Optical Topography System ETG-4100

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August 17, 2018 Hitachi Healthcare Americas Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park Twinsburg, Ohio 44087 Re: K172492 Trade/Device Name: Optical Topography System ETG-4100 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 13, 2018 Received: July 17, 2018 Dear Doug Thistlethwaite: 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 807); labeling (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, # Matthew C. Krueger -S for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K172492 Device Name Optical Topography System ETG-4100 Indications for Use (Describe) The intended use of the ETG-4100 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > 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}------------------------------------------------ # K172492 510(k) Summary ### Submitter Information | Submitter: | Hitachi Healthcare Americas | |-------------------|---------------------------------------| | | 1959 Summit Commerce Park | | | Twinsburg, Ohio 44087-2371 | | Contact: | Douglas J. Thistlethwaite | | Telephone number: | 330-425-1313 | | Telephone number: | 330-963-0749 | | E-mail: | thistlethwaited@hitachihealthcare.com | | Date: | August 17, 2018 | ## Subject Device | Trade/Proprietary Name: | Optical Topography System ETG-4100 | |-------------------------|------------------------------------| | Regulation Number: | 21 CFR 870.2700 | | Regulation Name: | Oximeter | | Product Code | DQA | | Class | II | | 510(k) Review Panel | Neurology | #### Predicate Device | Trade/Proprietary Name: | K042501 Optical Topography System ETG-4000 | |-------------------------|--------------------------------------------| | Regulation Number: | 21 CFR 870.2700 | | Regulation Name: | Oximeter | | Product Code | DQA | | Class | II | | 510(k) Review Panel | Anesthesiology | #### Device Intended Use The intended use of the ETG-4100 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin based on the amount of reflected or scattered radiation following transmission of radiation at known wavelengths through blood. #### Indications for Use The intended use of the ETG-4100 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin. (Rx Use) ### Device Description The Optical Topography System ETG-4100 is a device that measures and displays relative changes of oxy-hemoglobin, deoxy-hemoglobin and total hemoglobin in the cerebral cortex at multiple points on the head. The ETG-4100 system emits near-infrared light (670-1300mm) of two different wavelengths (695nm and 830nm) that can efficiently penetrate the skull where the light is scattered, absorbed by hemoglobin and unabsorbed light is reflected back. #### Physical and Performance Characteristics Light-emitting and detecting optical fibers are arranged in fiber holders in specific configurations which can be attached in numerous positions to the subject's head via flexible head caps. The ETG-4100 system detects the reflected light and calculates the relative changes of oxyhemoglobin, deoxy-hemoglobin and total hemoglobin based on the difference between injected and reflected light. The technology is non-invasive and less restraining for the subject, reducing discomfort considerably in comparison to other brain imaging technologies. The spring-loaded fiber tips provide efficient contact between fiber tip and scalp. Contact between fiber tip and scalp is indicated by a shaft that protrudes from the top of the fiber tip touches the scalp; the firmer the contact, the more the shaft protrudes. The ETG-4100 is equipped with a highly sensitive avalanche photodiode allowing the use of {4}------------------------------------------------ relatively low light intensities, reducing potential harm to the subject and extending the lifetime of the laser diodes. Simultaneous measurement of all measurement channels is achieved by frequency-modulating the light intensity of each individual light source. The frequency of reflected near infrared light is analyzed by a lock-in amplifier which assigns the incoming signals to their respective measurement channel based on their frequencies. The individual frequencies of the emitted near infrared light are different from that of daylight or artificial indoor light, the ETG-4100 can be operated under daylight conditions. Measured changes in hemoglobin concentrations can be displayed as time-course graphs or as 2D or 3D topographic images. ### Comparison of Technological Characteristics The technological characteristics of the Optical Topography System ETG-4100 as compared to the predicate are listed in the following table. Where applicable, differences are discussed in detail in the comment table that follows the comparison table below to demonstrate how these characteristics compare to the predicate. | | K172492 | K042501 | | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------| | ITEM | OPTICAL TOPOGARAPHY SYSTEM ETG-4100 | OPTICAL TOPOGRAPHY SYSTEM ETG-4000 | DIFFERENCE | | System Configuration | | | See 01 | | Illustration | Image: OPTICAL TOPOGARAPHY SYSTEM ETG-4100 | Image: OPTICAL TOPOGRAPHY SYSTEM ETG-4000 | | | Indications for Use | The intended use of the ETG-4100 is the<br>measurement of relative levels of cerebral<br>deoxyhemoglobin and oxyhemoglobin. (Rx<br>Use) | The intended use of the ETG-4000 is the<br>measurement of relative levels of cerebral<br>deoxyhemoglobin and oxyhemoglobin. (Rx use) | No | | Dimensions | $582(W)×933(D)×1,430(H)mm$ | $560(W)×933(D)×1,470(H)mm$ | See 01 | | Weight | 165kg | 130kg | See 01 | | Power Source | AC100/120V 500VA<br>AC220/230/240V 700VA | AC100/120V 500VA<br>AC220/230/240V 700VA | No | | Holder and Probe Configurations | | | | | 3x3 holder | Yes | Yes | No | | 4x4 holder | Yes | Yes | No | | 3x5 holder | Yes | Yes | No | | 3x11 holder | Yes | Yes | No | | 2x11 holder | Yes | No | See 02 | | 4x4DD holder | Yes | No | See 02 | | 3x5DD holder | Yes | No | See 02 | | 3x5MD holder | Yes | No | See 02 | | 3x5 Neonate/ Infant probe | Yes | Yes | No | | 3x3 Neonate/ Infant probe | Yes | Yes | No | | Non-magnetic Probe Type T | Yes | No | See 03 | | Non-magnetic probe type M<br>(length: 7.5m) | Yes | No | See 03 | | Non-magnetic probe type M<br>(length: 10.5m) | Yes | No | See 03 | | Fiber Configurations | | | | | Removable Infant Fiber | Yes | No | See 04 | | Long Fiber(length:5.5m) | Yes | No | See 05 | | Long Fiber(length:6.5m) | Yes | No | See 05 | | Measurement Parameters | | | | | Oxyhemoglobin concentration | Yes | Yes | No | | Deoxyhemoglobin concentration | Yes | Yes | No | | ITEM | K172492 | K042501 | DIFFERENCE | | | OPTICAL TOPOGARAPHY SYSTEM ETG-4100 | OPTICAL TOPOGRAPHY SYSTEM ETG-4000 | | | Total hemoglobin concentration | Yes | Yes | No | | Light Source Configurations | | | | | Light component | Laser diode | Laser diode | No | | Wavelength | 695, 830nm | 695, 830nm | No | | Output | 4mW/wavelength | 4mW/wavelength | No | | Device Model | L9135-41 (695nm), Hamamatsu<br>HL8837MG-A (830nm), Ushio Opt | L9135-41 (695nm), Hamamatsu<br>HL8837MG-A (830nm), Ushio Opt | No | | Detection method | Frequency modulated locked-in amplifier<br>(Frequency range: 12.0 to 23.8kHz) | Frequency modulated locked-in amplifier (Frequency range:<br>12.0 to 23.8kHz) | No | | Sampling rate | 10Hz | 10Hz | No | | Emitters | 18 | 18 | No | | Laser safety | IEC 60825-1, Class 1M | IEC 60825-1, Class 1M | No | | Source detector separation<br>distance | 30 mm for adult and child<br>20 mm for neonate, infant and child | 30 mm for adult and child<br>20 mm for neonate, infant and child | No | | Detector | | | | | Detector component | APD | APD | No | | Detectors | 16 | 16 | No | | Model | C8546, Hamamatsu | C8546, Hamamatsu | No | | Maximum No. of Channels | 52 | 52 | No | | Computer | | | | | Operating system | Windows7 (64bit) | Windows2000 (32bit) | See 06 | | Features | | | | | Interface for the video recording | Yes | Yes | No | | system | | | | | 3D Positioning Unit | Yes | Yes | No | | 3D Composite Display Unit | Yes | Yes | No | | Task Presentation System<br>VFT | Yes | No | See 07 | | Task Presentation System<br>Custom | Yes | No | See 07 | | Report Display System VFT | Yes | No | See 08 | | Report Display System Custom | Yes | No | See 08 | | Double Density Function | Yes | No | See 09 | | Multi-Distance ICA Function | Yes | No | See 010 | | PCA Analysis | Yes | No | See 011 | | Multi Data Analysis | Yes | No | See 011 | | Waveform Analysis | Yes | No | See 011 | | Real-time Output | Yes | No | See 012 | {5}------------------------------------------------ #### Discussion of differences between the predicate device and the Optical Topography System ETG-4100 are explained in the table below. | System Configuration | | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 01 | The differences in appearance, weight, and size have no effect on the safety and effectiveness of the device. | | Holder and Probe Configurations | | | 02 | The differences in size and/or optical fiber layout have not effect on the safety, effectiveness and performance of the device. | | 03 | Changing the holder material to non-magnetic material while retaining the other specifications of the predicate holders does not effect on the safety, effectiveness and performance of the device. | | Fiber Configurations | | | 04 | This fiber is for Infant use with shape of tip smaller than previous fiber for adult. However, the other specifications are same as previous neonate/infant probe. Therefore, they have no effect on the safety, effectiveness and performance of the device. | | 05 | These fibers are longer than previous fiber (normally 3.5m). The longer fibers