The Clarifi™ Imaging System is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

The Clarifi Imaging 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) ●
Oxyhemoglobin (HbO2), and .
Deoxyhemoglobin (HbR) .
in superficial tissue.

Device Description

The Clarifi Imaging System is a noninvasive non-contact imaging device used to visualize spatially-resolved functional parameters of biological tissue. The Clarifi Imaging System shares fundamental principles with other oximeters and tissue oxygenation measurement systems. 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. Spectral analysis is used to measure tissue oxygen saturation (StO2), oxyhemoglobin (HbO2), deoxyhemoglobin (HbR), and total hemoglobin (HbT: superficial and subsurface hemoglobin) and determine tissue optical properties (absorption and scattering). The Clarifi Imaging System 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. The analysis for Clarifi is based on principles of multi-spectral imaging and Spatial Frequency Domain Imaging (SFDI).

The Clarifi system displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving device conformance, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Ox-Imager CS - K153426) based on similar performance and design. The performance data section describes verification testing, which implies internal acceptance limits were met, but these limits are not explicitly listed as "acceptance criteria."

However, we can infer some performance aspects from the "Performance Testing" section:

Acceptance Criteria (Inferred from Performance Testing)	Reported Device Performance (Clarifi Imaging System)
Linearity of diffuse reflectivity (vs. NIST-traceable Spectralon standards)	Strong, linear agreement (r² > 0.9) with predicate device
Precision of reflectivity measurements	Within specifications (< 5% error)
Stability of reflectivity measurements	Acceptable (< 1% drift)
Image homogeneity	< 4% roll-off
Signal-to-noise ratio (SNR)	> 40

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The performance testing was done on "NIST-traceable Spectralon standards" and "reflectance targets," which suggests a benchtop test rather than a clinical study with patient samples.
Data Provenance: The testing was conducted as "bench performance data... under design validation 21 CFR 820.30(g)." This indicates internal laboratory testing, not patient data from a specific country or setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. The "ground truth" for the bench performance tests was based on "NIST-traceable Spectralon standards" and physical "reflectance targets," which have known properties, not expert interpretation.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The performance testing was based on direct measurements against established physical standards and device specifications, not on expert adjudication of ambiguous cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done? No. The submission focuses on demonstrating substantial equivalence through technical and bench performance comparisons to a predicate device, not through a comparative effectiveness study with human readers.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

Standalone Performance Done? Yes, effectively. The reported performance data (linearity, precision, stability, image homogeneity, SNR) are measurements of the device's intrinsic capabilities and performance characteristics as a standalone system (Clarifi Imaging System) when compared against physical standards and its predicate device. There is no mention of a "human-in-the-loop" component for these specific validation tests.

7. The Type of Ground Truth Used

Type of Ground Truth: For the performance tests, the ground truth was based on physical standards (NIST-traceable Spectralon standards) and known properties of reflectance targets.

8. The Sample Size for the Training Set

Sample Size for Training Set: The document does not describe a "training set" in the context of machine learning or AI models. The Clarifi Imaging System uses "principles of multi-spectral imaging and Spatial Frequency Domain Imaging (SFDI)" and "spectral model-based analysis." This indicates a physics-based model rather than a data-driven machine learning model that would typically require a training set. Therefore, this concept is not applicable as described in the provided text.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for a machine-learning model. The system relies on physical principles and models to determine oxygenation levels.

Summary

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July 19, 2018

Modulated Imaging, Inc. % Maureen O'connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, Massachusetts 01864

Re: K181623

Trade/Device Name: Clarifi Imaging System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: June 19, 2018 Received: June 20, 2018

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, 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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in 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.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181623

Device Name Clarifi™ Imaging System

Indications for Use (Describe)

The Clarif™ Imaging System 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 AveIrvine, CA 92614David CucciaTelephone: 949-825-5070
Contact Person:	Maureen O'ConnellRegulatory ConsultantTelephone: 978-207-1245Email: Maureen@oconnellregulatory.com

Summary Preparation Date:	July 16, 2018

Device Information

Device Trade Names:	Clarifi™ Imaging System
Common Name:	Oximeter
Classification Name:	Oximeter, Tissue Saturation(21 CFR 870.2700, Product Code: MUD)
Submission Type:	Special 510(k)
Submission Reason:	Device Modifications
Predicate Device:

Device Name:	Ox-Imager CS System
510(k) Clearance Number:	K153426

Intended Use

The Clarifi Imaging 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) ●
Oxyhemoglobin (HbO2), and .
Deoxyhemoglobin (HbR) .

in superficial tissue.

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Indications for Use

The Clarifi™ Imaging System is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Device Description

Device Modifications

The device modifications were made primarily to address parts obsolescence and manufacturability. The changes included revising the projector and camera design, changing the LED vendor, increasing the field of view, updating the PC board and firmware design, replacing the battery and the aiming laser.

Technological Characteristics and Substantial Equivalence

Modulated Imaging's Clarifi Imaging System is substantially equivalent to the company's Ox-Imager CS ("the predicate device", K153426). As explained in more detail below, Clarifi has the same intended use and indications for use, and principles of operation as the previously cleared predicate device, with one minor difference in a technological characteristic. A substantial equivalence chart comparing the similarities and differences between the Clarifi and its predicate device is provided below.

