(128 days)
No
The description focuses on traditional radiotherapy technology (Cobalt-60 rotary focusing, gamma beam stereotactic radiation therapy) combined with image guidance (IGRT). There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a "radiotherapy equipment" intended to provide "stereotactic radiosurgery and precision radiotherapy" for "lesions, tumors, and conditions in the brain and head where radiation treatment is indicated," directly indicating a therapeutic purpose.
No
The device is described as a "teletherapy device" and "stereotactic radiotherapy equipment" intended to "deliver radiation treatments" for lesions and tumors. It is used to apply therapy, not to diagnose conditions.
No
The device description explicitly lists multiple hardware components (gantry, treatment head, image guidance subsystem, couch, power supply, etc.) and the performance studies include hardware verification and validation testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 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." This describes a therapeutic device that delivers radiation to treat conditions within the body.
- Device Description: The description details a system that delivers radiation treatments using a Cobalt-60 source and image guidance. This is consistent with a radiotherapy device, not a device used to examine specimens from the human body in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, urine, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is designed to deliver treatment directly to the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IWB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CBCT, kV-kV
Anatomical Site
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)
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. 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.
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
§ 892.5750 Radionuclide radiation therapy system.
(a)
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.(b)
Classification. Class II.
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 (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) 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)
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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
| 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: +86 15389012257 | |
| Email: qi.liu@ourunited.com |
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.
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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
O. | Feature | New Device | Predicate
Device
(K200050) | Reference Device
(K193207) | Analysis of
Differences |
|---------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Product
Name | OUR TaiChiC Rotating
Gamma System. | Akesis Galaxy RTx | OUR TaiChiA Medical
Linear
Accelerator | |
| 2 | Intended
Use | TaiChiC 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. | The Akesis Galaxy
RTx system is a
teletherapy device
intended for the
stereotactic
irradiation of head
structures. | 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. | The new device has
same intended use
as the Predicate
device,
and has same
intended use as the
Reference device
for treatment of
lesions in the brain
and head |
| 3 | Indications
for Use | ThiChiC 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. | The Akesis Galaxy
RTx system is a
teletherapy device
intended for the
stereotactic
irradiation of head
structures. | 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. | The new device has
same intended use
as the Predicate
device,
and has same
intended use as the
Reference device
for treatment of
lesions in the brain
and head |
| 4 | Radiation
source | Cobalt 60 | Cobalt 60 | 6MV X-ray | The new device
radiation source is
the same with the
Predicate Device |
| 5 | Initial Total
activity | 22860 Ci ±5% | 6000 Ci ±10% | Treatment beam 6 MV
nominal photon beam
energy. | The new device
total cobalt-60
activity at loading is
higher than the
Predicate Device,
but the dose rate at
the focal spot is at
the same level. |
| 6 | Number of
radiation
sources | 18 | 30 | Treatment beam 6 MV
nominal photon beam
energy. | The radioactive
sources of the new
device have higher
activities, and so
less radiation
sources are needed
compared with
Predicate device |
| | | Initial Dose
rate at the
focal spot | $\textgreater 3.0Gy / min$ | Up to 14 Gy / min | Radiation dose rate
at focal spot at
loading for the new
device is very
comparable to the
Predicate device
which is
appropriate for the
intended use. |
| 8 | Number of
collimator
sizes
(and
nominal
aperture
size) | 7:
$φ$ 6mm, $φ$ 9mm,
$φ$ 12mm, $φ$ 16mm,
$φ$ 20mm, $φ$ 25mm
and $φ$ 35mm | 4:
$φ$ 4 mm, $φ$ 8 mm,
$φ$ 14 mm, $φ$ 18 mm | NA | The new device
utilizes 7 sets of
collimator cones to
collimate the
Gamma rays, the
collimator sizes of
the new device
collimator sizes
( $φ$ 6mm, $φ$ 9mm,
$φ$ 12mm, $φ$ 16mm)
are similar with the
Predicate device. |
| 9 | Radiologic
accuracy | $\textless 0.5mm$ | $\textless 0.5mm$ | $\textless 1.0mm$ | The new device
radiologic accuracy
is the same as the
Predicate device |
| 10 | Patient
Couch | Yes | Yes | Yes | All systems have a
patient couch to
support patient
during treatment. |
| 11 | Imaging
techniques | CBCT、kV-kV | NA | CBCT、kV-kV | The new device
imaging techniques
is the same with the
Reference device. |
| 12 | Patient
immobilization
method | The Encompass™ SRS | Stereotactic Head
Frame and
Positioning System | The Encompass™ SRS
Immobilization System | The new device
lesion localization
falls within the
range of the
predicate, and same
as the reference
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.