CURA 778

K192590 · Fmi Medical Systems, Inc. · JAK · Mar 5, 2020 · Radiology

Device Facts

• Record ID: K192590
• Device Name: CURA 778
• Applicant: Fmi Medical Systems, Inc.
• Product Code: JAK · Radiology
• Decision Date: Mar 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CURA 778 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes. The system may include signal analysis and display equipment supports, components and accessories. The CURA 778 scanner is a whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

Device Story

CURA 778 is a stationary whole-body CT scanner; utilizes rotating X-ray tube and detector array to acquire transmission data; reconstructs cross-sectional images. Features retina solid-state detector technology, ultrafast scintillator, integrated anti-scatter grid (ASG), and ASIC A/D technology to maximize SNR. Gantry design optimizes airflow and structural stability. Operated by physicians, CT technicians, or field service engineers in clinical settings. Software manages scan protocols, image reconstruction (3D, MPR, CPR, MIP), analysis (ROI), and dose modulation (imA). Output aids diagnosis and treatment planning. Integrates with third-party PACS (CREALIFE Anythink).

Clinical Evidence

Bench testing only. Verification and validation testing performed to ensure functional requirements met. Dosimetric testing conducted to confirm allowable limits. Sample clinical images evaluated by a certified radiologist.

Technological Characteristics

Stationary full gantry CT system; 70 cm aperture; +/- 30-degree tilt. Solid-state GOS detectors; 128 slices; 40 mm coverage. 80 kW generator; 8.0 MHU anode heat capacity. Flying focal spot (Z-direction). Connectivity: DICOM/PACS integration. Software: Moderate level of concern. Standards: IEC 60601-1, 60601-1-2, 60601-2-44, 60601-1-3, 60825-1, 61223-3-5, 62366-1, ISO 14971, ISO 13485.

Indications for Use

Indicated for whole body, cardiac, and vascular X-ray Computed Tomography imaging in patients of all ages.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Philips Ingenuity CT (K160743)
• CURA 16 (K173076)

Reference Devices

• CREALIFE Anythink PACS Workstation (K131299)

Submission Summary (Full Text)

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FMI Medical Systems, Inc. % Dazhuang Meng Senior Director of Product Development 29001 Solon Road, Unit A SOLON OH 44139

March 5, 2020

Re: K192590

Trade/Device Name: CURA 778 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: November 5, 2019 Received: January 21, 2020

Dear Dazhuang Meng:

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/cfpmp/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 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

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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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K192590

Device Name CURA 778

Indications for Use (Describe)

The CURA 778 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes.

The system may include signal analysis and display equipment supports, components and accessories.

The CURA 778 scanner is a whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

| 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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## Section 5 - 510(k) Summary

#### K192590

| 510(k) Submitter: | FMI Medical Systems Inc.<br>29001 Solon Road, Unit A,<br>Solon, Ohio 44139, USA<br>Phone: [phone]<br>Email: [e-mail] |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Dazhuang Meng, Senior Director of Product Development |
| 510(k) Preparer: | FMI Medical Systems Inc.<br>29001 Solon Road, Unit A,<br>Solon, Ohio 44139, USA<br>Phone: [phone]<br>Email: [e-mail] |
| Device Classification: | |
| Device Name: | CURA 778 |
| Regulation Name: | Computed tomography x-ray system |
| Review Panel: | Radiology |
| Product Code: | JAK |
| Regulation Number: | 21 CFR 892.1750 |
| Device Class: | 2 |
| Predicate Device: | |
| Predicate Device: | Philips Ingenuity CT |
| Predicate 510(k): | K160743 |
| Regulation: | 21 CFR 892.1750 |
| Regulation Name: | Computed tomography x-ray system |
| Class: | II |
| Product Code: | JAK |
| Panel: | Radiology |
| Manufacturer: | Philips Medical Systems (Cleveland), Inc. |
| Device Description: | |

The CURA 778 scanner is a medical imaging device utilizing X-ray computed tomography (CT) to obtain images of the entire body. The CURA 778 is a high performance imaging system that uses retina Solid State Detector technology to ensure high image quality. It uses ultrafast scintillator technology and application optimized algorithm to enhance image details and integrated anti-scatter grid (ASG) and A/D technology (ASIC) to maximize SNR. It produces better image quality by innovative calibration algorithms. Efficient design of the gantry helps achieve structural stability under high G-Load and optimize the air flow to guarantee long thermal stability for wide range of ambient temperature and pleasant user experience.

