TISSUE SPECTROSCOPE

K992529 · Vital Medical , Ltd. · DPW · Nov 17, 2000 · Cardiovascular

Device Facts

• Record ID: K992529
• Device Name: TISSUE SPECTROSCOPE
• Applicant: Vital Medical , Ltd.
• Product Code: DPW · Cardiovascular
• Decision Date: Nov 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Indications for Use

The Tissue Spectroscope is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in these parameters provide information on tissue metabolic activity.

Device Story

Tissue Spectroscope performs in-vivo spectroscopic measurements; combines NADH Fluorometer and Laser Doppler Flowmeter. Inputs: radiation transmitted through tissue; outputs: fluorescence of NADH (420-480 nm), Doppler-shifted laser light (325 nm) from moving red blood cells, and total backscattered light (325 nm). Device calculates redox state of mitochondrial NAD/NADH, microvascular blood flow, and total blood volume. Backscattered light used to correct NADH fluorescence for blood volume changes. Changes in these parameters reflect oxygen supply/demand balance. Used by clinicians to monitor tissue metabolic activity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Combination device: NADH Fluorometer and Laser Doppler Flowmeter. Emits radiation at 325 nm; measures fluorescence at 420-480 nm. Parameters: NADH redox state, microvascular blood flow, total blood volume. No specific materials or software architecture details provided.

Indications for Use

Indicated for in-vivo monitoring of NADH redox state and microvascular perfusion to assess tissue metabolic activity.

Regulatory Classification

Identification

A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

Predicate Devices

• Laserflow BPM2
• INVOS 3100A Cerebral Oximeter
• LKB-Wallac 1230 Arcus Fluorometer

Submission Summary (Full Text)

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## NOV 1 7 2000

## SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

## Submitter:

Vital Medical Ltd., P.O. Box7292 Petach Tikva 49170, Israel Tel: [phone]; Fax: [phone];

Name of the Device: Tissue Spectroscope

- · Predicate Devices: The Tissue Spectroscope is substantially equivalent to a combination of the Laserflow BPM2, the INVOS 3100A Cerebral Oximeter and the LKB-Wallac 1230 Arcus Fluorometer.
Description of the Device: The Tissue Spectroscope is a device that carries out various in-vivo, spectroscopic measurements. It is a combination device consisting of an NADH Fluorometer and a Laser Doppler Flowmeter. The Tissue Spectroscope is used to transmit radiation at a known wavelength through tissue and to measure the fluorescence of NADH and the intensity of light reflected from the tissue, including the Doppler shift arising from the moving red blood cells.

The Tissue Spectroscope measures the following three parameters:

- 1. Mitochondrial NADH fluorescence at 420 nm to 480 nm.
- 2. Doppler shifted laser light (325nm) reflected from moving blood cells.
- 3. Total backscattered light (325nm) reflected from the tissue. This parameter allows for correction of the NADH fluorescence measurement due to changes in tissue blood volume.

These three parameters contain information, respectively, pertaining to the redox state of mitochondrial NAD/NADH of the tissue, microvascular blood flow in the tissue and total blood volume of the tissue. Changes in these values reflect changes in the balance between oxygen supply and oxygen demand.

The differences between the systems raise no new issues of safety or effectiveness.

July 25.99

Date

A. Mayevsky

Prof. Avraham Mayevsky, President

Tissue Spectroscope 510(k) Application

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2000

VITAL Medical Ltd. c/o Bruce F. Mackler, Ph.D. Heller Ehrman White & McAuliffe 815 Connnecticut Ave N.W. Suite 200 Washington, D.C. 20006-4004

K992529 Re: Trade Name: Tissue Spectroscope Requlatory Class: II (two) Product Code: DPW, DQA, KHO Dated: August 29, 2000 Received: August 29, 2000

Dear Dr. Mackler:

We have reviewed your Section 510(k) notification of intent to market we nave referenced above and we have determined the device is the device foreignealent (for the indications for use stated in the Subscancially of additionarketed predicate devices marketed in encrosure, co regulir 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls eno golors of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device add Eronar School of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Bruce F. Mackler, Ph.D.

This letter will allow you to begin marketing your device as described inis lecter will arrow you co boys. .......................................................................................................................................... In your 310(x) premarker noto a legally marketed predicate device equivalence or your device 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 and additionally 809.10 for in vitro reguration (ir ces), please contact the Office of Compliance at Graghosere actrossy promally, for questions on the promotion and [phone]. Addrefonally) 201 questics the Office of Compliance at Also, please note the regulation entitled, [phone]. "Misbranding by reference to premarket notification" (21CFR 807.97) . MSbranding by responsibilities under the Act may Ocher general Information of Small Manufacturers Assistance at its be obtained from the bivior. [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard J

on James E. Dillard III Director

> Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known)_K 992 529

Device Name_ The Tissue Spectroscope

Indications For Use:

The Tissue Spectroscope is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in these parameters provide information on tissue metabolic activity.

(for Miriam Provost
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Concurrence of CDRH, Office of Device Evaluation (ODE)

k Number

vision Sign-Off) (D) "sinn of Cardiovascut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over The Counter Use

(Optional Format 1-2-96)

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Tissue Spectroscope 510(k) Application