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.

OmniTom Elite with photon counting detectors (PCD) can generate spectral CT images at multiple energy levels. OmniTom Elite with PCD is only supported for adult imaging for anatomy that can be imaged in the 40cm aperture, primarily head and neck.

Device Description

The subject OmniTom Elite Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K202526). We have included some other design changes to make the system more robust and reliable. 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.

We have added the ability to upgrade the OmniTom Elite system with photon counting detector (PCD). OmniTom Elite with PCD is the same system as the predicate device OmniTom Elite energy integrating detector (EID) with the only difference being the detector array system, instead of the current gadolinium oxysulfide EID, it has a cadmium telluride based PCD.

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. OmniTom Elite with PCD has the capacity to more than double the EID detector spatial resolution.

AI/ML Overview

The provided text describes the OmniTom Elite CT system, which offers an optional Photon Counting Detector (PCD) upgrade. The submission aims to demonstrate substantial equivalence to its predicate device, OmniTom Elite with Energy Integrating Detector (EID) (K202526).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating the safety, effectiveness, and comparable image quality of the OmniTom Elite with PCD to its EID counterpart, without raising new questions of safety or effectiveness. Specific quantitative acceptance criteria are not explicitly listed in easily consumable metrics such as sensitivity/specificity/accuracy, but rather implied through compliance with standards, successful performance tests, and expert review.

Acceptance Criteria Category	Description	Reported Device Performance
Safety	Compliance with relevant electrical safety, radiation safety, and electromagnetic compatibility standards. Risk analysis and mitigation.	- "All components...are certified to meet those requirements [Federal Diagnostic Equipment Performance Standard and 21 CFR §1020.30 and §1020.33]." - "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." - Conformance with numerous harmonized standards including ISO 14971 (Risk Management), IEC 60601-1 (Basic Safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (Radiation Protection), IEC 60601-2-44 (CT Equipment Specific), NEMA XR 25, 26, 28, 29, 21 CFR §1020.30, §1020.33. - "The OmniTom Elite with PCD 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." - "The risk management analysis identified potential hazards which were controlled and mitigated during development."
Effectiveness/Functionality	Device performs as intended for CT imaging, including new PCD capabilities (multi-energy, spectral CT), without negative impact from design changes.	- "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." - PCD capabilities were tested to demonstrate properties of PCD in count and multi-energy mode. Imaging metrics demonstrated stability of the detector, analysis of the count rate and limited pileup loss at low dose scanning. - "Comparative study was conducted... The comparative study involved scanning the same subject using both the EID and the PCD CT systems at the same anatomical sections... These images were reviewed by two independent board-certified radiologists and confirmed diagnostic quality of the images demonstrating the effectiveness of the subject device for clinical scanning."
Image Quality	Image quality metrics (noise, slice thickness, resolution) are comparable to the predicate device and meet established criteria.	- "Imaging 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 (K202526) that had EID and meets all the image quality criteria that are used for testing."
PCD Specific Functionality	Ability to generate spectral CT images at multiple energy levels with configurable thresholds, minimal crosstalk, and enhanced spatial resolution for adults in head/neck. Stable detector and acceptable count rate.	- "PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition... The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images." - "OmniTom Elite with PCD has the capacity to more than double the EID detector spatial resolution." - "No crosstalk noticed between images." - "Imaging metrics demonstrated stability of the detector, analysis of the count rate and limited pileup loss at low dose scanning."
Usability/Movement Control	Enhanced movement controls for simpler/easier navigation, improved durability, and ease of operator transport.	- "The addition of a drive camera (SmartDrive) and new transport wheels (OmniWheels) for simpler navigation; the drive bar mechanism was enhanced for durability, easier manufacturability and ease of operator overall transportation of device." - "The improvements in movement performance were implemented to solely allow the operator to transport the device with ease."
Software Integrity	Software developed and tested in accordance with relevant standards and guidance; no negative impact on imaging.	- "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 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."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The text states, "Volunteers underwent scanning to aid in generation of comparative images." It does not specify the exact number of volunteers. It implies a small number, as it talks about "the same subject" being scanned.
Data Provenance: Not explicitly stated, but the mention of "an IRB" (Institutional Review Board) implies a prospective study involving human subjects. The country of origin is not specified but is likely the US given the FDA submission. It was a prospective study involving volunteers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: "two independent board-certified radiologists."
Qualifications: "board-certified radiologists." No further details on years of experience are provided, but board certification implies a high level of expertise in medical imaging interpretation.

