(29 days)
Not Found
No
The description focuses on traditional spectral analysis and spatial frequency domain imaging (SFDI) principles, and there is no mention of AI, ML, or related terms in the provided text.
No
The device is an imaging system that measures and reports oxygenation levels. It is not described as providing treatment or therapy.
Yes
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 reports approximate values of oxygen saturation, oxyhemoglobin, and deoxyhemoglobin, providing information to aid in the diagnosis of circulatory issues.
No
The device description explicitly states it is a "noninvasive non-contact imaging device" that uses "optical radiation of known wavelengths" and "captures the remitted light or reflectance." This indicates the presence of hardware components for emitting and capturing light, which are not software-only functions.
Based on the provided information, the Clarifi™ Imaging System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "determine oxygenation levels in superficial tissues for patients with potential circulatory compromise." This is a diagnostic purpose – it's providing information about a patient's physiological state (tissue oxygenation) to aid in diagnosis or assessment of a medical condition (potential circulatory compromise).
- Measurement of Physiological Parameters: The device measures and reports approximate values of oxygen saturation (StO2), oxyhemoglobin (HbO2), and deoxyhemoglobin (HbR) in superficial tissue. These are physiological parameters that are indicative of tissue health and function.
- Non-invasive Nature: While it's non-invasive, this doesn't preclude it from being an IVD. IVDs can be non-invasive if they are used to analyze samples or provide diagnostic information about a patient's condition. In this case, the "sample" is the tissue being imaged, and the analysis is the determination of oxygenation levels.
- Comparison to Other Oximeters: The description mentions that the Clarifi Imaging System "shares fundamental principles with other oximeters and tissue oxygenation measurement systems." Oximeters are generally considered diagnostic devices.
While the device doesn't analyze a traditional "in vitro" sample like blood or urine in a lab setting, the regulatory definition of an IVD is broader and includes devices used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the "specimen" is the superficial tissue being analyzed in situ.
Therefore, the Clarifi Imaging System fits the definition of an IVD because it is a device intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
N/A
Intended Use / Indications for Use
The ClarifiTM Imaging System 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 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Visible (VIS) and Near-infrared (NIR) wavelengths
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)
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 (40) are of sufficient quality. In summation, these data confirm that the Clarifi Imaging System is substantially equivalent to the Ox-Imager CS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: r2>0.9
Precision: 40
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.
Not Found
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/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA name on the right. The seal features a stylized eagle with its wings spread, and the FDA name is written in blue, with "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
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
1
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 Ave
Irvine, CA 92614
David Cuccia
Telephone: 949-825-5070 |
|-----------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
Regulatory Consultant
Telephone: 978-207-1245
Email: 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
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).
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. | Differences
and
Similarities
between
Subject and
Predicate
Device |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Product Name | Ox-Imager CS
(Predicate) | ClarifiTM Imaging System
(Subject) | - |
| 510(k) Number | K153426 | | - |
| Product Code | MUD | MUD | Same |
| 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 ClarifiTM Imaging System
is indicated for use to determine
oxygenation levels in
superficial tissues for 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. | Structured illumination and
spectral model-based analysis
of light returned from target
tissue. | Same |
| Data Display | Numeric and two-dimensional
color map of tissue oxygenation. | Numeric and two-dimensional
color map of tissue
oxygenation. | Same |
| Measurements
Made | Oxygen Saturation,
Oxyhemoglobin level,
Deoxyhemoglobin level,
Total hemoglobin level | Oxygen Saturation,
Oxyhemoglobin level,
Deoxyhemoglobin level,
Total hemoglobin level | Same |
| Wavelength of
Detection | Imager uses discrete
illumination wavelengths and
camera for collecting
hyperspectral images between
450nm and 1000nm | Clarifi uses discrete
illumination wavelengths and
cameras for collecting
hyperspectral images between
450nm and 1000nm | Same |
| Measurement
Sensor | CCD | CMOS | Substantially
Equivalent
(see SE
discussion) |
| Measurement Time | 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 (40) are of sufficient quality.
In summation, these data confirm that the Clarifi Imaging System is substantially equivalent to the Ox-Imager CS.