OmniTom Elite

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December 23, 2020 NeuroLogica Corporation, a subsidiary of Samsung Electronics % Ninad Gujar, MBA, Ph.D. Vice President, Regulatory Affairs and Quality Assurance 14 Electronics Avenue DANVERS MA 01923 Re: K202526 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: December 4, 2020 Received: December 7, 2020 Dear Dr. 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. 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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 {1}------------------------------------------------ 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 (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). 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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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202526 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 40cm field of view, 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. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="color: black;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Date Prepared: August 28, 2020 #### Submitter NeuroLogica Corp., a subsidiary of Samsung Electronics Co., Ltd. 14 Electronics Avenue, Danvers, MA 01923 Establishment Registration 3004938766 ## Official Correspondent Gina Cunsolo Regulatory Affairs Manager ## Contact Person Dr. Ninad Gujar Vice President, Regulatory Affairs & Quality Assurance 978-564-8632 ngujar@neurologica.com ### Device | 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 | Trade Name: | OmniTom (K171183) | |------------------------|----------------------------------| | Classification Name: | Computed Tomography X-ray System | | Product Code: | JAK | | Device Classification: | Class II (per 21 CFR § 892.1750) | {4}------------------------------------------------ ## Device Description The OmniTom Elite is an improved version of OmniTom computed tomography system, providing enhanced functionality. It still has the same high resolution, multi row, 40 cm bore, and 30 cm field of view x-ray computed tomography system. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, Gd2O2S detector array, 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 omnidirectional 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. ### 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 40cm field of view, 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. #### Comparison of Technological Characteristics with the Predicate Device We modified the cleared OmniTom (K171183) within our design controls to include technology improvements, that include hardware features like movement controls, power system efficiency, ruggedized covers and bumpers, patient auto alignment and software features like metal artifact reduction. CT angiography (CTA), CT perfusion (CTP), bolus tracking, axial and helical AEC and other post reconstruction enhancements. Both the predicate device (K171183) and the subject device have the same intended use. OmniTom Elite, for its intended use, is of comparable type in design, material, functionality, and technology and is substantially equivalent to the cleared predicate device – OmniTom (K171183). ## Similarities - . Design: The OmniTom Elite is similar in general design principle to OmniTom. and shares most of the control system designs and features of the OmniTom. {5}------------------------------------------------ - . Components: The OmniTom Elite uses similar components as the predicate device (OmniTom) such as x-ray generator, Gd2O2S detector array, collimator, slip ring, and data acquisition system. ## Differences The following differences exist between the subject device (OmniTom Elite) and the previously cleared predicate device (OmniTom K171183). - . Movement controls: The drive bar mechanism, system collision sensors, calibration were improved, in addition to audible and visual alerts for performance to avoid any possible unintentional or fast movement. - . Power system efficiency: Improved distribution of power in the system and design of the lithium batteries, allowing maintenance and protection of downstream electrical