Supria True64 Whole-Body X-Ray CT System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. February 1, 2019 Hitachi Healthcare Americas % Mr. Aaron Pierce Director of Regulatory Affairs and Quality Assurance 1959 Summit Commerce Park TWINSBURG OH 44087 Re: K183291 Trade/Device Name: Supria True64 Whole-body X-ray CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: November 20, 2018 Received: November 26, 2018 Dear Mr. Pierce: 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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). 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 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. Use 2. Mils for 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}------------------------------------------------ | 510(k) Number (if known) | K183291 | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Supria True64 Whole-body X-ray CT System | | Indications for Use (Describe) | The Supria True64 System is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes. The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician. | Type of Use (Select one or both, as applicable) | <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">□</span> 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." レート {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the word "HITACHI" in bold, black letters. Below the word "HITACHI" is the phrase "Inspire the Next" in a smaller, non-bold font. The word "Next" has a small red accent mark above the letter "t". ### K183291 # Section 5 510(k) Statement or Summary ## Submitter Information | Submitter: | Hitachi Healthcare Americas<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44087-2371 | |-------------------|----------------------------------------------------------------------------------------| | Contact: | Aaron Pierce | | Telephone number: | 330-425-1313 | | Telephone number: | 330-963-0749 | | E-mail: | piercea@hitachihealthcare.com | | Date: | November 20, 2018 | ## Subject Device Name | Trade/Proprietary Name: | Supria True64 Whole-body X-ray CT System | |-------------------------|------------------------------------------| | Regulation Number: | 21 CFR 892.1750 | | Regulation Name: | Computed tomography x-ray system | | Product Code | JAK, System, X-Ray, Tomography, Computed | | Class | II | | Panel | Radiology | ## Predicate Device Name | Predicate Device(s): | Supria True64 Whole-body X-ray CT System (K171738) | |----------------------|----------------------------------------------------| | Regulation Number: | 21 CFR 892.1750 | | Regulation Name: | Computed tomography x-ray system | | Product Code | JAK, System, X-Ray, Tomography, Computed | | Class | II | | Panel | Radiology | ## Indications for Use The Supria True64 system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes. The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician. ## Device Description ### Function The Supria True64 is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 64-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is in bold, black letters on the top line. The words "Inspire the Next" are in a smaller, black font on the second line. There is a red accent mark above the letter "t" in the word "Next". ## Scientific Concepts The Supria True64 system uses 64-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator, X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles. The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system. ## Physical and Performance Characteristics The Supria True64 system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories. The system performance is similar to the predicate device. ### Performance Comparison As part of our design validation, performance comparison analysis was conducted to demonstrate continued conformance with a special control or recognized standard. No new hazards were identified with the Supria True64 with ECG Prospective Scan (Axial). The subject device has been evaluated for effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards. | Testing Type | Rationale Analysis | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Validation Testing - Bench | Based on