(260 days)
No
The description focuses on multispectral imaging and spectral analysis for calculating StO2, without mentioning AI or ML algorithms. The performance study is a comparative clinical study, not a study evaluating AI/ML performance.
No
The device is a diagnostic tool that estimates the spatial distribution of percent oxygen saturation (StO2) in tissue, intended for monitoring patients and aiding in circulatory or perfusion examinations, rather than providing direct therapy.
Yes
The device is intended to "estimate the spatial distribution of percent oxygen saturation (StO2) in a volume of tissue" and is "indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation," which directly relates to identifying the presence or nature of a medical condition.
No
The device description explicitly states it is a "non-contacting, cordless, battery powered device" that captures images using "visible (VIS) and near-infrared (NIR) LED-illuminated wavelengths." This indicates the device includes hardware components for illumination and image capture, in addition to the software for processing and display.
Based on the provided information, the MIMOSA Imager is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body, such as blood, urine, or tissue samples, to provide information for diagnostic purposes.
- MIMOSA Imager's Function: The MIMOSA Imager is described as a non-contacting, non-invasive device that estimates tissue oxygen saturation (StO2) by analyzing light reflected from the tissue surface. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "non-invasively estimate the spatial distribution of percent oxygen saturation (StO2) in a volume of tissue." This is a measurement taken on the body, not from a specimen.
Therefore, the MIMOSA Imager falls under the category of a non-invasive medical device that measures physiological parameters directly from the patient's body, rather than an IVD device that analyzes samples.
N/A
Intended Use / Indications for Use
The MIMOSA Imager is intended to non-invasively estimate the spatial distribution of percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services. The MIMOSA Imager is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
Product codes
MUD
Device Description
The MIMOSA Imager is a non-contacting, cordless, battery powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device captures spatially-resolved images that is triggered by the end user via a smartphone-app interface. By tracking the spectral signatures of dominant chromophores in the patient's superficial tissue, the device calculates and displays the StO2 estimate on the connected android device screen.
The MIMOSA Imager is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that maps the tissue oxygen saturation (StO2) values to a spatially registered heatmap. The MIMOSA Imager 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 or reflected light. The remitted back scattered light is then used to calculate StO2 based on principles of multispectral imaging. Spectral analysis is used to measure StO2 using specific both visible (VIS) and near-infrared (NIR) LED-illuminated wavelengths. Other systems that also measure oxygenation levels in superficial tissue may use only VIS or NIR wavelengths.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multispectral imaging
Anatomical Site
skeletal muscle
Indicated Patient Age Range
21 to 70 years of age
Intended User / Care Setting
healthcare professionals in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services.
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
Clinical: A comparative study was performed for the MIMOSA Imager and predicate device with side-by-side comparison of clinical performance in order to demonstrate substantial equivalence. The objective of the study was to compare StO2 measurements for MIMOSA Imager and the Vioptix ODISsey in order to demonstrate substantial equivalence between the two devices. In terms of methodology, the study monitor tissue oxygen saturation in the thenar eminence and forearm during a vascular occlusion test (VOT) using both devices. The study population included a total of 39 individuals ranging from 21 to 70 years of age and (1-5) Fitzpatrick skin types. The study results in terms of the 95% confidence interval of the line of best fit narrowly constrains the slope of the line between 0.998 and 1.02. MIMOSA Imager measures were in statistical agreement with Vioptix for thenar eminence and forearm for age between 21-70 and range of Fitzpatrick skin types. The statistical agreement between the two devices support substantial equivalence of MIMOSA Imager and Vioptix, and no adverse events or complications were encountered during or after clinical testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MIMOSA Diagnostics Inc Yuan Fang Chief Regulatory Officer 1 Yonge St., Suite 201 Toronto, CA M5E1E5 Ontario
November 1, 2019
Re: K190334
Trade/Device Name: MIMOSA Imager Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: October 1, 2019 Received: October 4, 2019
Dear Yuan Fang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Neil R.P. Ogden, MS Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MIMOSA Imager
Indications for Use (Describe)
The MIMOSA Imager is intended to non-invasively estimate the spatial distribution of percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services. The MIMOSA Imager is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/3 description: The image shows the word "MIMOSA" in a sans-serif font, with the letters in a dark blue color. To the left of the word is a stylized flower-like design in shades of yellow and orange. The flower has multiple petals arranged in a circular pattern around a central point.
