RUS

K233457 · Hutom, Inc. · QIH · Jul 12, 2024 · Radiology

Device Facts

• Record ID: K233457
• Device Name: RUS
• Applicant: Hutom, Inc.
• Product Code: QIH · Radiology
• Decision Date: Jul 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Organ segmentation	CADD U-NET	DSC 0.920	DSC 0.927	—	—	60 imaging studies of patients	>1 (medical professionals)
Vessel segmentation	3D U-NET	DSC 0.890	DSC 0.920	—	—	60 imaging studies of patients	>1 (medical professionals)
Pneumoperitoneum detection	Linear regression	MAE ± 1.083mm	MAE +/- 0.972 mm	—	—	60 imaging studies of patients	>1 (medical professionals)
Length measurement	—	mean difference +/- 10%	mean difference +/- 10%	—	—	phantom data and hu3D data	—

Indications for Use

RUS is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients. RUS accepts DICOM compliant medical images acquired from iodine contrast-enhanced abdomen CT. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, image fusion, surface rendering, measurements, reporting, storing, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments, including path definition through vascular and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.

Device Story

RUS is a software suite (h-Server, h-Space, RUS Stomach Planning) used in hospitals by clinicians to assist in surgical planning. It ingests DICOM-compliant iodine contrast-enhanced abdomen CT images via PACS. The device anonymizes/pseudonymizes data, performs 3D reconstruction, and uses machine learning models to segment anatomical structures (organs, vessels) and detect pneumoperitoneum. Outputs include 2D/3D visualizations, anatomical atlases, and measurements. Clinicians use these outputs to evaluate patient anatomy and plan therapy or surgery. The device acts as an auxiliary tool; clinicians remain solely responsible for final patient management decisions.

Clinical Evidence

Bench testing only. Performance validated using 60 CT imaging studies (independent of training data). Organ segmentation achieved 0.927 DSC (target 0.920); Vessel segmentation achieved 0.920 DSC (target 0.890); Pneumoperitoneum detection achieved +/- 0.972 mm MAE (target +/- 1.083 mm). Length measurement accuracy verified on phantom and hu3D data within +/- 10% mean difference.

Technological Characteristics

Software-based medical image management and processing system. Operates on Windows PC. Uses DICOM standards for data input/output. Employs machine learning models for segmentation and detection. Includes 2D/3D visualization, measurement, and reporting tools. Complies with IEC 62304 software life cycle processes.

Indications for Use

Indicated for trained medical professionals (physicians, surgeons, technicians) to aid in reading, interpreting, reporting, and treatment planning using iodine contrast-enhanced abdomen CT images. Not for primary diagnostic interpretation of mammography.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Visible Patient Suite (K212896)
• Synapse 3D Base Tools v6.6 (K221677)

Submission Summary (Full Text)

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July 12, 2024

Image /page/0/Picture/1 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Hutom Inc. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 IRVINE CA 92612

Re: K233457

Trade/Device Name: RUS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: OIH Dated: June 14, 2024 Received: June 14, 2024

Dear Priscilla Chung:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

Zhkke

, for

Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products 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) K233457

Device Name RUS

#### Indications for Use (Describe)

RUS is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients. RUS accepts DICOM compliant medical images acquired from iodine contrast-enhanced abdomen CT.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, image fusion, surface rendering, measurements, reporting, storing, storing, general image management and administration tools, etc.

It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular structures, etc.), including interactive segmentation tools, basic image filters, etc.

It also includes detection and labeling tools of organ segments, including path definition through vascular and interactive labeling.

The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.

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

| <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary

(K233457)

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

#### 1. Date: 06/13/2024

#### 2. Applicant / Submitter

Hutom Inc. 6F, 279, Dongmak-ro, Mapo-gu, Seoul Republic of Korea

#### 3. U.S. Designated Agent

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Fax: [phone] Tel: [phone] Email: [e-mail]

#### 4. Device Information:

- Trade/Device Name: RUS
- Common Name: Automated Radiological Image Processing Software
- Regulation Name: Medical image management and processing system ●
- Regulation Number: 21 CFR 892.2050
- Regulatory Class: II
- Product Code: QIH ●

#### 5. Predicate Device:

- Primary Predicate Device: Visible patient Suite (K212896) by Visible Patient, SAS ●
- Reference Predicate Device: Synapse 3D Base Tools v6.6 (K221677) by FUJIFILM ● Corporation

#### 6. Device Description:

RUS uses DICOM (Digital Imaging and Communications in Medicine) standards to analyze CT images. This software provides trained medical professionals with tools to aid them in

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reading, interpreting, reporting, and treatment planning. By observing the medical images standard protocol (DICOM standards), this software can receive transmitted images from medical imaging devices through the h-Server and can be interfaced with PACS (Picture Archiving and Communication System).

