(167 days)
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.
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.
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).
The CURA 778 is a Computed Tomography X-Ray system. The provided text details the device's characteristics and compares it to two predicate devices (Philips Ingenuity CT and CURA 16) to establish substantial equivalence. However, the document does not present specific acceptance criteria in the form of a table with numerical thresholds for performance metrics that the device had to meet and then report the device's performance against those criteria. Instead, it argues for substantial equivalence based on comparable design, intended use, technology, and performance, asserting that any differences do not affect safety or efficacy.
The document mentions "Performance Testing" which states: "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."
This indicates that:
- Performance Testing was done: The device was tested to ensure it functions as intended, with dosimetric testing and image quality evaluation.
- Ground Truth for Image Quality: A certified radiologist evaluated image quality.
However, the specific "acceptance criteria" and "reported device performance" in a quantitative, side-by-side table are not explicitly provided in the furnished text. The tables provided are primarily for comparative characteristics between the CURA 778 and its predicates, aiming to demonstrate substantial equivalence, rather than a direct presentation of acceptance criteria and measured performance of the CURA 778 against those criteria.
Therefore, I cannot populate the requested table entirely as the specific acceptance criteria and the exact reported device performance against those criteria are not detailed in the provided text. The tables given show comparisons of specifications between the proposed device and predicates, with comments indicating "Compares favorably" or explaining why differences do not affect safety or efficacy, which serves the purpose of demonstrating substantial equivalence rather than fulfilling a predefined set of acceptance criteria.
Also, the document does not contain information on:
- Sample size used for the test set
- Data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set
- Qualifications of those experts (other than "certified radiologist")
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Effect size of human readers improvement with AI assistance
- Standalone (algorithm only without human-in-the-loop performance) study
- Type of ground truth used (other than for image quality evaluation by a radiologist)
- Sample size for the training set
- How the ground truth for the training set was established
Based on the provided text, here’s what can be extracted and what is missing:
Acceptance Criteria and Study for CURA 778
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not provide a table of explicit acceptance criteria with specific numerical thresholds and the CURA 778's measured performance against them. Instead, it uses comparative tables with predicate devices to demonstrate substantial equivalence in terms of design, specifications, and intended use. The "Comments" column in these tables serves as a narrative for why the CURA 778's specifications are considered acceptable relative to the predicate.
| Feature / Metric | Acceptance Criteria (from Document) | Reported Device Performance (from Document) | Comments in Document (Substantial Equivalence) |
|---|---|---|---|
| Indications for Use | Consistent with predicate | Whole body, cardiac, vascular X-ray CT applications in patients of all ages, with signal analysis and display equipment, patient and equipment supports, components and accessories. | The CURA 778 proposed indications for use are consistent with the predicate. Both systems are capable of imaging in axial and spiral planes, at multiple angles. Indication of potential for signal analysis and display equipment, patient and equipment supports, components and accessories. Whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages. (Note: Philips Ingenuity adds low dose CT lung cancer screening, which CURA 778 does not explicitly state it has, but this difference does not affect safety/efficacy for the stated indications). |
| Application | Full body (includes head) | Full body (includes head) | Compares favorably |
| Scan Regimen | Continuous rotation | Continuous rotation | Compares favorably |
