MOZI TPS

K223724 · Manteia Technologies Co., Ltd. · MUJ · Jul 10, 2023 · Radiology

Device Facts

• Record ID: K223724
• Device Name: MOZI TPS
• Applicant: Manteia Technologies Co., Ltd.
• Product Code: MUJ · Radiology
• Decision Date: Jul 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Automatic Organ-at-Risk (OAR) Segmentation	Equivalent performance to reference device K191928 (AccuContour™) based on Dice Similarity Coefficient (DSC).	Mean DSC values ranging from 0.61 to 0.99 across various OARs (e.g., Brainstem 0.88, Heart 0.98, Lung 0.99, Prostate 0.85).	560 training image sets from China.	187 testing image sets from the United States, independent of training data. Patient demographics: 57% male, 43% female; ages 21-100; 78% White, 12% Black or African American, 10% Other. Scanners: 28.3% GE, 33.7% Philips, 38% Siemens.
Automatic Deformable Image Registration	Non-inferiority to reference device K182624 (MIM-MRT Dosimetry) using Normalized Mutual Information (NMI) and Hausdorff Distance (HD).	NMI and HD values were non-inferior compared to the predicate device.	Not specified.	Multi-modality image sets from different patients generated in U.S. healthcare institutions, covering five major scanner vendors.

Indications for Use

The MOZI Treatment Planning System (MOZI TPS) is used to plan radiotherapy treatments with malignant or benign diseases. MOZI TPS is used to plan external beam irradiation with photon beams.

Device Story

MOZI TPS is a standalone software platform for radiotherapy treatment planning. It processes medical images (CT) to perform structure delineation, plan design, optimization, and evaluation. Inputs include patient imaging data; the system utilizes deep learning for automatic contouring and Monte Carlo methods for dose calculation. It supports rigid and deformable image registration. Operated by trained medical professionals in clinical settings, the software provides tools for IMRT and VMAT planning. Output includes treatment plans and dose distributions, which assist clinicians in designing and simulating radiation therapy. The device benefits patients by enabling precise, optimized radiation delivery for malignant or benign conditions.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing, including software verification/validation, commissioning per AAPM TG-119, and end-to-end testing on 18 patient cases. Automatic segmentation performance was validated against reference device K191928 using 560 training and 187 testing image sets, reporting Mean Dice Similarity Coefficient (DSC) values across various anatomical structures (e.g., Lung 0.99, Heart 0.98, Brainstem 0.88). Deformable registration was validated against reference device K182624 using NMI and HD metrics, showing non-inferiority.

Technological Characteristics

Standalone software; Windows-based. Features: Monte Carlo dose calculation (1-20 MeV), deep learning-based automatic segmentation, intensity-based rigid/deformable registration. Supports DICOM RT standards (Image, Structure, Plan, Dose). Complies with IEC 62083-2009, IEC 62304, and ISO 14971. No patient contact; no sterilization or biocompatibility requirements.

Indications for Use

Indicated for patients with malignant or benign diseases requiring external beam photon radiation therapy planning.

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

• Eclipse Treatment Planning System (Eclipse TPS) (K172163)

Reference Devices

• AccuContour™ (K191928)
• MIM-MRT Dosimetry (K182624)

Submission Summary (Full Text)

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Manteia Technologies Co., Ltd. Chao Fang RA 1903-1904, B Tower, Zijin Plaza, No.1811 Huandao East Road Xiamen. Fujian 361001 CHINA

Re: K223724

Trade/Device Name: MOZI TPS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: January 1, 2023 Received: January 3, 2023

Dear Mr. Chao Fang:

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

July 10, 2023

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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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner. The signature was created on July 10, 2023 at 17:31:17 -04'00'.

