(392 days)
The Ox-Imager CS™ is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
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 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).
The provided document is a 510(k) summary for the Ox-Imager CS device, seeking clearance based on substantial equivalence to a predicate device, the Hypermed, Inc. OxyVu-1 System. This type of document typically focuses on demonstrating equivalence rather than establishing new acceptance criteria or providing in-depth performance studies with detailed statistical analysis against pre-defined thresholds.
Therefore, the information available is primarily focused on demonstrating equivalence and device functionality rather than specific acceptance criteria thresholds for a standalone performance study.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity) for the Ox-Imager CS device's performance. Instead, the performance studies aim to demonstrate substantial equivalence to the predicate device and show that the device measures physiological changes as expected.
The key performance finding is:
"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."
This implies a qualitative "acceptance criterion" of:
- Highly correlated values of StO2 between the Ox-Imager CS and the predicate OxyVu-1 during a vascular occlusion test.
- Statistically significant decrease in tissue oxygen saturation (StO2) measured by both devices after circulatory compromise.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Highly correlated StO2 values with predicate device during vascular occlusion. | "the predicate OxyVu-1 and the Ox-Imager CS recover highly correlated values of StO2 during the time course of a vascular occlusion test" |
| Statistically significant decrease in StO2 after circulatory compromise. | "both devices measured a statistically significant decrease in tissue oxygen saturation (StO2) after circulatory compromise." Also, for the clinical study comparing StO2 to tcpO2 during vascular occlusion, "there was a significant change in both StO2 and tcPO2 values between baseline and tissue compromise timepoints." For the blood phantom study, "the pO2/StO2 curves showed strong agreement with expected StO2 values." For the rabbit study, "Results showed a strong linear and monotonic relationship between blood gas values and Ox-Imager CS measurements as fraction of inspired oxygen (FiQ2) was changed." These additional studies support the device's ability to accurately reflect physiological changes in oxygenation. |
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: The document does not specify the exact sample size (number of subjects/cases) for any of the clinical, pre-clinical, or benchtop studies. It mentions "a clinical study," "a pre-clinical study in rabbits," and "a blood phantom desaturation study."
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective, although clinical and pre-clinical studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable in the traditional sense for this device. The "ground truth" for an oximeter is primarily physiological measurements. The studies do not describe a process of expert review or consensus for establishing ground truth, as would be common in image-based diagnostic AI. Instead, the ground truth is established through:
- Physiological changes: Vascular occlusion (inducing circulatory compromise) acts as a physiological "ground truth" stimulus.
- Reference measurements: Co-oximeter values (SaO2/SvO2 from blood draws) and transcutaneous oxygen measurements (tcpO2) serve as reference "ground truth" data points against which the Ox-Imager CS measurements are correlated.
- Expected values: For the blood phantom study, the pO2/StO2 curves were compared to "expected StO2 values."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the "ground truth" is based on physiological changes and objective reference measurements, not expert review requiring adjudication.
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, an MRMC comparative effectiveness study was not done. The Ox-Imager CS is described as a measurement device that provides objective values and images of oxygenation levels, not an AI-assisted diagnostic tool that aids human readers in interpreting images. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device's reported evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies evaluate the standalone performance of the Ox-Imager CS device as a measurement tool. For example:
- The comparison between Ox-Imager CS and OxyVu-1 during vascular occlusion.
- The correlation of Ox-Imager CS StO2 with pO2 in blood phantoms.
- The correlation of Ox-Imager CS StO2 with co-oximeter values (SaO2/SvO2) in rabbits.
- The comparison of Ox-Imager CS StO2 with tcpO2 in a clinical study.
These are all assessments of the device's inherent measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for evaluating the Ox-Imager CS was based on:
- Physiological manipulation: Inducing a state of circulatory compromise (vascular occlusion) to predictably change tissue oxygenation.
- Reference standards/measurements:
- The predicate device (Hypermed OxyVu-1) was used for direct comparison of StO2 values.
- Co-oximeter values (SaO2/SvO2 from blood draws in the rabbit study).
- Transcutaneous oxygen measurements (tcpO2 in one clinical study).
- Expected StO2 values derived from pO2 curves for the blood phantom study.
