CereTom Elite

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NeuroLogica Corporation, subsidiary of Samsung Electronics Co., Ltd. % Ninad Gujar Director, Regulatory Affairs and Quality Assurance 14 Electronics Avenue DANVERS MA 01923 Re: K172539 Trade/Device Name: CereTom Elite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 31, 2017 Received: November 6, 2017 Dear Ninad Gujar: We have reviewed vour 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. November 22, 2017 {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Robert Oakes Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172539 Device Name CereTom Elite Indications for Use (Describe) The NL3000 [CereTom Elite] CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 25cm field of view, primarily head and neck. The CT system is intended to be used for both pediatric 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) | Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> | |----------------------------------------------|-------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div></div> | #### 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}------------------------------------------------ # 510(k) Summary This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92 Date: August 23, 2017 #### Submitter: NeuroLogica Corporation, subsidiary of Samsung Electronics Co., Ltd. 14 Electronics Avenue, Danvers, MA 01923 # Contact: Dr. Ninad Gujar Director, Regulatory Affairs & Quality Assurance Telephone: 978-564-8503 Fax: 978-564-8677 E-mail: ngujar@neurologica.com # Device Name: | Trade Name: | CereTom Elite | |------------------------|----------------------------------| | Device Model: | NL3000 | | Classification Name: | Computed Tomography X-ray System | | Product Code: | JAK | | Device Classification: | Class II (per 21 CFR § 892.1750) | #### Predicate Device: | Trade Name: | CereTom | |------------------------|-----------------------------------------------------------------------------------------------------------| | 510(k) number: | K051765 cleared 07/14/2005 | | Manufacturer: | NeuroLogica Corporation, subsidiary of Samsung<br>Electronics Co., Ltd. (same as that of proposed device) | | Classification Name: | Computed Tomography X-ray System | | Product Code: | JAK | | Device Classification: | Class II (per 21 CFR § 892.1750) | # Reference Device: | Trade Name: | Brilliance 16-slice Configuration | |----------------------|-----------------------------------------------------------------------------| | 510(k) number: | K012009 cleared 09/13/2001 | | Manufacturer: | (Marconi Medical Systems Inc.) Philips Medical Systems<br>(Cleveland), Inc. | | Classification Name: | Computed Tomography X-ray System | {4}------------------------------------------------ | Product Code: | JAK | |------------------------|--------------------------------| | Device Classification: | Class II (per 21 CFR 892.1680) | ### Device Description: The CereTom Elite is an improved version of CereTom computed tomography system providing enhanced functionality. It still has the same high resolution, 8 row, 32 cm bore and 25cm field of view. 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 and brushless DC servo drive system (disk rotation). 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, xray indicators, interlocks, patient alignment laser and 110% x-ray timer. CereTom Elite also has a scanner drive system (SDS), so that the system can be moved easily to different locations. #### Indications for Use: The NL3000 [CereTom Elite] is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 25cm 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. #### Substantial Equivalence: NeuroLogica Corporation has modified the cleared CereTom (K051765) within our design controls to include technology improvements and features like automatic exposure control, metal artifact reduction and wireless access point. Both the predicate and reference devices have the same intended use as the new device. CereTom Elite uses Gadolinium Oxysulfide as the detector material which is identical as the one already cleared for the reference device Philiance CT 16 - slice Configuration (K012009). CereTom Elite incorporates the same fundamental operating principles as the existing marketed products CereTom (K051765) and Philips Brilliance CT 16 (K012009). NeuroLogica Corporation believes that the CereTom Elite system, for its