RUS allows surgical planning by 3D modeling from patient's CT data. Surgical planning in RUS does not replace actual surgery and can only be used as an auxiliary tool.

CT is taken at the hospital, the patient's CT data is obtained from PACS, and the CT data is transferred from PACS to h-Server. When CT data and patient information are registered in the h-Server, the data is pseudonymized and anonymized and safely moved to the h-Space. If you request hu3D production by registering CT data and patient information through h-Server, hu3D will be provided within 72 hours. Then you may download the hu3D model through RUS Stomach Planning and perform Surgical planning.

RUS is a software suite and includes three software components: h-Server, h-Space, and RUS Stomach Planning.

### 1) h-Server

h-Server includes modules dedicated to data management and data gateway. The software is a simple tool either to anonymize or pseudonymize multidimensional digital images acquired from a variety of medical imaging modalities (DICOM images). There is no 3D data volume interpretation in this software.

### 2) h-Space

h-Space includes data management (except for DICOM files

anonymization/pseudonymization module) and 3D reconstruction. This software offers a flexible solution to help trained medical professionals with image processing knowledge (usually radiologists or radiologist technicians) in (1) the evaluation of patient's anatomy, and (2) in the creation of a 3D model of the patient's anatomy. This software proposes flexible workflow options: visualization of patient's anatomy from medical images; creation a 3D model of the patient's anatomical structures, organ segments and volumetric data; creation of an anatomical atlas (a colored image where each color represents a structure); and exports these medical data to be analyzed or reviewed later.

# 3) RUS Stomach Planning

RUS Stomach Planning includes modules dedicated to patient & data management and surgical planning. This software offers a flexible visualization solution to help trained medical professionals (clinicians) in the evaluation of patient's anatomy to plan therapy or surgery.

# 7. Indication for use:

RUS is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients. RUS accepts DICOM compliant medical images acquired from iodine contrast-enhanced abdomen CT.

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This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc.

It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular structures, etc.), including interactive segmentation tools, basic image filters, etc.

It also includes detection and labeling tools of organ segments, including path definition through vascular and interactive labeling.

The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.

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### 8. Substantial Equivalence:

The RUS is substantially equivalent to the following predicate devices:

- Primary Predicate Device: Visible Patient Suite (K212896) by Visible Patient, SAS
- Reference Device: Synapse 3D Base Tools v6.6 (K221677) by FUJIFILM Corporation

