(152 days)
No
The summary describes a device that performs spectroscopic measurements and displays trends, without mentioning any AI or ML components or processes.
No.
The device is used for monitoring tissue metabolic activity, not for treatment.
Yes
The device monitors changes in NADH redox state and microvascular perfusion, and provides information on tissue metabolic activity (blood flow change, blood volume change, and NADH concentration change). These measurements are used to provide information on a patient's physiological state, which is characteristic of a diagnostic device.
No
The device description explicitly states that the CritiView device "consists of NADH Fluorometer and Doppler Flowmeter" and uses "optical probes," indicating the presence of hardware components beyond just software.
Based on the provided information, the CritiView Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue." In-vivo means "within the living organism." IVD devices are designed to perform tests on samples taken from the body (in vitro, meaning "in glass" or "outside the living organism").
- Device Description: The description confirms that the device carries out "in-vivo, spectroscopic measurements."
- Lack of Mention of Samples: There is no mention of collecting or analyzing biological samples like blood, urine, tissue biopsies, etc., which are characteristic of IVD devices.
The CritiView Device is a medical device used for direct, real-time monitoring of physiological parameters within a living patient.
N/A
Intended Use / 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.
Product codes
DPW, EZL, KHO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain, liver, kidney, intestine, testis, skin, and urethra.
Indicated Patient Age Range
Pencil Style Probe: Neonate/infant, pediatric, and adult
Foley Catheter Probe: Hospitalized adults who are clinically indicated for a Foley catheter use.
Intended User / Care Setting
Hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K062977 Non-Confidential Summary of Safety and Effectiveness Page 1 of 4
21-Feb-07
| CritiSense Ltd.
11 Ben Gurion St.
Givat Shmuel 54101
Israel | Tel - +972-3-5325553
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
Fluorometer 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, K051145
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 |
| 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. | |
| Environments of use | Hospital - OR, ICU, Emergency Departments, High Dependency |
| Units Institutions | |
| Patient Population | Pencil type probe - Hospitalized patients - Neonate/infant, pediatrics, |
| adults. | |
| Foley catheter probe-Hospitalized adults who are clinically indicated | |
| for Foley catheter use. | |
| 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 also | |
| 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. | |
| Laser Class | Class 1 Laser Device |
| Measurement Technique | Absorption, reflection and fluorescence spectrometry |
| Light source Wavelengths | UV LED – 375 nm |
| Blue LED - 470 nm | |
| Green LED - 530 nm | |
| NIR Laser Diode - 785 nm | |
| Means for light transmission | In-vivo, fiber optic probe |
| Measured parameters | 1. Blood Flow [%] Doppler Shift |
- Blood Volume [%] of change
- 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 |
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)