| Scan Modes | Scout, Helical, Axial, Multi-Axial | Scout (Surview), Helical, Axial, Multi-Axial (Step and Shoot) | Compares favorably |
| Gantry Aperture | 70 cm | 70 cm | Compares favorably |
| Gantry Tilt | +/-30 degrees | +/-30 degrees | Compares favorably |
| Focus – Isocenter Distance | Similar to predicate (~570mm) | 558 mm | Isocenter distance for CURA 778 is 12 mm smaller than the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT). Compares favorably (When compared to CURA 16, both 558mm) |
| Focus – Detector Distance | Similar to predicate (~1040mm) | 950.25 mm | Detector distance for the CURA 778 is 89.75 mm smaller than the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT). Detector distance for the CURA 778 is 1.58 mm length than the predicate. This difference does not affect safety or efficacy. (When compared to CURA 16). |
| Rotation Times | Similar to predicate (0.4-2.0s) | 0.39, 0.5, 0.75, 1.0, 1.5, 2.0 seconds | Rotation time capability for CURA 778 (ranges from 0.39 to 2.0 seconds) is similar to the predicate (ranges from 0.4 to 2.0 seconds). For CURA 778, 5 out of 6 specific settings are identical. This does not affect safety or efficacy. (When compared to Ingenuity CT). Rotation time capability for CURA 778, 5 out of 6 specific settings (0.5, 0.75, 1.0, 1.5, and 2.0 seconds) are identical to the predicate. 0.39 second is the enhancement for this 64 row/128 slices machine. This does not affect safety or efficacy. (When compared to CURA 16). |
| Patient Supports | Included | Included | Compares favorably |
| Patient Table Scan Range | Similar to predicate (2000mm or 1700mm) | 1700 mm | The patient table scan range is 300 mm shorter than the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT). Compares favorably (When compared to CURA 16, both 1700mm). |
| Table Z-Position Accuracy | +/- 0.25 mm | +/- 0.25 mm | Compares favorably |
| Table Longitudinal Speed | Similar/Greater than predicate (1-100 mm/s or 1-150mm/s) | Up to 200 mm / second | The maximum speed capability of the CURA 778 is 100 mm/sec greater than the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT). The maximum speed capability of the CURA 778 is 50 mm/sec greater than the predicate. This difference does not affect safety or efficacy. (When compared to CURA 16). |
| Table Maximum Load Capacity | Similar to predicate (204kg or 205kg) | 205 kg | Table load capacities are similar. The table supports 1 additional kilogram compared to the predicate. This difference does not impact safety or efficacy. (When compared to Ingenuity CT). Compares favorably (When compared to CURA 16, both 205kg). |
| Generator Power Rating | Similar to predicate (80kW or 50kW) | 80 kW | Compares favorably (When compared to Ingenuity CT, both 80kW). Compares favorably (When compared to CURA 16, 50kW predicate vs 80kW proposed, still favorable). |
| kVp Settings | Similar to predicate | 80, 100, 120, 140 kV | Compares favorably (When compared to Ingenuity CT). CURA 778 has similar kV setting compared with CURA 16. This difference does not affect safety or efficacy. (When compared to CURA 16, which had 80, 110, 130 kV). |
| mA Range (Step Size) | Similar to predicate | 10 – 660 mA (10 mA steps) | The mA range for the CURA 778 (10 – 660 mA) is similar than the predicate (20 – 665 mA). Also, the step size (10 mA) is greater than that of predicate (1 mA). These differences do not affect safety or efficacy. (When compared to Ingenuity CT). The mA range for the CURA 778 (10 – 660 mA) is bigger than the predicate (10 – 420 mA), while has the same step size (10 mA). Bigger range enables more patient scan capacity and some specific application protocols. These differences do not affect safety or efficacy. (When compared to CURA 16). |
| Focal Spot Size | Similar to predicate | Small: 0.6 mm x 1.2 mm, Large: 1.1 mm x 1.2 mm | The focal spot sizes for the CURA 778 are greater than those of the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT's 0.5x1.0mm and 1.0x1.0mm). The focal spot sizes for the CURA 778 specs are smaller than those of the predicate. This difference does not affect safety or efficacy. (When compared to CURA 16's 0.7x1.2mm and 1.2x1.2mm). |
| Anode Effective Heat Capacity | Similar/Greater than predicate (8.0 MHU or 5.3MHU) | 8.0 MHU | Compares favorably (When compared to Ingenuity CT, both 8.0 MHU). CURA 778 anode effective heat capacity is bigger than the predicate (CURA 16, 5.3MHU). Bigger heat capacity enables more patient scan possibility and some specific application protocols. These differences do not affect safety or efficacy. |