# 8.1.Comparison Chart

| Elements of<br>Comparison | Subject Device | Primary Predicate | Additional Predicate | Comparison |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device Name | RUS | Visible patient Suite | Synapse 3D Base Tools v6.6 | |
| 510# | K233457 | K212896 | K221677 | |
| Manufacturer | Hutom | Visible Patient, SAS | FUJIFILM Corporation | |
| Classification<br>Name | System, Image Processing,<br>Radiological | System, Image Processing,<br>Radiological | System, Image Processing,<br>Radiological | Same |
| Regulation<br>Number No. | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Product Code | QIH | LLZ | LLZ | Same |
| Classification | Class II | Class II | Class II | Same |
| Indications for use | RUS is medical imaging software that<br>is intended to provide trained medical<br>professionals with tools to aid them in<br>reading, interpreting, reporting, and<br>treatment planning for patients. RUS<br>accepts DICOM compliant medical<br>images acquired from iodine contrast-<br>enhanced abdomen CT.<br>This product is not intended for use<br>with or for the primary diagnostic<br>interpretation of Mammography | Visible Patient Suite is medical<br>imaging software that is intended to<br>provide trained medical professionals<br>with tools to aid them in reading,<br>interpreting, reporting, and treatment<br>planning for both pediatric and adult<br>patients. Visible Patient Suite accepts<br>DICOM compliant medical images<br>acquired from a variety of imaging<br>devices, including CT, MR.<br>This product is not intended for use<br>with or for the primary diagnostic | Synapse 3D Base Tools is medical<br>imaging software that is intended to<br>provide trained medical professionals<br>with tools to aid them in reading,<br>interpreting, reporting, and treatment<br>planning. Synapse 3D Base Tools<br>accepts DICOM compliant medical<br>images acquired from a variety of<br>imaging devices including, CT, MR,<br>CR, US, NM, PT, and XA, etc. This<br>product is not intended for use with<br>or for the primary diagnostic | Same |
| Elements of<br>Comparison | Subject Device | Primary Predicate | Additional Predicate | Comparison |
| | images. | interpretation of Mammography | interpretation of Mammography | |
| | | images. | images. Synapse 3D Base Tools | |
| | The software provides several | The software provides several | provides several levels of tools to the | |
| | categories of tools. It includes basic | categories of tools. It includes basic | user: Basic imaging tools for general | |
| | imaging tools for general images, | imaging tools for general images, | images, including 2D viewing, | |
| | including 2D viewing, volume | including 2D viewing, volume | volume rendering and 3D volume | |
| | rendering and 3D volume viewing, | rendering and 3D volume viewing, | viewing, orthogonal/ oblique/ curved | |
| | image fusion, surface rendering, | orthogonal Multi-Planar | Multi-Planar Reconstructions (MPR), | |
| | measurements, reporting, storing, | Reconstructions (MPR), image fusion, | Maximum (MIP), Average (RaySum) | |
| | general image management and | surface rendering, measurements, | and Minimum (MinIP) Intensity | |
| | administration tools, etc. | reporting, storing, general image | Projection, 4D volume viewing, | |
| | | management and administration tools, | image fusion, image subtraction, | |
| | It includes a basic image processing | etc. | surface rendering, sector and | |
| | workflow and a custom UI to | It includes a basic image processing | rectangular shape MPR image | |
| | segment anatomical structures, which | workflow and a custom UI to segment | viewing, MPR for dental images, | |
| | are visible in the image data (bones, | anatomical structures, which are | creating and displaying multiple | |
| | organs, vascular structures, etc.), | visible in the image data (bones, | MPR images along an object, time- | |
| | including interactive segmentation | organs, vascular/airway structures, | density distribution, basic image | |
| | tools, basic image filters, etc. | etc.), including interactive | processing, noise reduction, CINE, | |
| | | segmentation tools, basic | measurements, annotations, | |
| | It also includes detection and labeling | image filters, etc. | reporting, printing, storing, | |
| | tools of organ segments, including | It also includes detection and labeling | distribution, and general image | |
| | path definition through vascular and | tools of organ segments (liver, lungs | management and administration | |
| | interactive labeling. | and kidneys), including path | tools, etc. | |
| | | definition through vascular/airway, | -Tools for regional segmentation of | |
| | The software is designed to be used | approximation of vascular/airway | anatomical structures within the | |
| | by trained professionals (including | territories from tubular structures and | image data, path definition through | |
| | physicians, surgeons and technicians) | interactive labeling. | vascular and other tubular structures, | |
| | and is intended to assist the clinician | The software is designed to be used | and boundary detection. | |
| | who is solely responsible for making | by trained professionals (including | -Image viewing tools for modality | |
| | all final patient management | physicians, surgeons and technicians) | specific images, including CT PET | |
| | decisions. | and is intended to assist the clinician | fusion and ADC image viewing for | |
| | | who is solely responsible for making | MR studies. | |
| Elements of<br>Comparison | Subject Device | Primary Predicate | Additional Predicate | Comparison |
| | | all final patient management<br>decisions. | -Imaging tools for CT images<br>including virtual endoscopic viewing<br>and dual energy image viewing.<br>-Imaging tools for MR images<br>including delayed enhancement<br>image viewing, diffusion-weighted<br>MRI image viewing. | |
| Intended user | Trained professionals (including<br>physicians, surgeons and technicians) | Trained professionals (including<br>physicians, surgeons and technicians)…