components. The design changes mitigate any inadvertent system shutdowns while providing health status on the operational state of the CT system and design changes increased mean time between failures (MTBF) for these critical components. - Ruggedized covers and bumpers: Design changes were made for improved durability of the CT system. - Patient auto alignment: Camera allows for rapid positioning of the scanner at the head of the bed, eliminating the need to adjust the patient bed. - . Metal artifact reduction (MAR): Streak artifacts are often seen around aneurysm clips, epilepsy probes or metal pins. The streaks can be reduced using MAR. Testing was carried out using an anatomical phantom and it was found that the MAR algorithm performs as indicated by successfully mitigating the streak artifacts that show up in the CT images without raising any new questions of safety or effectiveness of the device. - CT angiography (CTA), CT perfusion (CTP), bolus tracking: OmniTom Elite has . the ability for helical and dynamic scanning and includes dedicated functionality for contrast scanning. Similar to the predicate, OmniTom Elite does not control the dose, rate or route of administration for the contrast agent. - Automatic exposure control (AEC): Both axial and helical AEC are included in . OmniTom Elite for scanning with reduced radiation dose. AEC feature has been {6}------------------------------------------------ verified as part of IEC 60601-2-44, clause 203.102 in OmniTom Elite similar to the predicate device. - . Post reconstruction enhancements: Reconstruction algorithms were enhanced for better image quality with the addition of specific features to allow modified slice spacing and thickness, reduced field of view. - . Mobile Stroke Unit: Rail and plate configuration is included in a kit for OmniTom Elite to be used in ambulance environment. - . Accessories: OmniTom Elite has various adapters to allow scanning with all compatible beds, a pediatric platform that will allow scanning from head to torso of up to a typical 7-year-old and radiolucent skull clamp kits for use during imaging in neurosurgical environment. - = Software: The software has undergone several updates since the OmniTom (K171183) was cleared. The updates were implemented to enhance the user experience and improve clinical workflow while using the CT system by adding features based on feedback from our current customers. The updated changes do not impact software. The OmniTom Elite software functions in a similar to manner to the predicate OmniTom (K171183) device. The internal verification and validation activities and external testing of product safety and EMC / EMI was completed successfully. The differences noted above raise no new issues of safety or effectiveness based on all testing performed. Below a summary has been provided for the testing conducted. {7}------------------------------------------------ | Attributes | OmniTom Elite<br>(subject device) | OmniTom (predicate<br>device - K171183) | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The OmniTom Elite CT<br>system is intended to be<br>used for x-ray computed<br>tomography applications<br>for anatomy that can be<br>imaged in the 40 cm<br>aperture, primarily head<br>and neck.<br><br>The CT system is<br>intended to be used for<br>both pediatric and adult<br>imaging and as such has<br>preset dose settings<br>based upon weight and<br>age. The CT images can<br>be obtained either with<br>or without contrast. | The NL5000<br>[OmniTom] system is<br>intended to be used for<br>x-ray computed<br>tomography applications<br>for anatomy that can be<br>imaged in the 40 cm<br>aperture, primarily head<br>and neck.