(184 days)
Not Found
No
The description focuses on multispectral imaging and spectral analysis, with no mention of AI, ML, or related concepts like training/test sets for model development. The performance study describes a comparison to a predicate device using a forearm ischemia protocol, not the evaluation of an AI/ML algorithm.
No
The device is a measurement system that reports approximate values of oxygen saturation and relative hemoglobin levels. It provides information for diagnosis and monitoring, but it does not actively treat or prevent a disease or condition.
Yes
The device is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system to report approximate values of oxygen saturation (StO2), relative oxyhemoglobin level (HbO2), and relative deoxyhemoglobin (Hb) level in superficial tissue, and is indicated for use to determine oxygenation levels in superficial tissues. These measurements provide information that can be used for diagnosis or monitoring of a patient's condition.
No
The device description explicitly states that the Kent Camera consists of a camera, a recharger, and a reference card for calibration, indicating it includes hardware components beyond just software.
Based on the provided information, the Kent Camera is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Kent Camera's Function: The Kent Camera is described as a non-invasive tissue oxygenation measurement system. It directly measures oxygenation levels in superficial tissue on the body using multispectral imaging. It does not analyze samples taken from the body.
Therefore, the Kent Camera falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Kent Camera is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:
- oxygen saturation (StO2),
- relative oxyhemoglobin level (HbO2), and
- relative deoxyhemoglobin (Hb) level
in superficial tissue. The Kent Camera displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions.
The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues.
Product codes (comma separated list FDA assigned to the subject device)
MUD
Device Description
The Kent Camera is a handheld digital camera based on multispectral imaging technology and performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. The Kent Camera determines the approximate values of oxygen saturation (S.O2), relative oxyhemoglobin (HbO2) and deoxyhemoglobin levels (Hb) in superficial tissues and displays a two-dimensional, color-coded image of the tissue oxygenation (StO2).
The camera consists of a camera, a recharger, and a reference card for calibration and is used by healthcare professionals in a healthcare environment to determine oxygenation levels in superficial tissues for a patient population with potential circulatory compromise.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Multispectral imaging
Anatomical Site
superficial tissues, volar forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in a healthcare environment
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
A pre-clinical study was conducted comparing tissue oxygen hemoglobin saturation (StO2) measurements taken with the battery-powered Kent Camera (KC203) and the predicate Kent Camera (KC103). The agreement study used a forearm ischemia protocol to evaluate the performance of the devices both within the expected normal range of S-O2 as well as situations where S.O2 is depressed. The forearm ischemia protocol was intended to test the devices over the clinically meaningful dynamic range of StO2.
The study population consisted of 7 females and 10 males ranging in age from 23 to 72 with the mean age of the study participants being 49. The protocol involved taking pairs of S-O2 pictures with the two cameras of the same region of the volar forearm in quick succession. These were considered matched pairs. Matched pairs of pictures were collected with the forearm under normal baseline perfusion for each subject. Matched pairs of pictures were taken over 3 minutes with the blood flow to the forearm being occluded and for a further 3 minutes with perfusion restored (reperfusion). This occlusion – reperfusion cycle was repeated a second time for each study participant.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Pre-clinical agreement study
Sample Size: 17 volunteer participants (7 females, 10 males), mean age 49, ranging from 23 to 72.
Key Results:
- The devices show a linear agreement over a wide dynamic range of S.O2 spanning the range expected for normal healthy tissue and ischemic tissue.
- The Deming regression line of agreement has a 95% confidence interval for the slope [0.932 - 0.959] and intercept [0.020 0.040].
- The Bland-Altman analysis shows little to no bias between the devices, 95% confidence interval for the intercept [-0.004 0.003] S:O2 units (using S:O2 reported on a scale of 0 to 1).
- The slope -0.0057, [-0.009 -0.002] indicates less than a 1% scale shift between the two cameras.
- The 95% limits of agreement (LoA) for the battery-powered minus the predicate device being -0.13 to 0.12 S-O2 units.
- More than 85% of the paired measurements from the two cameras differ less than 0.1 S.O2 units.
