Hybrid3D

K171719 · Hermes Medical Solutions AB · KPS · Nov 21, 2017 · Radiology

Device Facts

• Record ID: K171719
• Device Name: Hybrid3D
• Applicant: Hermes Medical Solutions AB
• Product Code: KPS · Radiology
• Decision Date: Nov 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Hybrid3D that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

Device Story

Hybrid3D is a software module for medical imaging processing, display, and management. It accepts multi-modal data (PET, CT, MR, SPECT) transferred from external workstations or acquisition stations. The device performs multi-modal coregistration, interactive fusion, 3D segmentation, cropping, and interpolation. It includes a Lung Lobe Quantification module that automates 3D lobar anatomy computation from CT, integrating functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI). Used in clinical settings by healthcare professionals, the software allows clinicians to define VOIs, perform logic operations on structures, and render 3D fusion images. Output is provided as DICOM files for review and research. By facilitating accurate anatomical-to-functional mapping and quantitative analysis (SUV metrics), the device assists clinicians in diagnostic and treatment planning workflows.

Clinical Evidence

Bench testing only. Verification and validation performed per design control procedures. Comparative analysis between Hybrid3D v2.0 and Hermes Medical Imaging Suite v5.6 using phantom and patient studies. Metrics included linear measurements (r=0.999), Hounsfield units (r=0.999), and SUV parameters (SUVmax, SUVmean, SUVpeak) based on body weight, surface area, lean body mass, and BMI. SUV results generally within 5-10% variance, with Pearson's r ranging from 0.955 to 0.999. Automatic registration and RT structure set compatibility were verified as equivalent.

Technological Characteristics

Software-based image processing system. Features multi-modal coregistration, interactive fusion, 3D segmentation, and automated lobar anatomy quantification. Supports DICOM import/export. Operates as a workstation-based module for processing transferred medical imaging data. No hardware components; software-only device.

Indications for Use

Indicated for processing, displaying, analyzing, and managing nuclear medicine and other medical imaging data (PET, CT, MR, SPECT) for clinical use.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• Hermes Medical Imaging Suite v5.6 (K153056)
• Hybrid3D v1.0 (K163394)

Submission Summary (Full Text)

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November 21, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Hermes Medical Solutions AB % Joakim Arwidson Vice President Quality & Regulatory Affairs Skeppsbron 44 Stockholm. 11130 SWEDEN

Re: K171719

Trade/Device Name: Hybrid3D Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: September 15, 2017 Received: October 16, 2017

Dear Joakim Arwidson:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K171719

Device Name Hybrid3D

Indications for Use (Describe)

Hybrid3D that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 5.0 510 (k) SUMMARY

### A. Submitted by:

- Submitters name and address: Hermes Medical Solutions AB Skeppsbron 44 111 30 Stockholm Sweden
#### . Submitters telephone number

| Phone: | [phone] |
|---------|-----------------------------------|
| Cell: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

#### ● Contact person

Joakim Arwidson Quality Manager Hermes Medical Solutions AB Skeppsbron § 111 30 Stockholm Sweden

- . Reqistration number 9710645
### B. Preparation date:

2017-05-15

### C. Proprietary/Trade name, Common name, Classification name:

- Proprietary/Trade name . Hybrid3D v2.0
- . Common name Image processing systems
- . Classification name Emission Computer Tomography System, Class II, 21CFR892.1200

### D. Legally marketed device (predicate device):

Following legally marketed device has been used for comparison.

- Hermes Medical Imaging Suite v5.6 (K153056) ●
- . Hybrid3D v1.0 (K163394)

# E. Description of the device that is subject of this premarket notification:

HERMES Hybrid3D is a reading and processing module for the advanced needs in medical imaging. It offers multi-modal (PET/CT/MR/SPECT) coregistration and interactive fusion of multiple datasets. HybridViewer 3D handles viewing and fusion of multi-sequence MRI studies with oblique orientation and allows switching between original and standard TCS view orientation as well as defining own slice directions. 3D segmentation, cropping and interpolation techniques allow

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complex tasks in VOI definition and can cover cases like cavities, splitting structures into subsections or logic operations (compute intersections, merge, grow). Results can be imported and exported as DICOM and are therefore available for research in 3rd party tools. Additionally, it provides tools for advanced 3D fusion rendering of studies and VOIs.

The Lung Lobe Quantification module in Hybrid 3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function.

# F. Intended use:

Hybrid3D that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

# G. Technological characteristics:

The proposed device Hybrid3D has the same technological characteristics as the predicate device and the same indication for use.

# H. Testing:

The tests for verification and validation followed Hermes Medical Solutions AB design controlled procedures. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria.

# l. Substantially Equivalent/Conclusions:

The proposed device Hybrid3D and the predicate devices HERMES Medical Imaging Suite v5.6 (K153056) and Hybrid 3D v1.0 (K163394) have the same indication for use.

The proposed device will use similar technology and fundamental concepts and operation are also the same, as described in the 510(k) submission.

Comparisons were made between Hybrid 3D v2.0 and Hybrid Viewer in Hermes Medical Imaging Suite v5.6 (K153056).

- Linear measurements were made on phantom studies acquired with cameras from two ● different vendors and showed good results (Pearsons coeff. r = 0.999).
- Hounsfield units were estimated on CT phantom studies acquired with cameras from two different vendors and showed good results (Pearsons coeff. r = 0.999).
- Quantitative parameters SUV max, SUV mean and SUV peak, based on SUV Body Weight, were calculated on patient studies acquired with cameras from two different vendors. The results were generally within 5% (Pearsons coeff. r = 0.999) with the exception of SUV peak which differed in some cases by up to 10% (Pearsons coeff. r = 0.993). This parameters is sensitive to the exact position of the VOI from which the parameter is being measured, so this result is unsurprising as volumes had to be drawn separately in the 2 applications with inevitable operator variation.
- Quantitative parameters SUV max, SUV mean and SUV peak based on SUV Surface Area, Lean Body Mass and Body Mass Index were calculated on patient studies acquired with cameras from two different vendors. The results were generally within 5% (Pearsons coeff. r = 0.999) with the exception of SUV peak which differed in some cases by up to 10% (Pearsons coeff. r = 0.988). This parameters is sensitive to the exact position of the

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VOI from which the parameter is being measured, so this result is unsurprising as volumes had to be drawn separately in the 2 applications with inevitable operator variation.

- . SUV max and SUV mean were compared for Quick VOIs. The results for SUX max were within 6% (r=0.991) and for SUVmean within 10% (r=0.955). The poorer result for SUVmean is due to the fact that the VOI had to be positioned manually in the 2 applications with inevitable operator variation.
- Image labelling was compared and was shown to be the same.
- Automatic registration was compared with serial PT/CT patient studies, a PT study and external MR study, and a SPECT study and external CT study. The results in all were equivalent in the two applications.
- . Verification was made that RT structure sets saved in Hybrid 3D and loaded in Hybrid Viewer give the same results in both applications, and that RTP Structure Sets saved in HERMES Hybrid Viewer and loaded in Hybrid 3D give the same results in both applications. The results showed good agreement.

In summary, the Hybrid3D v2.0 described in this submission is in our opinion substantially equivalent to the predicate devices.