Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly mentions "Deep learning contouring," which is a type of machine learning technology.

Therapeutic

No
The device is a software tool used for image processing and analysis to aid in treatment planning, not to directly treat or diagnose a disease.

Diagnostic

No

The device is used for treatment planning, evaluation, and adaptation in radiation oncology, which falls under therapeutic rather than diagnostic purposes. While it processes medical images, its output is primarily used to guide treatment, not to diagnose a condition.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that AccuContour is a "standalone software" and lists only software-based functions like image processing, data management, and analysis. There is no mention of accompanying hardware components that are part of the device itself.

IVD (In Vitro Diagnostic)

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 used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
Device Function: The described device, AccuContour, is a software used for image processing (registration and segmentation) of medical images (CT, MRI, PET, CBCT). It operates on images acquired from the patient's body, not on samples taken from the body.
Intended Use: The intended use is for radiation oncology treatment planning, evaluation, and adaptation, which is a clinical process involving medical imaging, not laboratory testing of biological samples.

The device is clearly a medical imaging software used in a clinical setting for treatment planning, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.

Overview

Intended Use / Indications for Use

It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.

Product codes (comma separated list FDA assigned to the subject device)

QKB

Device Description

The proposed device, AccuContour, is a standalone software which is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.

The product has two image processing functions:

(1) Deep learning contouring: it can automatically contour organs-at-risk, in head and neck, thorax, abdomen and pelvis (for both male and female) areas,
(2) Automatic registration: rigid and deformable registration, and
(3) Manual contouring.

It also has the following general functions:

Receive, add/edit/delete, transmit, input/export, medical images and DICOM data;
Patient management;
Review of processed images;
Extension tool;
Plan evaluation and plan comparison;
Dose analysis.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes - Deep learning contouring

Input Imaging Modality

Non-Contrast CT
Auto rigid registration: CT, MRI, PET
Auto deformable registration: CT, MRI, CBCT

Anatomical Site

head and neck, thorax, abdomen and pelvis (for both male and female)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

radiation oncology department

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Deformable registration performance test:
The registration performance test was performed on proposed device and reference device (K182624) to evaluate the deformable registration accuracy. All fixed images and moving images are generated in healthcare institutions in U.S. The scanner models covered products from five major vendors. The image registration feature is tested on multi-modality image sets from different patients. The Normalized Mutual Information (NMI) was used for evaluation. NMI values were calculated on two sets of images for both the proposed device and reference device (K182624), respectively. The NMI value of proposed device was compared with that of the reference device. According to the results, it could be concluded that the NMI of proposed device was non-inferior to that of the reference device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Normalized Mutual Information (NMI)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191928

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K182624, K173636, K181572

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Summary

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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: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. The full name of the agency, "U.S. Food & Drug Administration," is written in blue letters next to the acronym.

Manteia Technologies Co., Ltd. % Dandan Chen RA 1903, B Tower, Zijin Plaza No. 1811 Huandao East Road Xiamen, 361001 CHINA

Re: K221706

Trade/Device Name: AccuContour Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QKB Dated: Mav 31, 2022 Received: June 13, 2022

Dear Dandan Chen:

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

March 9, 2023

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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 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 (OS) 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 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 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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner. The date of the signature is March 9th, 2023. The time of the signature is 19:17:29 -05'00'.

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221706

Device Name AccuContour

Indications for Use (Describe)

It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.

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)

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510(k) Summary

I . SUBMITTER

Manteia Technologies Co., Ltd. 1903, B Tower, Zijin Plaza, No.1811 Huandao East Road, Xiamen

China Establishment Registration Number: 3016686005

Contact Person: Dandan Chen Position: RA Tel: +86 592-6100813 Email: chendandan@manteiatech.com

Date Prepared: March 9, 2023

II . DEVICE

Name of Device: AccuContour Common or Usual Name: Medical Imaging Software Classification Name: System, Imaging processing, Radiological Regulatory Class: II Product Code: QKB Regulation Number: 21CFR 892.2050 Review Panel: Radiology

III. PREDICATE DEVICE

Device	510(k) Number	Product Name
Predicate Device	K191928	AccuContour™
Reference Device	K182624	MIM-MRT Dosimetry
Reference Device	K173636	Velocity
Reference Device	K181572	Workflow Box

IV. DEVICE DESCRIPTION

The proposed device, AccuContour, is a standalone software which is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.

The product has two image processing functions:

(1) Deep learning contouring: it can automatically contour organs-at-risk, in head and neck,

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thorax, abdomen and pelvis (for both male and female) areas,

(2) Automatic registration: rigid and deformable registration, and
(3) Manual contouring.

It also has the following general functions:

Receive, add/edit/delete, transmit, input/export, medical images and DICOM data;
Patient management;
Review of processed images;
► Extension tool;
Plan evaluation and plan comparison;
► Dose analysis.

V . INDICATIONS FOR USE

It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.