| X-ray Tube Max Applied Power | Similar to predicate (665mA or 420mA) | 660 mA | X-ray tube maximum applied power for the CURA 778 is 5 mA smaller than the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT). X-ray tube maximum applied power for the CURA 778 is 240 mA bigger than the predicate. This difference does not affect safety or efficacy. (When compared to CURA 16). |
| Detectors | Solid-state GOS or similar | Solid-state GOS | Compares favorably (When compared to Ingenuity CT). Compares favorably (When compared to CURA 16, which used "Solid-state ultra-high speed rare earth ceramic scintillator"). |
| Slices | Similar/Greater than predicate (128 slices or 16 slices) | 128 slices | Compares favorably (When compared to Ingenuity CT, both 128 slices). CURA 778 is a 128 slices product, while CURA 16 is a 16 slices one. This difference does not affect safety. 128 slices can have more features, for example cardiac. |
| Coverage | Similar/Greater than predicate (40mm or 18.56mm) | 40 mm | Compares favorably (When compared to Ingenuity CT, both 40mm). Coverage for the CURA 778 is 21.44 mm wider than the predicate. This difference does not affect safety. With bigger coverage detector, product can have more features, for example cardiac. (When compared to CURA 16). |
| Slice Thickness (Axial Reconstruction) | Similar range and options to predicate | 0.5mm, 0.625mm, 1.25mm, 2.5mm, 5mm, 10mm (for axial) | For reconstruction of axial images, the range of and number of options for slice thickness are similar between the CURA 778 and the predicate. Multiple options provide the user with the ability to select parameters that support required image quality and capture the target area of interest. The differences do not affect safety or efficacy. |
| Slice Thickness (Helical Reconstruction) | Similar range and options to predicate | 0.5mm, 0.625mm, 1mm, 1.25mm, 2mm, 2.5mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm (for helical) | For reconstruction of helical images, the range of and number of options for slice thickness are similar between the CURA 778 and the predicate. Multiple options provide the user with the ability to select parameters that support required image quality and capture the target area of interest. The differences do not affect safety or efficacy. |
| Scan Field | Similar to predicate | 250 mm, 500 mm | Compares favorably (When compared to Ingenuity CT). Compares favorably (When compared to CURA 16, starting from 500mm predicate to 250mm, 500mm optional). |
| Image Matrix | Similar options to predicate | 512 x 512, 1,024 x 1,024 (Optional) | The image matrix of the CURA 778 is less than the predicate (Ingenuity CT, which has 512x512, 768x768, 1024x1024). This difference does not affect safety or efficacy. The image matrix of the CURA 778 has more option than the predicate (CURA 16, only 512x512). This difference does not affect safety or efficacy. |
| Image Quality | Implied adequate | Evaluated by a certified radiologist | "Sample clinical images have been provided within the submission. The image quality has been evaluated by a certified radiologist." |
| Dosimetric Performance | Implied within allowable limits | Evidence provided within submission | "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." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The text mentions "Sample clinical images have been provided," but no details on their origin or nature (retrospective/prospective) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: "A certified radiologist" evaluated image quality. No further details (e.g., years of experience, subspecialty) are provided.
4. Adjudication method for the test set:
- Not specified in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study or AI assistance evaluation is mentioned for this device. The CURA 778 is described as a Computed Tomography X-Ray system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not mentioned, as the device is a CT scanner, not an AI algorithm.
7. The type of ground truth used:
- For image quality, "evaluation by a certified radiologist" served as the ground truth.
- For dosimetric performance, "allowable limits set forth by FMI Medical Systems" were used as criteria.
- For other functional and technical specifications, compliance with engineering design and relevant 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) implies conformance to established physical and performance benchmarks, which effectively serve as a form of ground truth for those technical aspects.
