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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Hitachi Healthcare Americas Optical Topography System ETG-4100 (K172492), based on the provided document:

The document (510(k) summary) focuses on demonstrating substantial equivalence to a predicate device (Optical Topography System ETG-4000 (K042501)), rather than defining specific, quantitative acceptance criteria for device performance based on clinical outcomes. The "acceptance criteria" in this context refer to the successful demonstration that the new device is as safe and effective as the predicate device, despite minor differences.

1. Table of Acceptance Criteria (Substantial Equivalence) and Reported Device Performance

Given the nature of a 510(k) for substantial equivalence, the "acceptance criteria" are tied to comparing the new device's characteristics and performance to the predicate device. The device "performance" here refers to demonstrating that differences do not negatively impact safety and effectiveness.

Acceptance Criteria Category (Demonstration of Substantial Equivalence)	Reported Device Performance (ETG-4100 vs. ETG-4000)
Indications for Use (IFU)	Met: The ETG-4100 has the identical Indications for Use as the ETG-4000: "The intended use of the ETG-4100 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin."
Fundamental Scientific Technology	Met: Both devices use near-infrared light (695nm and 830nm wavelengths) to measure relative changes of oxyhemoglobin, deoxy-hemoglobin, and total hemoglobin in the cerebral cortex. Both use frequency-modulated locked-in amplifiers and avalanche photodiodes (APD) for detection. Both are non-invasive and measure at a 10Hz sampling rate.
Physical and Performance Characteristics	Met (with acceptable differences):
- System Configuration (Size, Weight)	Differences in appearance, weight, and size (e.g., ETG-4100: 582x933x1430mm, 165kg vs. ETG-4000: 560x933x1470mm, 130kg) were assessed and deemed to have "no effect on the safety and effectiveness of the device."
- Holder and Probe Configurations	New configurations (2x11, 4x4DD, 3x5DD, 3x5MD holders; non-magnetic probe types T, M) were assessed. Differences in size/optical fiber layout or non-magnetic materials were deemed to have "no effect on the safety, effectiveness, and performance of the device."
- Fiber Configurations	New removable infant fiber and longer fibers (5.5m, 6.5m). The infant fiber was similar to previous neonate/infant probes, and longer fibers had a smaller transparent area, reducing power to the patient, thus improving safety with no effect on effectiveness. Assessed as "no effect on the safety, effectiveness and performance of the device."
- Computer Operating System	Upgrade from Windows2000 (32bit) to Windows7 (64bit) was deemed to have "no effect on the safety and effectiveness of the device."
- New Features (Software functionality)	New features like Task Presentation System (VFT, Custom), Report Display System (VFT, Custom), Double Density Function, Multi-Distance ICA Function, PCA Analysis, Multi Data Analysis, Waveform Analysis, and Real-time Output. These new features were described as primarily related to presenting tasks, displaying results, providing additional data analysis, or enabling real-time data output. They were assessed as having "no effect on the safety, effectiveness and performance of the device" or, in the case of Double Density and Multi-Distance ICA, "minimal effect on performance" with "no effect on safety and effectiveness."
Non-Clinical Performance Testing	Met:
- Signal Stability	Testing was conducted on the subject device and predicate device to show that new characteristics produced matching results and output. (Specific quantitative results are not provided in this summary, but the assertion is that they match).
- Software Verification & Validation	Reports were submitted to account for new features, demonstrating that the algorithm performs its intended use (measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin) acceptably compared to the predicate.
Conformance to Standards	Met: The ETG-4100 conforms to applicable parts of several international standards: AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60825-1, IEC 62304, IEC 60601-1-6, ISO 10993-1, ISO 10993-5, and ISO 10993-10. This demonstrates safety aspects like electrical safety, EMC, laser safety, software lifecycle, usability, and biocompatibility.

Study Information

The provided document describes a "Summary of Non-Clinical Testing" rather than a traditional clinical study with human subjects for efficacy or diagnostic performance. This is typical for a 510(k) submission focused on demonstrating substantial equivalence to a legally marketed predicate device.

Here's what can be inferred about the "study" (non-clinical testing):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of patients or cases. The "signal stability testing" would likely involve laboratory or bench testing rather than patient data.
- Data Provenance: Not specified, but given it's non-clinical testing, it would be laboratory or bench data, not human subject data from a specific country or collected retrospectively/prospectively.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of non-clinical, substantial equivalence testing. Ground truth, in the sense of expert review for diagnostic accuracy, is not described in a 510(k) summary for a device like an oximeter, especially when arguing substantial equivalence through technical characteristics and signal stability.
Adjudication method for the test set:
- Not applicable. There is no mention of expert adjudication as there were no patient-level performance evaluations requiring such a process.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is an oximeter, not an AI-assisted diagnostic imaging tool with human readers. The document does not describe any AI component or human-in-the-loop performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone non-clinical testing was performed. The "signal stability testing" and "software verification and validation" were evaluations of the device's inherent performance and its new features in an isolated, technical context, without human interaction in a diagnostic or clinical decision-making loop. The device directly measures and displays hemoglobin levels; it doesn't process images or inputs for human interpretation in the way AI radiology devices do.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For signal stability testing, the "ground truth" would be established physical or electrical parameters or established measurements from the predicate device and calibration standards. It is not biological "ground truth" like pathology.
- For software verification and validation, the ground truth would be the documented functional requirements and design specifications of the software, confirming that the software behaves as intended.
The sample size for the training set:
- Not applicable. This document describes non-clinical testing for a medical device that measures physiological parameters, not an AI/ML model that is 'trained' on data.
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI/ML training set mentioned or implied.

Summary

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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

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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

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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)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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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

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

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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 themeasurement of relative levels of cerebraldeoxyhemoglobin and oxyhemoglobin. (RxUse)	The intended use of the ETG-4000 is themeasurement of relative levels of cerebraldeoxyhemoglobin 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 500VAAC220/230/240V 700VA	AC100/120V 500VAAC220/230/240V 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(length: 7.5m)	Yes	No	See 03
Non-magnetic probe type M(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), HamamatsuHL8837MG-A (830nm), Ushio Opt	L9135-41 (695nm), HamamatsuHL8837MG-A (830nm), Ushio Opt	No
Detection method	Frequency modulated locked-in amplifier(Frequency range: 12.0 to 23.8kHz)	Frequency modulated locked-in amplifier (Frequency range: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 separationdistance	30 mm for adult and child20 mm for neonate, infant and child	30 mm for adult and child20 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 SystemVFT	Yes	No	See 07
Task Presentation SystemCustom	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

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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.

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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 judgesthat the Optical Topography System ETG-4100 device has no additional issues with safety andeffectiveness.

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.
1. 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.
1. 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
1. IEC 60825-1 Edition 2.0 2007-03

Safety of laser products - part 1: equipment classification, and requirements

1. IEC 62304:2006 Medical Device Software - Software Life Cycle Processes.
1. 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
1. ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity. (Biocompatibility)

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1. 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).

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).