4. Adjudication Method for the Test Set

The text states: "These images were reviewed by two independent board-certified radiologists and confirmed diagnostic quality of the images demonstrating the effectiveness of the subject device for clinical scanning."

This indicates a consensus or agreement-based approach for diagnostic quality, where both radiologists had to confirm it. There is no mention of a formal adjudication process (e.g., 2+1 or 3+1 where a third or fourth reader resolves discrepancies), beyond the agreement on diagnostic quality. It seems the goal was to confirm diagnostic quality, not necessarily to create a "ground truth" for specific disease detection where adjudication for disagreements would be critical.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a formal MRMC comparative effectiveness study to assess improvement in human readers with AI vs. without AI assistance was not conducted or described. The study described was a comparative imaging study to show that images from the new PCD system were of diagnostic quality and comparable to the EID system. The focus was on the device's image quality and diagnostic utility as a standalone imaging system, not its impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes, a standalone assessment was a primary component of the submission. The "Image quality evaluation" section describes rigorous phantom testing and measurements of "noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function." This demonstrates the algorithm's (and hardware's) performance in generating images. The clinical evaluation with radiologists also served to confirm the diagnostic quality of the images generated by the device itself, implicitly assessing its standalone performance.

7. The Type of Ground Truth Used

The ground truth for the device's image quality and diagnostic utility was established through:

Phantom Tests: For objective image quality metrics (noise, resolution, MTF, etc.).
Expert Consensus/Opinion: For confirming the "diagnostic quality" of the clinical images by two independent board-certified radiologists. This isn't a "pathology" or "outcomes data" ground truth, but rather a subjective assessment by experts of the image's clinical utility.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device is a CT scanner, not an AI/ML diagnostic algorithm that requires a separate training set of patient data for model development. The "training" here refers to the engineering and validation processes (design verification, software testing, bench testing, etc.) that ensure the system functions correctly and produces high-quality images.

9. How the Ground Truth for the Training Set Was Established

As explained above, there isn't a "training set" in the sense of patient data used to train an AI model. The system's "ground truth" (i.e., its correct operational parameters and expected image output) was established through:

Engineering Specifications and Design Requirements: What the system was designed to achieve.
Reference Standards: Adherence to IEC 60601-x standards, NEMA, and FDA performance standards.
Phantom Studies: Objective measurements against known targets.
Bench Testing: Verification and validation of hardware and software components against their specified functions.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

NeuroLogica Corporation, a subsidiary of Samsung Electronics Co., Ltd % Ninad Gujar Vice President, Regulatory Affairs and Quality Assurance 14 Electronics Avenue DANVERS MA 01923

Re: K211711

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: January 26, 2022 Received: January 28, 2022

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.

February 25, 2022

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 mediation-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,

Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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) K211711

Device Name OmniTom Elite

Indications for Use (Describe)

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.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/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 "NeuroLogica" is replaced with a blue circle. Below the logo, in a smaller font, is the text "A Subsidiary of Samsung Electronics Co., Ltd."

510(k) Summary

K211711

In accordance with 21 CFR § 807.92, the 510(k) summary includes information on safety and effectiveness.

Date Prepared: June 2, 2021

Submitter

NeuroLogica Corporation, a subsidiary of Samsung Electronics Co., Ltd 14 Electronics Avenue, Danvers, MA 01923

Establishment Registration

3004938766

Manufacturing Site

NeuroLogica Corporation, 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):	K202526
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}------------------------------------------------

Device Description:

Indications for Use:

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.

