TaiChiC

K203250 · Our United Corporation · IWB · Mar 12, 2021 · Radiology

Device Facts

• Record ID: K203250
• Device Name: TaiChiC
• Applicant: Our United Corporation
• Product Code: IWB · Radiology
• Decision Date: Mar 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The system is a teletherapy device intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.

Device Story

TaiChiC is a stereotactic radiotherapy system using Cobalt-60 rotary focusing technology; delivers radiation to brain/head lesions based on a prescribed plan. System components: gantry with slip ring, focusing gamma ray treatment head, image guidance subsystem (CBCT, kV-kV), patient couch, power supply, and control console. Operated by clinicians in a clinical setting. Integrates gamma beam therapy with image-guided radiotherapy (IGRT) to enhance precision. Healthcare providers use interface software to monitor treatment and control radiation delivery. Benefits include precise targeting of intracranial lesions while sparing surrounding healthy tissue. Device uses 18 Cobalt-60 sources with higher activity to achieve dose rates comparable to predicate systems with more sources.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-11, IEC 60601-1-3, IEC 60601-2-68, IEC 61217, IEC 62274, IEC 62366-1, IEC 60601-1-6, ISO 15223-1, and ISO 10993-1. Hardware and software verification/validation performed per 21 CFR 820 and ISO 13485.

Technological Characteristics

Radionuclide radiation therapy system using Cobalt-60 sources. Features gantry with slip ring, 7 sets of collimators (6mm-35mm), and CBCT/kV-kV imaging. Dimensions/form factor include treatment bore and patient couch. Connectivity includes control console interface. Software level of concern: major. Sterilization: not applicable (non-invasive). Standards: IEC 60601-1, IEC 60601-2-11, IEC 60601-2-68, ISO 10993-1.

Indications for Use

Indicated for patients with lesions, tumors, and conditions in the brain and head requiring stereotactic radiosurgery or precision radiotherapy.

Regulatory Classification

Identification

A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

Predicate Devices

• Akesis Galaxy RTx (K200050)

Reference Devices

• TaiChiA Medical Linear Accelerator (K193207)

Submission Summary (Full Text)

{0}------------------------------------------------

March 12, 2021

Image /page/0/Picture/1 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 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 % Mr. 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: K203250

Trade/Device Name: TaiChiC Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: Class II Product Code: IWB Dated: February 3, 2021 Received: February 10, 2021

Dear Mr. 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 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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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) K203250

Device Name TaiChiC

Indications for Use (Describe)

The system is a teletherapy device intended 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 TaiChiC Rotating Gamma System

The following information is provided following the format of 21 CFR 807.92.

# I. GENERAL INFORMATION

K203250

| Submitter's Name: | OUR UNITED CORPORATION |
|-------------------|----------------------------------------------------------|
| | 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: [phone] |
| | Email: [e-mail] |

Date Prepared: Oct. 30th 2020

## II. DEVICE INFORMATION

| Proprietary Name: | TaiChiC |
|----------------------|---------------------------------------|
| Common/Usual Name: | Rotating Gamma System |
| Classification Name: | Radionuclide radiation therapy system |
| Device Regulation: | 21 CFR 892.5750 |
| Regulatory Class: | II |
| Product Code: | IWB |

## III. PREDICATE DEVICE

| Primary Device | Akesis Galaxy RTx (K200050) |
|----------------------|---------------------------------------|
| Classification Name: | Radionuclide radiation therapy system |
| Device Regulation: | 21 CFR 892.5750 |
| Regulatory Class: | II |

{4}------------------------------------------------

| Product Code: | IWB |
|----------------------|---------------------------------------------------|
| Reference Device | TaiChiA Medical Linear Accelerator (K193207) |
| Classification Name: | Medical charged-particle radiation therapy system |
| Device Regulation: | 21 CFR 892.5050 |
| Regulatory Class: | II |
| Product Code: | IYE |

### IV. Device Description:

TaiChiC Rotating Gamma System has been designed to deliver radiation treatments in accordance with a prescribed plan. This system is a stereotactic radiotherapy equipment developed by applying the principle and mature technology of Cobalt-60 rotary focusing. It is suitable for brain and head lesions and tumors requiring radiotherapy, and provides image guided stereotactic radiosurgery and precision radiotherapy.

