(198 days)
Not Found
No
The summary describes standard CT technology and image processing techniques (material decomposition, VMI) without mentioning AI or ML. The performance studies focus on traditional image quality metrics and clinical equivalence, not AI/ML model performance.
No.
This device is an imaging system (CT scanner) used for diagnostic purposes, primarily head and neck imaging, to aid in diagnosis, not to provide therapy.
Yes
Explanation: The device is an x-ray computed tomography (CT) system intended for imaging primarily the head and neck. The generated CT images are used for medical diagnosis, as evidenced by the clinical evaluation where radiologists confirmed "diagnostic quality of the images" and the ability to "generate diagnostically acceptable images." This directly indicates its use in the diagnostic process.
No
The device description clearly outlines a physical CT system with hardware components such as an x-ray generator, collimator, gantry, and detectors. While it includes software for control and reconstruction, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck." This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description details a CT system, including components like an x-ray generator, detector, gantry, and software for image reconstruction. This aligns with the description of an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body. IVDs are designed to perform tests on these types of samples to provide information for diagnosis, monitoring, or treatment.
In summary, the OmniTom Elite CT system is an in-vivo medical imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OmniTom Elite CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.
OmniTom Elite with photon counting detectors (PCD) configuration has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI). OmniTom Elite with PCD is only supported for adult axial imaging for head and neck.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The subject OmniTom Elite Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K211711). Both computed tomography systems are identical in terms of the high resolution, 16 row, 40 cm bore, and 30 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360-degree movement and electrical drive system so the system can be moved easily to different locations.
The ability to upgrade the OmniTom Elite system with photon counting detector (PCD) remains the same. PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Computed Tomography (CT)
Anatomical Site
head and neck
Indicated Patient Age Range
pediatric and adult
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing: The software contained in the proposed device has been developed & tested in accordance with IEC 62304, and the FDA guidance for Content of Premarket Submissions for Software Contained in Medical Devices. Design verification and design validation testing was performed to confirm all design and user requirements were met. The proposed OmniTom Elite device demonstrated that the new features did not exhibit any negative effects on the requirements in place, as well as they did not exhibit any concerns that may impact safety and effectiveness. Software verification and software validation testing was executed to confirm all software requirements were met. For material decomposition, the multi-energy CT phantom was scanned, where three basic materials, water, iodine and calcium were decomposed. The materials were well represented in the respective decomposition maps. The OmniTom Elite with PCD underwent Electrical Safety and Electromagnetic Compatibility testing and proved to be in compliance with IEC 60601-1-2, and IEC 60601-2-44.
Image quality evaluation: Image quality metrics such as noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests. Imaging metrics successfully demonstrated that the proposed device with PCD has comparable image quality with its previous version, predicate device (K211711) and meets all the image quality criteria that are used for testing. PCD capabilities were tested to demonstrate properties of PCD in count mode and multi-energy mode. For imaging purposes, the pixels were binned to match the predicate device detector geometry. Imaging metrics demonstrated stability of the detector, analysis of the count rate and limited pileup loss at low dose scanning.
Clinical evaluation: Comparative study was conducted under an IRB for comparison between OmniTom Elite with PCD and OmniTom Elite with EID images. Volunteers underwent CT scanning for a full head scan, from the upper jaw to the top of the skull to aid in generation of comparative images. Three locations were selected for the comparative study: The sinuses, the mid brain, and the top of the skull. These images were reviewed by three independent board-certified practicing radiologists and confirmed diagnostic quality of the images demonstrating the effectiveness of the subject device for clinical scanning. The clinical scans indicate the ability of the PCD configuration of the OmniTom Elite device to generate diagnostically acceptable images, which are equivalent to those produced by the OmniTom Elite with EID. Multi-energy studies demonstrate the PCD's ability not only to produce diagnostically acceptable images but also to ability to decompose images using different basis materials such as iodine and calcium.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
June 1, 2023
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
NeuroLogica Corporation, a subsidiary of Samsung % Ninad Gujar Vice President, Regulatory Affairs and Quality Assurance Electronics Co., Ltd. 14 Electronics Avenue DANVERS MA 01923
Re: K223447
Trade/Device Name: OmniTom Elite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: April 28, 2023 Received: May 2, 2023
Dear Ninad Gujar:
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/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/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).
