CRITIVIEW

K051145 · Critisense , Ltd. · DPW · Jan 18, 2006 · Cardiovascular

Device Facts

• Record ID: K051145
• Device Name: CRITIVIEW
• Applicant: Critisense , Ltd.
• Product Code: DPW · Cardiovascular
• Decision Date: Jan 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

CritiView is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in the measured parameters, blood flow change, blood volume change, and NADH concentration change that provide information on tissue metabolic activity. The CritiView uses a pencil style probe which is in contact with the tissue to be measured / monitored. The device may be used up to eight (8) hours per twenty-four (24) hour period. Tissues which may be monitored are brain, liver, kidney, intestine, testis, skin. Note that heart may not be used, as the heart beating motion may not provide a reliable probe contact surface.

Device Story

CritiView is a multi-parametric monitoring device for assessing tissue metabolic state. It utilizes a pencil-style fiber optic probe for direct tissue contact. The device employs absorption, reflection, and fluorescence spectrometry using UV LEDs (375nm) and a NIR laser diode (785nm) to measure NADH concentration, blood flow, and blood volume changes. Data is processed and displayed as a trend for clinical review. Used in hospital settings (OR, ICU, ED, High Dependency Units) by healthcare professionals. The device provides real-time metabolic monitoring to assist clinicians in evaluating tissue perfusion and metabolic activity, potentially aiding in the management of hospitalized patients. It is limited to 8 hours of use per 24-hour period.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-parametric monitor using absorption, reflection, and fluorescence spectrometry. Light sources: 375nm UV LEDs and 785nm NIR laser diode. Fiber optic pencil-style probe for direct tissue contact. Class 1 Laser Device. Power: 110-240V. No specific software architecture or material standards provided.

Indications for Use

Indicated for in-vivo monitoring of NADH redox state and microvascular perfusion (blood flow/volume changes) in hospitalized patients (neonates, infants, pediatrics, adults) to assess tissue metabolic activity. Applicable to brain, liver, kidney, intestine, testis, and skin. Contraindicated for heart tissue due to motion artifacts.

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

• Tissue Spectroscope, Vital Medical (K992529)

Submission Summary (Full Text)

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KOS 1145

Attachment \$2.1

| | Page 1 of 2<br>14-Dec-05 |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------|
| CritiSense Ltd.<br>11 Ben Gurion St.<br>Givat Shmuel 54101<br>Israel | Tel - [phone]<br>Fax - [phone] |
| Official Contact: | Dalia Givony - Manager Regulatory |
| Proprietary or Trade Name: | CritiView |
| Common/Usual Name: | Cardiovascular blood flowmeter |
| | Fluorometer for clinical use |
| Classification Name: | Cardiovascular blood Flowmeter (DPW) |
| | Fluorometer for clinical use (KHO) |
| Device: | CritiView |
| Predicate Devices: | Tissue Spectroscope, Vital Medical - K992529 (Vital<br>Medical became CritiSense). |

# 510(k) Summary of Safety and Effectiveness

## Device Description:

The CritiView device carries out certain in-vivo, spectroscopic measurements and displays them as a trend. The parameters measured are blood flow change, blood volume change, and NADH concentration change. It is a multi-parametric monitoring device intended for the measurement of tissue metabolic state. The CritiView device consists of NADH Fluorometer and Doppler Flowmeter. The CritiView device is a modification of the predicate, Tissue Spectroscope (K992529).

#### Indications for Use:

CritiView is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in the measured parameters, blood flow change, blood volume change, and NADH concentration change that provide information on tissue metabolic activity.

The CritiView uses a pencil style probe which is in contact with the tissue to be measured / monitored. The device may be used up to eight (8) hours per twenty-four (24) hour period.

Tissues which may be monitored are brain, liver, kidney, intestine, testis, skin. Note that heart may not be used, as the heart beating motion may not provide a reliable probe contact surface.

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## Summary of Safety and Effectiveness Page 2 of 2 14-Dec-05

## Patient Population:

The device is intended for the monitoring of tissue metabolic activity of hospitalized patients. i.e., neonate/infant, pediatrics, and adults.

## Summary of Specifications:

| | CritiView |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | In-vivo monitoring of changes in NADH redox state and<br>microvascular perfusion in tissue. Changes in the measured<br>parameters, blood flow change, blood volume change, and NADH<br>concentration change that provide information on tissue metabolic<br>activity. |
| Environments of use | Hospital - OR, ICU, Emergency Departments, High Dependency<br>Units Institutions |
| Patient Population | Hospitalized patients - Neonate/infant, pediatrics, adults. |
| Contraindications | Same as Tissue Spectroscope |
| Laser Class | Class 1 Laser Device |
| Measurement Technique | Absorption, reflection and fluorescence spectrometry |
| Light Source & Wavelength | UV LED 375nm<br>UV LED 375nm<br>NIR Laser Diode 785nm |
| Means for light transmission | In-vivo, fiber optic probe |
| Measured parameters | 1. Blood Flow [%] Doppler Shift<br>2. Blood Volume [%] of change<br>3. NADH concentration [%] of change |
| Power Requirements | 110 to 240V ±10 |
| Method of measurement / probe | Direct tissue contact / Pencil type probe |
| Duration of use | Eight (8) hours per twenty-four (24) hours period |

## Differences Between Other Legally Marketed Predicate Devices:

There are no significant differences between the CritiView and the predicate – Tissue Spectroscope, K992529

.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2006

CritiSense Ltd. c/o Mr. Paul E. Dryden President ProMedic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055-9501

> K051145 Trade Name: CritiSense CritiView Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW and KHO Dated: December 14, 2005 Received: December 15, 2005

Dear Mr. Dryden:

Re:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Paul E. Dryden

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Brimmer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment S2.1

Page 1 of 1

.

| 510(k) Number: | K051145 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | CritiView |
| Indications for Use: | CritiView is indicated for in-vivo monitoring of changes<br>in NADH redox state and microvascular perfusion in tissue.<br>Changes in the measured parameters, blood flow change,<br>blood volume change, and NADH concentration change<br>provide information on tissue metabolic activity. |
| | The CritiView uses a pencil style probe which is in contact<br>with the tissue(s) to be measured / monitored. The device<br>may be used for up to eight (8) hours per twenty-four (24)<br>hour period. |
| | Tissues which may be monitored are: brain, liver, kidney,<br>intestine, testis, skin. Note that heart may not be used, as<br>the heart beating motion may not provide a reliable probe<br>contact surface. |
| | Environment of use include - hospital - OR, ICU,<br>Emergency Departments, High Dependency Units<br>Institutions |
| Prescription Use XX | |

Prescription (Per CFR 801.109)

·

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blhumman

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number