ETG-4000 OPTICAL TOPOGRAPHY SYSTEM

K042501 · Hitachi Medical Corp. · DQA · Oct 12, 2004 · Cardiovascular

Device Facts

• Record ID: K042501
• Device Name: ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
• Applicant: Hitachi Medical Corp.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The intended use of the ETG-4000 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin.

Device Story

ETG-4000 is a non-invasive optical topography system; measures relative changes in cerebral oxy-hemoglobin, deoxy-hemoglobin, and total hemoglobin concentrations. Device beams frequency-modulated near-infrared light (670-1300nm) into scalp/skull; light reflects through cerebral cortex and is collected by optical fiber array. System processes absorption data to generate 2D and 3D dynamic images representing metabolic and circulatory status of cerebral cortex. Used in clinical settings; operated by trained personnel. Output provides time-course graphic representations and images of brain surface activity; assists clinicians in assessing cerebral hemodynamic status.

Clinical Evidence

Bench testing only. No clinical data provided. The device was validated in accordance with design controls and applicable safety standards to demonstrate substantial equivalence to the predicate.

Technological Characteristics

Non-invasive optical topography system; uses near-infrared light (670-1300nm) for sensing. Employs an array of optical fiber tips for scalp contact. Measures light absorption to calculate hemoglobin concentration changes. No moving parts. Complies with applicable safety standards.

Indications for Use

Indicated for the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin in patients.

Regulatory Classification

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.

Predicate Devices

• Hitachi ETG-100 (K011320)

Submission Summary (Full Text)

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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: [phone] fax: [phone]

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 [phone] 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_