(210 days)
No
The description focuses on traditional algorithms like Monte Carlo and data integrity checks, with no mention of AI/ML terms or methodologies.
No
The device is described as quality assurance software used for data transfer integrity checks, secondary dose calculation, and treatment plan verification, specifically stating it is not a treatment planning system or a radiation delivery device. Its primary purpose is quality assurance rather than direct treatment or diagnosis.
No.
AccuCheck is explicitly described as quality assurance software for radiotherapy, performing tasks like data integrity checks, secondary dose calculations, and treatment plan/delivery verification. It is not used for diagnosing medical conditions or diseases in patients. Instead, it assesses the accuracy and integrity of radiotherapy plans and deliveries.
Yes
The device description explicitly states "AccuCheck is a quality assurance software" and details its functions as software modules (TPS Check, Dose Check, Transfer Check, Pre-treatment Check, Treatment Check) that process data from other medical devices (TPS, LINAC delivery logs). There is no mention of accompanying hardware components included with the device itself.
Based on the provided information, AccuCheck is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AccuCheck's Function: AccuCheck's intended use and device description clearly state that it is a quality assurance software for radiotherapy. Its functions involve:
- Data transfer integrity checks.
- Secondary dose calculations using a Monte Carlo algorithm.
- Treatment plan verification.
- Independent dose verification based on LINAC delivery logs.
- No Specimen Analysis: AccuCheck does not analyze any biological specimens from a patient. It operates on data related to the radiotherapy treatment plan and delivery, which are physical parameters and logs, not biological samples.
Therefore, AccuCheck falls under the category of medical device software used in the context of radiation therapy, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution.
AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
Product codes
IYE
Device Description
AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
AccuCheck performs using the TPS Check module to check related parameters in the radiotherapy plan to determine if the plan is executable by the linear accelerator( LINAC).
AccuCheck also performs using the Dose Check module to conduct dose calculation verification for radiation treatment plans before radiotherapy by doing an independent calculation of radiation dose using Monte Carlo algorithm. Radiation dose is initially calculated by a Treatment Planning System (TPS).
AccuCheck performs using the Transfer Check module to verify the integrity of the treatment plan transmitted from TPS to the LINAC to check if errors occur during the transmission.
AccuCheck performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a LINAC's delivery log files to reconstruct executed plan and calculate delivered dose. This is achieved through the software module of the Subject Device called Pre-treatment Check and Treatment Check. The difference lies in the usage scenario, where Pre-treatment Check processes the logs of the first execution of the treatment plan in LINAC without a patient actually being treated, while treatment check processes the logs of the second and subsequent execution of the treatment plan in LINAC with a patient actually being treated. AccuCheck cannot be used for log verification, but rather for dose calculation based on logs such as LINAC delivery log data. The reconstruct of the executed plan and calculation of the delivered dose from delivery logs on LINAC machines, including Varian LINAC and Elekta LINAC, are supported by AccuCheck.
The product provides with multiple tools to assist the analysis, including dose volume histogram, Gamma analysis, target coverage, Gamma passing rate of each ROI, dose statistics and clinical targets evaluation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT/CBCT/MR
Anatomical Site
Head and Neck, Chest, Abdomen (including Brain, Lung, GI cancers)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained radiation oncology personnel for quality assurance purposes.
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
A verification test for the secondary dose calculation of the subject device was perform for 20 patients that have been treated with IMRT and VMAT techniques. For each tumor location, there are 10 samples for Head and Neck cancers, 5 samples for Chest cancers and 5 samples for Abdomen samples, including Brain , Lung, Head and Neck, and GI cancers. The joint testing devices include two FDA-cleared LINACs and two FDA-cleared TPS systems from different vendors.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing (Non-Clinical Testing).
