SnapshotNIR

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November 10, 2020 Kent Imaging Liz Newell Director, Clinical Research 804B 16th Ave SW Calgary, Alberta t2r 0s9 Canada Re: K201976 Trade/Device Name: SnapshotNIR Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: July 15, 2020 Received: July 16, 2020 Dear Liz Newell: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201976 Device Name SnapshotNIR Indications for Use (Describe) SnapshotNIR is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurem tsystem that reports an approximate value of: - oxygen saturation (StO2), - relative oxyhemogoblin level (HbO2), and - relative deoxyhemoglobin (Hb) level in superficial tissue. SnapshotNIR displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. SnapshotNIR is indicated for use to determine oxygenation levels in superficial tissues. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ## SnapshotNik (November 2nd, 2020) #### Submittal Information: Post-approval contact: Liz Newell Kent Imaging Inc. 804B 16th Ave SW Calgary, AB, Canada T2R 0S9 Phone: 403-455-7610 Fax: 877-664-5450 ### Device Name and Classification | Proprietary Name: | SnapshotNIR | |-----------------------|---------------------------------------------------------------------| | Common Name: | Tissue Oximeter | | Classification Name: | Oximeter, Tissue Saturation (21 CFR 870.2700, Product Code: 74 MUD) | | Device Class: | Class II | | Classification Panel: | Cardiovascular | #### Device Description Snapshotwa, Model KD204 (K201976), is a modification to the Kent Camera, Model KD203 (K163070). The changes made to create the modified snapshot include modifications to the software. Both devices have similar hardware. Snapshotwa is 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. Snapshot;we determines the approximate values of oxygen saturation (S-O2), oxyhemoglobin levels (HbO₂), and deoxyhemoglobin levels (Hb) in superficial tissues and displays a two-dimensional, color-coded image of the tissue oxygenation (S-O2). The camera consists of: - Camera: Contains light source, camera and touchscreen PC - Recharger: Used to recharge the camera ● - Reference Card: To calibrate the camera ### Intended Use Snapshotma is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of: - oxygen saturation (StO2), - oxyhemoglobin level (HbO₂), and - deoxyhemoglobin (Hb) level {4}------------------------------------------------ in superficial tissue. Snapshotwa displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. The Snapshotwa is indicated for use to determine oxygenation levels in superficial tissues. | Comparative<br>Feature | Kent Imaging Inc.<br>Modified SnapshotNIR-<br>KD204<br>(K201976) | Kent Imaging Inc.<br>Predicate Kent Camera<br>- KD203<br>(K163070) | Significant<br>Differences | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The Kent Camera is<br>intended for use by<br>healthcare professionals<br>as a non-invasive tissue<br>oxygenation<br>measurement system<br>that reports an<br>approximate value of<br>oxygen saturation<br>(StO2), oxyhemoglobin<br>level (HbO2), and<br>deoxyhemoglobin (Hb)<br>level in superficial tissue.<br>The Kent Camera<br>displays two-dimensional<br>color-coded images of<br>tissue oxygenation of the<br>scanned surface and<br>reports multispectral<br>tissue oxygenation<br>measurements for<br>selected tissue regions.<br>The Kent Camera is<br>indicated for use to<br>determine oxygenation<br>levels in superficial<br>tissues. | The Kent Camera is<br>intended for use by<br>healthcare professionals<br>as a non-invasive tissue<br>oxygenation<br>measurement system<br>that reports an<br>approximate value of<br>oxygen saturation<br>(StO2), oxyhemoglobin<br>level (HbO2), and<br>deoxyhemoglobin (Hb)<br>level in superficial<br>tissue. The Kent Camera<br>displays two-<br>dimensional color-coded<br>images of tissue<br>oxygenation of the<br>scanned surface and<br>reports multispectral<br>tissue oxygenation<br>measurements for<br>selected tissue regions.<br>The Kent Camera is<br>indicated for use to<br>determine oxygenation<br>levels in superficial<br>tissues. | Same | | Measurements | Oxygen saturationOxyhemoglobin levelDeoxyhemoglobin<br>level | Oxygen saturationOxyhemoglobin<br>levelDeoxyhemoglobin<br>level | Same | | Method of<br>Measurement | Non-invasive, non-<br>patient contacting<br>imaging head illuminates<br>the surface and receives | Non-invasive, non-<br>patient contacting<br>imaging head<br>illuminates the surface | Same | | | returned light | and receives returned light | | | | 6 wavelengths between<br>600nm and 1000nm | 6 wavelengths between<br>600nm and 1000nm | Same | | | A CMOS image sensor<br>with global shutter is<br>used as the detector | A CMOS image sensor<br>with global shutter is<br>used as the detector | Same | | | Spectral analysis at<br>specific wavelengths of<br>light returned from the<br>target tissue | Spectral analysis at<br>specific wavelengths of<br>light returned from the<br>target tissue | Similar -<br>improved signal<br>to noise in<br>modified device | | Light Source | LEDs | LEDs | Same | | Lens | Corrected and optimized<br>for use from 400nm to<br>1000nm | Corrected and optimized<br>for use from 400nm to<br>1000nm | Same | | | ● Two-dimensional<br>color-coded map of<br>estimated oxygen<br>saturation | ● Two-dimensional<br>color-coded map of<br>estimated oxygen<br>saturation | Same | | Output Display | ● Numeric data | ● Numeric data | | | Power Source | DC (battery-powered) | DC (battery-powered) | Same | | Patient Contact | None | None | Same | | Control Method | Computer controlled | Computer controlled | Same | | | Preformed at start-up by<br>operator and repeated if<br>operating conditions of<br>camera change to the<br>degree that necessitates<br>recalibration | Preformed at start-up by<br>operator. Performed<br>periodically during<br>extended picture<br>capturing sessions | Similar;<br>Modified device<br>monitors<br>operating<br>conditions and<br>requires<br>recalibration<br>based on<br>changed<br>operating<br>conditions | | Calibration | | | | | Sterility | Device is not considered<br>sterile | Device is not considered<br>sterile | Same | | Software<br>Language | C# | LabVIEW | Similar;<br>The change in<br>programming<br>languages had no<br>effect on<br>performance.