(28 days)
The intended use of the ETG-4000 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin.
The ETG-4000 is a device that measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin and total hemoglobin (678-1200 m) that sam near-infrared light (670-1300nm) that can the surface area of the cerebra. Sed is absorbed by the hemoglobin in the blood.
The ETG-4000 displays the changes of overall Hemoglobin concentration in time- course images (motion images and still images) based on the data from multiple point measurements.
This is a non-invasive test that is done by contacting an array of small optical fiber tips on the surface of the scalp.
The ETG-4000 beams frequency modulated near-infrared light into the surface of the brain. The light passes through the scalp, skull and upper layer of illiough several or the optical noves read by the hemoglobin in the blood and is reflected back and is collected by optical fibers.
The ETG-4000 measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin at multiple points on the head simultaneously by utilizing the changes of light absorption.
The ETG-4000 provides data that show the activity status of the cerebral cortex by displaying the changes of oxy-hemoglobin and deoxy-hemoglobin concentration in the brain surface, and the metabolic and circulatory status of the cerebral cortex in a time-course graphic representation of oxy-hemoglobin, deoxy-hemoglobin and total hemoglobin, 2D dynamic images and 3D dynamic images.
This document is a 510(k) summary for the Hitachi ETG-4000 Optical Topography System. It states that the device measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin and total hemoglobin using near-infrared light. It is intended for non-invasive measurement of cerebral activity by displaying changes in hemoglobin concentration over time. The document claims substantial equivalence to the predicate device, Hitachi ETG-100 (K011320), based on similar materials, technology, and functional methodology. It also states that the device is non-invasive and complies with applicable safety standards.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of numerical thresholds or performance metrics (e.g., accuracy, sensitivity, specificity, or error rates). The document focuses on demonstrating substantial equivalence to a predicate device (Hitachi ETG-100, K011320) rather than setting and meeting new performance acceptance criteria as would typically be seen for a novel device or a device with new claims.
The closest statements to "reported device performance" are:
- "The ETG-4000 system has been developed and validated in accordance with design controls and applicable standards."
- "Testing has permitted the determination that the system is safe and effective for the indicated applications."
- "There are no new safety issues associated with this system as compared with the predicate device."
Since specific numerical acceptance criteria are not provided, a table cannot be meaningfully constructed. The "performance" is implicitly tied to demonstrating equivalence to the predicate device, which itself would have had its own "performance" deemed acceptable at the time of its clearance.
2. Sample Size for the Test Set and Data Provenance
The document does not provide any information regarding the sample size used for a test set or the provenance of any data (e.g., country of origin, retrospective or prospective). The submission relies on design control validation and comparison to a predicate device, not a distinct clinical performance study with a test set as typically defined for algorithm-driven devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a ground truth for a test set. This type of information is usually found in submissions for diagnostic algorithms that require expert interpretation for ground truth labeling. The ETG-4000 is described as measuring physiological changes, not making diagnostic interpretations independently.
4. Adjudication Method for the Test Set
Since no test set or expert ground truth establishment is mentioned, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is an "Optical Topography System" that measures physiological parameters. It does not appear to be an AI-assisted diagnostic tool that would be evaluated in the context of human reader performance.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone performance study for an algorithm. The ETG-4000 itself is the device designed to measure and display physiological data. Its performance is stated to be safe and effective, and substantially equivalent to its predicate.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to performance studies for diagnostic AI algorithms (e.g., pathology, outcomes data, expert consensus) is not discussed in this 510(k) summary. The device measures "relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin and total hemoglobin." The "truth" of these measurements would be a comparison to a gold standard measurement method or established physiological norms, but this type of comparative study is not detailed.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This indicates that the ETG-4000, as described in this 2004 submission, is likely a hardware-based measurement system with embedded algorithms, rather than a machine learning or AI algorithm that would typically require a distinct training phase with a large dataset.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how ground truth for a training set was established.