{5}------------------------------------------------

Comparison of Technological Characteristics with the Predicate Device:

We modified the cleared OmniTom Elite (K202526) within our design controls to include technology improvements that include hardware features for enhancing movement control, manufacturability, and serviceability of the CT system.

The indications for use between the subject device (K211711) and the predicate device (K202526) only vary slightly, in that the subject device offers the optional addition of the photon counting detector. The subject device (K211711) still contains the same basic functionality as the predicate device (K202526), 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 with PCD (Subject –K211711)	OmniTom Elite with EID (Predicate –K202526)
The OmniTom Elite computed tomography(CT) system is intended to be used for x-raycomputed tomography applications foranatomy that can be imaged in the 40cmaperture, primarily head and neck.	The OmniTom Elite computed tomography(CT) system is intended to be used for x-raycomputed tomography applications foranatomy that can be imaged in the 40cmaperture, primarily head and neck.
The CT system is intended to be used forboth pediatric and adult imaging and assuch has preset dose settings based uponweight and age. The CT images can beobtained either with or without contrast.	The CT system is intended to be used forboth pediatric and adult imaging and assuch has preset dose settings based uponweight and age. The CT images can beobtained either with or without contrast.
OmniTom Elite with photon countingdetectors (PCD) can generate spectral CTimages at multiple energy levels. OmniTomElite with PCD is only supported for adultimaging for anatomy that can be imaged inthe 40cm aperture, primarily head and neck.

For the optional upgrade of the photon counting detector (PCD), updates were made to the data acquisition system for PCD. OmniTom Elite with the optional PCD kit can replace the existing EID based data acquisition system, and 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 (K202526).

{6}------------------------------------------------

Similarities

ı Design: The OmniTom Elite is similar in general 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 ■ (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 (K202526). 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 (K202526).

. Movement controls: The addition of a drive camera (SmartDrive) and new transport wheels (OmniWheels) for simpler navigation; the drive bar mechanism was enhanced for durability, easier manufacturability and ease of operator overall transportation of device.
. Noise reduction algorithms: The algorithms are sinogram and image-based reconstruction algorithms designed for the purpose of allowing low-dose scanning by decreasing the noise level in the reconstructed images. The feature is used during post reconstruction and recommended for pediatric scanning and for scanning large patients. The noise algorithm has been enhanced to allow for the use of the three output energy levels.
Addition of optional PCD upgrade; these changes/features are only included if the . PCD kit is chosen by end user:
- . Update to the detector material to CdTe (cadmium telluride) and the data acquisition system (DAS).
- Minor software differences to allow for the generation of the multi-energy . levels derived from the primary scan.
- . The ability to contain configurable energies prior to starting scans
- . No crosstalk noticed between images

{7}------------------------------------------------

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 in conformance with all applicable parts of the following FDA recognized consensus standards:

