CURA 16; ScintCare CT16

K173076 · Fmi Medical Systems, Inc. · JAK · Oct 4, 2018 · Radiology

Device Facts

• Record ID: K173076
• Device Name: CURA 16; ScintCare CT16
• Applicant: Fmi Medical Systems, Inc.
• Product Code: JAK · Radiology
• Decision Date: Oct 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The CURA CT16/ScintCare CT16 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 system is suitable for all patients.

Device Story

CURA CT16/ScintCare CT16 is a stationary full-gantry CT scanner for whole-body imaging. System inputs include X-ray transmission data acquired via a rotating X-ray tube and detector array. The gantry utilizes retina solid-state detector technology with ultrafast scintillators, integrated anti-scatter grids (ASG), and ASIC technology to maximize signal-to-noise ratio. Data is transmitted to an operator console for reconstruction into cross-sectional images. Used in controlled clinical settings by physicians, CT technicians, or field service engineers. Software supports protocol management, scan execution, image viewing (3D, MPR, CPR, MIP), analysis (ROI), and reporting. Device aids in diagnosis and treatment of medical conditions. Benefits include high-quality imaging through optimized calibration algorithms and structural stability under high G-loads. Future options include metal artifact reduction, iterative reconstruction, and dose modulation (imA).

Clinical Evidence

Bench testing only. System functionality verified throughout design process. Dosimetric testing performed to ensure limits are accurate and achievable. Sample clinical images evaluated by a certified radiologist.

Technological Characteristics

Stationary full-gantry CT system. Components: X-ray tube, pre-patient collimator, detector array, cooling fans, power distribution unit, high voltage inverter/generator, DCB electronics. Detector: Solid-state ultra-high speed rare earth ceramic scintillator. Gantry: 70 cm aperture, +/- 30-degree tilt. Connectivity: Operator console for data reconstruction. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-44, IEC 60601-1-3, IEC 60825-1, IEC 61223-3-5, IEC 62366-1, ISO 14971:2012, ISO 13485:2016.

Indications for Use

Indicated for all patients requiring cross-sectional body imaging via X-ray computed tomography reconstruction.

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

• SOMATOM Emotion 16 (K151752)

Submission Summary (Full Text)

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FMI Medical Systems Inc. % Paul McFeely Ouality Assurance Engineer FMI Medical Systems. Inc. 29001 Solon Rd, Unit A Solon, OH 44139

October 4, 2018

Re: K173076

Trade/Device Name: CURA 16; ScintCare CT16 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 28, 2017 Received: September 29, 2017

Dear Paul McFeely:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 A. 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) K173076

Device Name CURA CT16 ScintCare CT16

#### Indications for Use (Describe)

The CURA CT16/ScintCare CT16 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 system is suitable for all patients.

| 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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# Section 5 - 510(k) Summary

| 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: | Scott LeMaster, Executive Vice President |
| Date of Submission: | September 13, 2018 |
| 510(k) Preparer: | Paul McFeely<br>Quality Assurance Engineer<br>FMI Medical Systems Inc.<br>29001 Solon Road, Unit A, Solon, Ohio 44139<br>Phone: [phone]<br>Email: [e-mail] |
| Device Classification: | |
| Device Name: | CURA CT16, ScintCare CT16 |
| Regulation Name: | Computed tomography x-ray system |
| Review Panel: | Radiology |
| Product Code: | JAK |
| Regulation Number: | 21 CFR 892.1750 |

### Predicate Device:

Device Class:

| Predicate Device: | SOMATOM Emotion 16 |
|-------------------|-------------------------------------|
| Predicate 510(k): | K151752 |
| Regulation: | 21 CFR 892.1750 |
| Regulation Name: | Computed tomography x-ray system |
| Class: | II |
| Product Code: | JAK |
| Panel: | Radiology |
| Manufacturer: | Siemens Medical Solutions USA, Inc. |

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#### Device Description:

The CURA CT16/ScintCare CT16 computed tomography (CT) scanner is a medical imaging device utilizing X-ray computed tomography to obtain images of the entire body. The CURA CT16/ScintCare CT16 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

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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.

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 CT16/ScintCare CT16 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 CT16/ScintCare CT16 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 CT16/ScintCare CT16 system is a stationary full 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 utilitate the transfer of electrical power and data between the gantry rotor and stator.

The CURA CT16/ScintCare CT16 system software implements many of the CURA CT16/ScintCare CT16 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
- Metal artifact reduction is a capability of the system software, but is currently a future option.
- Iterative reconstruction is a capability of the system software, but is currently a future option.
- Dose modulation feature (imA) is a capability of the system software, but is currently a future option.

# Device Safety and Risk Management:

The CURA CT16/ScintCare CT16 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:

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- . 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
- 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 CT16/ScintCare CT16 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 CT16/ScintCare CT16 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 CT16/ScintCare CT16 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 CT16/ScintCare CT16 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.

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### Indications for Use:

The CURA CT16/ScintCare CT16 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. The system is suitable for all patients.

## Substantial Equivalence:

FMI Medical Systems Inc. is citing substantial equivalence of the CURA CT16/ScintCare CT16 System to the 510(k), K151752, Predicate Device Siemens SOMATOM Emotion 16.