TaiChiC consists of a gantry with a slip ring, a focusing gamma ray treatment head, image guidance subsystem, couch, power supply and electrical cabinet, main cover and treatment bore etc. TaiChiC combines gamma beam stereotactic radiation therapy technology with contemporary advanced image guidance technology (IGRT) to provide image guided stereotactic radiotherapy and precision radiotherapy.

## v. Intended Use:

The system is a teletherapy device intended 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:

The system is a teletherapy device intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.

{5}------------------------------------------------

### VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

TaiChiC and predicate Akesis Galaxy RTx are both Radionuclide radiation therapy system. falling within 21 CFR 892.5750, product code IWB. The proposed TaiChiC is comparable to the predicate device with respect to the intended use, indications for use, technological characteristics and similar performance specifications.

The TaiChiC is also appropriately comparable to another device, TaiChiA Medical Linear Accelerator, cleared under 510(k) K193207. TaiChiA Medical Linear Accelerator is classified as a Medical charged-particle radiation therapy system, falling within 21 CFR 892.5050, product code IYE. This reference device is included as it is similar to TaiChiC with respect to indications for use, imaging techniques, gantry rotation, patient immobilization, couch and other features.

With regards to technological characteristics, the TaiChiC Rotating Gamma System, the predicate device and the reference device all have similar features and components. TaiChiC and the predicate device have same intended use, and both fall within the broader scope of the reference device. TaiChiC and Akesis Galaxy RTx both utilize Cobalt-60 radiation source to generate the treatment beam. All three systems have patient supporting system (couch) to support and position the patient during the treatment. All three systems have control consoles and interface software to control and monitor the systems. All three systems protect the operator and the general public from the radiation from the machine.

The main differences between TaiChiC and the predicate device include the number of sources used, the image guidance and the number of the collimator sets.

Comparing with the predicate device with 30 radioactive sources, TaiChiC has only 18 sources but with higher activities to provide a comparable dose rate at the focal spot, which is appropriate for the intended use.

The CBCT and kV-kV imaging techniques used in TaiChiC are similar as those in the reference device, while the predicate device does not provide this technique.

TaiChiC provides 7 sets of collimators with beam diameter at the focal spot of 6mm, 9mm, 12mm, 16mm, 20mm, 25mm and 35mm. While the predicate device provides 4 sets of collimators ¢ 4 mm, Φ 8 mm, Φ 14 mm and Φ 18 mm. The first four sets of TaiChiC collimators ( d 6mm, o 12mm, φ16mm) are comparable to those of the predicate device and all the collimators of TaiChiC fall within the broad beam collimating sizes of the reference device.

The above differences among the proposed device, the predicate and the reference device do not raise any safety and effectiveness issues.

The comparisons between the proposed TaiChiC Rotating Gamma System and the predicate device Akesis Galaxy RTx, the reference device TaiChiA Medical Linear Accelerator are provided in the table below.

