CRITIVIEW, MODEL CRV3

{0}------------------------------------------------ ## K062977 Non-Confidential Summary of Safety and Effectiveness Page 1 of 4 21-Feb-07 | CritiSense Ltd.<br>11 Ben Gurion St.<br>Givat Shmuel 54101<br>Israel | Tel - +972-3-5325553<br>Fax - +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 flowmeter<br>Fluorometer for clinical use | | | Classification Name: | Cardiovascular blood Flowmeter (DPW)<br>Fluorometer for clinical use (KHO)<br>Catheter, retention type, balloon accessory (EZL) | | | Device: | CritiView Model CRV3 | | | Predicate Devices: | CritiView, CritiSense Ltd, K051145<br>Mallinckrodt - Foley with temperature - K923538 | | ## General 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. ## Indications for Use: 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. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a series of handwritten numbers and a letter. The characters appear to be 'K62977'. The handwriting is somewhat rough, and the numbers are not perfectly aligned, giving the image a casual, handwritten feel. ## 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. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K062977' and appear to be written with a dark pen or marker on a white surface. The writing style is somewhat rough, with variations in stroke thickness and character alignment. # 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 and<br>microvascular perfusion in tissue. Changes in the measured<br>parameters--blood flow change, blood volume change, and NADH<br>concentration change -- provide information on tissue metabolic<br>activity. | | Environments of use | Hospital - OR, ICU, Emergency Departments, High Dependency<br>Units Institutions | | Patient Population | Pencil type probe - Hospitalized patients - Neonate/infant, pediatrics,<br>adults.<br>Foley catheter probe-Hospitalized adults who are clinically indicated<br>for Foley catheter use. | | Contraindications | The CritiView should not be used on people that are hypersensitive to<br>UV radiation. The device should not be used on patients taking<br>photosensitizing drugs.<br>When monitoring the urethral wall tissue the device should not also<br>be used on patients with urinary tract or bladder infection or in any<br>case when the patient clinical condition prevents the use of a Foley<br>catheter. | | Laser Class | Class 1 Laser Device | | Measurement Technique | Absorption, reflection and fluorescence spectrometry | | Light source Wavelengths | UV LED – 375 nm<br>Blue LED - 470 nm<br>Green LED - 530 nm<br>NIR Laser Diode - 785 nm | | 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 /<br>probe | Direct tissue contact / Pencil type probe; Foley Catheter probe | | Duration of use | Optical portion of the probe:<br>Eight (8) hours per twenty-four (24) hours period.<br>Foley catheter:<br>Can be left in placed up to 5 days. | | Foley catheter sizes offered | 16 and 18 French, for adults only | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence appears to be "K062977". The characters are written in a simple, slightly irregular style, with varying stroke thicknesses. # 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. {4}------------------------------------------------ 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ ## Indications for Use Statement 510(k) Number: K062977 Device Name: Indications for Use: 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. CritiView (CRV3) 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. ## 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 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 {7}------------------------------------------------ # 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. 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. Prescription Use XX (Per CFR 801.109) Concurrence of CDRH, Office of Device Evaluation (ODE)