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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Kent Camera, a non-invasive tissue oxygenation measurement system.

Acceptance Criteria and Study Details

The primary goal of the study was to demonstrate the substantial equivalence of the modified Kent Camera (KC203, battery-powered) to its predicate device (KC103, AC-powered). The acceptance criteria revolved around demonstrating linear agreement, minimal bias, and a small scale shift between the StO2 measurements of the two devices across a clinically meaningful dynamic range.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Linear relationship of StO2 measurements between the two devices over a clinically meaningful dynamic range.	Demonstrated linear relationship. The Deming regression line of agreement has a 95% confidence interval for the slope [0.932 - 0.959] and intercept [0.020 - 0.040]. StO2 values from both cameras show an excellent linear correlation over a wide range of StO2 levels (normal, mildly ischemic, critically ischemic conditions).
Quantify any scale shift (slope) between the devices and estimate the 95% levels of agreement.	The slope -0.0057, with a 95% confidence interval of [-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 are -0.13 to 0.12 StO2 units. More than 85% of the paired measurements from the two cameras differ less than 0.1 StO2 units.
Quantify any bias (difference in mean values) between the devices.	Bland-Altman analysis shows little to no bias between the devices, with a 95% confidence interval for the intercept of [-0.004, 0.003] StO2 units (using StO2 reported on a scale of 0 to 1).
Devices should share a common scale.	The devices share a common scale (within 1%).
Devices should show minimal to no bias.	The devices show minimal to no bias.
Ability to report a drop in StO2 levels under ischemia and a trend consistent with physiological response.	The study demonstrated that StO2 values from both cameras report a drop from basal StO2 levels under conditions of known ischemia and report a trend in StO2 values consistent with the physiological response expected for forearm ischemia - reperfusion.
StO2 readings are not statistically and operationally significantly different.	The two devices show an excellent linear relationship and provide StO2 readings which statistically and operationally are not significantly different.

2. Sample Size for the Test Set and Data Provenance

Sample Size: 17 volunteers (7 females, 10 males)
Data Provenance: The study was a "pre-clinical study" conducted using a "forearm ischemia protocol" in an unnamed location. The volunteers "self-reported as being healthy." The study was prospective in nature, as it involved taking measurements from human subjects under controlled conditions for the purpose of the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The study did not involve experts establishing a "ground truth" in the traditional sense of diagnostic interpretation. Instead, the study assessed the agreement between two devices by comparing their measurements against each other and against an induced physiological state (forearm ischemia/reperfusion). The "ground truth" was essentially the known physiological changes induced in the forearm, and the device measurements were compared against each other, not against an expert-derived interpretation.

4. Adjudication Method for the Test Set

No adjudication method was described, as the study design was an agreement study comparing two devices' direct measurements, not an interpretation task requiring expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The study focused on device-to-device agreement, not the improvement of human readers with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The study implicitly evaluated the standalone performance of the device's algorithm by comparing the StO2 measurements generated by the KC203 directly with those generated by the KC103. Both devices generate StO2 values independently, and the comparison assesses the equivalence of these generated values. Human operators were involved in taking the measurements, but the performance being evaluated (StO2 measurement accuracy and agreement) is that of the device's algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for the test set was:

Known physiological changes: The forearm ischemia protocol provided a controlled and expected range of StO2 values (normal, ischemic, reperfusion). The basis for comparison was the agreement between the two devices' measurements across these known physiological states, rather than a single absolute "ground truth" reference measurement (like pathology).

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is a 510(k) submission, typically focusing on demonstrating substantial equivalence of a modified device to a predicate device, rather than a novel algorithm development where training set details are paramount. The "training" of the device involves its inherent multispectral imaging technology and the application of a modified Beer-Lambert model, which are fundamental scientific principles rather than a machine learning training process with a distinct training dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable/not provided. As mentioned above, the device's operation is based on established physical principles of light absorption and scattering for tissue oxygenation, rather than a machine learning model trained on a specific dataset with established ground truth labels in the typical sense. The "ground truth" for developing the underlying technology would be physiological models and empirical data relating light spectroscopy to oxygen saturation, but this is not described in terms of a "training set" in the context of this regulatory document.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

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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

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

The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues.

