Ox-Imager CS

K153426 · Modulated Imaging, Inc. · MUD · Dec 21, 2016 · Cardiovascular

Device Facts

• Record ID: K153426
• Device Name: Ox-Imager CS
• Applicant: Modulated Imaging, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

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.

Device Story

Ox-Imager CS is a non-contact, non-invasive imaging system used by healthcare professionals to visualize and quantify tissue oxygenation. The device uses structured illumination and multispectral imaging to capture remitted light from superficial tissue. It employs Spatial Frequency Domain Imaging (SFDI) and spectral model-based analysis to calculate oxygen saturation (StO2), oxy-hemoglobin (HbO2), and deoxy-hemoglobin (HbR) concentrations. The system uses discrete visible and near-infrared (450-1000nm) LED wavelengths. Outputs include numeric values and 2D color-coded maps of tissue oxygenation displayed on a workstation. The device is intended as an adjunct to other clinical assessments for patients with potential circulatory compromise; it does not provide a medical diagnosis. By mapping oxygenation parameters, it assists clinicians in evaluating tissue perfusion, potentially aiding in the management of conditions involving circulatory compromise.

Clinical Evidence

Clinical and pre-clinical evidence includes: 1) A vascular occlusion study comparing Ox-Imager CS to the OxyVu-1, showing highly correlated StO2 values and statistically significant detection of circulatory compromise. 2) A blood phantom desaturation study showing strong agreement between StO2 and pO2. 3) A rabbit study correlating tissue StO2 with blood gas co-oximeter values (SaO2/SvO2) during inspired oxygen challenges, demonstrating a strong linear/monotonic relationship. 4) A clinical study comparing StO2 to transcutaneous oxygen measurements (tcPO2) during transient ischemia, confirming the device's sensitivity to circulatory compromise with results matching literature expectations.

Technological Characteristics

Non-contact imaging system using CCD camera and discrete LED illumination (450-1000nm). Employs Spatial Frequency Domain Imaging (SFDI) and spectral model-based analysis. Data processed via CPU hard disk. No patient-contacting components. Complies with AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 60825-1, and IEC 62366.

Indications for Use

Indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Regulatory Classification

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.

Predicate Devices

• Hypermed, Inc. OxyVu-1 System (K073656)

Reference Devices

• Kent Camera (K113507)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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 [e-mail]

"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.<br>17151 Gillette Ave<br>Irvine, CA 92614<br>David Cuccia<br>Telephone: [phone] |
|---------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell<br>Regulatory Consultant<br>Telephone: [phone]<br>Email: [e-mail] |
| Summary Preparation Date: | December 16, 2016 |
| Device Information | |
| Device Trade Names: | Ox-Imager CS |
| Common Name: | Oximeter |
| Classification Name: | Oximeter, Tissue Saturation<br>(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<br>Similarities<br>between Subject<br>and Predicate<br>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<br>use to determine oxygenation levels<br>in superficial tissues for patients<br>with potential circulatory<br>compromise. | The OxyVu-1 system is indicated for<br>use to determine oxygenation levels<br>in superficial tissues in patients<br>with potential circulatory<br>compromise. | Same |
| Clearance Type | Prescription | Prescription | Same |
| Measurement<br>Method | Structured illumination and spectral<br>model-based analysis of light<br>returned from target tissue. | Spectral model-based analysis of<br>light returned from target tissue. | Similar<br>Spatial Frequency<br>Domain Imaging<br>(SFDI) is used as an<br>adjunct method to fit<br>spectra. |
| Data Display | Numeric and two dimensional color<br>map of tissue oxygenation. | Numeric and two dimensional color<br>map of tissue oxygenation. | Same |

{5}------------------------------------------------

| Measurements Made | Oxygen Saturation<br>Oxy-hemoglobin level<br>Deoxy-hemoglobin level | Oxygen Saturation<br>Oxy-hemoglobin level<br>Deoxy-hemoglobin level | Same |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Wavelength of<br>Detection | Imager uses discrete illumination<br>wavelengths and camera for<br>collecting hyperspectral images<br>between 450 and 1000nm | Imager uses a broadband<br>illuminator, camera and a spectral<br>filter for collecting hyperspectral<br>images using 15 wavelengths<br>between 500 and 660nm. | Similar<br>Wavelength range for<br>Ox-Imager CS<br>includes both visible<br>and near-infrared<br>light (see reference) |
| Measurement Sensor | CCD Camera | CCD Camera | Same |
| Measurement Time | <30s | < 30s | Same |
| Data Output | Display of color map data and print-<br>ready PDF of report | Display of color map data and print<br>of report | Same |
| Data Storage | CPU Hard disk | CPU Hard disk | Same |
| Analysis Method | Uses oxy-hemoglobin and deoxy-<br>hemoglobin spectra and structured<br>illumination to fit the measured<br>tissue spectra and determine tissue<br>optical properties (absorption and<br>scattering). Oxygen saturation is<br>calculated from the oxy-hemoglobin<br>and deoxy-hemoglobin fit<br>coefficients. | Uses oxy-hemoglobin and deoxy-<br>hemoglobin spectra and a slope and<br>offset to fit the measured tissue<br>spectra. Oxvgen saturation is<br>calculated from the oxy-hemoglobin<br>and deoxy-hemoglobin fit<br>coefficients. | Similar<br>Spatial Frequency<br>Domain Imaging<br>(SFDI) is used as an<br>adiunct method to fit<br>spectra. |
| Location of<br>Measurement | Two-dimensional area of superficial<br>microvasculature | Two-dimensional area of superficial<br>microvasculature | Same |
| Patient Contact | None | Uses a disposable Target Pad placed<br>on patient near the area of interest | Same as reference<br>device |

#### Reference Table

| Manufacturer | Modulated Imaging | Kent Imaging, Inc. | Differences and<br>Similarities<br>between Subject<br>and Reference<br>Device |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 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 for<br>use to determine oxygenation levels<br>in superficial tissues for patients<br>with potential circulatory<br>compromise. | The Kent Camera is indicated for<br>use to determine oxygenation levels<br>in superficial tissues in patients<br>with potential circulatory<br>compromise. | Same |
| Clearance Type | Prescription | Prescription | Same |
| Measurement<br>Method | Structured illumination and spectral<br>model-based analysis of light<br>returned from target tissue. | Spectral model-based analysis of<br>light returned from target tissue. | Similar<br>Spatial Frequency<br>Domain Imaging<br>(SFDI) is used as an<br>adjunct method to fit<br>spectra. |
| Data Display | Numeric and two dimensional color<br>map of tissue oxygenation. | Numeric and two dimensional color<br>map of tissue oxygenation. | Same |
| Measurements Made | Oxygen Saturation<br>Oxy-hemoglobin level<br>Deoxy-hemoglobin level | Oxygen Saturation<br>Oxy-hemoglobin level<br>Deoxy-hemoglobin level | Same |

{6}------------------------------------------------

| Wavelength of<br>Detection | Imager uses discrete illumination<br>wavelengths and camera for<br>collecting hyperspectral images<br>between 450 and 1000nm | Imager collects multiple<br>hyperspectral images in the near-<br>infrared (600-1000nm) | Similar<br>Wavelength range for<br>Ox-Imager CS<br>includes both visible<br>and near-infrared<br>light (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.