear accelerator designed to deliver Image Guided Radiation Therapy and Radiosurgery, using 3DCRT, IMRT and VMAT techniques. It consists of the accelerator and patient support within a radiation shielded treatment room and a control console in the control room.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
kV
Anatomical Site
anywhere in the body
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)
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on this medical device. The system complies with the IEC 60601-1Medical Electrical Equipment - Part I General requirements for basic safety and essential performance for the safety and the IEC 60601-1-2 Medical electrical equipment Part 1-2 General requirements for basic safety and essential performance -Collateral standard Electromagnetic compatibility-Requirements and tests for EMC.
Successful testings were performed in accordance with following standards:
IEC60601-2-1:2005, 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
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
IEC60976:2007, Medical electrical equipment Medical electron accelators - Functional performance characteristics
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
ISO10993-1:2009. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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 conformance to applicable requirements specifications and assured hazard safeguards functioned properly. Software verification 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.
The verification and validation testing demonstrated that TaiChiA has met its specifications, demonstrated substantially equivalent performance to the predicate device 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.
Varian Medical Systems Halcyon (K181032)
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.
TrueBeam, TrueBeam STx, and Edge Radiotherapy Delivery System (K171733)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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 % Qi Liu Regulatory Affairs Engineer 3rd Floor, Unit 1, Block 28 ShouChuang International Business Center, NO.66 Xi'an. Shaan xi 710018 CHINA
August 7, 2020
Re: K193207
Trade/Device Name: TaiChiA Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: July 5, 2020 Received: July 10, 2020
Dear 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 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
1
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,
For
Thalia T. Mills, Ph.D. 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) K193207
Device Name TaiChiA
Indications for Use (Describe)
TaiChiA, is a Medical Linear Accelerator intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors,and conditions anywhere in the body where radiation treatment is indicated.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Premarket Notification [510(k)] Summary OUR UNITED CORPORATION TaiChiA Medical Linear Accelerator
The following information is provided following the format of 21 CFR 807.92. I.GENERAL INFORMATION
| Date Prepared: | July 5th 2020 |
|---|---|
| Submitter's Name: | OUR UNITED CORPORATION |
| 3rd Floor, Unit 1, Block 28, ShouChuang International Business | |
| Center, No.66, Fengcheng 12 Road, Weiyang District, Xi'an | |
| City, Shaanxi Province, China. | |
| Contact Person: | Qi Liu |
| Phone: +86 15389012257 | |
| Email: qi.liu@ourunited.com | |
| II.DEVICE | |
| INFORMATION | |
| Proprietary Name: | TaiChiA |
| Classification Name: | Medical charged-particle radiation therapy system |
| Device Regulation: | 21 CFR 892.5050 |
| Device Class: | Class II |
| Product Code: | IYE |
| Common/Usual Name: | Medical Linear Accelerator |
| III.PREDICATE | |
| DEVICE | Varian Medical Systems Halcyon (K181032) |
| Reference Device | TrueBeam, TrueBeam STx, and Edge Radiotherapy Delivery |
| System (K171733) | |
| IV. Device Description: | TaiChiA Medical Linear Accelerator, has been designed to |
| deliver radiation treatment in accordance with a prescribed plan. | |
| This system utilizes kV image guidance technology (IGRT) to | |
| deliver photon based radiation therapy treatments, using an | |
| integrated rotating linear accelerator system. | |
| TaiChiA is a single energy medical linear accelerator designed to | |
| deliver Image Guided Radiation Therapy and Radiosurgery, | |
| using 3DCRT, IMRT and VMAT techniques. It consists of the | |
| accelerator and patient support within a radiation shielded | |
| treatment room and a control console in the control room. | |
| V. Intended Use: | TaiChiA, is a Medical Linear Accelerator intended to provide |
| stereotactic radiosurgery and precision radiotherapy for lesions, | |
| tumors, and conditions anywhere in the body where radiation | |
| treatment is indicated. | |
| VI. Indications for Use: | TaiChiA, is a Medical Linear Accelerator intended to provide |
| stereotactic radiosurgery and precision radiotherapy for lesions. | |
| tumors, and conditions anywhere in the body where radiation |
4
VII. COMPARISION WITH THE PREDICATE DEVICE
treatment is indicated.
The Halcyon system (K181032) from Varian Medical Systems, Inc. (Palo Alto, CA) is selected as the primary predicate device of the TaiChiA system from OUR United Corporation (Xi'an, China) because of their similarities. Both devices have the same general intended use and indications for use, i.e., provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. The two systems have similar major components and comparable specifications that include beam energy, Dmax, depth dose at 10cm, symmetry, off axis intensity, dose output and constancy, collimator rotation, target to gantry axis distance, bore diameter, radiation isocenter size, maximum leaf over travel, leaf interdigitating, leaf end position accuracy, low MLC leakage, shift positioning accuracy and degrees of freedom.
The two systems have few different specifications on beam collimation, maximum dose rate, imaging system, gantry rotation and couch. Regarding beam collimation, TaiChiA is equipped with a single layer MLC with a maximum leaf speed of 2.5cm/s and maximum field size of 40cm, while Halcyon has a double layer MLC with maximum leaf speed of 5.0cm/s and maximum field size of 28cm x 28cm. Halcyon supports a faster MLC leaf speed but has a smaller treatment field size. Compared to Halcyon, TaiChiA has a higher maximum dose rate (1400cGy/min vs. 800cGy/min) which can improve treatment efficiency. Regarding gantry rotations, based on slip-ring technology, TaiChiA can rotate the gantry continuously, while Halcyon is limited to +/- 185 degrees from the nominal angle with a state of zero degree, but has a faster maximum rotation speed. While both systems have a treatment couch weight specification which supports 95% of the patient population, Halcyon has a higher supported maximum weight limit. Due to the differences of isocenter height and gantry structure, TaiChiA has different couch travel range than Halcyon, but both systems meet the clinical coverage requirements of all standard treatment types.