{6}------------------------------------------------

| N<br>O. | Feature | New Device | Predicate<br>Device<br>(K200050) | Reference Device<br>(K193207) | Analysis of<br>Differences |
|---------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Product<br>Name | OUR TaiChiC Rotating<br>Gamma System. | Akesis Galaxy RTx | OUR TaiChiA Medical<br>Linear<br>Accelerator | |
| 2 | Intended<br>Use | TaiChiC is a<br>teletherapy device<br>intended to provide<br>stereotactic<br>radiosurgery and<br>precision radiotherapy<br>for lesions, tumors, and<br>conditions in the brain<br>and head where<br>radiation treatment is<br>indicated. | The Akesis Galaxy<br>RTx system is a<br>teletherapy device<br>intended for the<br>stereotactic<br>irradiation of head<br>structures. | TaiChiA is a Medical<br>Linear<br>Accelerator, intended to<br>provide stereotactic<br>radiosurgery and<br>precision radiotherapy for<br>lesions,<br>tumors, and conditions<br>anywhere in<br>the body where radiation<br>treatment<br>is indicated. | The new device has<br>same intended use<br>as the Predicate<br>device,<br>and has same<br>intended use as the<br>Reference device<br>for treatment of<br>lesions in the brain<br>and head |
| 3 | Indications<br>for Use | ThiChiC is a<br>teletherapy device<br>intended to provide<br>stereotactic<br>radiosurgery and<br>precision radiotherapy<br>for lesions, tumors, and<br>conditions in the brain,<br>and head, where<br>radiation treatment is<br>indicated. | The Akesis Galaxy<br>RTx system is a<br>teletherapy device<br>intended for the<br>stereotactic<br>irradiation of head<br>structures. | 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. | The new device has<br>same intended use<br>as the Predicate<br>device,<br>and has same<br>intended use as the<br>Reference device<br>for treatment of<br>lesions in the brain<br>and head |
| 4 | Radiation<br>source | Cobalt 60 | Cobalt 60 | 6MV X-ray | The new device<br>radiation source is<br>the same with the<br>Predicate Device |
| 5 | Initial Total<br>activity | 22860 Ci ±5% | 6000 Ci ±10% | Treatment beam 6 MV<br>nominal photon beam<br>energy. | The new device<br>total cobalt-60<br>activity at loading is<br>higher than the<br>Predicate Device,<br>but the dose rate at<br>the focal spot is at<br>the same level. |
| 6 | Number of<br>radiation<br>sources | 18 | 30 | Treatment beam 6 MV<br>nominal photon beam<br>energy. | The radioactive<br>sources of the new<br>device have higher<br>activities, and so<br>less radiation<br>sources are needed<br>compared with<br>Predicate device |
| | | Initial Dose<br>rate at the<br>focal spot | $\textgreater 3.0Gy / min$ | Up to 14 Gy / min | Radiation dose rate<br>at focal spot at<br>loading for the new<br>device is very<br>comparable to the<br>Predicate device<br>which is<br>appropriate for the<br>intended use. |
| 8 | Number of<br>collimator<br>sizes<br>(and<br>nominal<br>aperture<br>size) | 7:<br>$φ$ 6mm, $φ$ 9mm,<br>$φ$ 12mm, $φ$ 16mm,<br>$φ$ 20mm, $φ$ 25mm<br>and $φ$ 35mm | 4:<br>$φ$ 4 mm, $φ$ 8 mm,<br>$φ$ 14 mm, $φ$ 18 mm | NA | The new device<br>utilizes 7 sets of<br>collimator cones to<br>collimate the<br>Gamma rays, the<br>collimator sizes of<br>the new device<br>collimator sizes<br>( $φ$ 6mm, $φ$ 9mm,<br>$φ$ 12mm, $φ$ 16mm)<br>are similar with the<br>Predicate device. |
| 9 | Radiologic<br>accuracy | $\textless 0.5mm$ | $\textless 0.5mm$ | $\textless 1.0mm$ | The new device<br>radiologic accuracy<br>is the same as the<br>Predicate device |
| 10 | Patient<br>Couch | Yes | Yes | Yes | All systems have a<br>patient couch to<br>support patient<br>during treatment. |
| 11 | Imaging<br>techniques | CBCT、kV-kV | NA | CBCT、kV-kV | The new device<br>imaging techniques<br>is the same with the<br>Reference device. |
| 12 | Patient<br>immobilization<br>method | The Encompass™ SRS | Stereotactic Head<br>Frame and<br>Positioning System | The Encompass™ SRS<br>Immobilization System | The new device<br>lesion localization<br>falls within the<br>range of the<br>predicate, and same<br>as the reference<br>device. |

{7}------------------------------------------------

{8}------------------------------------------------

#### 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 standards for safety and the IEC 60601-1-2 standard for EMC.

#### Bench Test

Successful testing was performed in accordance with following standards:

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 Xray 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

ISO10993-1:2009, 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.

{9}------------------------------------------------

Test results showed conformance to applicable requirements specifications and assured 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 TaiChiC

#### Summary

The verification and validation testing demonstrated that TaiChiC has met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use.

#### VI. CONCLUSIONS

The TaiChiC has the same intended use, indications for use, fundamental scientific technology as the predicate device.

The difference among TaiChiC and predicate does not raise any new safety or effectiveness issues. The differences are substantial equivalent to the reference device

The Verification and Validation demonstrates that the device is as safe and effective as the predicate device.

Based on the comparison and analysis above, OUR therefore believes that TaiChiC is substantially equivalent to the predicate device.