8. The sample size for the training set:
- Not applicable/Not mentioned, as this is a hardware device (CT scanner) and not an AI algorithm that typically requires a large training dataset. The software mentioned (e.g., "Image viewing (3d reconstruction, MPR, CPR, MIP), Image analysis (ROI), Dose modulation feature (imA)") are standard CT functionalities, not typically requiring "training sets" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized emblem with text encircling it. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in bold blue letters, with "ADMINISTRATION" written below in a smaller font.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.29001 Solon Road, Unit A,Solon, Ohio 44139, USAPhone: +1 440-600-5952Email: dazhuang.meng@fmimedical.com |
|---|---|
| Company Contact: | Dazhuang Meng, Senior Director of Product Development |
| 510(k) Preparer: | FMI Medical Systems Inc.29001 Solon Road, Unit A,Solon, Ohio 44139, USAPhone: +1 440-600-5952Email: dazhuang.meng@fmimedical.com |
| 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 –Components /Specifications | Predicate:Ingenuity CT | Proposed:CURA 778 | Comments |
|---|---|---|---|
| Indications for use | The Ingenuity CT is aComputed Tomography X-Ray System intended toproduce images of the headand body by computerreconstruction of x-raytransmission data taken atdifferent angles and planes.These devices may includesignal analysis and displayequipment, patient andequipment supports,components andaccessories.The Ingenuity CT is indicatedfor head, whole body, cardiacandvascular X-ray ComputedTomography applications inpatients of all ages.These scanners are intendedto be used for diagnosticimaging and for low dose CTlung cancer | The CURA 778 is a ComputedTomography X-Ray System thatis intended to produce cross-sectional images of the body bycomputer reconstruction of X-raytransmission data collected atdifferent angles and planes.The system may include signalanalysis and display equipment,patient and equipment supports,components and accessories.The CURA 778 scanner is awhole body scanner, withcardiac and vascular X-rayComputed Tomographyapplications in patients of allages. | The CURA 778 proposedindications for use areconsistent with the predicate.Both systems are capable ofimaging in axial and spiralplanes, at multiple angles.Indicates the potential forsignal analysis and displayequipment, patient andequipment supports,components and accessories.Whole body scanner, withcardiac and vascular X-rayComputed Tomographyapplications in patients of allages.Difference is that PhilipsIngenuity has low dose CTlung 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)Helical ScanAxial Scan | Scout (Surview)HelicalAxialMulti-Axial(Step and Shoot) | Compares favorably |
| Gantry | |||
| Gantry aperture(bore) size | 70 cm | 70 cm | Compares favorably |
| Gantry tilt | +/-30 degrees | +/-30 degrees | Compares favorably |
| Focus –isocenter distance | 570mm | 558 mm | Isocenter distance for CURA778 is 12 mm smaller than thepredicate. This difference doesnot affect safety or efficacy. |
| Focus - detectordistance | 1040 mm | 950.25 mm | Detector distance for theCURA 778 is 89.75 mm smallerthan the predicate. Thisdifference does not affectsafety 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 forCURA 778 (ranges from 0.39 |
| Characteristics –Components /Specifications | Predicate:Ingenuity CT | Proposed:CURA 778 | Comments |
| to 2.0 seconds) is similar tothe predicate (ranges from 0.4to 2.0 seconds). For CURA 778,5 out of 6 specific settings(0.5, 0.75, 1.0, 1.5, and 2.0seconds) are identical to thepredicate. This does not affectsafety or efficacy. | |||
| Patient Support / Couch / Table | |||
| Patient supports | Included | Included | Compares favorably |