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The primary components of this system include the gantry, patient table, operator console and power distribution unit. Patient images are acquired, through the use of both hardware and software, via a rotating X-ray tube and detector array on the opposite side. The collected data is transmitted to the operator console for reconstruction into cross-sectional images.

The CURA 778 is designed for use in a controlled clinical setting, to collect X-ray images that aid in the diagnosis and treatment of various medical conditions by a physician or similarly licensed medical professional. The CURA 778 is intended for use by an appropriately trained or licensed professional, such as a physician, CT X-ray technician, or field service engineer. This device is restricted to sale by or on the order of a physician or similarly licensed medical professional (i.e. by prescription only).

The CURA 778 system is a stationary full gantry device. The gantry is comprised of several subsystems, including the X-ray tube, pre-patient collimator, detector array, cooling fans, power distribution unit, high voltage inverter, high voltage generator, data collection board (DCB) electronics and support electronics. The gantry is organized into two distinct sections, the stator (stationary elements) and the rotor (rotating elements). Slip rings are utilized to facilitate the transfer of electrical power and data between the gantry rotor and stator.

The CURA 778 system software implements many of the CURA 778 Whole Body system scanner. Among the functions performed by the software are:

- Entering and editing protocol, patient, and scan parameter data
- Initiating scans, executing scan protocols, monitoring status, and responding to faults ●
- Collecting image data and generating image views
- Image viewing (3d reconstruction, MPR, CPR, MIP)
- Image analysis (ROI)
- Reporting and image filming
- Exporting data for external viewing or printing
- Performing calibrations
- Performing diagnostics
- Dose modulation feature (imA)
- . Integrate a 30 party device for cardiac image processing, CREALIFE Anythink PACS Workstation, K131299 (510(k) number).

### Device Safety and Risk Management:

The CURA 778 system device safety and risk management activities are documented in an associated Risk Management Plan. This document defines that the system complies with the following safety standards:

- . IEC 60601-1, Medical electrical equipment
- IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- . IEC 60601-2-44, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

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- IEC 60601-1-3, Medical electrical equipment Part 1-3: General requirements for basic . safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60825-1, Safety of laser products - Part 1: Equipment classification and requirements
- . IEC 61223-3-5, Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
- IEC 62366-1, Medical devices -- Part 1: Application of usability engineering to medical devices

The Risk Management Plan has also documented the assessment of risk utilizing ISO standard ISO 14971:2012, Application of Risk Management to Medical Devices. The CURA 778 system has been assessed and evaluated for risk, via defined Criteria for Risk Acceptability, through an approved Risk Management Matrix.

The following reference standards and guidance documents were utilized in the design and development of the CURA 778 system:

- . ISO 14971:2012, Medical devices. Application of risk management to medical devices
- ISO 13485:2016, Application of quality management system for the design and manufacture of medical devices
- 21 CFR 820, Quality System Regulation
- 21 CFR 1020.33, Computed Tomography Equipment ●
- 21 CFR 1040.10, Laser Products (IEC 60825-1)
- 21 CFR 1020.30, Performance Standard for Diagnostic X-Ray Systems
- IEC 62304, Medical Device Software – Software life cycle processes

In addition, the CURA 778 system software documentation has been submitted according to a moderate level of concern utilizing the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued 05/11/05).

### Performance Testing:

The CURA 778 system was tested to ensure it functions as intended throughout the design process. The executed test documents were reviewed for accuracy and appropriateness as part of the design of the system. Additionally, evidence of dosimetric testing has been provided within this submission and was performed to ensure the allowable limits set forth by FMI Medical Systems are accurate and achievable by the system. Sample clinical images have been provided within the submission. The image quality has been evaluated by a certified radiologist.

### Indications for Use:

The CURA 778 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes.

The system may include signal analysis and display equipment, patient and equipment supports, components and accessories.