8. The sample size for the training set
The document does not describe a "training set" as would be relevant for a machine learning or AI model. The Ox-Imager CS uses "spectral analysis" and "model-based analysis of light" based on principles of multispectral imaging and Spatial Frequency Domain Imaging (SFDI). These are physics-based models rather than data-driven machine learning models that require a distinct training set. The device's "training" would be more akin to software calibration or model development based on established optical properties and physiological principles, rather than a dataset of labeled clinical images.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a traditional "training set" with ground truth labels in the context of machine learning. The device's underlying models are based on physical and biological principles.
{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
{2}------------------------------------------------
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)
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}------------------------------------------------
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 AveIrvine, CA 92614David CucciaTelephone: 949-596-7492 |
|---|---|
| Contact Person: | Maureen O'ConnellRegulatory ConsultantTelephone: 978-207-1245Email: 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 andSimilaritiesbetween Subjectand PredicateDevice |
|---|---|---|---|
| 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 foruse to determine oxygenation levelsin superficial tissues for patientswith potential circulatorycompromise. | The OxyVu-1 system is indicated foruse to determine oxygenation levelsin superficial tissues in patientswith potential circulatorycompromise. | Same |
| Clearance Type | Prescription | Prescription | Same |
| MeasurementMethod | Structured illumination and spectralmodel-based analysis of lightreturned from target tissue. | Spectral model-based analysis oflight returned from target tissue. | SimilarSpatial FrequencyDomain Imaging(SFDI) is used as anadjunct method to fitspectra. |
| Data Display | Numeric and two dimensional colormap of tissue oxygenation. | Numeric and two dimensional colormap of tissue oxygenation. | Same |
{5}------------------------------------------------
| Measurements Made | Oxygen SaturationOxy-hemoglobin levelDeoxy-hemoglobin level | Oxygen SaturationOxy-hemoglobin levelDeoxy-hemoglobin level | Same |
|---|---|---|---|
| Wavelength ofDetection | Imager uses discrete illuminationwavelengths and camera forcollecting hyperspectral imagesbetween 450 and 1000nm | Imager uses a broadbandilluminator, camera and a spectralfilter for collecting hyperspectralimages using 15 wavelengthsbetween 500 and 660nm. | SimilarWavelength range forOx-Imager CSincludes both visibleand near-infraredlight (see reference) |
| Measurement Sensor | CCD Camera | CCD Camera | Same |
| Measurement Time | <30s | < 30s | Same |
| Data Output | Display of color map data and print-ready PDF of report | Display of color map data and printof report | Same |
| Data Storage | CPU Hard disk | CPU Hard disk | Same |
| Analysis Method | Uses oxy-hemoglobin and deoxy-hemoglobin spectra and structuredillumination to fit the measuredtissue spectra and determine tissueoptical properties (absorption andscattering). Oxygen saturation iscalculated from the oxy-hemoglobinand deoxy-hemoglobin fitcoefficients. | Uses oxy-hemoglobin and deoxy-hemoglobin spectra and a slope andoffset to fit the measured tissuespectra. Oxvgen saturation iscalculated from the oxy-hemoglobinand deoxy-hemoglobin fitcoefficients. | SimilarSpatial FrequencyDomain Imaging(SFDI) is used as anadiunct method to fitspectra. |
| Location ofMeasurement | Two-dimensional area of superficialmicrovasculature | Two-dimensional area of superficialmicrovasculature | Same |
| Patient Contact | None | Uses a disposable Target Pad placedon patient near the area of interest | Same as referencedevice |
Reference Table
| Manufacturer | Modulated Imaging | Kent Imaging, Inc. | Differences andSimilaritiesbetween Subjectand ReferenceDevice |
|---|---|---|---|
| Product Name | Ox-Imager CS | Kent Camera | |
| 510(k) Number | K153426 | K113507 | |
| Product Code | MUD | MUD | |
| Indications for Use | The Ox-Imager CS is indicated foruse to determine oxygenation levelsin superficial tissues for patientswith potential circulatorycompromise. | The Kent Camera is indicated foruse to determine oxygenation levelsin superficial tissues in patientswith potential circulatorycompromise. | Same |
| Clearance Type | Prescription | Prescription | Same |
