(259 days)
With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.
Klarity SGRT system offers a dedicated non-irradiating and non-invasive surface guided radiation therapy solution. SGRT system includes three main application modules: patient positioning, treatment (motion) monitoring and respiratory gating.
With the patient positioning module, the SGRT system continuously senses the 3D patient body surface and compares it with the prerecorded reference surface by 3D image registration: The calculated 6 degree-of-freedom positioning deviations are visualized and sent to the positioning couch, to ensure a consistent and efficient inter-session patient setup/positioning, both manually and automated.
With the treatment (motion) monitoring module, the SGRT system monitors the patient's surface in real-time throughout the treatment session. Once the body part surface exceeds the predefined tolerance, the system will automatically alert the therapist and turnoff the beam immediately.
With the respiratory gating module, the system keeps tracking the patient's respiratory movements in real-time. During the treatment delivery, this functionality is used to maximize the protection of organs-at-risk; And in CT room, this functionality is used to make the 4DCT imaging best adapt to the patient's breathing in order to minimize the 4DCT imaging artifacts caused by the respiratory motion.
Klarity SGRT system mainly consists of advanced software. PC workstation, one or three 3D cameras and calibration tools. SGRT system provides two models, ARSG-E1A and ARSG-E3A.
The Klarity SGRT System (ARSG-E1A, ARSG-E3A) is a surface-guided radiation therapy solution. The following table outlines its acceptance criteria and reported performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) | Predicate Device (K113276) Performance | Reference Device (K082582) Performance |
|---|---|---|---|---|
| Measurement Accuracy | Better than 1mm | Better than 1mm | Better than 1mm | Better than 1mm |
| Measurement Reproducibility | Not greater than 0.5mm | Not greater than 0.5mm | 0.2mm | 0.2mm |
| Respiratory Gating Accuracy | ≤1mm | ≤1mm | Within 1mm for rigid body | Within 1mm for rigid body |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "Non-clinical tests were conducted to verify that the Klarity SGRT System (ARSG-E1A, ARSG-E3A) meets all design specifications". The provenance of the data for these non-clinical tests is not specified in terms of country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications. The studies mentioned are non-clinical performance and comparative tests, not expert-opinion based evaluations.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for a test set, as no clinical study involving human judgment is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. The document explicitly states: "The clinical test is not applicable, there's no clinical data."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, numerous standalone performance tests were conducted. The document states: "Non-clinical tests were conducted to verify that the Klarity SGRT System (ARSG-E1A, ARSG-E3A) meets all design specifications...". This includes specific performance metrics like measurement accuracy, reproducibility, and respiratory gating accuracy. These tests inherently evaluate the algorithm's performance in a standalone manner, separate from human intervention in a clinical setting.
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" would be established by precise physical measurements and reference systems used during these engineering and performance verification tests. This is not derived from expert consensus, pathology, or outcomes data, but rather from direct physical measurement.
8. The Sample Size for the Training Set
The document does not provide information about the sample size for a training set. As the device is referred to as "advanced software" and performs tasks like 3D image registration and real-time motion monitoring, it likely involves algorithms that would require training data, but details are not disclosed.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any potential training set was established.
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March 18, 2025
Klarity Medical & Equipment (GZ) Co., Ltd. % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China
Re: K241937
Trade/Device Name: Klarity SGRT System (ARSG-E1A, ARSG-E3A) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: June 24, 2024 Received: July 2, 2024
Dear Tracy Che:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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
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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,
Locon Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Klarity SGRT System (ARSG-E1A, ARSG-E3A)
Indications for Use (Describe)
With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information
| 510 (k) owner's name: | Klarity Medical & Equipment (GZ) Co., Ltd. | ||
|---|---|---|---|
| Address: | No. 14, 3rd Street Shawan GETDD Guangzhou Guangdong510730 China | ||
| Contact person: | Guohuang Zhou | ||
| Phone number: | +86 13580340561 | ||
| Fax number: | / | ||
| Email: | zhgh@klarity-medical.com | ||
| Date of summary prepared: | 2025-02-20 |
(2) Proprietary name of the device
| Trade name/Model: | Klarity SGRT System/Models: ARSG-E1A, ARSG-E3A |
|---|---|
| Common name: | Medical charged-particle radiation therapy system. |
| Classification name: | Accelerator, Linear, Medical |
| Regulation number: | 892.5050 |
| Product code: | IYE |
| Review panel: | Radiology |
| Regulation class: | Class II |
| Predicate device | |
|---|---|
| Sponsor | C-RAD POSITIONING AB |
| Device Name and Model | CATALYST |
| 510(k) Number | K113276 |
| Product Code | IYE |
| Regulation Number | 892.5050 |
| Regulation Class | Class II |
| Reference device | |
| Sponsor | C-RAD POSITIONING AB |
| Device Name and Model | SENTINEL, MODEL SP-001 |
| 510(k) Number | K082582 |
(3) Predicate and reference device
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| Product Code | IYE |
|---|---|
| Regulation Number | 892.5050 |
| Regulation Class | Class II |
(4) Description/ Design of device
Klarity SGRT system offers a dedicated non-irradiating and non-invasive surface guided radiation therapy solution. SGRT system includes three main application modules: patient positioning, treatment (motion) monitoring and respiratory gating.