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The CURA 778 scanner is a whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

## Substantial Equivalence:

FMI Medical Systems Inc. is citing substantial equivalence of the CURA 778 system to the 510(k), K160743, predicate device Philips Ingenuity CT. Second substantial equivalence to the 510(k), K173076, predicate device CURA 16.

## Substantial Equivalence Statement:

FMI Medical Systems Inc. is citing substantial equivalence of the CURA 778 System to the Philips Ingenuity CT. Regulatory citations for the Philips Ingenuity CT are as follows:

| Predicate Device: | Philips Ingenuity CT |
|-------------------|-------------------------------------------|
| Predicate 510(k): | K160743 |
| Regulation: | 21 CFR 892.1750 |
| Class: | II |
| Product Code: | JAK |
| Panel: | Radiology |
| Manufacturer: | Philips Medical Systems (Cleveland), Inc. |

The CURA 778 System is substantially equivalent in design, intended use, indications for use and technology with the currently marketed predicate. There are no significant differences in materials, energy source, or technological characteristics. Both the proposed system and the predicate are computed tomography scanners that support visualization tools. The design and fundamental scientific technology of both systems compare favorably.

The CURA 778 System and the predicate both produce images of the head and body by computer reconstruction of X-ray transmission data. The subsystems (patient supports, generator, x-ray tube and detector) of both devices compare favorably, with only minor differences that do not affect safety and efficacy. This is supported by a comparison of system component characteristics and specifications in the table above.

The CURA 778 System is as safe and effective as the predicate device, as demonstrated by successful completion of verification and validation testing, risk management activities and conformance to international standards. It is the conclusion of FMI Medical Systems that the CURA 778 System is substantially equivalent to the predicate, Philips Ingenuity CT, and that there are no significant differences that raise new issues of safety or efficacy.

Additional comparisons are listed in the table below.

