(117 days)
Not Found
No
The summary describes multispectral imaging and spectral analysis to determine oxygenation levels. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/inference processes typically associated with AI/ML in medical devices. The performance study focuses on agreement with a predicate device, not on validating an AI/ML algorithm's performance.
No
The device is described as a measurement and imaging system for tissue oxygenation, intended to aid in diagnosis or monitoring by providing information on oxygen levels, but it does not directly offer treatment or therapy.
Yes
The device is intended to measure and report approximate values of oxygen saturation, relative oxyhemoglobin, and relative deoxyhemoglobin levels, and to display two-dimensional color-coded images of tissue oxygenation. This information is used to determine oxygenation levels in superficial tissues, which serves as a diagnostic purpose by providing data for medical evaluation.
No
The device description explicitly lists hardware components (Camera, Recharger, Reference Card) and states that the modification is to the software of an existing hardware device.
Based on the provided information, the SnapshotNIR device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SnapshotNIR device is described as a non-invasive system that measures tissue oxygenation directly on the patient's superficial tissue. It does not analyze samples like blood, urine, or tissue biopsies.
- The intended use and device description clearly state it's for non-invasive measurement of superficial tissue oxygenation. This involves direct interaction with the patient's body, not the analysis of a collected specimen.
Therefore, the SnapshotNIR device falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MUD
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Multispectral imaging
Anatomical Site
Superficial tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Field data acquired on 38 volunteer subjects undergoing a forearm ischemia - reperfusion challenge.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
R2 > 0.98 with RMSE r[Hb] = 0.000239 and RMSE r[Hbo] = 0.00208.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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) | |
|---|---|
| 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
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
Feature | Kent Imaging Inc.
Modified SnapshotNIR-
KD204
(K201976) | Kent Imaging Inc.
Predicate Kent Camera
- KD203
(K163070) | Significant
Differences |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Kent Camera is
intended for use by
healthcare professionals
as a non-invasive tissue
oxygenation
measurement system
that reports an
approximate value of
oxygen saturation
(StO2), oxyhemoglobin
level (HbO2), and
deoxyhemoglobin (Hb)
level in superficial tissue.
The Kent Camera
displays two-dimensional
color-coded images of
tissue oxygenation of the
scanned surface and
reports multispectral
tissue oxygenation
measurements for
selected tissue regions.
The Kent Camera is
indicated for use to
determine oxygenation
levels in superficial
tissues. | 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), oxyhemoglobin
level (HbO2), and
deoxyhemoglobin (Hb)
level in superficial
tissue. The Kent Camera
displays two-
dimensional color-coded
images of tissue
oxygenation of the
scanned surface and
reports multispectral
tissue oxygenation
measurements for
selected tissue regions.
The Kent Camera is
indicated for use to
determine oxygenation
levels in superficial
tissues. | Same |
| Measurements | Oxygen saturationOxyhemoglobin levelDeoxyhemoglobin
level | Oxygen saturationOxyhemoglobin
levelDeoxyhemoglobin
level | Same |
| Method of
Measurement | Non-invasive, non-
patient contacting
imaging head illuminates
the surface and receives | Non-invasive, non-
patient contacting
imaging head
illuminates the surface | Same |
| | returned light | and receives returned light | |
| | 6 wavelengths between
600nm and 1000nm | 6 wavelengths between
600nm and 1000nm | Same |
| | A CMOS image sensor
with global shutter is
used as the detector | A CMOS image sensor
with global shutter is
used as the detector | Same |
| | Spectral analysis at
specific wavelengths of
light returned from the
target tissue | Spectral analysis at
specific wavelengths of
light returned from the
target tissue | Similar -
improved signal
to noise in
modified device |
| Light Source | LEDs | LEDs | Same |
| Lens | Corrected and optimized
for use from 400nm to
1000nm | Corrected and optimized
for use from 400nm to
1000nm | Same |
| | ● Two-dimensional
color-coded map of
estimated oxygen
saturation | ● Two-dimensional
color-coded map of
estimated oxygen
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
operator and repeated if
operating conditions of
camera change to the
degree that necessitates
recalibration | Preformed at start-up by
operator. Performed
periodically during
extended picture
capturing sessions | Similar;
Modified device
monitors
operating
conditions and
requires
recalibration
based on
changed
operating
conditions |
| Calibration | | | |
| Sterility | Device is not considered
sterile | Device is not considered
sterile | Same |
| Software
Language | C# | LabVIEW | Similar;
The change in
programming
languages had no
effect on
performance.
This change does
not present any
additional safety |
| | | | or effectiveness
concerns. |
| Selection Tools | Circle (StO2%)
Region/Perimeter (StO2%
and cm²)
Line (cm) | Circle (%) | Similar;
Modified device
displays
approximate 2D
measures in
addition to %StO2 |
| Region of
Interest (ROI)
Area | Support freehand
drawing ROI selection
(cm²) | None | Similar; users can
draw a custom
region of
interest.
The change to
include freehand
ROI drawing had
no effect on the
performance of
the device. |
| System
Components | Camera, Calibration card
and recharger | Camera, Calibration card
and recharger | Same |
| Image Format | DICOM | DICOM | Same |
| Connectivity | Wi-Fi available only
when emailing a report | Wi-Fi not enabled | Similar; Wi-Fi
only available
when emailing
reports.
The change to
turn on Wi-Fi
does not affect
the performance
of the device and
does not present
any effectiveness
concerns or
unacceptable
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).