| Patient table scanrange | 2000 mm | 1700 mm | The patient table scan range is300 mm shorter than thepredicate. This difference doesnot affect safety or efficacy. |
| Table Z-positionaccuracy | +/- 0.25 mm | +/- 0.25 mm | Compares favorably |
| Table longitudinalspeed | 1 to 100 mm / second | Up to 200 mm / second | The maximum speedcapability of the CURA 778 is100 mm/sec greater than thepredicate. This difference doesnot affect safety or efficacy. |
| Table maximum loadcapacity | 204 kg | 205 kg | Table load capacities aresimilar. The table supports 1additional kilogramscompared to the predicate.This difference does notimpact safety or efficacy. |
| Generator | |||
| Generator powerrating | 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 CURA778 (10 – 660 mA) is similarthan the predicate (20 – 665mA). Also, the step size of theCURA 778 (10 mA) is greaterthan that of the predicate (1mA). These differences do notaffect safety or efficacy. |
| Characteristics –Components /Specifications | Predicate:Ingenuity CT | Proposed:CURA 778 | Comments |
| Focal spot size | 0.5 x 1.0 mm1.0 x 1.0 mm | 0.6 mm x 1.2 mm (small)1.1 mm x 1.2 mm (large) | The focal spot sizes for theCURA 778 are greater thanthose of the predicate. Thisdifference does not affectsafety or efficacy. |
| Anode effective heatcapacity | 8.0 MHU | 8.0 MHU | Compares favorably |
| X-ray tube,maximum appliedpower | 665 mA | 660 mA | X-ray tube maximum appliedpower for the CURA 778 is 5mA smaller than thepredicate. This difference doesnot 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)(imagereconstruction) | 0.5mm-12.5mm | 0.5 mm0.625 mm1.25 mm2.5 mm5 mm10 mm | For reconstruction of axialimages, the range of andnumber of options for slicethickness are similar betweenthe CURA 778 and thepredicate. Multiple optionsprovide the user with theability to select parametersthat support required imagequality and capture the targetarea of interest. Thedifferences do not affectsafety or efficacy. |
| Slice thickness (mm)(imagereconstruction) | 0.55 mm-5mm | 0.5 mm0.625 mm1mm1.25 mm2mm2.5 mm3mm4mm5 mm6mm7mm8mm9mm10 mm | For reconstruction of helicalimages, the range of andnumber of options for slicethickness are similar betweenthe CURA 778 and thepredicate. Multiple optionsprovide the user with theability to select parametersthat support required imagequality and capture the targetarea of interest. Thedifferences do not affectsafety or efficacy. |
| Characteristics -Components /Specifications | Predicate:Ingenuity CT | Proposed:CURA 778 | Comments |
| Scan field | 250 mm, 500 mm | 250 mm, 500 mm | Compares favorably |
| Image matrix | 512 x 512768 x 7681,024 x 1,024 | 512 x 5121,024 x 1,024 (Optional) | The image matrix of the CURA778 is less than the predicate.This difference does not affectsafety or efficacy. |
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FMI Medical Systems Inc. is citing second substantial equivalence of the CURA 778 system to the CURA 16. Regulatory citations for the CURA 16 are as follows:
| Predicate Device: | CURA 16 |
|---|---|
| Predicate 510(k): | K173076 |
| Regulation: | 21 CFR 892.1750 |
| Class: | II |
| Product Code: | JAK |
| Panel: | Radiology |
| Manufacturer: | FMI Medical Systems, Inc. |
The CURA 778 system is substantially equivalent (with some enhancement) in design, intended use, indications for use and technology with the currently marketed predicate. There are no significant differences in materials, 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, except the energy source, detector coverage. On CURA 778, the energy source has bigger capacity, and the detector has larger coverage, which enable more patient through output, lower dose, and advanced features (for example: cardiac, vascular, ... ...)