- The study demonstrated that S.O2 values from both cameras show an excellent linear correlation, 95% Cl for slope [0.932 0.959] and intercept [0.020 0.040], evaluated over wide range of S-O2 levels encompassing the clinical range expected for normal, mildly ischemic and critically ischemic conditions.
- Both cameras report a drop from basal S.O2 levels under conditions of known ischemia and report a trend in S-O2 values consistent with the physiological response expected for forearm ischemia - reperfusion.
- The two devices show an excellent linear relationship and provide S.O2 readings which statistically and operationally are not significantly different.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing to the right. The symbol is stylized and appears to be formed from a single continuous line.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 05, 2017
Kent Imaging Inc. Darrell Barnhart Vice President 1440, 720 - 13th Avenue SW Calgary, T2R 1M5 CA
Re: K163070
Trade/Device Name: Kent Camera Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: April 4, 2017 Received: April 5, 2017
Dear Darrell Barnhart:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
M.R. Hilleman
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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Indications for Use
510(k) Number (if known) K163070
Device Name Kent Camera
Indications for Use (Describe)
The Kent Camera is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:
- oxygen saturation (StO2),
- relative oxyhemoglobin level (HbO2), and
- relative deoxyhemoglobin (Hb) level
in superficial tissue. The Kent Camera displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions.
The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Kent Imaging Inc. The word "Kent" is written in large, bold, blue letters. Below the word "Kent" and slightly to the right, the words "Imaging Inc" are written in smaller, black letters. The background of the image is white.
510(k) Summary
Kent Camera (May 4, 2017)
Submittal Information:
Post-approval contact: Darrell Barnhart Kent Imaging Inc. 1440, 720 - 13th Avenue SW Calgary, AB, Canada T2R 1M5
Phone: 403-455-7610 Fax: 877-664-5450
Device and Classification Name
Proprietary Name: Kent Camera Common Name: Tissue Oximeter Oximeter, Tissue Saturation (21 CFR 870.2700, Product Code: 74 MUD) Classification Name:
Predicate Device
Kent Camera, 510(k) K113507, Kent Imaging Inc.
Intended Use
The Kent Camera is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:
- oxygen saturation (StO2),
- . relative oxyhemoglobin level (HbO2), and
- relative deoxyhemoglobin (Hb) level
in superficial tissue. The Kent Camera displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions.
The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues.
Device Description
The Kent Camera is a handheld digital camera based on multispectral imaging technology and performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. The Kent Camera determines the approximate values of oxygen saturation (S.O2), relative oxyhemoglobin (HbO2) and deoxyhemoglobin levels (Hb) in superficial tissues and displays a two-dimensional, color-coded image of the tissue oxygenation (StO2).
The camera consists of a camera, a recharger, and a reference card for calibration and is used by healthcare professionals in a healthcare environment to determine oxygenation levels in superficial tissues for a patient population with potential circulatory compromise.
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Comparison to predicate device
| Comparative
Feature | Kent Imaging, Inc.
Modified Kent
Camera | Kent Imaging, Inc.
Predicate Kent Camera | Significant Differences |
|------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Same | The Kent Camera is intended
for use by healthcare
professionals as a non-
invasive tissue oxygenation
measurement system that
reports an approximate
value of oxygen saturation
$(StO2)$ , relative
oxyhemoglobin (HbO₂) and
deoxyhemoglobin (Hb) level
in superficial tissue. The Kent
Camera displays two-
dimensional color-coded
images of tissue oxygenation
of the scanned surface and
reports multispectral tissue
oxygenation measurements
for selected tissue regions.