510(k) Summary
[As required by 21 CFR 807.92]
| Submitter's Name: | MIMOSA Diagnostics, Inc. |
|---|---|
| Address: | 1 Yonge Street, Suite 201, Toronto, ON M5E 1E5 |
| Contact: | General Leung, PhD CTO |
| Telephone: | (844) 646-6721 |
| Primary Email: | general@mimosadiagnostics.com |
| Secondary Email: | yuan@mimosadiagnostics.com |
| Date Summary was prepared: | October 29, 2019 |
| Information Regarding the device classification: | |
| Trade Name: | MIMOSA Imager |
| Common Name: | Tissue Oximeter |
| Classification Regulation: | 21 CFR 870.2700 |
| Classification Regulation Name: | Oximeter |
| Product Code: | MUD |
| Device Class: | II |
| Information regarding the legally marketed device to which we are claiming equivalence [807.92(a)(3)] | |
| 510(k) Reference #: | K042657 |
| Device Name: | ODISsey Tissue Oximeter |
| 510(k) Holder: | ViOptix, Inc. |
| Information regarding Reference Devices with the MUD product code: | |
| Reference Device: | |
| 510(k) Reference #: | K113507 |
| Device Name: | Kent Camera |
| 510(k) Holder: | Kent Imaging, Inc. |
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Image /page/4/Picture/3 description: The image shows the word "MIMOSA" in a sans-serif font, with each letter in a dark blue color. To the left of the word is a stylized flower-like graphic. The graphic is composed of several teardrop-shaped petals arranged around a central point. The petals are colored in a gradient of yellow and orange, giving them a three-dimensional appearance. The overall design is clean and modern, suggesting a brand or logo.
Description of the Device:
The MIMOSA Imager is a non-contacting, cordless, battery powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device captures spatially-resolved images that is triggered by the end user via a smartphone-app interface. By tracking the spectral signatures of dominant chromophores in the patient's superficial tissue, the device calculates and displays the StO2 estimate on the connected android device screen.
The MIMOSA Imager is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that maps the tissue oxygen saturation (StO2) values to a spatially registered heatmap. The MIMOSA Imager 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 or reflected light. The remitted back scattered light is then used to calculate StO2 based on principles of multispectral imaging. Spectral analysis is used to measure StO2 using specific both visible (VIS) and near-infrared (NIR) LED-illuminated wavelengths. Other systems that also measure oxygenation levels in superficial tissue may use only VIS or NIR wavelengths.
Indications for Use:
The MIMOSA Imager is intended to non-invasively estimate the spatial distribution of percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services.
The MIMOSA Imager is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
| Parameter | Subject Device: MIMOSA
IMAGER | Predicate Device
(ODISsey) | Comparison |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k # | This Submission | K042657 | |
| Indications
for Use | The MIMOSA Imager is
intended to non-invasively
estimate the spatial
distribution of percent
oxygen saturation in a
volume of tissue (StO2).
This is performed in
medical environments
including physician offices,
hospitals, ambulatory care
and Emergency Medical
Services. | The ViOptix ODISsey
Tissue Oximeter is
intended to non-invasively
estimate the percent
oxygen saturation in a
volume of tissue (StO2).