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) K223724

Device Name MOZI TPS

Indications for Use (Describe)

The MOZI Treatment Planning System (MOZI TPS) is used to plan radiotherapy treatments with malignant or benign diseases. MOZI TPS is used to plan external beam irradiation with photon beams.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

The following information is provided as required by 21 CFR 807.92. The assign 510(k) Number: K223724

## 1. SUBMITTER

| Name and Address: | Manteia Technologies Co., Ltd. |
|---------------------------------------|----------------------------------|
| | 1903-1904, B Tower, Zijin Plaza, |
| | No.1811 Huandao East Road, |
| | Xiamen, China |
| Establishment Registration<br>Number: | 3016686005 |
| Contact Person: | Chao Fang |
| | RA&QA Manager |
| | Email: [e-mail] |
| Date of Preparation: | July 9, 2023 |

## 2. DEVICE

| Device/Trade Name: | MOZI TPS |
|-------------------------|---------------------------------------------------|
| Common Name: | MOZI Treatment Planning System (MOZI TPS) |
| Product Classification: | Class II |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Product Code: | MUJ |
| Regulation Number: | 21CFR 892.5050 |
| Regulation Description: | Medical charged-particle radiation therapy system |

### 3. PREDICATE DEVICE

| Predicate Device: | K172163 (Eclipse Treatment Planning System (Eclipse TPS)) |
|---------------------|-----------------------------------------------------------|
| Reference Device 1: | K191928 (AccuContour™) |
| Reference Device 2: | K182624 (MIM-MRT Dosimetry) |

# 4. Device Description:

The proposed device, MOZI Treatment Planning System (MOZI TPS), is a standalone software which is used to plan radiotherapy treatments (RT) for patients with malignant or benign diseases.

Its core functions include image processing, structure delineation, plan design, optimization and evaluation. Other functions include user login, graphical interface, system and patient management. It can provide a platform for completing the related work of the whole RT plan.

The product uses generally accepted methods for below automatic function:

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> automatic rigid and deformable registration of image processing

- > dose calculation with Monte Carlo method of plan design and optimization
And it also uses deep learning method for automatic contouring of structure delineation.

### 5. INDICATIONS FOR USE

The MOZI Treatment Planning System (MOZI TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. MOZI TPS is used to plan external beam irradiation with photon beams.

## 6. SUBSTANTIALLY EQUIVALENT(SE) COMPARISON

The Subject Device, MOZI TPS, makes use of a Predicate Device, Eclipse TPS(K172163), as the Predicate Device for substantial equivalence comparison, and Reference Device 1, AccuContour™(K191928), and Reference Device 2, MIM-MRT Dosimetry(K182624), as Reference Device for performance comparison on automatic function of rigid registration, deformable registration and contouring. In addition, the subject device adopts the same algorithm as AccuContour™(K191928) on automatic function of rigid registration and contouring.

At a high level, both the predicate device and the subject device are based on the same characteristics:

· Both the subject device and the predicate provide software tools for planning the treatment of malignant or benign diseases with radiation.

· They are computer-based software devices used by trained medical professionals to design and simulate radiation therapy treatments.

- · They are both capable of planning treatments for external beam irradiation with photon.
The significant differences compared with the predicate device are as follows:

- 1. The intended use range of subject device is less than predicate device, which has been clearly stated in the intended use of subject device.
- 2. For dose calculation, the subject device incorporates a Monte Carlo based algorithm while the predicate device an AAA/AXB based algorithm. Both have been verified to be substantially equivalent by a performance test.
- 3. Performance test report on automatic rigid registration and contouring has been performed in subject device and reference device 1, AccuContour™(K191928). The test result is acceptable.
- 4. Performance test on automatic deformable has been performed in subject device and reference device 2, MIM-MRT Dosimetry(K182624). The test result is acceptable.

The following comparison table "Device Comparison Table" provides a detailed comparison.

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| 510(k) Summary |
|----------------|
| |