have a smaller transparent which reduces the power to the patient. Therefore safety is improved with no effect on effectiveness. | | Computer | | | 06 | Changing from Windows2000 (32bit) to Windows7 (64bit) has no effect on the safety and effectiveness of the device. | | Features | | | 07 | These features present tasks to the patient during the measurement. Therefore, they have no effect on the safety, effectiveness and performance of the device. | | 08 | These features display the measurement results in the above task presentation system. Therefore, they have no effect on the safety, effectiveness and performance of the device. | | 09 | The Double Density option overlays a standard 3x5 or 4x4 fiber configuration with a second set of detectors and emitters resulting in a spatial resolution twice that of the standard configuration. Therefore, they have no effect on the safety and effectiveness and minimal effect on performance of the device. | | 010 | Multi-Distance Measurement Function performs two different SD distance measurements and separates hemoglobin data into deep components and shallow blood flow components. Therefore, they have no effect on the safety and effectiveness and minimal effect on performance of the device. | | 011 | These features provide additional data analysis techniques which no not affect the measurement function. Therefore, they have no effect on the safety, effectiveness and performance of the device. | | 012 | This feature allows hemoglobin data to be sent in real time to the PC through the LAN during measurement. Therefore, they have no effect on the safety, effectiveness and performance of the device. | {6}------------------------------------------------ Therefore, based on a thorough analysis and comparison of the Optical Topography System ETG-4100 and the predicate device, the technological characteristics do not impact safety and effectiveness. ## Substantial Equivalence Substantial Equivalence was based on analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance testing which are summarized in the following table: | ITEM | OVERALL RATIONALE ANALYSIS | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | System Configuration | Based on that there are no significant differences from the predicate device, Hitachi judges that the | | Holder and Probe Configurations | Optical Topography System ETG-4100 has no additional issues with safety and effectiveness. | | Fiber Configurations | | | Measurement Parameters | | | Light Source Configurations | | | Detector | | | Computer | | | Features | Based on results of design inspection as confirmed in the Declaration of Conformity, Hitachi judges<br>that the Optical Topography System ETG-4100 device has no additional issues with safety and<br>effectiveness. | # Summary of Non-Clinical Testing The Optical Topography System ETG-4100 is in conformance with the applicable parts of the following standards: - 1. Signal stability testing for the subject device and predicate device were submitted to show that the new characteristics produce matching results and output. - 2. Software verification and validation reports were submitted to account for the new features proposed in the subject device. These reports demonstrate that the subject device with these new features is substantially equivalent to the predicate since the methods acceptably demonstrate that the algorithm that achieves the intended use (measurement of the relative levels of cerebral deoxyhemoglobin and oxyhemoglobin) as compared to the predicate. - 3. 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 4. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - 5. IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - part 1: equipment classification, and requirements - 6. IEC 62304:2006 Medical Device Software - Software Life Cycle Processes. - 7. IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability - ISO 10993-1 Fourth edition 2009-10-15 8. Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process [including: technical corrigendum - 9. ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity. (Biocompatibility) {7}------------------------------------------------ - 10. ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - part 10: tests for irritation and skin sensitization. (Biocompatibility) #### Conclusions The proposed Optical Topography System ETG-4100 is considered substantially equivalent to the currently marketed predicate device (Optical Topography System ETG-4000 (K042501) in terms of design features, fundamental scientific technology, intended use, and safety and effectiveness. Based on the technological characteristics and performance testing to account for any differences in those characteristics, Optical Topography System ETG-4100 is substantially equivalent to the Optical Topography System ETG-4000 (K042501).