With the patient positioning module, the SGRT system continuously senses the 3D patient body surface and compares it with the prerecorded reference surface by 3D image registration: The calculated 6 degree-of-freedom positioning deviations are visualized and sent to the positioning couch, to ensure a consistent and efficient inter-session patient setup/positioning, both manually and automated.
With the treatment (motion) monitoring module, the SGRT system monitors the patient's surface in real-time throughout the treatment session. Once the body part surface exceeds the predefined tolerance, the system will automatically alert the therapist and turnoff the beam immediately.
With the respiratory gating module, the system keeps tracking the patient's respiratory movements in real-time. During the treatment delivery, this functionality is used to maximize the protection of organs-at-risk; And in CT room, this functionality is used to make the 4DCT imaging best adapt to the patient's breathing in order to minimize the 4DCT imaging artifacts caused by the respiratory motion.
Klarity SGRT system mainly consists of advanced software. PC workstation, one or three 3D cameras and calibration tools. SGRT system provides two models, ARSG-E1A and ARSG-E3A.
(5) Indications for Use
With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.
| ComparisonElements | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 510(k) Number | K241937 | K113276 | K082582 | / |
| Trade name | Klarity SGRT System | Catalyst | SENTINEL, MODEL | / |
| ComparisonElements | Subject Device | Predicate Device | Reference Device | Remark |
| SP-001 | ||||
| Manufacturer | Klarity Medical & Equipment(GZ) Co., Ltd. | C-Rad Positioning AB | C-Rad Positioning AB | / |
| Regulationnumber | 21 CFR 892.5050 | 21 CFR 892.5050 | 21 CFR 892.5050 | Same |
| Product code | IYE | IYE | IYE | Same |
| Deviceclassification | Class II | Class II | Class II | Same |
| Indicationforuse/ Intended use | With radiotherapy equipment(Medical Linac, CT-Sim), it isused for patient positioningbefore treatment and continuousmonitoring of patients duringtreatment, and can also be usedto track patients' breathingmode(including DIBH, EEBH,4DCT three breathing modes),in order to implement imageacquisition synchronized withbreathing and radiation therapy. | The Catalyst system isintended for use in radiationtherapy clinics to accuratelyset-up and position patientsin a reproducible way prior totreatment, and to monitor thepatient continuously duringtreatment.The systemprovides information about apatient's position and theadjustments required in orderto position the patient asclose as possible to areference setup.Duringmonitoring, the systemreports deviations in thepatient's position duringtreatment and disables thetreatment beam in case oflarge detected movements.The system can also track thepatient's respiratory motionfor supporting synchronizedimage acquisition or gatedtreatment delivery.The system shall only beused by hospital personnel,qualified to work in radiationtherapy or diagnosticimaging departments. | The Sentinel system isintended for use inradiation therapy clinics toaccurately position patientsin a reproducible way,prior to treatment and tomonitor the patientcontinuously duringtreatment.The systemprovides information abouta patient's position and theadjustments required inorder to position thepatient as close as possibleto a reference setup.During monitoring, thesystem reports deviationsin the patient's positionduring treatment.The system shall only beused by hospital personnel,qualified to work inradiation therapy ordiagnostic imagingdepartments. | Same |
| PrescriptionOrOTC | Prescription | Prescription | Prescription | Same |
| ComparisonElements | Subject Device | Predicate Device | Reference Device | Remark |
| Targetpopulation | External-beam radiation therapypatients | External-beamradiationtherapy patients | External-beamradiationtherapy patients | Same |
| Anatomical sites | No specific restrictions | No specific restrictions | No specific restrictions | Same |
| Where used | Hospital | Hospital | Hospital | Same |
| Energy usedand/or delivered | Visible light (LED)Wavelength: 465nm | Visible light (LED)Wavelength: 405nm | Visible light (laser) | Similar |
| Human factors | Only qualified and trainedpersonnel are allowed to run thesystem. | Only qualified and trainedpersonnel are allowed to runthe system. Usabilityvalidation tests performed incollaboration with hospitals. | Only qualified and trainedpersonnel are allowed torun the system. Usabilityvalidation tests performedin collaboration withhospitals. | Same |
| Design | Opticaltriangulationmeasurement systemusingstructured visible light patternusing LED light source anddigital cameras. | Opticaltriangulationmeasurement system usingstructured visible lightpattern using one LED lightsource and digital camera.Additional LED light sourcesfor projecting visible lightpatterns. | Opticaltriangulationmeasurement system usingstructured visible lightpattern using one LEDlight source and onedigital camera. | Same |