The Clarifi System is intended for use by healthcare professionals as a noninvasive tissue oxygenation measurement to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise. The system reports an approximate value of oxygen saturation, oxyhemoglobin levels, deoxyhemoglobin levels and total hemoglobin levels in superficial tissue.

The Clarifi system displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.

The Clarifi and the Ox-Imager CS system have identical Indications for Use and identical Intended Use. Both devices use the same core technology and display data in the same context.

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The following table compares Clarifi to the predicate device regarding indications for use, principles of operation, and technological characteristics. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The Clarifi system does not raise any new issues of safety of effectiveness based on the similarities to the predicate device.

Manufacturer	Modulated Imaging, Inc.	Modulated Imaging, Inc.	DifferencesandSimilaritiesbetweenSubject andPredicateDevice
Product Name	Ox-Imager CS(Predicate)	ClarifiTM Imaging System(Subject)	-
510(k) Number	K153426		-
Product Code	MUD	MUD	Same
Indications forUse	The Ox-Imager CS is indicatedfor use to determineoxygenation levels in superficialtissues for patients withpotential circulatorycompromise.	The ClarifiTM Imaging Systemis indicated for use to determineoxygenation levels insuperficial tissues for patientswith potential circulatorycompromise.	Same
Clearance Type	Prescription	Prescription	Same
MeasurementMethod	Structured illumination andspectral model-based analysis oflight returned from target tissue.	Structured illumination andspectral model-based analysisof light returned from targettissue.	Same
Data Display	Numeric and two-dimensionalcolor map of tissue oxygenation.	Numeric and two-dimensionalcolor map of tissueoxygenation.	Same
MeasurementsMade	Oxygen Saturation,Oxyhemoglobin level,Deoxyhemoglobin level,Total hemoglobin level	Oxygen Saturation,Oxyhemoglobin level,Deoxyhemoglobin level,Total hemoglobin level	Same
Wavelength ofDetection	Imager uses discreteillumination wavelengths andcamera for collectinghyperspectral images between450nm and 1000nm	Clarifi uses discreteillumination wavelengths andcameras for collectinghyperspectral images between450nm and 1000nm	Same
MeasurementSensor	CCD	CMOS	SubstantiallyEquivalent(see SEdiscussion)
Measurement Time	<30s	<30s	Same
Data Output	Display of color map data andprint- ready PDF of report	Display of color map data andprint- ready PDF of report	Same
Data Storage	CPU Hard disk	CPU Hard disk	Same
Analysis Method	Uses oxy-hemoglobin anddeoxy- hemoglobin spectra andstructured illumination to fit themeasured tissue spectra anddetermine tissue opticalproperties (absorption andscattering). Oxygen saturation iscalculated from the oxy-hemoglobin and deoxy-hemoglobin fitcoefficients.	Uses oxy-hemoglobin anddeoxy- hemoglobin spectra andstructured illumination to fit themeasured tissue spectra anddetermine tissue opticalproperties (absorption andscattering). Oxygen saturation iscalculated from the oxy-hemoglobin and deoxy-hemoglobin fitcoefficients.	Same
Location ofMeasurement	Two-dimensional area ofsuperficial microvasculature	Two-dimensional area ofsuperficial microvasculature	Same
Patient Contact	None	None	Same
Form factor	Cart-based system~9.5" x 8.5" x 7.5" Head Unit	Cart-Based System;~8" x 3.5" x 7.5" Head Unit	Similar(see SEdiscussion)

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Performance Data

The Clarifi Imaging System 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 Edition 4.0 Medical electrical equipment-Part 1-2: General ● requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
IEC 60601-2-57 Edition 1.0 Particular Requirements for the Basic Safety and Essential Performance of Non-Laser Light Source Equipment Intended for Therapeutic, Diagnostic, Monitoring and Cosmetic/Aesthetic Use
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
IEC 60601-2-57 Edition 1.0 Medical Electrical Equipment Part 2-57: . Particular Requirements for the Basic Safety and Essential Performance of Non-Laser Light Source Electrical Equipment Intended for Therapeutic, Diagnostic, Monitoring and Cosmetic/Aesthetic Use

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Performance Testing

Bench performance data were conducted under design validation 21 CFR 820.30(g). In a first set of tests, bench performance verification testing was performed to confirm the linearity, precision, and stability of the Clarifi Imaging System reflectivity (Ra) measurements. Using NIST-traceable Spectralon standards, a strong, linear agreement (r2>0.9) of diffuse reflectivity is found between the predicate device (Ox-Imager CS - K153426) and the subject device. The precision of the Clarifi Imaging System is shown to be within specifications (<5% error), and measurement stability is acceptable (<1% drift). Additional testing on reflectance targets verified the device imaging performance. Image homogeneity (< 4 % roll-off), and signal-to-noise ratio (SNR>40) are of sufficient quality.

In summation, these data confirm that the Clarifi Imaging System is substantially equivalent to the Ox-Imager CS.

Regulation Number and Section

§ 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).