<br>This change does<br>not present any<br>additional safety | | | | | or effectiveness<br>concerns. | | Selection Tools | Circle (StO2%)<br>Region/Perimeter (StO2%<br>and cm²)<br>Line (cm) | Circle (%) | Similar;<br>Modified device<br>displays<br>approximate 2D<br>measures in<br>addition to %StO2 | | Region of<br>Interest (ROI)<br>Area | Support freehand<br>drawing ROI selection<br>(cm²) | None | Similar; users can<br>draw a custom<br>region of<br>interest.<br><br>The change to<br>include freehand<br>ROI drawing had<br>no effect on the<br>performance of<br>the device. | | System<br>Components | Camera, Calibration card<br>and recharger | Camera, Calibration card<br>and recharger | Same | | Image Format | DICOM | DICOM | Same | | Connectivity | Wi-Fi available only<br>when emailing a report | Wi-Fi not enabled | Similar; Wi-Fi<br>only available<br>when emailing<br>reports.<br><br>The change to<br>turn on Wi-Fi<br>does not affect<br>the performance<br>of the device and<br>does not present<br>any effectiveness<br>concerns or<br>unacceptable<br>risks. | ## Comparison with the Predicate Device ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {5}------------------------------------------------ {6}------------------------------------------------ # Similarities and Differences The changes made to create the modified Snapshotwa are software specific. Both devices have the same hardware (LEDs, image sensor, enclosure) and are the same mechanically. Both cameras use spectral analysis to determine oxygenation levels in near-surface tissues. Both cameras display numeric values of approximate oxygen saturation of the hemoglobin as well as displaying the related approximate oxyhemoglobin and deoxyhemoglobin levels necessary for {7}------------------------------------------------ the oxygen saturation calculation. Both cameras provide two-dimensional mapping of colorcoded oxygenation levels. Both cameras do not come in contact with the patient. Both cameras have the same indications for use and the same fundamental scientific technology. The modified Snapshotwa has several software specific differences compared to the predicate Kent Camera. Snapshotwa application is written in C# where the predicate device was written in LabVIEW. Snapshotma has a modified algorithm for calculating SQ2. The updated algorithm was implemented to increase the signal to noise ratio and provide better image quality is relies on the same fundamental scientific principles as the predicate algorithm. Lastly, Snaphotwa has an updated user interface which allows for freehand selection of areas and approximate 2D size measurements and can be connected to a wireless network. The user follows the same workflow for capturing images with the modified device as with the predicate. ### Non-Clinical Tests The modified device went through and passed both internal testing for user and design requirements, as did the predicate device. The modified device compared to the predicate device has no change to the hardware or to the fundamental way it interacts with or configures the hardware therefore although testing wasn't repeated, it is still compliant with the international standards below. - · Electrical safety and essential performance: ANSI/AAMI ES60601-1:2005/(R)2012 - · Electromagnetic compatibility: IEC 60601-1-2: 2014 Both the predicate and modified devices are battery (DC) powered. The same battery is used in both devices and it is compliant with the following standards: - Battery safety testing: IEC 62133:2012 - Transportation safety testing of lithium batteries: UN38.3:2009 T #### Performance Data A pre-clinical study was conducted comparing tissue oxygen hemoglobin saturation (StO2) measurements taken with the predicate Kent Camera (KD203) and the modified device (KD204). 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 new StO2 algorithm has superior performance and stability when measuring low reflectivity tissue than the predicate algorithm. - . 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. {8}------------------------------------------------ # 510(k) Summary Field data acquired on 38 volunteer subjects undergoing a forearm ischemia - reperfusion challenge confirmed stimulation and lab bench testing that the replacement algorithm provides estimates for relative oxy- [Hbo] and deoxy- [Hb] hemoglobin linearly related to the original (predicate) algorithm R2 > 0.98 with RMSE r[Hb] = 0.000239 and RMSE r[Hbo] = 0.00208. These hemoglobin estimates are used to calculate an estimated tissue hemoglobin oxygenation (StO2). S:O2 = r[Hbo] / (r[Hb] + r[Hbo]). Linear regression in conjunction with Bland – Altman analysis was used to compare StO2 estimates for the predicate algorithm and the proposed replacement algorithm. The agreement study concluded that StO2 measurements from the modified device (KD204) and the predicate Kent Camera (KD203) show a linear relationship over a wide and clinically meaningful dynamic range of S-O2. These findings support the use of the modified device (KD204) to non-invasively measure superficial tissue hemoglobin oxygen saturation. ### Basis of Substantial Equivalence The KD204 (K201976) near infrared imaging device has the same indications for use, similar technology characteristics and principles of operation as the predicate device, KD203 (K163070). The modifications between the KD204 and KD203 do not raise new or different types of questions regarding safety and effectiveness. Non-clinical performance data supports the safety and effectiveness of the KD204 device. Therefore the KD204 (K201976) is considered substantially equivalence to the KD203 (K23432).