the results of the ECG Prospective Scan Performance Testing Report contained in Verification and Validation<br>Documentation of Section 9, Hitachi judged that Supria True64 with ECG Prospective Scan (Axial) performs to<br>specifications. | | Validation Testing - Clinical | None required | The analysis confirms the performance characteristics of the Supria True64 are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent to Supria True64 Whole-body X-ray CT System (K171738). # Device Technological Characteristics The technological characteristics of the Supria True64 and the predicate device are listed in Table 1 Technological Characteristic Differences. | ITEM | Supria True64 | Supria True64 (K171738) | Difference | |-----------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------| | Gantry | | | | | Geometry | Rotate-rotate with offset detector system, slip ring | Rotate-rotate with offset detector system, slip ring | No | | Scan Time | 0.75, 1.0, 1.5, 2.0 [s] | 0.75, 1.0, 1.5, 2.0 [s] | No | | X-ray Fan Beam Angle | 51 [deg] | 51 [deg] | No | | Gantry Tilt | -30 to +30 [deg] | -30 to +30 [deg] | No | | Gantry Aperture | 750 [mm] | 750 [mm] | No | | Gantry Dimensions | 1990 x 920 x 1842.5 [mm] | 1990 x 920 x 1842.5 [mm] | No | | Gantry Weight | 1600 [kg] | 1600 [kg] | No | | Scan Localizer | Laser | Laser | No | | Detector | | | | | Type | Solid state | Solid state | No | | ITEM | Supria True64 | Supria True64 (K171738) | Difference | | Number of Channels | 880 [ch] (16 slice)<br>888 [ch] (64 slice) | 880 [ch] (16 slice)<br>888 [ch] (64 slice) | No | | Number of Rows | 16 (16 slice)<br>64 (64 slice) | 16 (16 slice)<br>64 (64 slice) | No | | Number of Slices | 16 [slice/scan] (Axial) (16 slice)<br>64 [slice/scan] (Axial) (64 slice) | 16 [slice/scan] (Axial) (16 slice)<br>64 [slice/scan] (Axial) (64 slice) | No | | X-ray Tube | | | | | Anode Heat Storage | 5 [MHU] | 5 [MHU] | No | | Dissipation Rate | 470 [kHU/min] | 470 [kHU/min] | No | | Tube cooling | Oil/air | Oil/air | No | | Tube focal spot | Dual 0.7 x 0.8, 1.2 x 1.4 [mm] | Dual 0.7 x 0.8, 1.2 x 1.4 [mm] | No | | X-ray Generator | | | | | kW Output | System Maximum 48[kW] /<br>Generator Maximum 51 [kW] | System Maximum 48[kW] /<br>Generator Maximum 51 [kW] | No | | Max. Power Input | 75 [kVA] | 75 [kVA] | No | | kVp Range | 80, 100, 120, 140 [kVp] | 80, 100, 120, 140 [kVp] | No | | mA Range | 10 to 400 [mA] @120kV, 48kW | 10 to 400 [mA] @120kV, 48kW | No | | Patient Table | | | | | Range of Movement,<br>Vertical | 450 to 1000 [mm] (CT-WT-21) | 450 to 1000 [mm] (CT-WT-21) | No | | Range of Movement,<br>Longitudinal | 1910 [mm] (CT-WT-21) | 1910 [mm] (CT-WT-21) | No | | Range of Movement,<br>Lateral | N/A | N/A | No | | Scannable Range | 155 cm | 155 cm | No | | Maximum Load<br>Capacity | 227 [kg] | 227 [kg] | No | | Display | | | | | Monitor Type | 24" LCD | 24" LCD | No | | Matrices, Pixels | 1920 x 1200 | 1920 x 1200 | No | | Image Enlargements | Up to 9.99x | Up to 9.99x | No | | Max. Slices Displayed<br>at Once | 25 | 25 | No | | Image Storage | | | | | Hard Disk | 110 [GB] (images),<br>200 [GB] (raw data) (16 slice)<br>800 [GB] (raw data) (64 slice) | 110 [GB] (images),<br>200 [GB] (raw data) (16 slice)<br>800 [GB] (raw data) (64 slice) | No | | Storage Images | 200,000 | 200,000 | No | | Archival Storage<br>(Media) | DVD-R/RW, CD-R/RW | DVD-R/RW, CD-R/RW | No | | Scanning, Reconstruction | | | | | Localization Scan | Real time | Real time | No | | Localization Scan<br>Length | 150, 250, 350, 500, 750,<br>1000, 1250, 1500, 1750 [mm] | 150, 250, 350, 500, 750,<br>1000, 1250, 1500, 1750 [mm] | No | | Max. Scan Time | 100 [s] | 100 [s] | No | | Helical Beam Pitch | 0.56, 0.81, 1.06, 1.31, 1.56 (16 slice)<br>0.58, 0.83, 1.08, 1.33, 1.58 (64 slice) | 0.56, 0.81, 1.06, 1.31, 1.56 (16 slice)<br>0.58, 0.83, 1.08, 1.33, 1.58 (64 slice) | No | | Collimation | 1.25, 5, 10, 15, 20 [mm] | 1.25, 5, 10, 15, 20 [mm] | No | | Reconstruction Matrix | 512 x 512 [pix] | 512 x 512 [pix] | No | | Reconstruction FOVs | 20 to 500 [mm] | 20 to 500 [mm] | No | | Slice Thickness | 0.625, 1.0, 1.25, 2.5, 3.75,<br>5.0, 7.5, 10.0 [mm] | 0.625, 1.0, 1.25, 2.5, 3.75,<br>5.0, 