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VI. SUBSTANTIALLY EQUIVALENT (SE) COMPARISION

Table 1 Comparison of Technology Characteristics

| ITEM | Proposed Device | Predicate Device
K191928 | Reference Device
K182624 | Reference Device
K173636 | Reference Device
K181572 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information | | | | | |
| Regulation No. | 21CFR 892.2050 | 21CFR 892.2050 | 21CFR 892.2050 | 21CFR 892.2050 | 21CFR 892.2050 |
| Product Code | QKB | QKB | LLZ | LLZ | LLZ |
| Indication for Use | It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation. | It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT information for treatment planning, treatment evaluation and treatment adaptation. | MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:
Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.Create, display and print reports from medical images. | Velocity is a software package that provides the physicians a means for comparison of medical data including imaging data that is DICOM compliant.
It allows the display, annotation, volume operation, volume rendering, registration, and fusion of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. Velocity is not intended for mammography. | Workflow Box is a software system designed to allow users to route DICOM-compliant data to and from automated processing components.
Supported modalities include CT, MR, RTSTRUCT.
Workflow Box includes processing components for automatically contouring imaging data using deformable image registration to support atlas based contouring, re-contouring of the same patient and machine learning based contouring.
Workflow Box is a data routing and image processing tool which automatically applies contours to |

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		Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. Evaluation of cardiac left ventricular function and perfusion, including left ventricular enddiastolic volume, end-systolic volume, and ejection fraction. Localization and definition of objects such as tumors and normal tissues in medical images. Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy transferring contours to
		radiation
therapy
		transferring contours to
		radiation therapy treatment
		planning systems,
and
		archiving contours for
		patient
follow-up
and
		management.
	●	Quantitative and statistical
		analysis of PET/SPECT
		brain scans by comparing
		to other

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |

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| Label/labeling | Conform with 21CFR
Part 801 | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 |
|-----------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| Operating
System | Windows | Windows | Windows and MAC system | Windows and MAC system | Windows |
| Segmentation Features
Algorithm | Deep Learning | Deep Learning | Atlas-based | Atlas-based | Atlas Based contouring |
| | | | ones, this device should
only be used for research
purposes.
Lossy compressed
mammographic images and
digitized film screen images
must not be reviewed for
primary image interpretations.
Images that are printed to film
must be printed using an
FDA-approved printer for the
diagnosis of digital
mammography images.
Mammographic images must be
viewed on a display system that
has been cleared by the FDA for
the diagnosis of digital
mammography images. The
software is not to be used for
mammography CAD. | | |
| | | | | | registration based |
| | | | | | re-contouring, machine learning
based contouring |
| Compatible
Modality | Non-Contrast CT | Non-Contrast CT | Non-Contrast CT | Non-Contrast CT | CT、MR |
| Compatible
Scanner Models | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. |
| Compatible
Treatment
Planning
System | No Limitation on TPS model, DICOM
3.0 compliance required. | No Limitation on TPS model, DICOM
3.0 compliance required. | No Limitation on TPS model, DICOM
3.0 compliance required. | No Limitation on TPS model, DICOM
3.0 compliance required. | No Limitation on TPS model, DICOM
3.0 compliance required. |
| Unattended
workstation | Yes | No | Not stated | No | Yes |
| Registration Features | | | | | |
| Algorithm | Intensity Based. | Intensity Based. | Intensity Based. | Intensity Based. | Intensity Based. |
| Image
registration | Auto rigid registration and auto deformable registration. | Auto rigid registration | Auto rigid registration and deformable registration. | Auto rigid registration and deformable registration. | Auto rigid registration and deformable registration. |
| Compatible
Modality | Auto rigid registration:
CT, MRI, PET
Auto deformable
registration: CT, MRI, CBCT | CT, MRI, PET | CT, MRI, CR, DX, MG, US, SPECT, PET and XA | PET/SPECT/CT/MRI | CT, MRI |
| | Compatible
Scanner Models | | | | |
| Compatible
Scanner Models | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. |
| Compatible
Treatment
Planning
System | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. | No Limitation on scanner model,
DICOM 3.0 compliance required. |
| Plan Evaluation Feature | | | | | |
| Display of
DICOM RT
Plans | Yes | No | Not stated | Yes | No |
| Isodose Line
Display | Yes | No | Not stated | Yes | No |
| DVH statistics
display | Yes | No | Not stated | Yes | No |
| RT Plans
comparison | Yes | No | Not stated | Yes | No |
| Dose Analysis Feature | | | | | |
| Display of
DICOM RT
Doses | Yes | No | Not stated | Yes | No |
| Dose
accumulation | Yes | No | Not stated | Yes | No |

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

1. Non-Clinical Test Conclusion

Deformable registration performance test

The registration performance test was performed on proposed device and reference device (K182624) to evaluate the deformable registration accuracy. All fixed images and moving images are generated in healthcare institutions in U.S. The scanner models covered products from five major vendors. The image registration feature is tested on multi-modality image sets from different patients. The Normalized Mutual Information (NMI) was used for evaluation. NMI values were calculated on two sets of images for both the proposed device and reference device (K182624), respectively. The NMI value of proposed device was compared with that of the reference device. According to the results, it could be concluded that the NMI of proposed device was non-inferior to that of the reference device.

2. Clinical Test Conclusion

No clinical study is included in this submission.

3. Software Verification and Validation Testing

Software verification and validation testing 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.

Software bench testing in the form of Unit, System and Integration tests were performed to evaluate the performance and functionality of the new features and software updates. Software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.

VIII. SUBSTANIALLY EQUIVALENT (SE) CONCLUSION

The proposed device is substantially equivalent to the predicate device AccuContour™ (K191928).