AccuCheck

K223834 · Manteia Technologies Co., Ltd. · IYE · Jul 20, 2023 · Radiology

Device Facts

• Record ID: K223834
• Device Name: AccuCheck
• Applicant: Manteia Technologies Co., Ltd.
• Product Code: IYE · Radiology
• Decision Date: Jul 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

AccuCheck is a radiotherapy quality assurance software; operates in clinical settings by radiation oncology personnel. Inputs include radiotherapy treatment plans (TPS data) and LINAC delivery log files. Modules: TPS Check (parameter verification); Dose Check (secondary dose calculation via Monte Carlo algorithm); Transfer Check (data integrity verification); Pre-treatment/Treatment Check (reconstructs executed plans from LINAC logs to calculate delivered dose). Outputs include dose volume histograms, Gamma analysis, target coverage, and dose statistics. Healthcare providers use these outputs to verify plan executability, transmission integrity, and dose accuracy before and after treatment. Benefits include improved quality assurance and independent verification of radiation delivery, reducing potential errors in radiotherapy workflows.

Clinical Evidence

Bench testing only. No clinical data. Verification testing performed on 20 patient cases (IMRT/VMAT) across various tumor sites (Head/Neck, Chest, Abdomen). Evaluated dose-volume histograms (DVH), 3D dose distribution, dose profiles, and 3D gamma passing rates against FDA-cleared TPS systems. All test cases met pre-defined acceptance criteria.

Technological Characteristics

Software-only device; standalone. Supports DICOM RT (CT, CBCT, MR, RTStruct, RTPlan, RTDose). Dose calculation via Monte Carlo algorithm. Compatible with Varian and Elekta LINAC delivery logs. Conforms to IEC 62366-1, IEC 61217, and IEC 62304. Software level of concern: Major.

Indications for Use

Indicated for trained radiation oncology personnel to perform quality assurance, including data transfer integrity checks, secondary dose calculations using Monte Carlo algorithms, treatment plan verification, and independent dose verification based on LINAC delivery logs in radiotherapy.

Regulatory Classification

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.

Predicate Devices

• Mobius 3D v4.0 (K203669)

Reference Devices

• INTDose (K213137)

Submission Summary (Full Text)

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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

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

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# 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) | <span style="font-size: 1em;">☑</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |

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# 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: [e-mail]

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)

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# 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.

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# 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<br>assurance software used<br>for data transfer integrity<br>check, secondary dose<br>calculation with Monte<br>Carlo algorithm, and<br>treatment plan verification<br>in radiotherapy.<br>AccuCheck also provides<br>independent dose<br>verification based on<br>LINAC delivery log after<br>radiotherapy plan<br>execution.<br>AccuCheck is not a<br>treatment planning system<br>or a radiation delivery<br>device. It is to be used<br>only by trained radiation<br>oncology personnel for<br>quality assurance<br>purposes. | Mobius 3D (K203669)<br>Mobius3D software is<br>used for quality<br>assurance, treatment plan<br>verification, and patient<br>alignment and anatomy<br>analysis in radiation<br>therapy. It calculates<br>radiation dose<br>three-dimensionally in a<br>representation of a<br>patient or a phantom. The<br>calculation is based on<br>read-in treatment plans<br>that are initially<br>calculated by a treatment<br>planning system and may<br>additionally be based on<br>external measurements of<br>radiation fields from<br>other sources such as<br>linac delivery log data.<br>Patient alignment and<br>anatomy analysis is | INTDose (K213137)<br>INTDose is a software<br>product intended to<br>support the radiation<br>therapy treatment<br>planning process by<br>providing independent<br>dose verification<br>through Monte Carlo<br>simulation.<br>INTDose is not a<br>treatment planning<br>system or a radiation<br>delivery device and<br>should only be used by<br>trained radiation<br>oncology personnel as<br>a quality assurance<br>tool. |

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| based on read-in<br>treatment planning<br>images (such as<br>computed tomography)<br>and read-in daily<br>treatment images (such<br>as registered cone beam<br>computed tomography).<br><br>Mobius3D is not a<br>treatment planning<br>system. It is only to be<br>used by trained radiation<br>oncology personnel as a<br>quality assurance tool. | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Independent<br>Software | Yes | Yes | Yes |
| Product Code | IYE | IYE | IYE |
| Intended users | Trained radiation<br>oncology personnel | Trained radiation<br>oncology personnel | Trained radiation<br>oncology personnel |
| Regulation No. | 21 CFR 892.5050 | 21 CFR 892.5050 | 21 CFR 892.5050 |
| Patient management features | | | |
| Displaying Patient<br>and plan list | Yes | Yes | Yes |
| Displaying of Plan<br>Check Results | Yes | Yes | Yes |
| DICOM RT | Yes<br>(The device supports CT/<br>CBCT/ MR/ RTStruct/<br>RTPlan,/ RTDose) | Yes<br>(The device supports CT/<br>CBCT/ RTStruct/<br>RTPlan,/ RTDose) | Yes<br>(The device supports<br>CT/CBCT/ RTStruct/<br>RTPlan,/ RTDose) |
| Plan parameters checking features | | | |
| Supported treatment<br>techniques | 3D-CRT, IMRT, VMAT,<br>SRS, SBRT | 3D-CRT, IMRT, VMAT,<br>SRS, SBRT,<br>Brachythreaphy | TomoTherapy®,<br>3D-CRT, IMRT,<br>VMAT |
| Displaying of<br>inspection results | Yes | Yes | Yes |
| Dose verification features based on imported plan | | | |
| Supported treatment<br>techniques | 3D-CRT, IMRT, VMAT,<br>SRS, SBRT | 3D-CRT, IMRT, VMAT,<br>Brachythreaphy | TomoTherapy®,<br>3D-CRT, IMRT,<br>VMAT |
| DICOM data<br>supported by dose<br>calculation | CT/CBCT/MR, RTDose,<br>RTStructures, RTPlan) | CT/CBCT, RTDose,<br>RTStructures, RTPlan | CT/CBCT, RTDose,<br>RTStructures, RTPlan |

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| Beam type | Photon | Photon, Electron | Photon |
|-------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------|
| Dose calculation<br>algorithm | Monte Carlo algorithm | CCC/S algorithm for<br>photo, PBRA algorithm<br>for electron | Monte Carlo algorithm |
| Dose comparison | Yes | Yes | Yes |
| Displaying of<br>inspection results | Yes | Yes | Yes |
| Plan transmission verification features | | | |
| Supported treatment<br>techniques | 3D-CRT, IMRT, VMAT,<br>SRS, SBRT | 3D-CRT, IMRT, VMAT,<br>SRS, SBRT,<br>Brachythreaphy | TomoTherapy®,<br>3D-CRT, IMRT,<br>VMAT |
| Consistency check<br>on transferred plans | Yes | Yes | No |
| Displaying of check<br>results | Yes | Yes | N/A |
| Dose verification features based on accelerators' log | | | |
| LINAC log analysis | Varian's Linear<br>accelerators' log, Elekta's<br>linear accelerators' log | Varian's Linear<br>accelerators' log,<br>Elekta's linear<br>accelerators' log | N/A |
| Beam type | Photon | Photon, electron | Photon |
| Dose calculation<br>algorithm | Monte Carlo algorithm | CCC/S algorithm for<br>photo, PBRA algorithm<br>for electron | Monte Carlo algorithm |
| Dose comparison | Yes | Yes | Yes |
| Displaying of<br>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

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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).