Device Description

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Comparison to predicate device

ComparativeFeature	Kent Imaging, Inc.Modified KentCamera	Kent Imaging, Inc.Predicate Kent Camera	Significant Differences
Indications forUse	Same	The Kent Camera is intendedfor use by healthcareprofessionals as a non-invasive tissue oxygenationmeasurement system thatreports an approximatevalue of oxygen saturation$(StO2)$ , relativeoxyhemoglobin (HbO₂) anddeoxyhemoglobin (Hb) levelin superficial tissue. The KentCamera displays two-dimensional color-codedimages of tissue oxygenationof the scanned surface andreports multispectral tissueoxygenation measurementsfor selected tissue regions.The Kent Camera is indicatedfor use to determineoxygenation levels insuperficial tissues.	none
Measurements	Same	oxygen saturation relative oxyhemoglobin level relative deoxyhemoglobin level	none
Method ofMeasurement	Same	Non-invasive, non-patientcontacting imaging headilluminates the surface andreceives returned light	none
	Minor centerwavelength changeand increasedbandwidth	Four wavelengths between600nm and 1000nm	Different. Both use specificweighted coefficients. Thechange had no effect onperformance and does notpresent any additional safetyor effectiveness concerns.
	A CMOS imagesensor with globalshutter is used asthe detector	A wavelength-filtered CMOSimage sensor with rollingshutter is used as thedetector	Similar. Both are CMOSsensors. The change inshutter type had no effect onperformance and does notpresent any additional safety
			or effectiveness concerns.
	Same	Spectral analysis at specificwavelengths of lightreturned from the targettissue	none
Light Source	Higher intensity,shorter duration	Lower intensity, longerduration	Similar. Both use LEDs. Thechange in LEDs had no effecton performance and doesnot present any additionalsafety or effectivenessconcerns.
Ambient Light	Insignificantcontribution toimage (relative toNIR LEDs) due toshort exposure time	Blocked by optical filters	Different. Both compensatefor ambient light. Thechange in filtering of lighthad no effect onperformance and does notpresent any additional safetyor effectiveness concerns.
Excessively BrightAmbient Light	Same	Checked for in software	none
Working Distance	Approximately 12"	Approximately 16"	Similar. Both have the sameapproximate workingdistance. The change inworking distance had noeffect on performance anddoes not present anyadditional safety oreffectiveness concerns.
Output Display	Same	Two-dimensional color-coded map of estimatedoxygen saturation Numeric data	none
Power Source	DC (battery-powered)	AC	Different. The device powersource was changed from ACto DC (battery-powered).The change from AC to DC(battery-powered) does notaffect the oxygenation dataprovided, had no effect onperformance and does notpresent any additional safetyor effectiveness concerns.
Patient Contact	Same	None	none
PatientPopulation andEnvironment	Same	Healthcare environment forpatient population withpotential circulatorycompromise	none
Location ofMeasurement	Same	Two-dimensional area ofsuperficial tissue	none
Control Method	Same	Computer controlled	none
Calibration	Same	Preformed at start-up byoperator. Performedperiodically during extendedpicture capturing sessions	none
Sterility	Same	Camera and components arenot supplied sterile, nor arethey considered sterile or areto be sterilized	none
	Same	• DC-poweredtouchscreen PC• DC-powered camera(imaging head)	none
User Interface	Computer and abatteryincorporated intocamera enclosure	Stand based designsupporting computer, powersupply and camera head	Different. The update of thecamera from the stand-baseddevice to a handheld deviceinvolved changes to thepower source, overalldimensions and packaging.The change from stand-based to handheld had noeffect on performance anddoes not present anyadditional safety oreffectiveness concerns as thefundamental 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

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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).

Regulation Number and Section

§ 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).