<br><br>The CT system is<br>intended to be used for<br>both pediatric and adult<br>imaging and as such has<br>preset dose settings<br>based upon weight and<br>age. The CT images can<br>be obtained either with<br>or without contrast. | | Aperture (cm) | 40 | 40 | | Image Field Of View (cm) | 30 | 30 | | Detector Material | Gadolinium Oxysulfide | Gadolinium Oxysulfide | | Detector Coverage (mm) | 16 x 0.625 mm | 16 x 0.625 mm | | Slice Configurations | 16 | 16 | | Spatial Resolution<br>MTF at 0% (lp/cm) | Soft tissue kernel:<br>6.7 lp/cm<br>High resolution kernel:<br>14.8 lp/cm | Soft tissue kernel:<br>6.0 lp/cm<br>High resolution kernel:<br>14.0 lp/cm | | X-ray Tube Type | Grounded/Fixed<br>Anode/Monoblock | Grounded/Fixed<br>Anode/Monoblock | | Attributes | OmniTom Elite<br>(subject device) | OmniTom (predicate<br>device - K171183) | | Heat Storage (MHU) | 0.72 | 0.72 | | Cooling | Water-Glycol | Water-Glycol | | Tube Current (Ma) | 5 – 45 | 5 – 45 | | Tube Voltage Range (Kv) | 80, 100, 120 | 80, 100, 120 | | Rotation time (s) | 1, 2 | 1, 2 | | Gantry Weight (lbs) | 1700 | 1700 | | Mobile / Stationary | Mobile | Mobile | | Battery / Wall power | Lithium Iron Phosphate | Lithium Iron Phosphate | | Input Voltage | Single Phase<br>90 – 264 VAC/1300<br>watts peak | Single Phase<br>90 – 264 VAC/1300<br>watts peak | | Max Input Power (Kva) | 5.4 Kw | 5.4 Kw | | PACS DICOM 3.1 | Yes | Yes | | 2D Scout Scan | Yes | Yes | | Bolus Tracking | Yes | No | | Axial Scan | Yes | Yes | | Helical Scan | Yes | Yes | | Dynamic Scan | Yes | Yes | | 2D Viewing | Yes | Yes | | MPR Viewing | Yes | Yes | | Attributes | OmniTom Elite<br>(subject device) | OmniTom (predicate<br>device - K171183) | | 3D Viewing | Yes | Yes | | Max Scan Range (cm) | 40 | 40 | | Scan Localizer | Laser | Laser | | Cardiac/Respiratory Gating | No | No | | Patient Table | No | No | | Image recon speed max (images<br>per second) | 16 image/s | 16 image/s | | X-ray Warning Lights | Yes | Yes | | 110% X-ray Timer | Yes | Yes | | Emergency Stop | Yes | Yes | | Operator X-ray On Switch | Yes | Yes | | Quality Test Phantom | Yes | Yes | | Quality Test Report | Yes | Yes | | X-ray Filter | Bowtie | Bowtie | | Administrator Privileges | Yes | Yes | | Dose Display | Yes | Yes | | Dose Report / Audit | Yes | Yes | | Protocol Override Protection | Yes | Yes | | Dose Check | Yes | Yes | | Attributes | OmniTom Elite<br>(subject device) | OmniTom (predicate<br>device – K171183) | | Pediatric Protocols | Yes<br>By Age/weight | Yes<br>By Age/weight | | Automatic Exposure Control | Yes | Yes | | Biocompatibility | Yes | N/A | | Sterility | N/A | N/A | | Chemical Safety | N/A | N/A | | EM Emissions | ETL Testing | ETL Testing | | Electrical Safety (IEC 60601-1) | ETL Testing | ETL Testing | | Mechanical Safety (IEC 60601-1) | ETL Testing | ETL Testing | | Where Used | (Mobile) Radiology,<br>ICU, ED, OR, Clinic,<br>Office, Ambulance | (Mobile) Radiology,<br>ICU, ED, OR, Clinic,<br>Office | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ## General Safety and Effectiveness Concerns: 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 and ISO 13485:2016 requirements. The device is in conformance with all applicable parts of the following FDA recognized consensus standards: {11}------------------------------------------------ | FDA<br>Recognition<br>Number | Standard | Description | Version | |-------------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | 19-4 | AAMI / ANSI<br>ES 60601-1 | Medical Electrical Equipment --<br>Part 1: General Requirements For<br>Basic Safety And Essential<br>Performance | 2012 | | 19-8 | IEC 60601-1-2 | Medical electrical equipment -<br>Part 1-2: General Requirements<br>for Basic Safety and Essential<br>Performance - Collateral Standard:<br>Electromagnetic Compatibility.<br>Requirements and Tests | 2014 | | 12-269 | IEC 60601-1-3 | Medical Electrical Equipment -<br>Part 1-3: General Requirements<br>For Basic Safety And Essential<br>Performance - Collateral Standard:<br>Radiation Protection In Diagnostic<br>X-Ray Equipment | 2013 | | 5-89 | IEC 60601-1-6 | Medical Electrical Equipment -<br>Part 1-6: General Requirements<br>For Basic Safety And Essential<br>Performance - Collateral Standard:<br>Usability | 2013 | | 12-302 | IEC 60601-2-44 | Medical Electrical Equipment-<br>Part 2-44: Particular Requirements<br>for Basic Safety and Essential<br>Performance of X-Ray Equipment<br>for Computed Tomography | 2016 | | 12-273 | IEC 60825-1 | Safety Of Laser Products - Part 1:<br>Equipment Classification, And<br>Requirements | 2007 | | 5-40 | ISO 14971 | Medical Devices - Application Of<br>Risk Management To Medical<br>Devices | 2007 | | FDA<br>Recognition<br>Number | Standard | Description | Version | | 13-79 | IEC 62304 | Medical Device Software -<br>Software Life Cycle Processes | 2015 | | 5-117 | AAMI / ANSI /<br>ISO 15223-1 | Medical Devices - Symbols To Be<br>Used With Medical Device<br>Labels, Labelling, And<br>Information To Be Supplied - Part<br>1: General Requirements | 2016 | | 2-258 | 10993-1 | Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>testing within a risk management<br>process | 2018 | | 2-245 | 10993-5 | Biological evaluation of medical<br>devices - Part 5: Tests for in vitro<br>cytotoxicity | 2009 | | 2-174 | 10993-10 | Biological evaluation of medical<br>devices - Part 10: Tests for<br>irritation and skin sensitization | 2010 | | 12-325 | NEMA XR 25 | Computed Tomography Dose<br>Check | 2019 | | NR | NEMA XR 26 | Access Controls for Computer<br>Tomography: Identification,<br>Interlocks, and Logs | 2012 | | FDA<br>Recognition<br>Number | Standard | Description | Version | | 12-330 | NEMA XR 28 | Supplemental Requirements for<br>User Information and System<br>Function Related to Dose in CT | 2018 | | NR | NEMA XR 29 | Standard Attributes on Computed<br>Tomography (CT) Equipment<br>Related to Dose Optimization and<br>Management | 2013 | | 12-300 | NEMA PS 3.1 -<br>3.20 | Digital Imaging and<br>Communications in Medicine<br>(DICOM) Set | 2016 | | 21 CFR<br>subchapter J<br>§ 1020.30 | FDA | Performance Standards for<br>Ionizing Radiation Emitting<br>Products: Diagnostic x-ray<br>systems and their major<br>components | 2019 | | 21 CFR<br>subchapter J<br>§ 1020.33 | FDA | Performance Standards for<br>Ionizing Radiation Emitting<br>Products: Computed tomography<br>(CT) equipment | 2019 | {12}------------------------------------------------ {13}------------------------------------------------ The OmniTom Elite was designed and manufactured in accordance with the following FDA Guidance Documents: - Guidance for the Content of Premarket Submissions for Management of 트 Cybersecurity in Medical Devices, October 2018 - Off-The-Shelf Software Use in Medical Devices, September 2019 - . Guidance for Medical X-Ray Imaging Devices Conformance with IEC Standards, May 2019 - . Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device Premarket Notifications, November 2017 - Guidance for Industry and FDA Staff : Laser Products Conformance with IEC . 60825-1 and IEC 60601-2-22, June 24, 2007 {14}------------------------------------------------ - Radiofrequency Wireless Technology in Medical Devices, August 14, 2013 In addition to conformance to the above harmonized standards, OmniTom Elite quality assurance activities include the following: - 트 Risk analysis and mitigation - 트 Software verification and validation testing - . System verification and validation testing - 트 Image quality tests - I Testing at unit level 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. The OmniTom Elite underwent Electrical Safety and Electromagnetic Compatibility testing and proved to be in compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-44. 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. 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. The OmniTom Elite system successfully demonstrated that it has comparable image quality as the predicate device OmniTom (K171183) and meets all the image quality criteria that are used for testing the OmniTom. Clinical performance of the CT system was evaluated using an ACR Phantom was used to measure image metrics, such as CT number linearity, image slice thickness, image noise, {15}------------------------------------------------ low contrast resolution and high contrast resolution. The data provided clinical demonstration of the operation of the device and the images reviewed by a board-certified radiologist were of diagnostic quality. ### Conclusion Both the proposed device (OmniTom Elite) and the predicate device (OmniTom) are CT systems that are used for pediatric and adult imaging (same intended use). 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 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 OmniTom Elite CT system performs as well in its intended use as similar CT devices currently on the market.