Sincerelv.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223447
Device Name OmniTom Elite
Indications for Use (Describe)
The OmniTom Elite CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. The CT system is intended to be used for both pediativ and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.
OmniTom Elite with photon counting detectors (PCD) configuration has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI). OmniTom Elite with PCD is only supported for adult axial imaging for head and neck.
| 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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3
Neur Logica
A Subsidiary of Samsung Electronics Co., Ltd.
510(k) Summarv
In accordance with 21 CFR § 807.92, the 510(k) summary includes information on safety and effectiveness.
Date Prepared: April 27, 2023
Submitter
NeuroLogica Corp., a subsidiary of Samsung Electronics Co., Ltd 14 Electronics Avenue, Danvers, MA 01923
Establishment Registration
3004938766
Manufacturing Site
NeuroLogica Corp., a subsidiary of Samsung Electronics Co., Ltd 14 Electronics Avenue, Danvers, MA 01923
Official Correspondent & Contact Person
Dr. Ninad Gujar Vice President, Regulatory Affairs & Quality Assurance Telephone: 978-564-8632 E-mail: ngujar@neurologica.com
Device Name:
| Trade Name: | OmniTom Elite |
|---|---|
| Device Model: | NL5000 |
| Classification Name: | Computed Tomography X-ray System |
| Product Code: | JAK |
| Device Classification: | Class II (per 21 CFR § 892.1750) |
Predicate Device:
| 510(k): | K211711 |
|---|---|
| Trade Name: | OmniTom Elite |
| Device Model: | NL5000 |
| Classification Name: | Computed Tomography X-ray System |
| Product Code: | JAK |
| Device Classification: | Class II (per 21 CFR § 892.1750) |
4
Image /page/4/Picture/0 description: The image shows the logo for NeuroLogica. The logo consists of the word "NeuroLogica" in a bold, sans-serif font. The "o" in "Neuro" is replaced with a blue circle. Below the logo is the text "A Subsidiary of Samsung Electronics Co., Ltd" in a smaller font.
Device Description:
The subject OmniTom Elite Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K211711). Both computed tomography systems are identical in terms of the high resolution, 16 row, 40 cm bore, and 30 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360-degree movement and electrical drive system so the system can be moved easily to different locations.
The ability to upgrade the OmniTom Elite system with photon counting detector (PCD) remains the same. PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images.
Indications for Use:
The OmniTom Elite CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.
OmniTom Elite with photon counting detectors (PCD) configuration has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI). OmniTom Elite with PCD is only supported for adult axial imaging for head and neck.
Comparison of Technological Characteristics with the Predicate Device:
We modified the cleared OmniTom Elite (K211711) within our design controls to include technology improvements that includes multiple spatial resolution modes for PCD along with CT functionality for material decomposition and virtual monoenergetic images (VMI).
5
The indications for use between the subject device and the predicate device (K211711) only vary slightly, in that the subject device offers the optional CT multi-energy of the photon counting detector. The subject device still contains the same basic functionality as the predicate device (K211711), and therefore, is one of many reasons why safety and efficacy are not of a concern. Please find both the subject and predicate indications for use below.