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| Characteristics –<br>Components /<br>Specifications | Predicate:<br>Ingenuity CT | Proposed:<br>CURA 778 | Comments |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Ingenuity CT is a<br>Computed Tomography X-<br>Ray System intended to<br>produce images of the head<br>and body by computer<br>reconstruction of x-ray<br>transmission data taken at<br>different angles and planes.<br><br>These devices may include<br>signal analysis and display<br>equipment, patient and<br>equipment supports,<br>components and<br>accessories.<br><br>The Ingenuity CT is indicated<br>for head, whole body, cardiac<br>and<br>vascular X-ray Computed<br>Tomography applications in<br>patients of all ages.<br><br>These scanners are intended<br>to be used for diagnostic<br>imaging and for low dose CT<br>lung cancer | The CURA 778 is a Computed<br>Tomography X-Ray System that<br>is intended to produce cross-<br>sectional images of the body by<br>computer reconstruction of X-ray<br>transmission data collected at<br>different angles and planes.<br><br>The system may include signal<br>analysis and display equipment,<br>patient and equipment supports,<br>components and accessories.<br><br>The CURA 778 scanner is a<br>whole body scanner, with<br>cardiac and vascular X-ray<br>Computed Tomography<br>applications in patients of all<br>ages. | The CURA 778 proposed<br>indications for use are<br>consistent with the predicate.<br>Both systems are capable of<br>imaging in axial and spiral<br>planes, at multiple angles.<br>Indicates the potential for<br>signal analysis and display<br>equipment, patient and<br>equipment supports,<br>components and accessories.<br>Whole body scanner, with<br>cardiac and vascular X-ray<br>Computed Tomography<br>applications in patients of all<br>ages.<br><br>Difference is that Philips<br>Ingenuity has low dose CT<br>lung cancer screening feature. |
| Design | | | |
| Application | Head / body | Full body (includes head) | Compares favorably |
| Scan regimen | Continuous rotation | Continuous rotation | Compares favorably |
| Scan modes | Surview (Scout)<br>Helical Scan<br>Axial Scan | Scout (Surview)<br>Helical<br>Axial<br>Multi-Axial(Step and Shoot) | Compares favorably |
| Gantry | | | |
| Gantry aperture<br>(bore) size | 70 cm | 70 cm | Compares favorably |
| Gantry tilt | +/-30 degrees | +/-30 degrees | Compares favorably |
| Focus –<br>isocenter distance | 570mm | 558 mm | Isocenter distance for CURA<br>778 is 12 mm smaller than the<br>predicate. This difference does<br>not affect safety or efficacy. |
| Focus - detector<br>distance | 1040 mm | 950.25 mm | Detector distance for the<br>CURA 778 is 89.75 mm smaller<br>than the predicate. This<br>difference does not affect<br>safety or efficacy. |
| Rotation times | 0.4,0.5, 0.75, 1, 1.5,2.0 seconds | 0.39, 0.5, 0.75, 1.0, 1.5, 2.0 seconds | Rotation time capability for<br>CURA 778 (ranges from 0.39 |
| Characteristics –<br>Components /<br>Specifications | Predicate:<br>Ingenuity CT | Proposed:<br>CURA 778 | Comments |
| | | | to 2.0 seconds) is similar to<br>the predicate (ranges from 0.4<br>to 2.0 seconds). For CURA 778,<br>5 out of 6 specific settings<br>(0.5, 0.75, 1.0, 1.5, and 2.0<br>seconds) are identical to the<br>predicate. This does not affect<br>safety or efficacy. |
| Patient Support / Couch / Table | | | |
| Patient supports | Included | Included | Compares favorably |
| Patient table scan<br>range | 2000 mm | 1700 mm | The patient table scan range is<br>300 mm shorter than the<br>predicate. This difference does<br>not affect safety or efficacy. |
| Table Z-position<br>accuracy | +/- 0.25 mm | +/- 0.25 mm | Compares favorably |
| Table longitudinal<br>speed | 1 to 100 mm / second | Up to 200 mm / second | The maximum speed<br>capability of the CURA 778 is<br>100 mm/sec greater than the<br>predicate. This difference does<br>not affect safety or efficacy. |
| Table maximum load<br>capacity | 204 kg | 205 kg | Table load capacities are<br>similar. The table supports 1<br>additional kilograms<br>compared to the predicate.<br>This difference does not<br>impact safety or efficacy. |
| Generator | | | |
| Generator power<br>rating | 80 kW | 80 kW | Compares favorably |
| kVp settings | 80, 100, 120, 140 kV | 80, 100, 120, 140 kV | Compares favorably |
| mA range (step size) | 20-665 mA (1 mA steps) | 10 – 660 mA (10 mA steps) | The mA range for the CURA<br>778 (10 – 660 mA) is similar<br>than the predicate (20 – 665<br>mA). Also, the step size of the<br>CURA 778 (10 mA) is greater<br>than that of the predicate (1<br>mA). These differences do not<br>affect safety or efficacy. |
| Characteristics –<br>Components /<br>Specifications | Predicate:<br>Ingenuity CT | Proposed:<br>CURA 778 | Comments |
| Focal spot size | 0.5 x 1.0 mm<br>1.0 x 1.0 mm | 0.6 mm x 1.2 mm (small)<br>1.1 mm x 1.2 mm (large) | The focal spot sizes for the<br>CURA 778 are greater than<br>those of the predicate. This<br>difference does not affect<br>safety or efficacy. |
| Anode effective heat<br>capacity | 8.0 MHU | 8.0 MHU | Compares favorably |
| X-ray tube,<br>maximum applied<br>power | 665 mA | 660 mA | X-ray tube maximum applied<br>power for the CURA 778 is 5<br>mA smaller than the<br>predicate. This difference does<br>not affect safety or efficacy. |
| Detector (DMS or Data Management System) | | | |
| Detectors | Solid-state GOS | Solid-state GOS | Compares favorably |
| Slices | 128 slices | 128 slices | Compares favorably |
| Coverage | 40 mm | 40 mm | Compares favorably |
| Slice thickness (mm)<br>(image<br>reconstruction) | 0.5mm-12.5mm | 0.5 mm<br>0.625 mm<br>1.25 mm<br>2.5 mm<br>5 mm<br>10 mm | For reconstruction of axial<br>images, the range of and<br>number of options for slice<br>thickness are similar between<br>the CURA 778 and the<br>predicate. Multiple options<br>provide the user with the<br>ability to select parameters<br>that support required image<br>quality and capture the target<br>area of interest. The<br>differences do not affect<br>safety or efficacy. |
| Slice thickness (mm)<br>(image<br>reconstruction) | 0.55 mm-5mm…