As TaiChiA has some appreciable differences with Halcyon regarding the maximum dose rate, the beam collimation system, and the imaging system, the Varian TrueBeam system (K171733) is selected as the reference device for comparisons with TaiChiA. The TrueBeam system just like TaiChiA has an identical intended use, a 6MV FFF beam with maximum dose rate of 1400cGy/min, and is equipped with a single layer MLC system with 2.5cm/s maximum leaf speed and a maximum field size of 40cm x 40cm, and kV imaging capabilities.
5
The above-mentioned differences between TaiChiA and Halcyon have been verified and validated. It is demonstrated that these differences do not affect the TaiChiA's safety and effectiveness for patient treatment. The TaiChiA system is as safe and effective as the predicate device.
Detailed comparisons of TaiChiA with Halcyon (the predicate device) and TrueBeam (the reference device) are provided in the following tables, respectively.
| NO. | Attribute/Feature | Predicate Device
Varian Halcyon (K181032) | Proposed Device
TaiChiA Medical Linear
Accelerator |
|-----------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | General Information | | |
| 1 | Intended Use | The Halcyon radiotherapy delivery system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. | TaiChiA, is a Medical Linear Accelerator, intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. |
| 2 | Indications for Use | Halcyon is indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated for adults and pediatric patients. | TaiChiA, is a Medical Linear Accelerator, intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. |
| | Beam Specification | | |
| 3 | Beam energy (MV) | 6MV, FFF | 6MV, FFF |
| 4 | Maximum dose rate (cGy/min) | Up to 800 | Up to 1400 |
| 5 | Maximum treatment field (cm) | 28×28 | 40×40 |
| 6 | Dmax (cm) | $1.3\pm0.2$ | $1.5\pm0.2$ |
| 7 | Percentage dose at 10 cm depth (%) | $63.0\pm1.0$ | $65.0 \pm 2.0$ |
| 8 | Off axis intensity (%) | $79.0\pm2.0$ | $76.0 \pm 2.0$ |
| 9 | Symmetry (%) | $\le2.0$ | $\le3.0$ |
| | Dosimetry Specifications | | |
| 10 | Dose output vs. Total MU requested | 1.0% or 1.0 MU whichever is greater | 2% |
| 11 | Dose output constancy vs gantry angle (%) | $\pm 1.0$ | $\pm 1.0$ |
| | Geometric Specifications | | |
| 12 | Gantry rotation range (degrees) | $\pm 185$ | No limit (continuous rotation) |
| 13 | Collimator rotation
range (degrees) | $\pm$ 90 | $\pm$ 90 |
| 14 | Source to axis
distance (cm) | 100 | 100 |
| 15 | Isocenter height
relative to the floor
(cm) | 110 | 95 |
| 16 | Bore Diameter (cm) | 100 | 95 |
| 17 | Radiation isocenter
size (mm) | $\le$ 0.90 | $\le$ 1.0 |
| 18 | Gantry maximum
rotational speed
(RPM) | Up to 4.0 | Up to 1.0 |
| 19 | Collimator
maximum rotation
speed (RPM) | Up to 2.5 | Up to 1.0 |
| | Beam Shaping Specifications | | |
| 20 | Multi-Leaf
Collimator (MLC) | Two layers opposed leaf banks | Single layer opposed leaf banks |
| 21 | Maximum leaf
speed (cm/sec) | Up to 5.0 | Up to 2.5 |
| 22 | Number of MLC
leaves | 114 (in two layers) | 120 |
| 23 | Leaf resolution at
isoplane (cm) | 1.0 | 0.5 and 1.0 |
| 24 | Maximum leaf over
travel (cm) | 14.0 | 16.0 |
| 25 | Leaf interdigitating | Yes | Yes |
| 26 | Leaf end position
accuracy (cm) | $\pm$ 0.1 | $\pm$ 0.1 |
| 27 | Average leaf
transmission (%) | $\le$ 0.01 | $\le$ 1.0 |
| | Couch Specifications | | |
| 28 | Weight limit with
IGRT couch top
(kg) | 228 | 135 |
| 29 | Shift positioning
accuracy (cm) | $\le$ 0.05 | $\le$ 0.05 |
| 30 | Degrees of freedom | 3 | 3 |
| 31 | Lateral travel range
(cm) | $\pm$ 20.8 | $\pm$ 15.0 |
| 32 | Vertical travel
range (cm) | -47.5 to 0.0 | -28.0 to 10.0 |
| 33 | Longitudinal travel
range (cm) | 165.5 | 180.0 |
| Imaging Specifications | | | |
| 34 | Imaging beam | MV | kV |
| 35 | Imaging field of | $28.0 \times 28.0$ | $\phi$ 25.0 for head scan |
| | view (cm) | | $\phi$ 44.5 for body scan |
| 36 | Image
and | $\leq$ 0.1 | $\leq$ 0.1 |
| | treatment | | |
| | coincidence (cm) | | |
| 37 | CBCT acquisition | 256 x 256 reconstruction matrix / | 512 $\times$ 512 reconstruction matrix/ |
| | mode | 200 | 200 (head) or 360 (body) |
| | (pixels/degrees) | | |
| 38 | Dose per | 2 or 4MU (cGy) |