| OmniTom Elite (Subject Device) | OmniTom Elite (Predicate – K211711) |
|---|---|
| The OmniTom Elite CT system is intended | |
| to be used for x-ray computed tomography | |
| applications for anatomy that can be imaged | |
| in the 40cm aperture, primarily head and | |
| neck. | The OmniTom Elite computed tomography |
| (CT) system is intended to be used for x-ray | |
| computed tomography applications for | |
| anatomy that can be imaged in the 40cm | |
| aperture, primarily head and neck. | |
| The CT system is intended to be used for | |
| both pediatric and adult imaging and as such | |
| has preset dose settings based upon weight | |
| and age. The CT images can be obtained | |
| either with or without contrast. | The CT system is intended to be used for |
| both pediatric and adult imaging and as such | |
| has preset dose settings based upon weight | |
| and age. The CT images can be obtained | |
| either with or without contrast. | |
| OmniTom Elite with photon counting | |
| detectors (PCD) configuration has multi- | |
| energy CT functionality with spectral | |
| capability for material decomposition and | |
| virtual monoenergetic images (VMI). | |
| OmniTom Elite with PCD is only supported | |
| for adult axial imaging for head and neck. | OmniTom Elite with photon counting |
| detectors (PCD) has multi-energy CT | |
| functionality with spectral capability. | |
| OmniTom Elite with PCD is only supported | |
| for adult imaging for anatomy that can be | |
| imaged in the 40cm aperture, primarily head | |
| and neck. |
The optional upgrade of the photon counting detector (PCD) remains the same from a hardware standpoint. OmniTom Elite with the optional PCD kit for its intended use, is of comparable type in design, material, functionality, and technology and is substantially equivalent to the cleared predicate device - OmniTom Elite (K211711).
6
Similarities
- I Design: The OmniTom Elite is identical in design characteristics to its previous version and shares all of the control system designs and features of the cleared predicate device.
- Components: The OmniTom Elite uses similar components as the predicate device I (OmniTom Elite) such as x-ray generator, collimator, slip ring and power system.
- . Software: The OmniTom Elite, with the exclusion of PCD kit, uses the same software as the predicate (K211711). Refer to the differences listed below for software differences with PCD.
Differences
The following differences exist between the subject device (OmniTom Elite) and its previously cleared version, predicate device (K211711).
- The PCD configuration now includes the following:
- o Addition of high-resolution mode (smaller grouping of detectors) without physically changing the detector array.
- Ability to provide reliable multi-energy images with material o decomposition and VMI.
- PCD scanning is limited to 20 cm field of view and adult axial images adults o only.
- For scanning with PCD, scan voltage is 120 kV and scan current is о selectable from 5mA to 20 mA.
- While using the PCD configuration, operating environment ambient O temperature is 15°C/59°F - 22°C/73 °F.
- Detector coverage is the following: o
- 16 x 0.707 mm for PCD (standard resolution) o
- 26 X 0.424 mm for PCD (high resolution) o
General Safety and Effectiveness:
All components of the subject OmniTom Elite CT system that are subject to Federal Diagnostic Equipment Performance Standard and applicable regulations of 21 CFR $1020.30 and §1020.33 are certified to meet those requirements. To minimize electrical, mechanical and radiation hazards, NeuroLogica adheres to recognized and established industry practices.
OmniTom Elite CT system is designed and manufactured to comply with the FDA Quality System Regulations (21 CFR part 820) and ISO 13485:2016 requirements. The device is
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Image /page/7/Picture/0 description: The image shows the logo for NeurLogica, a subsidiary of Samsung Electronics Co., Ltd. The logo is in black text, with the "o" in NeurLogica represented by a blue circle. The text "A Subsidiary of Samsung Electronics Co., Ltd" is in a smaller, blue font below the main logo.
