(392 days)
No
The description focuses on established optical principles (multispectral imaging, SFDI) and spectral analysis for calculating oxygenation parameters, without mentioning AI/ML algorithms.
No
The device is indicated for determining oxygenation levels, which is a diagnostic function, not a therapeutic intervention.
Yes
Explanation: The device is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise, which is a diagnostic purpose. It measures and presents values of oxygen saturation, oxy-hemoglobin, and deoxy-hemoglobin to assess these levels.
No
The device description explicitly states it is a "non-contact imaging device" that uses "specific LED wavelengths and patterns" and "captures the remitted light or reflectance," indicating the presence of hardware components for light emission and detection.
Based on the provided information, the Ox-Imager CS™ is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens derived from the human body. The Ox-Imager CS™ is a non-contact imaging device that measures oxygenation levels in superficial tissues in vivo (on the living patient). It does not analyze blood, urine, tissue samples, or any other specimen taken from the body.
- The device description explicitly states it's a "noninvasive tissue oxygenation measurement system." This reinforces that it's used directly on the patient's tissue, not on a sample.
- The intended use is to "determine oxygenation levels in superficial tissues for patients with potential circulatory compromise." This is a direct measurement on the patient, not an analysis of a specimen.
Therefore, the Ox-Imager CS™ falls under the category of a non-invasive diagnostic device used for in vivo measurements, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ox-Imager CS™ is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
Product codes (comma separated list FDA assigned to the subject device)
MUD
Device Description
The Ox-Imager CS™ is intended for use by healthcare professionals as a noninvasive tissue oxygenation measurement system that maps value of: oxygen saturation, oxy-hemoglobin, and deoxy-hemoglobin into 2D/3D visual presentations. The Ox-Imager™ CS is a non-contact imaging device to visualize spatially-resolved optical and functional parameters of biological tissue. The Ox-Imager CS shares fundamental principles with other oximeters and tissue oxygenation measurement systems. Spectral analysis is used to measure oxygen saturation (StO2), oxyhemoglobin (HbO2), deoxyhemoglobin (HbR) and determine tissue optical properties (absorption and scattering) using specific LED wavelengths and patterns. The Ox-Imager CS uses both visible (VIS) and near infrared (NIR) wavelengths; other systems that also measure oxygenation levels in superficial tissue may use only VIS or NIR wavelengths. Tissue oximetry exposes tissue to optical radiation of known wavelengths and captures the remitted light or reflectance. The remitted back scattered light is then used to calculate the tissue constituents mentioned above based on principles of multispectral imaging and Spatial Frequency Domain Imaging (SFDI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Multispectral imaging and Spatial Frequency Domain Imaging (SFDI)
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)
- Clinical Study: compared the Ox-Imager CS to the predicate device, HyperMed OxyVu-1. The objective was to establish substantial equivalence. Circulatory compromise was mimicked by performing a vascular occlusion test using both devices to determine if there was a statistically significant decrease in tissue oxygen saturation (StO2) between baseline and compromised tissue states. It was demonstrated that the predicate OxyVu-1 and the Ox-Imager CS recover highly correlated values of StO2 during the time course of a vascular occlusion test and that both devices measured a statistically significant decrease in tissue oxygen saturation (StO2) after circulatory compromise.
- Blood Phantom Desaturation Study: conducted to correlate changes in tissue oxygen saturation (StO2) to pO2. The pO2/StO2 curves showed strong agreement with expected StO2 values.
- Pre-clinical Study: conducted in rabbits that correlated co-oximeter values (SaO2/SvO2) from blood draws to tissue oxygen saturation (StO2) during an inspired oxygen challenge. Results showed a strong linear and monotonic relationship between blood gas values and Ox-Imager CS measurements as fraction of inspired oxygen (FiO2) was changed.
- Clinical Study: compared tissue oxygen saturation values (StO2) to transcutaneous oxygen measurements (tcpO2) during a vasculature occlusion test meant to mimic transient ischemia. Average values at baseline and at the end of occlusion (tissue compromise state) were compared to determine sensitivity to circulatory compromise. The shape of both curves during transient ischemia matched literature and there was a significant change in both StO2 and tcPO2 values between baseline and tissue compromise timepoints.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Modulated Imaging, Inc. % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, Massachusetts 01864
Re: K153426
Trade/Device Name: Ox-Imager CS Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: November 29, 2016 Received: November 30, 2016
Dear Maureen O'Connell:
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
1
the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mule Jellman
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) K153426
Device Name Ox-Imager CS
Indications for Use (Describe)
The Ox-Imager CS™ is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
General Information
| 510(k) Owner: | Modulated Imaging, Inc.