## Substantial Equivalence Statement:

FMI Medical Systems Inc. is citing substantial equivalence of the CURA CT16/ScintCare CT16 System to the Siemens SOMATOM Emotion 16. Regulatory citations for the SOMATOM Emotion 16 are as follows:

Predicate Device: SOMATOM Emotion 16 Predicate 510(k): K151752 Regulation: 21 CFR 892.1750 Class: II Product Code: JAK Panel: Radiology Manufacturer: Siemens Medical Solutions USA, Inc.

The CURA CT16/ScintCare CT16 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 CT16/ScintCare CT16 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 CT16/ScintCare CT16 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 CT16/ScintCare CT16 System is substantially equivalent to the predicate, Siemens SOMATOM Emotion 16, 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>Siemens<br>SOMATOM Emotion 16 | Proposed:<br>CURA CT16/ScintCare<br>CT16 | Comments |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The SOMATOM Emotion<br>6/16 systems are<br>intended to produce<br>cross-sectional images<br>of the body by computer<br>reconstruction of x-ray<br>transmission data from<br>either the same axial<br>plane taken at different<br>angles or spiral planes*<br>taken at different angles.<br>(*spiral planes: the axial<br>planes resulted from the<br>continuous rotation of<br>detectors and x-ray tube,<br>and the simultaneous<br>translation of the<br>patient.) | The CURA<br>CT16/ScintCare CT16 is<br>a Computed<br>Tomography X-Ray<br>System that is intended<br>to produce cross-<br>sectional images of the<br>body by computer<br>reconstruction of X-ray<br>transmission data<br>collected at different<br>angles and planes. The<br>system may include<br>signal analysis and<br>display equipment,<br>patient and equipment<br>supports, components<br>and accessories. The<br>system is suitable for all<br>patients. | The CURA<br>CT16/ScintCare CT16<br>proposed indications for<br>use are consistent with<br>the predicate. Both<br>systems are capable of<br>imaging in axial and<br>spiral planes, at multiple<br>angles. The CURA<br>CT16/ScintCare CT16<br>also indicates the<br>potential for signal<br>analysis and display<br>equipment, patient and<br>equipment supports,<br>components and<br>accessories. In addition,<br>the CURA<br>CT16/ScintCare CT16<br>system specifies<br>suitability for all patients. |
| Design | | | |
| Scan modes | Surview (scout)<br>Helical<br>Axial | Scout (surview)<br>Helical<br>Axial<br>Multi-Axial | Compares favorably |
| Gantry | | | |
| Gantry aperture (bore)<br>size | 70 cm | 70 cm | Compares favorably |
| Gantry tilt | +/- 30 degrees | +/- 30 degrees | Compares favorably |
| Patient Support / Couch / Table | | | |
| Patient supports | Included | Included | Compares favorably |
| Patient table scan range | 160 cm (1600 mm) | 1700 mm (170 cm) | The CURA<br>CT16/ScintCare CT16<br>patient table scan range<br>is 10 cm longer than the<br>predicate. This<br>difference does not<br>affect safety or efficacy. |
| Generator power rating | 50 kW | 50 kW | Compares favorably |
| kVp settings | 80, 110, 130 kV | 80, 100, 120, 140 kV | kVp settings for CURA<br>CT16/ScintCare CT16<br>(ranges from 80 to 140<br>kVp) are similar to the<br>predicate (ranges from<br>80 to 130 kVp). For<br>CURA CT16/ScintCare<br>CT16, 1 of the 4 specific<br>settings (80 kVp) is<br>identical to the predicate.<br>This does not affect<br>safety or efficacy. |
| Characteristics – | Predicate: | Proposed: | Comments |
| Components / | Siemens | CURA CT16/ScintCare | |
| Specifications | SOMATOM Emotion 16 | CT16 | |
| mA range (step size) | 20-345 mA (1 mA steps) | 10 – 420 mA (10 mA<br>steps) | The mA range for the<br>CURA CT16/ScintCare<br>CT16 (10 - 420 mA) is<br>greater than the<br>predicate (20 - 345 mA).<br>Also, the step size of the<br>CURA CT16/ScintCare<br>CT16 (10 mA) is greater<br>than that of the predicate<br>(1 mA). These<br>differences do not affect<br>safety or efficacy. |
| Focal spot size | 0.8 x 0.5 mm<br>0.8 x 0.7 mm | 0.7 mm x 1.2 mm (small)<br>1.2 mm x 1.2 mm (large) | The focal spot sizes for<br>the CURA<br>CT16/ScintCare CT16<br>are greater than those of<br>the predicate. This<br>difference does not<br>affect safety or efficacy. |
| Anode effective heat<br>capacity | 5 MHU | 5.3 MHU | Anode effective heat<br>capacity of the CURA<br>CT16/ScintCare CT16 is<br>0.3 MHU greater than<br>the predicate. This<br>difference does not<br>affect safety or efficacy. |
| X-ray tube, maximum<br>applied power | 345 mA | 420 mA | X-ray tube maximum<br>applied power for the<br>CURA CT16/ScintCare<br>CT16 is 75 mA greater<br>than the predicate. This<br>difference does not<br>affect safety or efficacy. |
| Detector (DMS or Data Management System) | | | |
| Detectors | Solid state array, ultra-<br>fast ceramic (UFC) | Solid-state ultra-high<br>speed rare earth ceramic<br>scintillator | Compares favorably |
| Slices | 16 slices | 16 slices | Compares favorably |
| Coverage | Maximum 1500 mm | Maximum 1700 mm | Coverage for the CURA<br>CT16/ScintCare CT16 is<br>200 mm greater than the<br>predicate. This<br>difference does not<br>affect safety or efficacy. |

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