| MeasurementMethod | Structured illumination and spectralmodel-based analysis of lightreturned from target tissue. | Spectral model-based analysis oflight returned from target tissue. | SimilarSpatial FrequencyDomain Imaging(SFDI) is used as anadjunct method to fitspectra. |
| Data Display | Numeric and two dimensional colormap of tissue oxygenation. | Numeric and two dimensional colormap of tissue oxygenation. | Same |
| Measurements Made | Oxygen SaturationOxy-hemoglobin levelDeoxy-hemoglobin level | Oxygen SaturationOxy-hemoglobin levelDeoxy-hemoglobin level | Same |
{6}------------------------------------------------
| Wavelength ofDetection | Imager uses discrete illuminationwavelengths and camera forcollecting hyperspectral imagesbetween 450 and 1000nm | Imager collects multiplehyperspectral images in the near-infrared (600-1000nm) | SimilarWavelength range forOx-Imager CSincludes both visibleand near-infraredlight (see predicate) |
|---|---|---|---|
| Patient Contact | None | None | Same |
Modulated Imaging's Ox-Imager CS is substantially equivalent to the Hypermed, Inc. OxyVu-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System cleared in K073656. The Ox-Imager CS and the OxyVu-1 system have identical Indications for Use and identical Intended Use. Both devices use similar core technology and display data in a similar context. Performance testing shows equivalent results between the two systems.
Although there are many similarities between the Ox-Imager CS and the OxyVu-1 System, there are also minor differences in the technological characteristics. Both of the systems are non-invasive tissue oxygenation measurement systems that report an approximate value of: oxygen saturation (StO2), oxy-hemoglobin level (HbO2 ), and deoxy-hemoglobin (HbR) level in superficial tissue. Both of the systems display two-dimensional color-coded images of tissue oxygenation of the scanned surface and report approximate tissue oxygenation measurements for selected tissue regions. The data display and the measurements made are all the same.
Regarding the wavelength of detection, the Ox-Imager CS uses discrete visible and near-infrared wavelengths between 450 and 1000 nm and a CCD camera for collecting hyperspectral images while the OxyVu-1 System uses a broadband illuminator camera and a spectral filter for collecting hyperspectral images using 15 wavelengths between 500 and 660 nm. The reference device Kent Camera (K113507) is similar to the Ox-Imager CS device as it uses near-infrared wavelengths for detection. Performance data is provided which compares the Ox-Imager CS to the OxyVu-1 and demonstrates substantial equivalence.
Performance Data
The OxyVu-1 was tested and found to conform with the following recognized consensus standards:
- AAMI ANSI ES 60601-1:2005 +A1:2012 Medical electrical equipment-Part 1: General ● requirements for basic safety and essential performance
- . IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60825-1 Edition 2.0 Safety of Laser Products-Part 1: Equipment Classification and Requirements
- IEC 62366 Edition 1.0: Medical Devices-Part 1: Application of Usability Engineering to Medical Devices
{7}------------------------------------------------
Benchtop, pre-clinical and clinical performance data was provided which established that the Ox-Imager CS is substantially equivalent to the predicate OxyVu-1 device.
A clinical study was conducted which compared the Ox-Imager CS to the predicate device. The objective of the study was to establish that the Ox-Imager CS is substantially equivalent to the predicate HyperMed OxyVu-1 device. Circulatory compromise was mimicked by performing a vascular occlusion test using both devices and determine whether there is 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.
Additional testing included a 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. Also, a pre-clinical study was 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 (FiQ2) was changed. Finally, a clinical study was conducted which 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.
Additionally, the Kent Camera is provided as a reference device because of its shared use of near-infrared wavelengths which support the technical approach used in the Ox-Imager CS's method of measurement.
Risk/Benefit Information
The Ox-Imager CS does not provide any medical diagnosis in and of itself and is intended to be part of a larger assessment battery, as described in the instructions for use. The risk to patients is minimal since the Ox-Imager CS is a non-contact, non-invasive device.
The Ox-Imager CS is intended for use in conjunction with other clinical assessment and diagnostic tests. It is not intended to diagnose disease or prescribe a medical course of treatment.
Biocompatibility
There are no patient contacting components in the Ox-Imager CS.
§ 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).