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 provide information on tissue metabolic activity. The CritiView uses a pencil style probe which is in contact with the tissue(s) to be measured / monitored. The device may be used for 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. Environment of use include - hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions

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).

AI/ML Overview

The provided text is a 510(k) summary for the CritiView device, which is a cardiovascular blood flowmeter intended for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue.

It does not provide information on acceptance criteria or the specific study that proves the device meets acceptance criteria.

The document primarily focuses on:

Device Description: What the CritiView is and what it measures.
Indications for Use: How the device is intended to be used.
Patient Population: The types of patients for whom the device is intended.
Summary of Specifications: Technical details and operational parameters.
Predicate Device Comparison: Stating that there are no significant differences between CritiView and its predicate device (Tissue Spectroscope, K992529).
FDA Clearance Letter: Confirmation of substantial equivalence to a legally marketed predicate device.

Since the document explicitly states "There are no significant differences between the CritiView and the predicate – Tissue Spectroscope, K992529", it implies that the basis for clearance is substantial equivalence to the predicate device, rather than a new standalone clinical performance study with predefined acceptance criteria for the CritiView itself.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for the CritiView device is not available in the provided text. The 510(k) summary relies on the substantial equivalence to a predicate device, meaning that the predicate device would have undergone testing and had its performance established.

Summary

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KOS 1145

Attachment $2.1

	Page 1 of 214-Dec-05
CritiSense Ltd.11 Ben Gurion St.Givat Shmuel 54101Israel	Tel - +972-3-5325553Fax - +972-3-5325251
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 (VitalMedical became CritiSense).

510(k) Summary of Safety and Effectiveness

Device Description:

Indications for Use:

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 andmicrovascular perfusion in tissue. Changes in the measuredparameters, blood flow change, blood volume change, and NADHconcentration change that provide information on tissue metabolicactivity.
Environments of use	Hospital - OR, ICU, Emergency Departments, High DependencyUnits 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 375nmUV LED 375nmNIR Laser Diode 785nm
Means for light transmission	In-vivo, fiber optic probe
Measured parameters	1. Blood Flow [%] Doppler Shift2. Blood Volume [%] of change3. 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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 changesin NADH redox state and microvascular perfusion in tissue.Changes in the measured parameters, blood flow change,blood volume change, and NADH concentration changeprovide information on tissue metabolic activity.
	The CritiView uses a pencil style probe which is in contactwith the tissue(s) to be measured / monitored. The devicemay be used for 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, asthe heart beating motion may not provide a reliable probecontact surface.
	Environment of use include - hospital - OR, ICU,Emergency Departments, High Dependency UnitsInstitutions
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

Regulation Number and Section

§ 870.2100 Cardiovascular blood flowmeter.

(a)
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.(b)
Classification. Class II (performance standards).