| Mainfunctionmodules | Patient positioning:Inter-session patientsetup/positioning;Treatment (motion) monitoring:Monitor the patient's surface inreal-time throughout thetreatment session;Respiratory gating: Trackrespiratory movement. | cPosition: Fast and accuratepatient positioning;cMotion: Motion detectionduring treatment deliveryprocedure;cRespiration: Respiratorymotion monitoring. | cPosition: Fast andaccurate patientpositioning;cMotion: Motion detectionduring treatment deliveryprocedure. | Same |
| Power source | AC 100-240V, 47~63Hz | Not publicly available | Not publicly available | Different |
| Product structure | Advanced software, PCworkstation, one or three 3Dcameras and calibration tools. | Projector unit hardware andWindows based software | Scanner unit and c4Dmulti-application software | SimilarKeycomponents areall cameraand software |
| Measurementaccuracy | Measurement accuracy betterthan 1mm | Measurement accuracy betterthan 1mm | Measurement accuracybetter than 1mm | Same |
| ComparisonElements | Subject Device | Predicate Device | Reference Device | Remark |
| Scan volume | ARSG-E1A: Not less than 1100× 900×1000mm.ARSG-E3A: Not less than 1100× 1100×1000mm. | Not publicly available | 800×1300×700mm | Similar |
| Measurementreproducibility | No greater than 0.5mm | 0.2mm | 0.2mm | Similar |
| Respiratorygating accuracy | ≤1mm | Within 1mm for rigid body | Within 1mm for rigid body | Same |
| Laserclassification | Class I | Class II | Not publicly available | Different |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Same |
| Materials | No hazardous materials used,system not in direct contactwith patients. | No hazardous materials used,system not in direct contactwith patients. | No hazardous materials used, system not in direct contact with patients. | Same |
| Biocompatibility | Evaluated as per ISO 10993-1 | N/A | N/A | Similar |
| Compatibilitywiththeenvironment andother devices | EMC according to IEC60601-1-2 | EMC according to IEC60601-1-2 | EMC according to IEC60601-1-2 | Same |
| Sterility | N/ANot supplied sterile or intendedto be sterilized by user | N/A | N/A | Same |
| Mechanicalsafety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Same |
| Chemical safety | N/A | N/A | N/A | Same |
| Thermal safety | N/A | N/A | N/A | Same |
| Radiation safety | N/A | N/A | N/A | Same |
(6) Technological characteristics and substantial equivalence
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(7) Non-clinical studies and tests
Non-clinical tests were conducted to verify that the Klarity SGRT System (ARSG-E1A, ARSG-E3A) meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results also demonstrate that the device complies with the following standards and guidance:
- A IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests
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- IEC TS 60601-4-2, Medical electrical equipment Part 4-2: Guidance and interpretation > - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
-
IEC 60601-1-8, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 62471, Photobiological safety of lamps and lamp systems A
-
IEC 60825-1, Safety of laser products - Part 1: Equipment classification, and requirements
- A The FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices- Guidance for Industry and Food and Drug Administration Staff issued 2023". The software documentation for this device was considered as Enhanced Documentation Level.
- A The FDA "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions- Guidance for Industry and Food and Drug Administration Staff 2023.
Biocompatibility
The biocompatibility of this device have been evaluated and demonstrated conformance to the following standards:
- A ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Usability
Usability engineering study has been conducted and demonstrated conformance to the following standard and guidance:
- A IEC 60601-1-6. Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- A The FDA "Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff February 2016"
Performance
In order to verify and assure the performance, function and quality of the product, we have conducted performance verification to verify that the product performance conforms to device specification, compare the performance with predicate/reference device and verify the compatibility with CT and linear accelerator. The corresponding test reports can be seen in:
- A Performance test reports;
- A Comparative test reports;
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> Compatibility test reports with CT and Linear Accelerator.
Clinical testing
The clinical test is not applicable, there's no clinical data.
(8) Conclusion
Based on the above analysis and tests, it can be concluded that the Klarity SGRT System (ARSG-E1A, ARSG-E3A) is substantially equivalent to the predicate device Catalyst and the noted differences do not raise questions of safety and effectiveness.
§ 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.