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OCT 1 2 2004 Attachment 2
HITACI
HITACHI MEDICAL CORPORATION 1-1-14 Uchi-Kanda, Chiyoda-ku Tokyo 101-0047, Japan
510(k) Summary
KO42501
Submitter Information
Hitachi Medical Corporation Submitter: 1-1-14 Uchi-Kanda, Chiyoda-ku Tokyo 101-0047, Japan
Douglas J. Thistlethwaite Contact: ph: (330) 425-1313 fax: (330) 425-1410
Date: September 13, 2004
Device Name
Device Name: Optical Topography System Trade/Proprietary Name: ETG-4000 Optical Topography System Common Name: Oximeter Classification Name: Oximeter Classification Number: Sec. 870.2700
Predicate Device
Predicate Device: Hitachi ETG-100, K011320
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Device Description
Function
The ETG-4000 is a device that measures relative changes in tissue concentration of oxy-The E I G-4000 is a device that measures relative changuin to the level of blood) in
hemoglobin and deoxy-hemoglobin and total hemoglobin (678-1200 m) that sam hemoglobil and deoxy-nemogroom and total near-infrared light (670-1300nm) that can the surface area of the cerebra. Sed is absorbed by the hemoglobin in the blood.
The ETG-4000 displays the changes of overall Hemoglobin concentration in time- course I he ETO-4000 uisplays the changes of overally images (motion images and still images) based on the data from multiple point measurements.
ouse on a
This is a non-invasive test that is done by contacting an array of small optical fiber tips on the surface of the scalp.
The ETG-4000 beams frequency modulated near-infrared light into the surface of the brain I he £ I 0-4000 beams frequency modula it is a light passes through the scalp, skull and upper layer of illiough several or the optical noves read by the hemoglobin in the blood and is reflected back and is collected by optical fibers.
The ETG-4000 measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-The LTG-4000 incasures relative changes in multiple points on the head simultaneously by utilizing the changes of light absorption.
The ETG-4000 provides data that show the activity status of the cerebral cortex by displaying the The LTG++000 provides data that mich in the brain surface, and the metabolic and circulatory status of the cerebral cortex in a time-course graphic representation of oxy-hemoglobin, deoxy-Status of the coronal corent in bit, 2D dynamic images and 3D dynamic images.
Device Intended Use
The intended use of the ETG-4000 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin.
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Device Technological Characteristics
The characteristics of the ETG-4000 Optical Topography System compare substantially to the The characteristics of the LTG-400 Option Topography of and functional methodology.
ETG-100 predicate device in materials used, technology applied, and functional methodoney E I G-100 predicate device in materials acoup residently - intended use, or application Differences do not affect safety and effect for that is substantially equivalent to the cleared memods. The LTO-4000 operates and enhancement of the technology of the predicate.
Safety
The ETG-4000 is a non-invasive device with no moving parts. It has been designed to comply with all applicable safety standards.
Conclusions
The ETG-4000 system has been developed and validated in accordance with design controls and The LTG-4000 System has been developed at the system is safe and effective for the indicated appricable standards: Testing nas pe vat there are no new safety issues associated with this system as compared with the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
OCT 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hitachi Medical Corporation c/o Mr. Douglas J. Thistlethwaite Manager of Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44087
Re: K042501
K042301
Trade/Device Name: ETG-4000 Optical Topography System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 13, 2004 Received: September 14, 2004
Dear Mr. Thistlethwaite:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications referenced above and nave ucterimined the actived predicate devices marketed in interstate for use stated in the encrosule, to regally mancess to the Medical Device Amendments, or to commerce prior to May 28, 1770, the encentines with the provisions of the Federal Food, Drug, devices that have been reclassified in accreanse who a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. T and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the device, seeject to the many for annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me existing major regulations affecting your device can may be subject to such additional controller "Entrological" - " " " " " " be found in the Code of Pouchal Regeraing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issualled of a basedana.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must or any Federal statures and regulations daminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, more and manufacturing practice requirements as set CrK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Douglas J. Thistlethwaite
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin harketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale of the porm premarket notification. The PDA miding of Subscribed of the Pressure and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the latest of the more on 2011 5 - Alama lease note the roculation entit If you desire specific advice for your do no no no the regulation entitled, the regulation entitled, contact the Office of Compliance at (210) = 10 = 1 = 1 = 1 = 8 (1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = "Misbranding by relefence to premanter to be it from the Division of Small other general information on your responsible in to toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance of Architect (demansing http://www Manufacturers, micrnational and October http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam L. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K042501
ETG-4000 Optical Topography System Device Name:
Indications for Use:
The intended use of the ETG-4000 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin.
X Prescription Use
AND/OR
Over-the-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uriam C. Provost
Division of General, Restorative, and Neurological Devices
8042501 510(k) Number_
§ 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).