FDARecognitionNumber	Standard	Description	Version
19-4	AAMI / ANSIES 60601-1	Medical Electrical Equipment --Part 1: General Requirements forBasic Safety And EssentialPerformance	2012
19-8	IEC 60601-1-2	Medical electrical equipment -Part 1-2: General Requirementsfor Basic Safety and EssentialPerformance - Collateral Standard:Electromagnetic Compatibility.Requirements and Tests	2014
12-269	IEC 60601-1-3	Medical Electrical Equipment -Part 1-3: General Requirementsfor Basic Safety And EssentialPerformance - Collateral Standard:Radiation Protection In DiagnosticX-Ray Equipment	2013
5-89	IEC 60601-1-6	Medical Electrical Equipment -Part 1-6: General Requirementsfor Basic Safety And EssentialPerformance - Collateral Standard:Usability	2013
FDARecognitionNumber	Standard	Description	Version
12-302	IEC 60601-2-44	Medical Electrical Equipment-Part 2-44: Particular Requirementsfor Basic Safety and EssentialPerformance of X-Ray Equipmentfor Computed Tomography	2016
12-273	IEC 60825-1	Safety Of Laser Products - Part 1:Equipment Classification, AndRequirements	2007
5-125	ISO 14971	Medical Devices - Application ofRisk Management To MedicalDevices	2019
13-79	IEC 62304	Medical Device Software -Software Life Cycle Processes	2015
5-117	ISO 15223-1	Medical Devices - Symbols To BeUsed With Medical DeviceLabels, Labelling, AndInformation To Be Supplied - Part1: General Requirements	2016
2-258	ISO 10993-1	Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess	2018
2-245	ISO 10993-5	Biological evaluation of medicaldevices - Part 5: Tests for in vitrocytotoxicity	2009
FDARecognitionNumber	Standard	Description	Version
2-174	10993-10	Biological evaluation of medicaldevices - Part 10: Tests forirritation and skin sensitization	2010
12-325	NEMA XR 25	Computed Tomography DoseCheck	2019
NR	NEMA XR 26	Access Controls for ComputerTomography: Identification,Interlocks, and Logs	2012
12-330	NEMA XR 28	Supplemental Requirements forUser Information and SystemFunction Related to Dose in CT	2018
NR	NEMA XR 29	Standard Attributes on ComputedTomography (CT) EquipmentRelated to Dose Optimization andManagement	2013
12-300	NEMA PS 3.1 -3.20	Digital Imaging andCommunications in Medicine(DICOM) Set	2016
21 CFRsubchapter J$ 1020.30	FDA	Performance Standards forIonizing Radiation EmittingProducts: Diagnostic x-raysystems and their majorcomponents	2020
FDARecognitionNumber	Standard	Description	Version
21 CFRsubchapter J§ 1020.33	FDA	Performance Standards forIonizing Radiation EmittingProducts: Computed tomography(CT) equipment	2020

{8}------------------------------------------------

NeurOLogica

Asubsidiary of Samsung Electronics Co., Ltd

{9}------------------------------------------------

Image /page/9/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 the middle of the "O". Below the company name, the text "A Subsidiary of Samsung Electronics Co., Ltd" is written in a smaller, sans-serif font.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for NeuroLogica. The logo is black text with a blue circle in the middle of the word. Below the logo, in smaller text, it says "A Subsidiary of Samsung Electronics Co., Ltd."

The OmniTom Elite was designed in accordance with the following FDA Guidance documents:

트 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, I Mav 2019
트 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 24, 2007
. 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:

Risk analysis and mitigation
Software verification and validation testing
. System verification and validation testing
. Image quality tests
I 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

{11}------------------------------------------------

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.

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.

The OmniTom Elite with PCD 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.

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 (K202526) that had EID 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 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. The section on technological characteristics detailed that the subject and predicate device are mechanically identical. They have the same geometry, i.e., gantry size and weight and the same x-ray tube which guarantees that both scanners deliver the same photon number for the same exposure. The only difference is the DAS.

{12}------------------------------------------------

Volunteers underwent scanning to aid in generation of comparative images. The comparative study involved scanning the same subject using both the EID and the PCD CT systems at the same anatomical sections or as closely as possible. Three locations were selected for the comparative study: The sinuses, the mid brain, and the top of the skull. These images were reviewed by two independent board-certified radiologists and confirmed diagnostic quality of the images demonstrating the effectiveness of the subject device for clinical scanning. In addition, full head scan was conducted to demonstrate the ability of the PCD system in doing complete clinical scanning as needed.

Conclusion

Both the proposed device (OmniTom Elite) with the optional PCD upgrade and the predicate device with EID (K202526) 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 do not raise different questions of safety and effectiveness. The improvements in movement performance were implemented to solely allow the operator to transport the device with ease. The PCD optional kit provides a multi-energy CT functionality with spectral capability. 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.

Regulation Number and Section

§ 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.