(259 days)
No
The description focuses on 3D image registration and real-time monitoring based on predefined tolerances, without mentioning AI/ML techniques.
No.
The device is used for patient positioning, monitoring, and respiratory gating during radiotherapy. It does not directly provide therapy or treatment to the patient. It is used in conjunction with radiotherapy equipment, which delivers the therapeutic intervention.
No
The device is used for patient positioning, motion monitoring, and respiratory gating during radiation therapy and image acquisition. It does not diagnose medical conditions.
No
The device description explicitly states that the system consists of "advanced software. PC workstation, one or three 3D cameras and calibration tools," indicating the inclusion of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Klarity SGRT system works by sensing the external surface of the patient's body using visible light and cameras. It uses this information for patient positioning, motion monitoring, and respiratory gating during radiation therapy and imaging procedures.
- No Specimen Examination: The device does not involve the collection or analysis of any biological specimens from the patient. It interacts with the external surface of the body.
- Clinical Application: Its intended use is directly related to the delivery of radiation therapy and imaging, not the diagnosis or monitoring of a disease through the analysis of biological samples.
Therefore, the Klarity SGRT system falls under the category of a medical device used in the clinical setting for patient management during treatment and imaging, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IYE
Device Description
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.
Mentions image processing
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.
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.
The system can also track the patient's respiratory motion for supporting synchronized image acquisition or gated treatment delivery.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Visible light (LED)
Anatomical Site
No specific restrictions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by hospital personnel, qualified to work in radiation therapy or diagnostic imaging departments.
Care Setting: Hospital
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
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:
- IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- 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
- 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
- IEC 60825-1, Safety of laser products - Part 1: Equipment classification, and requirements
- 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.
- 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:
- 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:
- IEC 60601-1-6. Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- 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:
- Performance test reports;
- Comparative test reports;
- Compatibility test reports with CT and Linear Accelerator.
Clinical testing: The clinical test is not applicable, there's no clinical data.
Key Metrics
Measurement accuracy better than 1mm
Measurement reproducibility: No greater than 0.5mm
Respiratory gating accuracy: Between ≤1mm and within 1mm for rigid body
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
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.
1
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
2
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
3
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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."
4
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 Guangdong | ||
| 510730 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
5
| 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.
| Comparison
| Elements | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 510(k) Number | K241937 | K113276 | K082582 | / |
| Trade name | Klarity SGRT System | Catalyst | SENTINEL, MODEL | / |
| Comparison | ||||
| Elements | Subject Device | Predicate Device | Reference Device | Remark |
| SP-001 | ||||
| Manufacturer | Klarity Medical & Equipment | |||
| (GZ) Co., Ltd. | C-Rad Positioning AB | C-Rad Positioning AB | / | |
| Regulation | ||||
| number | 21 CFR 892.5050 | 21 CFR 892.5050 | 21 CFR 892.5050 | Same |
| Product code | IYE | IYE | IYE | Same |
| Device | ||||
| classification | Class II | Class II | Class II | Same |
| Indication | ||||
| for | ||||
| use/ Intended 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. | The Catalyst system is | |||
| intended for use in radiation | ||||
| therapy clinics to accurately | ||||
| set-up and position patients | ||||
| in a reproducible way prior to | ||||
| treatment, and to monitor the | ||||
| patient continuously during | ||||
| treatment. | ||||
| The system | ||||
| provides information about a | ||||
| patient's position and the | ||||
| adjustments required in order | ||||
| to position the patient as | ||||
| close as possible to a | ||||
| reference setup. | ||||
| During | ||||
| monitoring, the system | ||||
| reports deviations in the | ||||
| patient's position during | ||||
| treatment and disables the | ||||
| treatment beam in case of | ||||
| large detected movements. | ||||
| The system can also track the | ||||
| patient's respiratory motion | ||||
| for supporting synchronized | ||||
