(254 days)
Not Found
No
The summary describes multispectral imaging and image processing but does not mention AI, ML, or related terms. There is no information about training or test sets, which are typically associated with AI/ML development.
No.
The device measures oxygenation levels but does not provide therapy or a therapeutic effect; it is a diagnostic/measurement device.
Yes
The device is described as a "non-invasive tissue oxygenation measurement system" that reports approximate values for oxygen saturation and hemoglobin levels. Its indicated use is to "determine oxygenation levels in superficial tissues for patients with potential circulatory compromise." These functions involve assessing a patient's medical condition, which is a diagnostic purpose.
No
The device description explicitly lists hardware components: Imaging Head, Touchscreen Computer, and Cart.
Based on the provided information, the Kent Camera is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Kent Camera's Function: The Kent Camera is described as a "non-invasive tissue oxygenation measurement system." It uses multispectral imaging to measure oxygenation levels directly on the superficial tissues of the patient's body. This is an in vivo measurement, not an in vitro one.
- Intended Use: The intended use clearly states it's for measuring oxygenation levels in superficial tissues for patients. It doesn't mention analyzing samples taken from patients.
Therefore, the Kent Camera falls under the category of a medical device that performs measurements on the patient's body, rather than an IVD device that analyzes samples taken from the patient's body.
N/A
Intended Use / 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 for patients with potential circulatory compromise.
Product codes
MUD
Device Description
The Kent Camera 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. The Kent Camera determines the approximate values of oxygen saturation (StO₂), oxyhemoglobin levels (HbO₂), and deoxyhemoglobin levels (Hb) in superficial tissues and displays a two-dimensional, color-coded image of the tissue oxygenation (StO2).
The device consists of:
Imaging Head: Contains light sources, camera, and spectral filters for collecting image data.
Touchscreen Computer: User interface, display of images, and image data processing.
Cart: Support and attachment points for imaging head and touchscreen computer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Multispectral Imaging
Anatomical Site
superficial tissues
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K-113507
Image /page/0/Picture/1 description: The image shows the logo for Kent Imaging Inc. The word "Kent" is written in a large, bold, sans-serif font. Below the word "Kent" is the text "Imaging Inc" in a smaller font. The logo is simple and professional.
AUG 8 2012
510(k) Summary
Kent Camera (November 21, 2011)
Submittal Information:
Post-approval contact: Darrell Barnhart Kent Imaging Inc. 804-B, 16th Avenue SW Calgary, AB, Canada T2R 0S9
Phone: 403-455-7611 Fax: 877-664-5450
Device and Classification Name
| Proprietary Name: | Kent Camera |
|---|---|
| Common Name: | Tissue Oximeter |
| Classification Name: | Oximeter, Tissue Saturation (21 CFR 870.2700, Product Code: 74 MUD) |
Substantial Equivalence
The Kent Camera is substantially equivalent to the OxyVu-1 Hyperspectral Tissue Oxygenation Measurement System manufactured by Hypermed, Inc. The OxyVu-1 system was cleared in 510(k)s K061848 and K073656.
Device Description
The Kent Camera 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. The Kent Camera determines the approximate values of oxygen saturation (StO₂), oxyhemoglobin levels (HbO₂), and deoxyhemoglobin levels (Hb) in superficial tissues and displays a two-dimensional, color-coded image of the tissue oxygenation (StO2).
The device consists of:
Imaging Head: Contains light sources, camera, and spectral filters for collecting image data.
Touchscreen Computer: User interface, display of images, and image data processing.
Cart: Support and attachment points for imaging head and touchscreen computer.
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),
1440, 720 - 13th Avenue SW, Calgary, Alberta Canada, T2R 1M5 Tel: 403-455-7610 Kent Imaging, Inc.
1
- 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 for patients with potential circulatory compromise.
| Comparative Feature | Kent Imaging Inc.
"Kent Camera" | Hypermed Inc.
"OxyVu-1" |
|-----------------------|------------------------------------|-------------------------------------------------------------------------------------------|
| Measurements | Same | Oxygen saturation Oxyhemoglobin level Deoxyhemoglobin level |
| Method of Measurement | Same | Spectral analysis at specific
wavelengths of light returned from
target tissue. |
| Output Display | Same | Two-dimensional color-coded
map (image) of estimated
oxygen saturation Numeric data |
| Patient Contact | None | Uses a disposable "Target Pad"
placed on the patient near the area
of interest |
Comparison with the Predicate Device
Similarities and Differences
Both devices use spectral analysis to determine oxygenation levels in near-surface tissues. Both devices display numeric values of approximate oxygen saturation of the hemoglobin as well as displaying the related approximate oxyhemoglobin and deoxyhemoglobin levels necessary for the oxygen saturation calculation. Both devices provide two-dimensional mapping of colorcoded oxygenation levels.
The Kent Camera does not use any patient contacting components or accessories. The OxyVu-1 uses a disposable "Target Pad" accessory that contacts the patient near the area of interest.
Basis of Substantial Equivalence
Based on equivalent intended uses and technologies and results from performance testing, the Kent Camera is substantially equivalent to the OxyVu-1 Hyperspectral Tissue Oxygenation Measurement System.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 8 2012
Kent Imaging Inc. c/o Mr. Darrell Barnhart Vice President 1440, 720 - 13th Avenue SW Calgary, Alberta Canada, T2R 1M5
Re: K113507
Trade/Device Name: Kent Camera Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter, tissue saturation Regulatory Class: Class II (two) Product Code: MUD Dated: June 8, 2012 Received: June 11, 2012
Dear Mr. 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.
r
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Page 2 - Mr. Darrell Barnhart
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); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Kent Camera
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 for patients with potential circulatory compromise.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K113507 |
|---|---|
| --------------- | --------- |
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