The submission K192590 CURA 778 CT scanner device, is based on the mechanical and control system architecture of the previous one (CURA 16, K173076), with below enhancement:
| CURA 16 | CURA 778 | ||
|---|---|---|---|
| Tube and generator | 5.3MHU | 8MHU | Enhanced |
| Flying focal spot (Z direction) | No | Yes | Enhanced |
| Detector physical slices | 16 | 64 | Enhanced |
| Detector coverage (mm) | 18.56 | 40 | Enhanced |
| Rotation speed (second/rotation) | 0.5 | 0.39 | Enhanced |
| Motion control system | Same | ||
| Mechanical structure | Same | ||
| Software and Recon architecture | Same | ||
| Cardiac application | No | Yes | Enhanced |
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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 comparable or has similar architecture/technology behind them, 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 CURA778 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 (with some enhancement) to the predicate, CURA 16, and there are no significant differences that raise new issues of safety or efficacy.
| Characteristics -Components /Specifications | Predicate:CURA 16 | Proposed:CURA 778 | Comments |
|---|---|---|---|
| Indications for use | The CT16 is a ComputedTomography X-Ray Systemthat is intended to producecross-sectional images of thebody by computerreconstruction of X-raytransmission data collectedat different angles andplanes.The system may includesignal analysis and displayequipment, patient andequipment supports,components andaccessories.The system is suitable for allpatients. | The CURA 778 is a ComputedTomography X-Ray System thatis intended to produce cross-sectional images of the body bycomputer reconstruction of X-raytransmission data collected atdifferent angles and planes.The system may include signalanalysis and display equipment,patient and equipment supports,components and accessories.The CURA 778 scanner is awhole body scanner, withcardiac and vascular X-rayComputed Tomographyapplications in patients of allages. | The CURA 778 proposedindications for use areconsistent with the predicate.Both systems are capable ofimaging in axial and spiralplanes, at multiple angles.Indicates the potential forsignal analysis and displayequipment, patient andequipment supports,components and accessories.In addition, the CURA 778 isalso indicated for cardiac andvascular X-ray ComputedTomography applications inpatients of all ages. |
| Design | |||
| Application | Full body(includes head) | Full body (includes head) | Compares favorably |
| Scan regimen | Continuous rotation | Continuous rotation | Compares favorably |
| Scan modes | Scout(Surview) | Scout (Surview) | Compares favorably |
| Helical | Helical | ||
| Axial | Axial | ||
| Multi-Axial | Multi-Axial(Step and Shoot) | ||
| Gantry | |||
| Gantry aperture(bore) size | 70 cm | 70 cm | Compares favorably |
| Gantry tilt | +/-30 degrees | +/-30 degrees | Compares favorably |
| Focus - | 558mm | 558 mm | Compares favorably |
| Characteristics –Components /Specifications | Predicate:CURA 16 | Proposed:CURA 778 | Comments |
| isocenter distance | 948.40 mm | 950.25 mm | Detector distance for theCURA 778 is 1.58 mm lengththan the predicate. Thisdifference does not affectsafety or efficacy. |
| Focus – detectordistance | 948.40 mm | 950.25 mm | Detector distance for theCURA 778 is 1.58 mm lengththan the predicate. Thisdifference does not affectsafety or efficacy. |
| Rotation times | 0.5, 0.75, 1.0, 1.5, 2.0seconds | 0.39, 0.5, 0.75, 1.0, 1.5, 2.0seconds | Rotation time capability forCURA 778, 5 out of 6 specificsettings (0.5, 0.75, 1.0, 1.5,and 2.0 seconds) are identicalto the predicate. 0.39 secondis the enhancement for this 64row/128 slices machine. Thisdoes not affect safety orefficacy. |
| Patient Support / Couch / Table | |||
| Patient supports | Included | Included | Compares favorably |