The Kent Camera is indicated
for use to determine
oxygenation levels in
superficial tissues. | none |
| Measurements | Same | oxygen saturation relative oxyhemoglobin level relative deoxyhemoglobin level | none |
| Method of
Measurement | Same | Non-invasive, non-patient
contacting imaging head
illuminates the surface and
receives returned light | none |
| | Minor center
wavelength change
and increased
bandwidth | Four wavelengths between
600nm and 1000nm | Different. Both use specific
weighted coefficients. The
change had no effect on
performance and does not
present any additional safety
or effectiveness concerns. |
| | A CMOS image
sensor with global
shutter is used as
the detector | A wavelength-filtered CMOS
image sensor with rolling
shutter is used as the
detector | Similar. Both are CMOS
sensors. The change in
shutter type had no effect on
performance and does not
present any additional safety |
| | | | or effectiveness concerns. |
| | Same | Spectral analysis at specific
wavelengths of light
returned from the target
tissue | none |
| Light Source | Higher intensity,
shorter duration | Lower intensity, longer
duration | Similar. Both use LEDs. The
change in LEDs had no effect
on performance and does
not present any additional
safety or effectiveness
concerns. |
| Ambient Light | Insignificant
contribution to
image (relative to
NIR LEDs) due to
short exposure time | Blocked by optical filters | Different. Both compensate
for ambient light. The
change in filtering of light
had no effect on
performance and does not
present any additional safety
or effectiveness concerns. |
| Excessively Bright
Ambient Light | Same | Checked for in software | none |
| Working Distance | Approximately 12" | Approximately 16" | Similar. Both have the same
approximate working
distance. The change in
working distance had no
effect on performance and
does not present any
additional safety or
effectiveness concerns. |
| Output Display | Same | Two-dimensional color-
coded map of estimated
oxygen saturation Numeric data | none |
| Power Source | DC (battery-
powered) | AC | Different. The device power
source was changed from AC
to DC (battery-powered).
The change from AC to DC
(battery-powered) does not
affect the oxygenation data
provided, had no effect on
performance and does not
present any additional safety
or effectiveness concerns. |
| Patient Contact | Same | None | none |
| Patient
Population and
Environment | Same | Healthcare environment for
patient population with
potential circulatory
compromise | none |
| Location of
Measurement | Same | Two-dimensional area of
superficial tissue | none |
| Control Method | Same | Computer controlled | none |
| Calibration | Same | Preformed at start-up by
operator. Performed
periodically during extended
picture capturing sessions | none |
| Sterility | Same | Camera and components are
not supplied sterile, nor are
they considered sterile or are
to be sterilized | none |
| | Same | • DC-powered
touchscreen PC
• DC-powered camera
(imaging head) | none |
| User Interface | Computer and a
battery
incorporated into
camera enclosure | Stand based design
supporting computer, power
supply and camera head | Different. The update of the
camera from the stand-based
device to a handheld device
involved changes to the
power source, overall
dimensions and packaging.
The change from stand-
based to handheld had no
effect on performance and
does not present any
additional safety or
effectiveness concerns as the
fundamental scientific,
multispectral imaging,
technology is the same. |
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Nonclinical Tests
To support the substantial equivalence, the modified Kent Camera, like the predicate device before, went through and passed both internal testing for user and design requirements as well as international standards. The Kent camera passed testing for the following standards:
- Electrical safety and essential performance: ANSI/AAMI ES60601-1
- Electromagnetic compatibility: IEC 60601-1-2
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As mentioned previously, the modified Kent camera is battery (DC) powered. A medical grade battery was purchased for this purpose and it is compliant with the following standards:
- Battery safety testing: IEC 62133:2012
- Transportation safety testing of lithium batteries: UN38.3:2009
The predicate device uses LEDs in combination with bandpass filters in front of the detector to illuminate the target within narrow passbands. The subject device uses LEDs with minor changes in center wavelength and no bandpass filters which increases the bandwidth of each wavelength. Appropriate matching extinction coefficients are employed and weighted in the subject device to reflect the minor wavelength changes and increased bandwidth of each LED emission profile. This results in both cameras having effectively the same performance in obtaining StO2 values even in the presence of noise.
Performance Data
A pre-clinical study was conducted comparing tissue oxygen hemoglobin saturation (StO2) measurements taken with the battery-powered Kent Camera (KC203) and the predicate Kent Camera (KC103). The agreement study used a forearm ischemia protocol to evaluate the performance of the devices both within the expected normal range of S-O2 as well as situations where S.O2 is depressed. The forearm ischemia protocol was intended to test the devices over the clinically meaningful dynamic range of StO2.
The study objectives were as follows:
- Demonstrate the linear relationship between the S:O2 measurements from the two devices over a clinically meaningful dynamic range of StO2.