in conformance with all applicable parts of the following FDA recognized consensus standards:
| FDA
Recognition
| Number | Standard | Description | Version |
|---|---|---|---|
| 19-4 | AAMI / ANSI | ||
| ES 60601-1 | Medical Electrical Equipment -- | ||
| Part 1: General Requirements For | |||
| Basic Safety And Essential | |||
| Performance | 2012 | ||
| 19-8 | IEC 60601-1-2 | Medical electrical equipment - | |
| Part 1-2: General Requirements | |||
| for Basic Safety and Essential | |||
| Performance - Collateral Standard: | |||
| Electromagnetic Compatibility. | |||
| Requirements and Tests | 2014 | ||
| 12-269 | 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 | 2013 | ||
| 5-89 | IEC 60601-1-6 | Medical Electrical Equipment - | |
| Part 1-6: General Requirements | |||
| For Basic Safety And Essential | |||
| Performance - Collateral Standard: | |||
| Usability | 2013 | ||
| 12-302 | IEC 60601-2-44 | Medical Electrical Equipment- | |
| Part 2-44: Particular Requirements | |||
| for Basic Safety and Essential | |||
| Performance of X-Ray Equipment | |||
| for Computed Tomography | 2016 | ||
| 12-273 | IEC 60825-1 | Safety Of Laser Products - Part 1: | |
| Equipment Classification, And | |||
| Requirements | 2007 | ||
| FDA | |||
| Recognition | |||
| Number | Standard | Description | Version |
| 5-125 | ISO 14971 | Medical Devices - Application Of | |
| Risk Management To Medical | |||
| Devices | 2019 | ||
| 13-79 | IEC 62304 | Medical Device Software - | |
| Software Life Cycle Processes | 2015 | ||
| 5-117 | ISO 15223-1 | Medical Devices - Symbols To Be | |
| Used With Medical Device | |||
| Labels, Labelling, And | |||
| Information To Be Supplied - Part | |||
| 1: General Requirements | 2016 | ||
| 2-258 | ISO 10993-1 | Biological evaluation of medical | |
| devices - Part 1: Evaluation and | |||
| testing within a risk management | |||
| process | 2018 | ||
| 2-245 | ISO 10993-5 | Biological evaluation of medical | |
| devices - Part 5: Tests for in vitro | |||
| cytotoxicity | 2009 | ||
| 2-174 | 10993-10 | Biological evaluation of medical | |
| devices - Part 10: Tests for | |||
| irritation and skin sensitization | 2010 | ||
| 12-325 | NEMA XR 25 | Computed Tomography Dose | |
| Check | 2019 | ||
| FDA | |||
| Recognition | |||
| Number | Standard | Description | Version |
| NR | NEMA XR 26 | Access Controls for Computer | |
| Tomography: Identification, | |||
| Interlocks, and Logs | 2012 | ||
| 12-330 | NEMA XR 28 | Supplemental Requirements for | |
| User Information and System | |||
| Function Related to Dose in CT | 2018 | ||
| NR | NEMA XR 29 | Standard Attributes on Computed | |
| Tomography (CT) Equipment | |||
| Related to Dose Optimization and | |||
| Management | 2013 | ||
| 12-342 | NEMA PS 3.1 - | ||
| 3.20 | Digital Imaging and | ||
| Communications in Medicine | |||
| (DICOM) Set | 2021 | ||
| 21 CFR | |||
| subchapter J | |||
| § 1020.30 | FDA | Performance Standards for | |
| Ionizing Radiation Emitting | |||
| Products: Diagnostic x-ray | |||
| systems and their major | |||
| components | 2022 | ||
| 21 CFR | |||
| subchapter J | |||
| § 1020.33 | FDA | Performance Standards for | |
| Ionizing Radiation Emitting | |||
| Products: Computed tomography | |||
| (CT) equipment | 2022 |
8
NeuroLogica
Asubsidiary of Samsung Electronics Co., Ltd
9
Neur®Logica
The OmniTom Elite was designed in accordance with the following FDA Guidance documents:
- . Computer Software Assurance for Production and Quality System Software, September 2022
10
- . Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, April 2022
- . Content of Premarket Submissions for Device Software Functions, November 2021
- . Guidance for Postmarket Management of Cybersecurity in Medical Devices, December 2016
- . Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2018
- 트 Off-The-Shelf Software Use in Medical Devices, September 2019
- . Guidance for Medical X-Ray Imaging Devices Conformance with IEC Standards, Mav 2019
- Guidance for Industry and FDA Staff: Pediatric Information for X-ray Inaging Device Premarket Notifications, November 2017
- Guidance for Industry and FDA Staff : Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22, June 2007
- 트 Radiofrequency Wireless Technology in Medical Devices, August 2013
In addition to conformance to the above harmonized standards, OmniTom Elite quality assurance activities include the following:
- Risk analysis and mitigation ■
- Software verification and validation testing
- System verification and validation testing
- Image quality tests
- . Testing at unit level
Performance Data:
The risk analysis, verification and validation activities and testing of product safety and EMC / EMI was completed successfully. The differences noted raise no new issues of safety or effectiveness based on all testing performed and establish that specifications for the device have been met. Below a summary has been provided for the testing conducted.
