The CritiView Device 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.

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

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 Criti View device consists of NADH Fluorometer and Doppler Flowmeter. The CritiView (CRV3) device is a modification of the predicate, CritiView, K051145. Measurements are made with the use of optical probes, i.e. pencil type for direct tissue contact and Foley catheter for measurement on the urethral wall tissue.

AI/ML Overview

The provided text is a 510(k) Non-Confidential Summary of Safety and Effectiveness for the CritiView Model CRV3 device. This type of document is primarily focused on demonstrating substantial equivalence to a predicate device and includes details about the device's intended use, technical specifications, and comparison to existing devices. It does not contain information about acceptance criteria or specific study results that prove the device meets performance criteria in the way a clinical trial report or a dedicated validation study would.

Therefore, many of the requested items (acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) cannot be extracted from this document.

The document states: "There are no significant differences between the CritiView (CRV3) and the predicate --CritiView, K051145 and between the CritiView Foley catheter probe accessory and the predicate Foley catheter, Mallinckrodt - Foley with temperature - K923538." This implies that the device is considered safe and effective based on its substantial equivalence to previously cleared devices, rather than through a new, comprehensive performance study outlined in this summary.

Here's what can be answered based on the provided text:

Acceptance criteria and reported device performance: Not explicitly stated in this document. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is not described as an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for direct measurement, not an algorithm.
The type of ground truth used: Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary

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K062977 Non-Confidential Summary of Safety and Effectiveness Page 1 of 4

21-Feb-07

CritiSense Ltd.11 Ben Gurion St.Givat Shmuel 54101Israel	Tel - +972-3-5325553Fax - +972-3-5325251	FEB 28 200
Official Contact:	Dalia Givony - Clinical Research, Regulatory and QA Director
Proprietary or Trade Name:	CritiView
Model:	CRV3
Common/Usual Name:	Cardiovascular blood flowmeterFluorometer for clinical use
Classification Name:	Cardiovascular blood Flowmeter (DPW)Fluorometer for clinical use (KHO)Catheter, retention type, balloon accessory (EZL)
Device:	CritiView Model CRV3
Predicate Devices:	CritiView, CritiSense Ltd, K051145Mallinckrodt - Foley with temperature - K923538

General Device Description:

Indications for Use:

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K062977 Non-Confidential Summary of Safety and Effectiveness Page 2 of 4 21-Feb-07

Duration of Use:

The CritiView has two probes--a pencil style probe and a Foley catheter probe-- which are in contact with the tissue to be measured / monitored. The optical portion of the probe (device) may be used continuously for up to eight (8) hours per twenty-four (24) hour period.

The Foley can be left in place up to five (5) days.

Patient Population:

Pencil Style Probe: Neonate/infant, pediatric, and adult Foley Catheter Probe: Hospitalized adults who are clinically indicated for a Foley catheter use.

Environment of use:

Hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions

Contraindications:

The CritiView should not be used on people that are hypersensitive to UV radiation. The device should not be used on patients taking photosensitizing drugs.

When monitoring the urethral wall tissue the device should not be used on patients with urinary tract or bladder infection or in any case when the patient clinical condition prevents the use of a Foley catheter.

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K062977 Non-Confidential Summary of Safety and Effectiveness Page 3 of 4 21-Feb-07

Attribute	CritiView (CRV3)
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 -- provide information on tissue metabolicactivity.
Environments of use	Hospital - OR, ICU, Emergency Departments, High DependencyUnits Institutions
Patient Population	Pencil type probe - Hospitalized patients - Neonate/infant, pediatrics,adults.Foley catheter probe-Hospitalized adults who are clinically indicatedfor Foley catheter use.
Contraindications	The CritiView should not be used on people that are hypersensitive toUV radiation. The device should not be used on patients takingphotosensitizing drugs.When monitoring the urethral wall tissue the device should not alsobe used on patients with urinary tract or bladder infection or in anycase when the patient clinical condition prevents the use of a Foleycatheter.
Laser Class	Class 1 Laser Device
Measurement Technique	Absorption, reflection and fluorescence spectrometry
Light source Wavelengths	UV LED – 375 nmBlue LED - 470 nmGreen LED - 530 nmNIR Laser Diode - 785 nm
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; Foley Catheter probe
Duration of use	Optical portion of the probe:Eight (8) hours per twenty-four (24) hours period.Foley catheter:Can be left in placed up to 5 days.
Foley catheter sizes offered	16 and 18 French, for adults only

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K062977 Non-Confidential Summary of Safety and Effectiveness Page 4 of 4 21-Feb-07

Differences Between Other Legally Marketed Predicate Devices:

The new model (CRV3) has a new accessory, a Foley catheter probe intended for the measurement of the urethral tissue. Additionally, battery power operation is possible for the CRV3.

There are no significant differences between the CritiView (CRV3) and the predicate --CritiView, K051145 and between the CritiView Foley catheter probe accessory and the predicate Foley catheter, Mallinckrodt - Foley with temperature - K923538.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2007

CritiSense Ltd. c/o Mr. Paul E. Dryden President 3460 Ponte Creck Court #102 Bonita Spring, FL 34134-2015

Rc: K062977 Trade/Device Name: CritiView Model CRV3 Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW, EZL and KHO Dated: February 1, 2007 Received: February 2, 2007

Dear Mr. Dryden:

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 Cosmctic 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 docs 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

B. Himmelsfor

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

Enclosure

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Indications for Use Statement

510(k) Number: K062977 Device Name:

Indications for Use:

CritiView (CRV3)

Duration of Use:

The Foley catheter can be left in place up to five (5) days.

Patient Population:

Pencil Style Probe: Neonate/infant, pediatric, and adult Foley Catheter Probe: Hospitalized adults who are clinically indicated for a Foley catheter use.

Environment of use:

Hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions

Prescription Use XX (Per CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumima
division S.E. Off

Division of Cardiovascular Devices
510(k) Number K962977

Page 1 of 2

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Indications for Use Statement

K062977 510(k) Number:

Page 2 of 2

Device Name: CritiView (CRV3)

Contraindications:

The CritiView should not be used on people that are hypersensitive to UV radiation. The device should not be used on patients taking photosensitizing drugs.

Prescription Use XX (Per CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).