| image acquisition or gated | ||||
| treatment delivery. | ||||
| The system shall only be | ||||
| used by hospital personnel, | ||||
| qualified to work in radiation | ||||
| therapy or diagnostic | ||||
| imaging departments. | The Sentinel system is | |||
| intended for use in | ||||
| radiation therapy clinics to | ||||
| accurately position patients | ||||
| in a reproducible way, | ||||
| prior to treatment and to | ||||
| monitor the patient | ||||
| continuously during | ||||
| treatment. | ||||
| The system | ||||
| provides information about | ||||
| a patient's position and the | ||||
| adjustments required in | ||||
| order to position the | ||||
| patient as close as possible | ||||
| to a reference setup. | ||||
| During monitoring, the | ||||
| system reports deviations | ||||
| in the patient's position | ||||
| during treatment. | ||||
| The system shall only be | ||||
| used by hospital personnel, | ||||
| qualified to work in | ||||
| radiation therapy or | ||||
| diagnostic imaging | ||||
| departments. | Same | |||
| Prescription | ||||
| Or | ||||
| OTC | Prescription | Prescription | Prescription | Same |
| Comparison | ||||
| Elements | Subject Device | Predicate Device | Reference Device | Remark |
| Target | ||||
| population | External-beam radiation therapy | |||
| patients | External-beam | |||
| radiation | ||||
| therapy patients | External-beam | |||
| radiation | ||||
| therapy patients | Same | |||
| Anatomical sites | No specific restrictions | No specific restrictions | No specific restrictions | Same |
| Where used | Hospital | Hospital | Hospital | Same |
| Energy used | ||||
| and/or delivered | Visible light (LED) | |||
| Wavelength: 465nm | Visible light (LED) | |||
| Wavelength: 405nm | Visible light (laser) | Similar | ||
| Human factors | Only qualified and trained | |||
| personnel are allowed to run the | ||||
| system. | Only qualified and trained | |||
| personnel are allowed to run | ||||
| the system. Usability | ||||
| validation tests performed in | ||||
| collaboration with hospitals. | Only qualified and trained | |||
| personnel are allowed to | ||||
| run the system. Usability | ||||
| validation tests performed | ||||
| in collaboration with | ||||
| hospitals. | Same | |||
| Design | Optical | |||
| triangulation | ||||
| measurement system | ||||
| using | ||||
| structured visible light pattern | ||||
| using LED light source and | ||||
| digital cameras. | Optical | |||
| triangulation | ||||
| measurement system using | ||||
| structured visible light | ||||
| pattern using one LED light | ||||
| source and digital camera. | ||||
| Additional LED light sources | ||||
| for projecting visible light | ||||
| patterns. | Optical | |||
| triangulation | ||||
| measurement system using | ||||
| structured visible light | ||||
| pattern using one LED | ||||
| light source and one | ||||
| digital camera. | Same | |||
| Main | ||||
| function | ||||
| modules | Patient positioning: | |||
| Inter-session patient | ||||
| setup/positioning; | ||||
| Treatment (motion) monitoring: | ||||
| Monitor the patient's surface in | ||||
| real-time throughout the | ||||
| treatment session; | ||||
| Respiratory gating: Track | ||||
| respiratory movement. | cPosition: Fast and accurate | |||
| patient positioning; | ||||
| cMotion: Motion detection | ||||
| during treatment delivery | ||||
| procedure; | ||||
| cRespiration: Respiratory | ||||
| motion monitoring. | cPosition: Fast and | |||
| accurate patient | ||||
| positioning; | ||||
| cMotion: Motion detection | ||||
| during treatment delivery | ||||
| procedure. | Same | |||
| Power source | AC 100-240V, 47~63Hz | Not publicly available | Not publicly available | Different |
| Product structure | Advanced software, PC | |||
| workstation, one or three 3D | ||||
| cameras and calibration tools. | Projector unit hardware and | |||
| Windows based software | Scanner unit and c4D | |||
| multi-application software | Similar | |||
| Key | ||||
| components are | ||||
| all camera | ||||
| and software | ||||
| Measurement | ||||
| accuracy | Measurement accuracy better | |||
| than 1mm | Measurement accuracy better | |||
| than 1mm | Measurement accuracy | |||
| better than 1mm | Same | |||
| Comparison | ||||
| Elements | 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 | |
| Measurement | ||||
| reproducibility | No greater than 0.5mm | 0.2mm | 0.2mm | Similar |
| Respiratory | ||||
| gating accuracy | ≤1mm | Within 1mm for rigid body | Within 1mm for rigid body | Same |
| Laser | ||||
| classification | 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 contact | ||||
| with patients. | No hazardous materials used, | |||
| system not in direct contact | ||||
| with 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 |
| Compatibility | ||||
| with | ||||
| the | ||||
| environment and | ||||
| other devices | EMC according to IEC | |||
| 60601-1-2 | EMC according to IEC | |||
| 60601-1-2 | EMC according to IEC | |||
| 60601-1-2 | Same | |||
| Sterility | N/A | |||
| Not supplied sterile or intended | ||||
| to be sterilized by user | N/A | N/A | Same | |
| Mechanical | ||||
| safety | 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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8
(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
9
- 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;
10
> 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.