Secondary Dose Calculation verification test for 20 patients (10 Head and Neck, 5 Chest, 5 Abdomen/Brain/Lung/GI cancers) treated with IMRT and VMAT. The results of all test cases passed the test criteria and the following items were checked during the test: The dose - volume histogram (DVH), dose index, 3D dose distribution, dose profile, gamma distribution, pass/fail results for the dose - volume histogram (DVH) limits, the 3D gamma passing rate, and differences in dose indices between the subject device and the FDA cleared TPS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
July 20, 2023
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Manteia Technologies Co., Ltd. % Yingkai Lin RA Manager 1903-1904, B Tower, Zijin Plaza No.1811 Huandao East Road Xiamen. Fujian 361001 CHINA
Re: K223834
Trade/Device Name: AccuCheck Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: June 22, 2023 Received: June 22, 2023
Dear Yingkai Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lora 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
2
Indications for Use
510(k) Number (if known) K223834
Device Name AccuCheck
Indications for Use (Describe)
AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution.
AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
| 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.
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
510(k) Summary
The following information is provided as required by 21 CFR 807.92.
The assign 510(k) Number: K223834
1. SUBMITTER
Manteia Technologies Co., Ltd.
1903-1904, B Tower, Zijin Plaza, No.1811 Huandao East Road, Xiamen,, China
Establishment Registration Number: 3016686005
Contact Person: Chao Fang
Position: RA&OA Manager
Email: fangchao@manteiatech.com
Date of Preparation: July 20, 2023
2. Identification of Proposed Device
Device/Trade Name: AccuCheck Common Name: Radiotherapy Plan Quality Assurance System Regulatory Information Classification Name: accelerator, linear, medical Classification: II Product Code: IYE Regulation Number: 21CFR 892.5050
3. PREDICATE DEVICE
Review Panel: Radiology
Predicate Device: Mobius 3D v4.0 (K203669) Reference Device: INTDose (K213137)
4
510(K) Summary
4. DEVICE DESCRIPTION
AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
AccuCheck performs using the TPS Check module to check related parameters in the radiotherapy plan to determine if the plan is executable by the linear accelerator( LINAC).
AccuCheck also performs using the Dose Check module to conduct dose calculation verification for radiation treatment plans before radiotherapy by doing an independent calculation of radiation dose using Monte Carlo algorithm. Radiation dose is initially calculated by a Treatment Planning System (TPS).
AccuCheck performs using the Transfer Check module to verify the integrity of the treatment plan transmitted from TPS to the LINAC to check if errors occur during the transmission.
AccuCheck performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a LINAC's delivery log files to reconstruct executed plan and calculate delivered dose. This is achieved through the software module of the Subject Device called Pre-treatment Check and Treatment Check. The difference lies in the usage scenario, where Pre-treatment Check processes the logs of the first execution of the treatment plan in LINAC without a patient actually being treated, while treatment check processes the logs of the second and subsequent execution of the treatment plan in LINAC with a patient actually being treated. AccuCheck cannot be used for log verification, but rather for dose calculation based on logs such as LINAC delivery log data. The reconstruct of the executed plan and calculation of the delivered dose from delivery logs on LINAC machines, including Varian LINAC and Elekta LINAC, are supported by AccuCheck.
The product provides with multiple tools to assist the analysis, including dose volume histogram, Gamma analysis, target coverage, Gamma passing rate of each ROI, dose statistics and clinical targets evaluation.
5. INDICATIONS FOR USE
AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution.
AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
5
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
AccuCheck designed the corresponding functional modules considering the timeline of radiotherapy treatment. AccuCheck verified the feasibility and dose accuracy of the treatment plan before implementation. After execution, AccuCheck verified the consistency of data transmission and read the accelerator execution log to restore the treatment plan.
