Kent Camera

K163070 · Kent Imaging, Inc. · MUD · May 5, 2017 · Cardiovascular

Device Facts

• Record ID: K163070
• Device Name: Kent Camera
• Applicant: Kent Imaging, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: May 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

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 Story

Handheld digital camera; uses multispectral imaging to measure superficial tissue oxygenation. Inputs: back-scattered NIR light from tissue illuminated by LEDs. Processing: spectral analysis at 4 wavelengths; uses modified Beer-Lambert model to calculate StO2, HbO2, and Hb. Output: 2D color-coded oxygenation map and numeric measurements. Used in healthcare environments by professionals. Benefits: non-invasive visualization of local/regional tissue oxygenation; aids assessment of circulatory compromise. Battery-powered; replaces previous stand-based design.

Clinical Evidence

Clinical agreement study (n=17 healthy volunteers) compared battery-powered Kent Camera (KC203) to predicate (KC103) using a forearm ischemia-reperfusion protocol. Primary endpoints: linear relationship and bias quantification via Deming regression and Bland-Altman analysis. Results: 95% CI for slope [0.932-0.959], intercept [0.020-0.040]. Bland-Altman bias 95% CI [-0.004, 0.003] StO2 units. 95% limits of agreement -0.13 to 0.12 StO2 units. >85% of paired measurements differed by <0.1 StO2 units. Study confirmed excellent linear correlation and operational equivalence across normal and ischemic ranges.

Technological Characteristics

Handheld multispectral imaging system. CMOS image sensor with global shutter. Light source: LEDs (4 wavelengths, 600-1000nm). Power: DC battery-powered. Connectivity: standalone. Sterilization: not sterile. Software: modified Beer-Lambert model for spectral analysis. Compliant with ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 62133:2012, and UN38.3:2009.

Indications for Use

Indicated for healthcare professionals to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Regulatory Classification

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.

Predicate Devices

• Kent Camera (K113507)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <div><span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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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: [phone] Fax: [phone]

#### 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<br>Feature | Kent Imaging, Inc.<br>Modified Kent<br>Camera | Kent Imaging, Inc.<br>Predicate Kent Camera | Significant Differences |
|------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Same | The Kent Camera is intended<br>for use by healthcare<br>professionals as a non-<br>invasive tissue oxygenation<br>measurement system that<br>reports an approximate<br>value of oxygen saturation<br>$(StO2)$ , relative<br>oxyhemoglobin (HbO₂) and<br>deoxyhemoglobin (Hb) level<br>in superficial tissue. The Kent<br>Camera displays two-<br>dimensional color-coded<br>images of tissue oxygenation<br>of the scanned surface and<br>reports multispectral tissue<br>oxygenation measurements<br>for selected tissue regions.<br>The Kent Camera is indicated<br>for use to determine<br>oxygenation levels in<br>superficial tissues. | none |
| Measurements | Same | oxygen saturation relative oxyhemoglobin level relative deoxyhemoglobin level | none |
| Method of<br>Measurement | Same | Non-invasive, non-patient<br>contacting imaging head<br>illuminates the surface and<br>receives returned light | none |
| | Minor center<br>wavelength change<br>and increased<br>bandwidth | Four wavelengths between<br>600nm and 1000nm | Different. Both use specific<br>weighted coefficients. The<br>change had no effect on<br>performance and does not<br>present any additional safety<br>or effectiveness concerns. |
| | A CMOS image<br>sensor with global<br>shutter is used as<br>the detector | A wavelength-filtered CMOS<br>image sensor with rolling<br>shutter is used as the<br>detector | Similar. Both are CMOS<br>sensors. The change in<br>shutter type had no effect on<br>performance and does not<br>present any additional safety |
| | | | or effectiveness concerns. |
| | Same | Spectral analysis at specific<br>wavelengths of light<br>returned from the target<br>tissue | none |
| Light Source | Higher intensity,<br>shorter duration | Lower intensity, longer<br>duration | Similar. Both use LEDs. The<br>change in LEDs had no effect<br>on performance and does<br>not present any additional<br>safety or effectiveness<br>concerns. |
| Ambient Light | Insignificant<br>contribution to<br>image (relative to<br>NIR LEDs) due to<br>short exposure time | Blocked by optical filters | Different. Both compensate<br>for ambient light. The<br>change in filtering of light<br>had no effect on<br>performance and does not<br>present any additional safety<br>or effectiveness concerns. |
| Excessively Bright<br>Ambient Light | Same | Checked for in software | none |
| Working Distance | Approximately 12" | Approximately 16" | Similar. Both have the same<br>approximate working<br>distance. The change in<br>working distance had no<br>effect on performance and<br>does not present any<br>additional safety or<br>effectiveness concerns. |
| Output Display | Same | Two-dimensional color-<br>coded map of estimated<br>oxygen saturation Numeric data | none |
| Power Source | DC (battery-<br>powered) | AC | Different. The device power<br>source was changed from AC<br>to DC (battery-powered).<br>The change from AC to DC<br>(battery-powered) does not<br>affect the oxygenation data<br>provided, had no effect on<br>performance and does not<br>present any additional safety<br>or effectiveness concerns. |
| Patient Contact | Same | None | none |
| Patient<br>Population and<br>Environment | Same | Healthcare environment for<br>patient population with<br>potential circulatory<br>compromise | none |
| Location of<br>Measurement | Same | Two-dimensional area of<br>superficial tissue | none |
| Control Method | Same | Computer controlled | none |
| Calibration | Same | Preformed at start-up by<br>operator. Performed<br>periodically during extended<br>picture capturing sessions | none |
| Sterility | Same | Camera and components are<br>not supplied sterile, nor are<br>they considered sterile or are<br>to be sterilized | none |
| | Same | • DC-powered<br>touchscreen PC<br>• DC-powered camera<br>(imaging head) | none |
| User Interface | Computer and a<br>battery<br>incorporated into<br>camera enclosure | Stand based design<br>supporting computer, power<br>supply and camera head | Different. The update of the<br>camera from the stand-based<br>device to a handheld device<br>involved changes to the<br>power source, overall<br>dimensions and packaging.<br>The change from stand-<br>based to handheld had no<br>effect on performance and<br>does not present any<br>additional safety or<br>effectiveness concerns as the<br>fundamental scientific,<br>multispectral imaging,<br>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).