(117 days)
SnapshotNIR 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 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.
SnapshotNIR, 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.
SnapshotNIR 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. SnapshotNIR 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
The provided text is a 510(k) summary for the SnapshotNIR device, which is a modification of an existing predicate device. The primary focus of the document is to demonstrate "substantial equivalence" to the predicate device, rather than to establish new performance criteria for the device itself. Therefore, the "acceptance criteria" in the traditional sense of a new medical device approval (e.g., minimum sensitivity/specificity thresholds) and a separate "study that proves the device meets the acceptance criteria" are not explicitly defined in the provided document in the way one might expect for a novel device or AI/ML product.
Instead, the acceptance criteria are implicitly met through the demonstration of linear relationship and agreement between the modified device's algorithm and the predicate device's algorithm for StO2 measurements over a clinically meaningful range. The study is a pre-clinical agreement study conducted to support this substantial equivalence.
Here's the breakdown of the information based on your request, extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
As discussed, specific numerical "acceptance criteria" and "reported device performance" in terms of clinical accuracy (e.g., sensitivity, specificity, or specific error bounds against a gold standard) are not explicitly stated in the provided 510(k) summary for the modified device. The document primarily focuses on demonstrating that the modified device's performance (specifically the new StO2 algorithm) is linearly related and in agreement with the predicate device's performance.
The implicit "acceptance criteria" for demonstrating substantial equivalence for the modified algorithm is that it should:
* Show a linear relationship with the predicate algorithm for relative oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) estimates (R^2 > 0.98).
* Show a linear relationship over a wide and clinically meaningful dynamic range of StO2.
* Allow for quantification of scale shift and bias using Bland-Altman plots, with an estimation of 95% levels of agreement (though the specific numerical agreement is not detailed in the summary).
Reported Device Performance (against the Predicate Device's Algorithm):
| Measurement | Acceptance Criteria (Implicit from Equivalence Claim) | Reported Performance |
|---|---|---|
| r[Hb] | Linear relationship with predicate algorithm (R^2 near 1) | R^2 > 0.98 for r[Hb] |
| r[Hbo] | Linear relationship with predicate algorithm (R^2 near 1) | R^2 > 0.98 for r[Hbo] |
| RMSE r[Hb] | Low residual error compared to predicate algorithm | RMSE r[Hb] = 0.000239 |
| RMSE r[Hbo] | Low residual error compared to predicate algorithm | RMSE r[Hbo] = 0.00208 |
| StO2 | Linear relationship with predicate algorithm over clinically meaningful dynamic range; quantified bias | Concluded to show a linear relationship over a wide and clinically meaningful dynamic range of S-O2, supporting the use of the modified device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: 38 volunteer subjects.
- Data Provenance: Field data acquired (implies prospective data collection). No specific country of origin is mentioned, but the company address is Canada. The study involved a "forearm ischemia protocol," suggesting a controlled experimental setting rather than real-world patient data for diagnosis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This category is not applicable as the study did not establish a ground truth by human expert review in the traditional sense for an AI/ML diagnostic device. The study's purpose was to demonstrate agreement between the modified device's algorithm and the predicate device's algorithm. The ground truth, in this context, is the measurement provided by the predicate device (KD203).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There was no human expert review or adjudication process described as the ground truth was derived from the predicate device's measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This device is an oximeter, not an AI-assisted diagnostic imaging tool that would typically involve human reader improvement. The study compared the device's algorithm performance to its predicate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance reported is standalone (algorithm only). The study compared the StO2 measurements from the modified device (KD204) directly against the predicate device (KD203). The output of the device is a measurement (StO2, HbO2, Hb) and a color-coded image, not a diagnostic interpretation that typically involves human-in-the-loop assistance for clinical decision-making.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this agreement study was the measurements obtained from the predicate device (Kent Camera, Model KD203). The study's objective was to show that the modified device's StO2 algorithm produces results that are linearly related and agree with the predicate device over a clinically relevant range, essentially validating the new algorithm against the established (predicate) one.
8. The sample size for the training set
The document does not specify a sample size for a training set. The change is described as a "modified algorithm for calculating StO2" which "was implemented to increase the signal to noise ratio and provide better image quality." This implies an algorithmic refinement rather than a machine learning model that would typically require a separate, quantifiable training set. While algorithmic development often uses data, the document does not present it as a trained AI/ML model with a distinct training dataset.