- . Through the use of Bland-Altman plots quantify any scale shift (slope) and bias (difference in mean values) between the devices and estimate the 95% levels of agreement.
The volunteers for our agreement study self-reported as being healthy. We did no further screening to assess their vascular or general health. - The study population consisted of 7 females and 10 males ranging in age from 23 to 72 with the mean age of the study participants being 49. The protocol involved taking pairs of S-O2 pictures with the two cameras of the same region of the volar forearm in quick succession. These were considered matched pairs. Matched pairs of pictures were collected with the forearm under normal baseline perfusion for each subject. Matched pairs of pictures were taken over 3 minutes with the blood flow to the forearm being occluded and for a further 3 minutes with perfusion restored (reperfusion). This occlusion – reperfusion cycle was repeated a second time for each study participant.
Endpoints Demonstrating Agreement
The devices show a linear agreement over a wide dynamic range of ScO2 spanning the range expected for normal healthy tissue and ischemic tissue. The Deming regression line of agreement has a 95% confidence interval for the slope [0.932 - 0.959] and intercept [0.020 0.040]. The Bland-Altman analysis shows little to no bias between the devices, 95% confidence interval for the intercept [-0.004 0.003] S:O2 units (using S:O2 reported on a scale of 0 to 1). The slope -0.0057, [-0.009 -0.002] indicates less than a 1% scale shift between the two cameras. The 95% limits of agreement (LoA) for the battery-powered minus the predicate device being -0.13 to 0.12 S-O2 units. More than 85% of the paired measurements from the two cameras differ less than 0.1
8
S.O2 units. The agreement study concluded that S-O2 measurements from the batterypowered Kent Camera (KC203) and the predicate Kent Camera (KC103) show a linear relationship over a wide and clinically meaningful dynamic range of S-O2. The devices share a common scale (within 1%) and show minimal to no bias. These findings support the use of the battery-powered Kent Camera (KC203) to non-invasively measure superficial tissue hemoglobin oxygen saturation.
Conclusion
The predicate camera received 510(k) clearance in August 2012. Both cameras work by emitting near-infrared (NIR) light from light emitting diode (LED) sources, illuminating an area of tissue and collecting the back-scattered NIR light from the illuminated area. Both devices use backscattered light centred at 4 distinct near-infrared wavelengths well displaced from the isobestic point of hemoglobin (the point where oxygen bound hemoglobin without bound oxygen have equal light absorbance). Using the publicly available, and widely validated, near-infrared optical properties of hemoglobin and measuring the back-reflected near-infrared light, both devices determine the relative proportion of oxygen bound hemoglobin to the total hemoglobin in the microvascular bed (tissue hemoglobin oxygen saturation, S-O2) using a modified Beer-Lambert model.
In order to determine the operational equivalence of the battery-powered camera and the predicate camera, a convenience sample of 17 volunteer participants were measured over the course of a forearm ischemia protocol. This protocol offers a simple, yet clinically safe method to temporarily change hemoglobin oxygen levels of the forearm. Matched measurements were made with both devices and parametric correlation analysis was used to determine the linear relationship between the battery-powered camera and the predicate camera. The study demonstrated that SiO2 values from both cameras show an excellent linear correlation, 95% Cl for slope [0.932 0.959] and intercept [0.020 0.040], evaluated over wide range of S-O2 levels encompassing the clinical range expected for normal, mildly ischemic and critically ischemic conditions. Based on our study we can unequivocally state that both cameras report a drop from basal SeO2 levels under conditions of known ischemia and report a trend in S-O2 values consistent with the physiological response expected for forearm ischemia - reperfusion. The study supports the intended field of use for our camera, to help visualize local or regional tissue hemoglobin oxygenation (S-O2) in the general population. The two devices show an excellent linear relationship and provide SQ2 readings which statistically and operationally are not significantly different.
Basis of Substantial Equivalence
Based on identical manufacturer, intended use, unaltered fundamental scientific technology, equivalent effectiveness and safety results from comparative performance testing, the modified Kent Camera (KC203) is substantially equivalent to the unmodified Kent Camera (KC103).