The primary technical feature of AccuCheck and its predicate device is to check the information of the plan files according to relative parameters to ensure the quality of the treatment plan. The verification of dose is an important part of ensuring the quality of treatment plan. When verifying the dose of the treatment plan, AccuCheck and its predicate device are used to perform a secondary dose calculation on the read or imported file and compare with the original plan dose, and present the results in various ways. The technological characteristics are believed to be substantially equivalent to the predicate device. The following comparison table "Device Comparison Table" provides a detailed comparison.
| Comparison item | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Regulatory Information | |||
| Indication for use | AccuCheck is a quality | ||
| assurance software used | |||
| for data transfer integrity | |||
| check, secondary dose | |||
| calculation with Monte | |||
| Carlo algorithm, and | |||
| treatment plan verification | |||
| in radiotherapy. | |||
| AccuCheck also provides | |||
| independent dose | |||
| verification based on | |||
| LINAC delivery log after | |||
| radiotherapy plan | |||
| execution. | |||
| AccuCheck is not a | |||
| treatment planning system | |||
| or a radiation delivery | |||
| device. It is to be used | |||
| only by trained radiation | |||
| oncology personnel for | |||
| quality assurance | |||
| purposes. | Mobius 3D (K203669) | ||
| Mobius3D software is | |||
| used for quality | |||
| assurance, treatment plan | |||
| verification, and patient | |||
| alignment and anatomy | |||
| analysis in radiation | |||
| therapy. It calculates | |||
| radiation dose | |||
| three-dimensionally in a | |||
| representation of a | |||
| patient or a phantom. The | |||
| calculation is based on | |||
| read-in treatment plans | |||
| that are initially | |||
| calculated by a treatment | |||
| planning system and may | |||
| additionally be based on | |||
| external measurements of | |||
| radiation fields from | |||
| other sources such as | |||
| linac delivery log data. | |||
| Patient alignment and | |||
| anatomy analysis is | INTDose (K213137) | ||
| INTDose is a software | |||
| product intended to | |||
| support the radiation | |||
| therapy treatment | |||
| planning process by | |||
| providing independent | |||
| dose verification | |||
| through Monte Carlo | |||
| simulation. | |||
| INTDose is not a | |||
| treatment planning | |||
| system or a radiation | |||
| delivery device and | |||
| should only be used by | |||
| trained radiation | |||
| oncology personnel as | |||
| a quality assurance | |||
| tool. |
6
| based on read-in
treatment planning
images (such as
computed tomography)
and read-in daily
treatment images (such
as registered cone beam
computed tomography).
Mobius3D is not a
treatment planning
system. It is only to be
used by trained radiation
oncology personnel as a
| quality assurance tool. | |||
|---|---|---|---|
| Independent | |||
| Software | Yes | Yes | Yes |
| Product Code | IYE | IYE | IYE |
| Intended users | Trained radiation | ||
| oncology personnel | Trained radiation | ||
| oncology personnel | Trained radiation | ||
| oncology personnel | |||
| Regulation No. | 21 CFR 892.5050 | 21 CFR 892.5050 | 21 CFR 892.5050 |
| Patient management features | |||
| Displaying Patient | |||
| and plan list | Yes | Yes | Yes |
| Displaying of Plan | |||
| Check Results | Yes | Yes | Yes |
| DICOM RT | Yes | ||
| (The device supports CT/ | |||
| CBCT/ MR/ RTStruct/ | |||
| RTPlan,/ RTDose) | Yes | ||
| (The device supports CT/ | |||
| CBCT/ RTStruct/ | |||
| RTPlan,/ RTDose) | Yes | ||
| (The device supports | |||
| CT/CBCT/ RTStruct/ | |||
| RTPlan,/ RTDose) | |||
| Plan parameters checking features | |||
| Supported treatment | |||
| techniques | 3D-CRT, IMRT, VMAT, | ||
| SRS, SBRT | 3D-CRT, IMRT, VMAT, | ||
| SRS, SBRT, | |||
| Brachythreaphy | TomoTherapy®, | ||
| 3D-CRT, IMRT, | |||
| VMAT | |||