intended use, is of comparable type in design, components, functionality, and technology and is substantially equivalent to the cleared predicate device - CereTom (K051765). {5}------------------------------------------------ - Design: The CereTom Elite is similar in general design principle to both the ■ above listed CT systems. Specifically, it shares all of the control system designs and features of the CereTom. - Components: The CereTom Elite uses similar components as the predicate device (CereTom) such as x-ray generator, slip ring, rotational bearing, and motion control systems. The following technology differences exist between the subject device (CereTom Elite) and the previously cleared predicate device (CereTom). - . Detector material: The scintillation properties of the detector material Gadolinium Oxysulfide used in CereTom Elite CT system are more promising than the detector material Solid State CdWo4 used in the CereTom system (predicate device K051765). This material has already been cleared for use in the reference device Philips Brilliance CT 16-slice Configuration (K012009 cleared 09/13/2001). - . Automatic exposure control: AEC was not offered on the CereTom system at the time of 510(k) clearance (K051765) but introduced as a device modification through a software/firmware upgrade. AEC feature has been verified as part of IEC 60601-2-44, clause 203.102 in CereTom Elite similar to the predicate device. - . Metal artifact reduction: Streak artifacts are often seen around aneurysm clips, epilepsy probes or metal pins. The streaks can be reduced using metal artifact reduction (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. - . Wireless access point: The wireless access point provides better security and stability of wireless communication in CereTom Elite by creating a standalone wireless network for the scanner compared to the existing Ad-Hoc wireless environment. - Contrast capability: CereTom (predicate device) had the ability for helical and dynamic scanning for CT Angiography (CTA) and CT Perfusion (CTP) applications, including bolus tracking. The contrast imaging capability is added to the expanded indications for CereTom Elite (subject device) and additional performance testing data is provided for this purpose. The CereTom Elite scanner does not control the dose, rate or route of administration for the contrast agent. {6}------------------------------------------------ - NEMA XR-29: CereTom Elite is XR-29 compliant and as such includes four key features of CT equipment that enable optimization or management of radiation dose delivery – dose structured reporting, CT dose check, AEC and pediatric and adult reference protocols. 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. | Model # Name | CereTom Elite<br>(subject of this 510(k)) | CereTom<br>(predicate device<br>K051765) | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The NL3000 CereTom<br>Elite is intended to be<br>used for x-ray computed<br>tomography applications<br>for anatomy that can be<br>imaged in the 25cm field<br>of view, primarily head<br>and neck.<br>The CereTom system is<br>intended to be used for<br>both pediatric and adult<br>imaging and as such has<br>preset dose settings based<br>upon weight and age. The<br>CT images can be<br>obtained either with or<br>without contrast. | The NL3000 CereTom<br>Elite is intended to be<br>used for x-ray computed<br>tomography applications<br>for anatomy that can be<br>imaged in the 25cm field<br>of view, primarily head<br>and neck. | | Aperture (cm) | 32 | 32 | | Image Field Of View (cm) | 25 | 25 | | Detector Material | Gd2O2S | Solid State CdWO4 | | Detector coverage | 8 x 1.25 mm | 8 x 1.25 mm | | Model # Name | CereTom Elite<br>(subject of this 510(k)) | CereTom<br>(predicate device<br>K051765) | | Slice Configurations | 8 | 8 | | Spatial Resolution<br>MTF at 0% (lp/cm) | Soft tissue kernel:<br>7.0 lp/cm @ 0 % MTF<br>High resolution kernel:<br>15.0 lp/cm @ 0 % MTF | Soft tissue kernel:<br>7.0 lp/cm @ 0 % MTF<br>High resolution kernel:<br>15.0 lp/cm @ 0 % MTF | | X-ray Tube Type | Grounded/Fixed<br>Anode/Monoblock | Grounded/Fixed<br>Anode/Monoblock | | Heat Storage (MHU) | 0.45 | 0.45 | | Cooling | Air cooled | Air cooled | | Tube Current (mA) | 1-7 | 1-7 | | Tube Voltage Range (kV) | 100,120,140 | 100,120,140 | | Rotation time (s) | 2.0, 4.0, 6.0 | 2.0, 4.0, 6.0 | | Gantry Weight (pounds) | 966 | >900 | | Mobile / Stationary | Mobile | Mobile | | Battery / Wall power | Lead Acid Battery | Lead Acid Battery | | Input Voltage | Single phase<br>90-264 VAC | Single phase<br>90-264 VAC | | Max Input Power (kVA) | 1.3 kW | 1.3 kW | | PACS DICOM 3.0 | Yes | Yes | | 2D Scout Scan | Yes | Yes | | Bolus Tracking | Yes | Yes | | Axial Scan | Yes | Yes | | Model # Name | CereTom Elite<br>(subject of this 510(k)) | CereTom<br>(predicate device<br>K051765) | | Helical Scan | Yes | Yes | | Dynamic Scan | Yes | Yes | | 2D Viewing | Yes | Yes | | MPR Viewing | Yes | Yes | | 3D Viewing | Yes | Yes | | Gantry Tilt | No | No | | Max Scan Range (cm) | 64 | 64 | | Scan Localizer | Laser | Laser | | Cardiac/Respiratory Gating | No | No | | Patient Table | No | No | | Image recon speed max (images<br>per second) | 1 image/sec | 1 image/ sec | | 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 | | Model # Name | CereTom Elite<br>(subject of this 510(k)) | CereTom<br>(predicate device K051765) | | Administrator Privileges | Yes | Yes | | Dose Display | Yes | Yes | | Dose Report / Audit | Yes | Yes | | Protocol Override Protection | Yes | Yes | | Dose Check | Yes | Yes | | Pediatric Protocols | Yes<br>By Age / weight | Yes<br>By Age / weight | | Automatic Exposure Control | Yes | No | | 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, ICU, ED, OR, Clinic, Office | (Mobile) Radiology, ICU, ED, OR, Clinic, Office | | Anatomical Site | Head and Neck | Head and Neck | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ # General Safety and Effectiveness Concerns: All components of the CereTom Elite 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 Corporation adheres to recognized and established industry practices. {10}------------------------------------------------ CereTom Elite system is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485 requirements. The device is in conformance with all applicable parts of the following FDA Recognized Consensus Standards: - 그 IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety - 트 IEC 60601-1-2, Medical electrical equipment - Part 1-2: General Requirements Basic Safety and Essential Performance - Collateral Standard: for Electromagnetic Compatibility. Requirements and Test - 그 IEC 60601-1-3, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment - IEC 60601-2-44, Medical Electrical Equipment - Part 2-44: Particular Requirements for Basic Safety and Essential Performance of X-Ray Equipment for Computed Tomography - NEMA XR-25: Computed Tomography Dose Check - 트 NEMA XR-29: Standard Attributes on CT Equipment Related to Dose Optimization and Management - ISO 14971 Medical devices Application of risk management to medical devices ■ In addition to conformance to the above harmonized standards, CereTom 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 트 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 CereTom Elite CT scanner and a malfunction or design flaw in the software could result in delay in delivery of appropriate medical care. As such, the risk {11}------------------------------------------------ management analysis identified potential hazards which were controlled and mitigated during development of CereTom Elite. The level of concern for the software is Moderate because a failure, latent flaw, or delayed information could indirectly result in minor injury to the patient. The verification/validation testing ensured the safety and effectiveness of CereTom Elite. ### 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 CereTom Elite scanner successfully demonstrated that it has comparable image quality as the predicate device CereTom (K051765) and meets all the image quality criteria that are used for testing the CereTom. MAR protocols have been tested internally using an anatomical phantom and can be used with the filtered back projection reconstruction algorithms for CereTom Elite. ### Conclusion Based upon the above considerations, NeuroLogica Corporation believes that the CereTom Elite Computed Tomography System is of comparable type in design, functionality, and technology and is, for its intended use, substantially equivalent to the previous version and the predicate device: CereTom (K051765). The proposed modifications to CereTom do not result in any new safety or effectiveness concerns. The CereTom Elite CT system performs as well in its intended use as similar devices currently on the market.