Bench testing
The software contained in the proposed device has been developed & tested in accordance with IEC 62304, and the FDA guidance for Content of Premarket Submissions for Software Contained in Medical Devices. Software is critical to the operation of the OmniTom Elite CT system and a malfunction or design flaw in the software could result in delay in delivery of appropriate medical care. As such, the risk management analysis identified potential hazards which were controlled and mitigated during development of OmniTom Elite. The verification/validation testing ensured the safety and effectiveness of OmniTom Elite.
11
Design verification and design validation testing was performed to confirm all design and user requirements were met. The proposed OmniTom Elite device demonstrated that the new features did not exhibit any negative effects on the requirements in place, as well as they did not exhibit any concerns that may impact safety and effectiveness.
Software verification and software validation testing was executed to confirm all software requirements were met. The proposed OmniTom Elite device was shown to meet all requirements and to not have any impact on imaging.
For material decomposition, the multi-energy CT phantom was scanned, where three basic materials, water, iodine and calcium were decomposed. The materials were well represented in the respective decomposition maps, for example; iodine of varying densities highlighted on the iodine map.
The OmniTom Elite with PCD underwent Electrical Safety and Electromagnetic Compatibility testing and proved to be in compliance with IEC 60601-1-2, and IEC 60601-2-44.
Image quality evaluation
Image quality metrics such as noise, slice thickness, low and high contrast resolution. radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests in accordance with the equipment performance standards for diagnostic x-ray systems administered by the FDA. Imaging metrics successfully demonstrated that the proposed device with PCD has comparable image quality with its previous version, predicate device (K211711) and meets all the image quality criteria that are used for testing.
In addition, PCD capabilities were tested to demonstrate properties of PCD in count mode and multi-energy mode. For imaging purposes, the pixels were binned to match the predicate device detector geometry. Imaging metrics demonstrated stability of the detector, analysis of the count rate and limited pileup loss at low dose scanning.
Clinical evaluation
Comparative study was conducted under an IRB for comparison between OmniTom Elite with PCD and OmniTom Elite with EID images. All study protocols were performed in accordance with the relevant regulations and the guidelines. Volunteers underwent CT scanning for a full head scan, from the upper jaw to the top of the skull to aid in generation of comparative images. Three locations were selected for the comparative study: The sinuses, the mid brain, and the top of the skull. These images were reviewed by three independent board-certified practicing radiologists and confirmed diagnostic quality of the images demonstrating the effectiveness of the subject device for clinical scaming.
12
Image /page/12/Picture/0 description: The image shows the logo for NeuroLogica, a subsidiary of Samsung Electronics Co., Ltd. The word "NeuroLogica" is written in a bold, sans-serif font, with a blue circle in place of the "O". Below the logo, the text "A Subsidiary of Samsung Electronics Co., Ltd" is written in a smaller font.
The clinical scans indicate the ability of the PCD configuration of the OmniTom Elite device to generate diagnostically acceptable images, which are equivalent to those produced by the OmniTom Elite with EID. The subject device clinical benefits outweigh the risks and as such the device should be considered safe for its intended use and performs like other CT devices currently on the market. Multi-energy studies demonstrate the PCD's ability not only to produce diagnostically acceptable images but also to ability to decompose images using different basis materials such as iodine and calcium. This additional information can be beneficial in improving diagnostic confidence.
The clinical evaluation demonstrates safety and performance of the OmniTom Elite system with PCD, when used under the conditions and for the purposes intended.
Conclusion
Both the proposed device (OmniTom Elite) with the optional PCD upgrade and the predicate device (K211711) are CT systems that are used for similar CT imaging purposes. The overall design of the CT system and basic functionality that it provides to the end user are the same. The differences in technological characteristics through the additional software features adding applications utilizing the multi-energy CT functionality for high resolution mode, material decomposition, virtual monoenergetic images (VMI) do not raise different questions of safety and effectiveness.
The results of the performance testing and conformance to the harmonized standards demonstrate that the subject device operates in accordance with specifications and meets user needs and intended use. The proposed OmniTom Elite CT system performs as well in its intended use as similar CT devices currently on the market.