| Displaying of | |||
| inspection results | Yes | Yes | Yes |
| Dose verification features based on imported plan | |||
| Supported treatment | |||
| techniques | 3D-CRT, IMRT, VMAT, | ||
| SRS, SBRT | 3D-CRT, IMRT, VMAT, | ||
| Brachythreaphy | TomoTherapy®, | ||
| 3D-CRT, IMRT, | |||
| VMAT | |||
| DICOM data | |||
| supported by dose | |||
| calculation | CT/CBCT/MR, RTDose, | ||
| RTStructures, RTPlan) | CT/CBCT, RTDose, | ||
| RTStructures, RTPlan | CT/CBCT, RTDose, | ||
| RTStructures, RTPlan |
7
| Beam type | Photon | Photon, Electron | Photon |
|---|---|---|---|
| Dose calculation | |||
| algorithm | Monte Carlo algorithm | CCC/S algorithm for | |
| photo, PBRA algorithm | |||
| for electron | Monte Carlo algorithm | ||
| Dose comparison | Yes | Yes | Yes |
| Displaying of | |||
| inspection results | Yes | Yes | Yes |
| Plan transmission verification features | |||
| Supported treatment | |||
| techniques | 3D-CRT, IMRT, VMAT, | ||
| SRS, SBRT | 3D-CRT, IMRT, VMAT, | ||
| SRS, SBRT, | |||
| Brachythreaphy | TomoTherapy®, | ||
| 3D-CRT, IMRT, | |||
| VMAT | |||
| Consistency check | |||
| on transferred plans | Yes | Yes | No |
| Displaying of check | |||
| results | Yes | Yes | N/A |
| Dose verification features based on accelerators' log | |||
| LINAC log analysis | Varian's Linear | ||
| accelerators' log, Elekta's | |||
| linear accelerators' log | Varian's Linear | ||
| accelerators' log, | |||
| Elekta's linear | |||
| accelerators' log | N/A | ||
| Beam type | Photon | Photon, electron | Photon |
| Dose calculation | |||
| algorithm | Monte Carlo algorithm | CCC/S algorithm for | |
| photo, PBRA algorithm | |||
| for electron | Monte Carlo algorithm | ||
| Dose comparison | Yes | Yes | Yes |
| Displaying of | |||
| inspection results | Yes | Yes | Yes |
7. PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
Software Verification and Validation Testing (Non-Clinical Testing)
Software verification and validation 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.
Test results demonstrate conformance to applicable requirements and specifications. No animal studies or clinical tests have been included in this premarket submission.
Secondary Dose Calculation verification test
8
A verification test for the secondary dose calculation of the subject device was perform for 20 patients that have been treated with IMRT and VMAT techniques. For each tumor location, there are 10 samples for Head and Neck cancers, 5 samples for Chest cancers and 5 samples for Abdomen samples, including Brain , Lung, Head and Neck, and GI cancers. The joint testing devices include two FDA-cleared LINACs and two FDA-cleared TPS systems from different vendors. The results of all test cases passed the test criteria and the following items were checked during the test: The dose - volume histogram (DVH), dose index, 3D dose distribution, dose profile, gamma distribution, pass/fail results for the dose - volume histogram (DVH) limits, the 3D gamma passing rate, and differences in dose indices between the subject device and the FDA cleared TPS.
8. Standards Conformance
The subject device conforms in whole or in part with the following standards:
• IEC 62366-1:2015 Medical device Part 1 - Application of usability engineering to medical devices
- · IEC 61217:2011 Radiotherapy Equipment Coordinates, Movements and Scales
- · IEC 62304:2006+A1:2015 Medical device software Software life cycle processes
Further, during the development, potential hazards were controlled by a risk management plan including risk analysis, risk mitigation, verification and validation.
9. CONCLUSION
AccuCheck is believed to be substantially equivalent to the predicate device in terms of its indications for use, technical characteristics, and overall performance. The information provided in this submission indicates substantial equivalence to the predicate device.
Therefore, Manteia Technologies Co., Ltd. considers the subject device, AccuCheck, is substantially equivalent to the predicate device Mobius3D v4.0 (K203669).