9. How the ground truth for the training set was established
Since a "training set" with established ground truth for an AI/ML model is not explicitly mentioned or the focus of the document, this question is not applicable in the context of the provided text. The modified algorithm presumably underwent internal development and validation, but the mechanism for establishing "ground truth" for its development is not detailed. The primary validation shown to the FDA is the agreement study against the predicate device.
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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.
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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.
| ComparativeFeature | Kent Imaging Inc.Modified SnapshotNIR-KD204(K201976) | Kent Imaging Inc.Predicate Kent Camera- KD203(K163070) | SignificantDifferences |
|---|---|---|---|
| Indications forUse | The Kent Camera isintended for use byhealthcare professionalsas a non-invasive tissueoxygenationmeasurement systemthat reports anapproximate value ofoxygen saturation(StO2), oxyhemoglobinlevel (HbO2), anddeoxyhemoglobin (Hb)level in superficial tissue.The Kent Cameradisplays two-dimensionalcolor-coded images oftissue oxygenation of thescanned surface andreports multispectraltissue oxygenationmeasurements forselected tissue regions.The Kent Camera isindicated for use todetermine oxygenationlevels in superficialtissues. | The Kent Camera isintended for use byhealthcare professionalsas a non-invasive tissueoxygenationmeasurement systemthat reports anapproximate value ofoxygen saturation(StO2), oxyhemoglobinlevel (HbO2), anddeoxyhemoglobin (Hb)level in superficialtissue. The Kent Cameradisplays two-dimensional color-codedimages of tissueoxygenation of thescanned surface andreports multispectraltissue oxygenationmeasurements forselected tissue regions.The Kent Camera isindicated for use todetermine oxygenationlevels in superficialtissues. | Same |
| Measurements | Oxygen saturationOxyhemoglobin levelDeoxyhemoglobinlevel | Oxygen saturationOxyhemoglobinlevelDeoxyhemoglobinlevel | Same |
| Method ofMeasurement | Non-invasive, non-patient contactingimaging head illuminatesthe surface and receives | Non-invasive, non-patient contactingimaging headilluminates the surface | Same |
| returned light | and receives returned light | ||
| 6 wavelengths between600nm and 1000nm | 6 wavelengths between600nm and 1000nm | Same | |
| A CMOS image sensorwith global shutter isused as the detector | A CMOS image sensorwith global shutter isused as the detector | Same | |
| Spectral analysis atspecific wavelengths oflight returned from thetarget tissue | Spectral analysis atspecific wavelengths oflight returned from thetarget tissue | Similar -improved signalto noise inmodified device | |
| Light Source | LEDs | LEDs | Same |
| Lens | Corrected and optimizedfor use from 400nm to1000nm | Corrected and optimizedfor use from 400nm to1000nm | Same |
| ● Two-dimensionalcolor-coded map ofestimated oxygensaturation | ● Two-dimensionalcolor-coded map ofestimated oxygensaturation | 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 byoperator and repeated ifoperating conditions ofcamera change to thedegree that necessitatesrecalibration | Preformed at start-up byoperator. Performedperiodically duringextended picturecapturing sessions | Similar;Modified devicemonitorsoperatingconditions andrequiresrecalibrationbased onchangedoperatingconditions | |
| Calibration | |||
| Sterility | Device is not consideredsterile | Device is not consideredsterile | Same |
| SoftwareLanguage | C# | LabVIEW | Similar;The change inprogramminglanguages had noeffect onperformance.This change doesnot present anyadditional safety |
| or effectivenessconcerns. | |||
| Selection Tools | Circle (StO2%)Region/Perimeter (StO2%and cm²)Line (cm) | Circle (%) | Similar;Modified devicedisplaysapproximate 2Dmeasures inaddition to %StO2 |
| Region ofInterest (ROI)Area | Support freehanddrawing ROI selection(cm²) | None | Similar; users candraw a customregion ofinterest.The change toinclude freehandROI drawing hadno effect on theperformance ofthe device. |
| SystemComponents | Camera, Calibration cardand recharger | Camera, Calibration cardand recharger | Same |
| Image Format | DICOM | DICOM | Same |
| Connectivity | Wi-Fi available onlywhen emailing a report | Wi-Fi not enabled | Similar; Wi-Fionly availablewhen emailingreports.The change toturn on Wi-Fidoes not affectthe performanceof the device anddoes not presentany effectivenessconcerns orunacceptablerisks. |
Comparison with the Predicate Device
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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
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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.
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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).
§ 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).