17151 Gillette Ave
Irvine, CA 92614
David Cuccia
Telephone: 949-596-7492 |
|---------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
Regulatory Consultant
Telephone: 978-207-1245
Email: Maureen@oconnellregulatory.com |
| Summary Preparation Date: | December 16, 2016 |
| Device Information | |
| Device Trade Names: | Ox-Imager CS |
| Common Name: | Oximeter |
| Classification Name: | Oximeter, Tissue Saturation
(21 CFR 870.2700, Product Code: MUD) |
| Predicate Device | |
| Device Name: | Hypermed, Inc. OxyVu-1 System |
|---|---|
| 510(k) Clearance Number: | K073656 |
Device Description
The Ox-Imager CSTM is intended for use by healthcare professionals as a noninvasive tissue oxygenation measurement system that maps value of: oxygen saturation, oxy-hemoglobin, and deoxy-hemoglobin into 2D/3D visual presentations. The Ox-Imager™ CS is a non-contact imaging device to visualize spatially-resolved optical and functional parameters of biological tissue. The Ox-Imager CS shares fundamental principles with other oximeters and tissue oxygenation measurement systems. Spectral analysis is used to measure oxygen saturation (StO2), oxyhemoglobin (HbO2), deoxyhemoglobin (HbR) and determine tissue optical properties (absorption and scattering) using specific LED wavelengths and patterns. The Ox-Imager CS uses both visible (VIS) and near
4
infrared (NIR) wavelengths; other systems that also measure oxygenation levels in superficial tissue may use only VIS or NIR wavelengths. Tissue oximetry exposes tissue to optical radiation of known wavelengths and captures the remitted light or reflectance. The remitted back scattered light is then used to calculate the tissue constituents mentioned above based on principles of multispectral imaging and Spatial Frequency Domain Imaging (SFDI).
Intended Use
The Ox-Imager CS™ system is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:
- Oxygen Saturation (StO2)
- -Oxy-hemoglobin (HbO2), and
- Deoxy-hemoglobin (HbR) -
in superficial tissue.
Indications for Use
The Ox-Imager CS™ is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
Technological Characteristics and Substantial Equivalence
The following table provides a comparison of the intended use and technological characteristics of the Ox-Imager CS to the predicate device, OxyVu-1 System. In addition to the OxyVu-1 System, the Kent Camera was used as a reference device.
| Manufacturer | Modulated Imaging | Hypermed, Inc. | Differences and
Similarities
between Subject
and Predicate
Device |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Product Name | Ox-Imager CS | OxyVu-1 system | |
| 510(k) Number | K153426 | K073656 | |
| Product Code | MUD | MUD | |
| Indications for Use | The Ox-Imager CS is indicated for
use to determine oxygenation levels
in superficial tissues for patients
with potential circulatory
compromise. | The OxyVu-1 system is indicated for
use to determine oxygenation levels
in superficial tissues in patients
with potential circulatory
compromise. | Same |
| Clearance Type | Prescription | Prescription | Same |
| Measurement
Method | Structured illumination and spectral
model-based analysis of light
returned from target tissue. | Spectral model-based analysis of
light returned from target tissue. | Similar
Spatial Frequency
Domain Imaging
(SFDI) is used as an
adjunct method to fit
spectra. |
| Data Display | Numeric and two dimensional color
map of tissue oxygenation. | Numeric and two dimensional color
map of tissue oxygenation. | Same |
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| Measurements Made | Oxygen Saturation
Oxy-hemoglobin level
Deoxy-hemoglobin level | Oxygen Saturation
Oxy-hemoglobin level
Deoxy-hemoglobin level | Same |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Wavelength of
Detection | Imager uses discrete illumination
wavelengths and camera for
collecting hyperspectral images
between 450 and 1000nm | Imager uses a broadband
illuminator, camera and a spectral
filter for collecting hyperspectral
images using 15 wavelengths
between 500 and 660nm. | Similar
Wavelength range for
Ox-Imager CS
includes both visible
and near-infrared
light (see reference) |
| Measurement Sensor | CCD Camera | CCD Camera | Same |
| Measurement Time |