## Device Comparison Table

| ITEM | Subject Device | Predicate Device<br>K172163 | Reference Device<br>K191928 | Reference Device<br>K182624 |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information | | | | |
| Regulation No. | 21CFR 892.2050 | 21CFR 892.2050 | 21CFR 892.2050 | 21CFR 892.2050 |
| Product Code | MUJ | MUJ | QKB | LLZ |
| Class | II | II | II | II |
| Indication for Use | The MOZI Treatment<br>Planning System (MOZI<br>TPS) is used to plan<br>radiotherapy treatments<br>for patients with<br>malignant or benign<br>diseases. MOZI TPS is<br>used to plan external<br>beam irradiation with<br>photon beams. | The Eclipse Treatment<br>Planning System (Eclipse<br>TPS) is used to plan<br>radiotherapy treatments<br>for patients with<br>malignant or benign<br>diseases. Eclipse TPS is<br>used to plan external<br>beam irradiation with<br>photon, electron and<br>proton beams, as well as<br>for internal Irradiation<br>(brachytherapy)<br>treatments.<br>In addition, the Eclipse<br>Proton Eye algorithm is<br>specifically indicated for<br>planning proton treatment<br>of neoplasms of the eye. | It is used by radiation<br>oncology department to<br>register multi-modality<br>images and segment<br>(non-contrast) CT<br>images, to generate<br>needed information for<br>Treatment planning,<br>treatment evaluation and<br>treatment adaptation. | MIM software is used by trained<br>medical professionals as a tool to aid<br>in evaluation and Information<br>management of digital medical<br>images. The medical image<br>modalities include, but are not limited<br>to, CT, MRI, CR, DX, MG, US,<br>SPECT, PET and XA as supported by<br>ACR/NEMA DICOM 3.0. MIM<br>assists in the following indications:<br>- Receive, transmit, store,<br>retrieve, display, print, and<br>process medical images and<br>DICOM objects.<br>- Create, display and print reports<br>from medical images.<br>- Registration, fusion display, and<br>review of medical images for<br>diagnosis, treatment evaluation, |
| | | | | and treatment planning.<br>• Evaluation of cardiac left<br>ventricular function and<br>perfusion.<br>• Localization and definition of<br>objects such as tumors and<br>normal tissues in medical<br>images. |
| Label/labeling | Conform with 21CFR<br>Part 801 | Conform with 21CFR<br>Part 801 | Conform with 21CFR<br>Part 801 | Conform with 21CFR<br>Part 801 |
| Operating System | Windows | Windows | Windows | Windows and MAC |
| Technological Characteristics | | | | |
| Dose calculation algorithms | Monte Carlo (photon) | AAA、AXB | N/A | N/A |
| Auto rigid registration algorithms | Intensity based | Intensity based | Intensity based | Intensity based |
| Auto deformable registration algorithms | Intensity based | Intensity based | Intensity based | Intensity based |
| Auto segmentation algorithms | Deep learning | Atlas based | Deep learning | Atlas based |
| Graphical User Interface Features | | | | |
| Multiple-instance application | Yes | Yes | N/A | N/A |
| Multiple-workspace layout | Yes | Yes | N/A | N/A |
| Graphical display/editing of field<br>parameters | Yes | Yes | N/A | N/A |
| Beam's-Eye-View display | Yes | Yes | N/A | N/A |
| 3D patient image display | Yes | Yes | N/A | N/A |
| Dose-Volume Histogram display | Yes | Yes | N/A | N/A |
| Patient Management Features | | | | |
| DICOM RT | Yes | Yes | N/A | N/A |
| (the device supports RT<br>Image/ RT Structure/ RT<br>Plan/ RT Dose) | | (the device supports RT<br>Image/ RT Structure/ RT<br>Plan/ RT Dose) | | |
| Import/Delete/Export/Edit/Retrieve<br>patient data | Yes | Yes | N/A | N/A |
| Image Processing Features | | | | |
| CT/MR manual image registration | Yes | Yes | Yes | Yes |
| Auto rigid registration | Yes (Intensity Based) | Yes (Intensity Based) | Yes (Intensity Based) | Yes (Intensity Based) |
| Auto deformable registration | Yes (Intensity Based) | Yes (Intensity Based) | Yes (Intensity Based) | Yes (Intensity Based) |
| Structure Delineation Features | | | | |
| Automatic CT segmentation tool | Yes (deep learning) | Yes (Atlas based) | Yes (deep learning) | Yes (Atlas based) |
| Manual CT segmentation tool | Yes | Yes | Yes | Yes |
| Plan Design & Plan Optimization Features | | | | |
| Photon Calculation | Yes | Yes | N/A | N/A |
| - Energy Range | 1 MeV – 20 MeV | 1 MeV – 50 MeV | N/A | N/A |
| - 3-dimensional conformal radiation<br>therapy Planning | Yes | Yes | N/A | N/A |
| - Intensity modulated radiotherapy<br>Planning | Yes | Yes | N/A | N/A |
| - Volumetric modulated arc therapy<br>Planning | Yes | Yes | N/A | N/A |
| - Directional heterogeneity<br>correction | Yes | Yes | N/A | N/A |
| - Treatment Head modelling | Yes | Yes | N/A | N/A…