7.5, 10.0 [mm] | No | | Range of CT numbers | -2000 to +4000 (13bit)<br>-32768 to +32767 (16bit) | -2000 to +4000 (13bit)<br>-32768 to +32767 (16bit) | No | | ITEM | Supria True64 | Supria True64 (K171738) | Difference | | Reconstruction Time | 0.1 seconds per image or less | 0.1 seconds per image or less | No | | Performance | | | | | High-contrast spatial<br>resolution | 0.35 [mm] | 0.35 [mm] | No | | Low-contrast resolution<br>mm at % at ≤4 rads | 2.5 [mm] @ 0.25% | 2.5 [mm] @ 0.25% | No | | 10% MTF | 14.7 [lp/cm] | 14.7 [lp/cm] | No | | 50% MTF | 12.2 [lp/cm] | 12.2 [lp/cm] | No | | Dose Controls | | | | | Bow Tie Filter | Yes. Normal | Yes. Normal | No | | Automatic Exposure<br>Control | Yes. IntelliEC | Yes. IntelliEC | No | | Longitudinal Modulation | Yes | Yes | No | | Angular Modulation | Yes | Yes | No | | Iterative Reconstruction | Yes. Intelli IP Advanced, Intelli IP Quick | Yes. Intelli IP Advanced, Intelli IP Quick | No | | Maximum possible pitch | 1.56 (16 slice) | 1.56 (16 slice) | No | | with full image quality | 1.58 (64 slice) | 1.58 (64 slice) | No | | Dose Displays | | | | | CTDIv | Yes | Yes | No | | DLP | Yes | Yes | No | | Features | | | | | Axial Scan | Yes | Yes | No | | Helical Scan | Yes | Yes | No | | Dynamic Scan | Yes | Yes | No | | Predict Scan | Yes | Yes | No | | ECG Retrospective<br>Scan<br>(Helical) | No | No | No | | ECG Prospective Scan<br>(Axial) | Yes | No | See 01 | | guideShot Scan | Yes | Yes | No | | Automatic Exposure<br>Control | Yes | Yes | No | | Automatic Exposure<br>Control using Iterative<br>Reconstruction | No | No | No | | ECG Dose Modulation | No | No | No | | Adaptive Filter | No | No | No | | Iterative Reconstruction | Yes. Intelli IP Advanced, Intelli IP Quick | Yes. Intelli IP Advanced, Intelli IP Quick | No | | Injector Synchronization | Yes | Yes | No | | Dose Check | Yes | Yes | No | | Access Control | Yes | Yes | No | | Automatic Cardiac<br>Phase Search | No | No | No | | Preview Scan | No | No | No | | Double Slice at Axial<br>Scan | No | No | No | | Priority Recon. | No | No | No | | Dose Report | Yes. Simple Dose Report | Yes. Simple Dose Report | No | | DICOM | Yes | Yes | No | | ID Reader | Yes | Yes | No | | Exam Split | Yes | Yes | No | | Multi-Planar<br>Reconstruction (MPR) | Yes | Yes | No | | ITEM | Supria True64 | Supria True64 (K171738) | Difference | | Volume Rendering | Yes | Yes | No | | CT Angiography (CTA) | Yes | Yes | No | | Segmentation | Yes | Yes | No | | Retouch | Yes | Yes | No | | Quality Exam | Yes | Yes | No | | HiMAR | Yes | Yes | No | | Orbit synchronization<br>scan | Yes | Yes | No | | Off-time mode | Yes | Yes | No | | On-time standby | Yes | Yes | No | | Shutter Scan Reduction | Yes | Yes | No | ### Table 1 Technological Characteristic Differences ### @Hitachi Healthcare Americas 1959 Summit Commerce Park, Twinsburg, OH 44087 Tel:800-800-3106 www.hitachimed.com {5}------------------------------------------------ @Hitachi Healthcare Americas 1959 Summit Commerce Park, Twinsburg, OH 44087 Tel:800-800-3106 www.hitachimed.com {6}------------------------------------------------ @Hitachi Healthcare Americas 1959 Summit Commerce Park, Twinsburg, OH 44087 Tel:800-800-3106 www.hitachimed.com {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is in bold, black letters. Below it, in a smaller font, is the phrase "Inspire the Next" in black letters. The differences from the predicate device to the subject device are explained below table. | Feature | | |---------|----------------------------------------------------------------------------------------------------| | 01 | ECG Prospective Scan (Axial): scanning can be performed in synchronization with ECG trigger signal | ECG Prospective Axial Scan feature was originally cleared on the HITACHI SCENARIA Wholebody X-ray CT System (K101888). Therefore, based on a thorough analysis and comparison of subject device (Supria True64) and the predicate device, the technological characteristics do not impact safety and effectiveness. ## Substantial Equivalence A summary decision was based on analysis of Table 2. | Table 2 Rationale Analysis: Subject vs. Predicate Device | | |----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ITEM | Overall Rationale Analysis | | Gantry | There are no significant changes in technology characteristics, hardware, and software from the predicate device, Supria True64 Whole-body X-ray CT System (K171738). | | Detector | | | X-ray Tube | | | X-ray Generator | | | Patient Table | | | Display | | | Image Storage | | | Scanning, Reconstruction | | | Performance | | | Dose Controls | | | Dose Displays | | | Features | | Table 2 Rationale Analysis: Subiect vs. Predicate Device Therefore, based on a thorough analysis and comparison of the functions, scientific concepts. physical and performance characteristics, performance comparison and technological characteristics, the proposed Supria True64 Whole-body X-ray CT System is considered substantially equivalent to the currently marketed predicate device (Supria True64 Whole-body X-ray CT System (K171738)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is written in large, bold, black letters. Below the word "HITACHI" is the phrase "Inspire the Next" in a smaller, black font. There is a small red accent mark above the letter "t" in the word "Next". # Summary of Non-Clinical Testing This device complies with all applicable requirements for Dose Profile. Noise. Mean CT number and Uniformity, Spatial Resolution, Tomographic Section Thickness and Sensitivity Profile, Tomographic Plane Location, and CT dose index. Adding the ECG Prospective Scan (Axial) would not impact the results of the testing done in the original submission. Noise, Mean CT number, Uniformity and Spatial Resolution test results for the Supria True64 Whole-body X-ray CT System (K171738) would not be effected by this feature. In addition, the Supria True64 system is in conformance with the applicable parts of the following standards: - AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) - IEC 60601-1-2 Edition 3: 2007 . Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - IEC 60601-1-3 Edition 2.0 2008-01 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 Edition 3.0 2009-02 ● Medical electrical equipment Part 2-44: particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography. - NEMA XR 25 Computed Tomography Dose Check ● - NEMA XR26 Access Controls for Computer Tomography: Identification. Interlocks, and Logs ● - IEC 62304 First edition 2006-05. Medical device software Software life cycle processes . In addition, the ECG Prospective Scan feature was subject to performance tests, which confirmed that the X-ray was in synchronization with the ECG trigger and the acquired images. The results confirmed that images which are synchronized with ECG R-wave signal can be acquired by using ECG Prospective Scan. # Summary of Clinical Testing Based on verification and validation results and analysis of the additional feature, Hitachi believes clinical testing was not required. ## Conclusions The results of the performance testing, the validation and the electromagnetic compatibility electrical safety testing demonstrate that the proposed Supria True64 Whole-body X-ray CT System with ECG Prospective Axial Scan meets the acceptance criteria and is adequate for its intended use. In addition, the risk analysis demonstrate that all risks are sufficiently mitigated, that no new risks are introduced, and the overall residual risks are acceptable. Based on the supporting data provided in this submission, the proposed Supria True64 Wholebody X-ray CT System with ECG Prospective Axial Scan is considered substantially equivalent to the predicate device in terms of safety and effectiveness. There are no significant differences that may raise new issues of safety or effectiveness. Bench tests and user validation have been {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the Hitachi logo. The word "HITACHI" is written in large, bold, black letters. Below the logo, the words "Inspire the Next" are written in a smaller, less bold font. The word "Next" has a red accent mark above the letter "e". performed to demonstrate that the subject system is as safe and effective as the predicate device, without raising any new safety and/or effectiveness concerns.