| Patient table scanrange | 1700 mm | 1700 mm | Compares favorably |
| Table Z-positionaccuracy | +/- 0.25 mm | +/- 0.25 mm | Compares favorably |
| Table longitudinalspeed | 1 to 150 mm / second | Up to 200 mm / second | The maximum speedcapability of the CURA 778 is50 mm/sec greater than thepredicate. This difference doesnot affect safety or efficacy. |
| Table maximum loadcapacity | 205 kg | 205 kg | Compares favorably |
| Generator | |||
| Generator powerrating | 50 kW | 80 kW | Compares favorably |
| kVp settings | 80, 110,130 kV | 80, 100, 120, 140 kV | CURA 778 as similar kV settingcompare with CURA 16. Thisdifference does not affectsafety or efficacy. |
| mA range (step size) | 10-420 mA (10 mA steps) | 10 – 660 mA (10 mA steps) | The mA range for the CURA778 (10 – 660 mA) is biggerthan the predicate (10 – 420mA), while has the same stepsize (10 mA).Bigger range enable morepatients scan capacity and |
| Characteristics –Components /Specifications | Predicate:CURA 16 | Proposed:CURA 778 | Comments |
| some specific applicationprotocols.These differences do notaffect safety or efficacy. | |||
| X ray tube | |||
| Focal spot size | 0.7 x 1.2 mm (small)1.2 x 1.2 mm (large) | 0.6 mm x 1.2 mm (small)1.1 mm x 1.2 mm (large) | The focal spot sizes for theCURA 778 specs are smallerthan those of the predicate.This difference does not affectsafety or efficacy. |
| Anode effective heatcapacity | 5.3 MHU | 8.0 MHU | CURA 778 is bigger than thepredicate.Bigger heat capacity enablemore patients scan possibilityand some specific applicationprotocols.These differences do notaffect safety or efficacy. |
| X-ray tube,maximum appliedpower | 420 mA | 660 mA | X-ray tube maximum appliedpower for the CURA 778 is 240mA bigger than the predicate.This difference does not affectsafety or efficacy. |
| Detector (DMS or Data Management System) | |||
| Detectors | Solid-state ultra-high speedrare earth ceramicscintillator | Solid-state GOS | Compares favorably |
| Slices | 16 slices | 128 slices | CURA 778 is a 128 slicesproduct, while CURA 16 is a 16slices one. This differencedoes not affect safety. 128slices can have more features,for example cardiac. |
| Coverage | Maximum 18.56 mm | Maximum 40 mm | Coverage for the CURA 778 is21.44 mm wider than thepredicate. This difference doesnot affect safety. With biggercoverage detector, productcan have more features, forexample cardiac. |
| AxialSlice thickness (mm)(imagereconstruction) | 0.58 mm1.16 mm2.32 mm4.64 mm9.28 mm18.56 mm | 0.5 mm0.625 mm1.25 mm2.5 mm5 mm10 mm | For reconstruction of axialimages, the range of andnumber of options for slicethickness are similar betweenthe CURA 778 and thepredicate. Multiple options |
| Characteristics –Components /Specifications | Predicate:CURA 16 | Proposed:CURA 778 | Comments |
| provide the user with theability to select parametersthat support required imagequality and capture the targetarea of interest. Thedifferences do not affectsafety or efficacy. | |||
| HelicalSlice thickness (mm)(imagereconstruction) | 0.5 mm1.0 mm1.5 mm2.0 mm2.5 mm3.0 mm4.0 mm5.0 mm6.0 mm7.0 mm8.0 mm9.0 mm10.0 mm | 0.5 mm0.625 mm1mm1.25 mm2mm2.5 mm3mm4mm5 mm6mm7mm8mm9mm10 mm | For reconstruction of helicalimages, the range of andnumber of options for slicethickness are similar betweenthe CURA 778 and thepredicate. Multiple optionsprovide the user with theability to select parametersthat support required imagequality and capture the targetarea of interest. Thedifferences do not affectsafety or efficacy. |
| Scan field | 500 mm | 250 mm, 500 mm | Compares favorably |
| Image matrix | 512 x 512 | 512 x 5121,024 x 1,024 (Optional) | The image matrix of the CURA778 has more option than thepredicate. This difference doesnot affect safety or efficacy. |
Additional comparisons are listed in the table below.
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§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.