This is performed in
medical environments
including physician offices,
hospitals, ambulatory care
and Emergency Medical
Services. | Similar: only difference is
"spatial distribution of." |
| | The MIMOSA Imager is
indicated for use in
monitoring patients during
circulatory or perfusion
examinations of skeletal
muscle or when there is a
suspicion of compromised
circulation. | The ODISsey Tissue
Oximeter is indicated for
use in monitoring patients
during circulatory or
perfusion examinations of
skeletal muscle or when
there is a suspicion of
compromised circulation. | |
| Measured
Parameters | Tissue oxygen saturation
(StO2) information | Tissue oxygen saturation
(StO2) information | Same |
| Operating
Principle | Spectrophotometric
oximetry | Spectrophotometric
oximetry | Same |
| Light Source | Near-infrared light Source:
LED chips Wavelengths:
620, 630, 700, 810, 880,
980 nm | Near-infrared light Source:
laser diodes Wavelengths:
690, 830 nm | Similar: the MIMOSA
Imager delivers
additional wavelengths of
light to the tissue in order
to improve measurement
reliability and providing a
more robust dataset. The
additional wavelengths
have been assessed
based on IEC 62471 and
were found to not pose
any safety concerns and
effectiveness
demonstrated through
performance (bench and
clinical) testing . This
does not raise any new
questions in safety or
efficacy. |
| Reusable | Yes | Yes | Same |
| Contact | Non-Contact | Direct Contact | Different: The MIMOSA
Imager is a non-contact
device while the
predicate is not. Other
devices within the MUD
class, including
reference device (Kent
Camera, K113507) is
non-contacting. In our
performance testing, this
difference raises no new
questions regarding
either safety or efficacy. |
| Power Source | Powered with a
rechargeable Li-polymer
battery. | AC power-operated with
30-minute lithium-ion
battery backup. | Different: The MIMOSA
lmager is powered by a
lithium-polymer battery
certified to IEC 62133
and UN 38.3. This raises
no new questions in
safety or efficacy. |
| Measurement
Range | 1-99% StO2 | 1-99% StO2 | Same |
| Display | Attached Android Device
Display | Computer console display
module | Similar |
| Materials | Plastic (Nylon 12 / PETG)
Enclosure connected to a
front-glass, aluminum body
smartphone with a PVC
cover sheath USB
connector cable. | Plastic Enclosure, Metal
and Epoxy probe head.
PVC cable cover sheath. | Similar |
| Internal
Storage | 32000 MB | 2000 MB | Similar |
| Ambient Light | Insignificant contribution to
image (relative to NIR
LEDs) due to short
exposure time | Probe must physically
block out all ambient light. | Different: Both devices
compensate for ambient
light. The MIMOSA
lmager uses a short
exposure time and a
background light
compensation algorithm.
The predicate device
physically attempts to
block out light by putting
the probe in contact with
the imaged tissue. This
change in filtering of light
had no effect on
performance and does
not present any
additional safety or
effectiveness concerns. |
| Patient
Population
and
Environment | Healthcare environment for
patient population with
potential circulatory
compromise | Healthcare environment for
patient population with
potential circulatory
compromise | Same |
| Control
Method | Android Device controlled | PC controlled | Similar |
| Sterility | non-sterile | non-sterile | Same |
Substantial Equivalence Comparison
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Image /page/5/Picture/3 description: The image shows the word "MIMOSA" in blue font, with a stylized yellow flower to the left of the word. The flower has a central circle with six petals radiating outwards. The font is a simple sans-serif typeface. The overall design is clean and modern.
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Image /page/6/Picture/3 description: The image shows the word "MIMOSA" in a sans-serif font, with each letter in a dark blue color. To the left of the word is a stylized flower with multiple petals in shades of yellow and orange. The flower is positioned so that it appears to be blooming or radiating outward.
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Image /page/7/Picture/3 description: The image shows the logo for Mimosa. The logo consists of a stylized flower on the left and the word "MIMOSA" in blue on the right. The flower has multiple petals and a gradient from yellow to orange. The text is in a sans-serif font.
Performance Testing - Non-Clinical & Clinical
Using NIST-calibrated spectrometer instruments, the device's LED-system is systematically tested to ensure that it meets tolerances set for illumination wavelength ranges, relative intensity differences between LEDs, as well as overall system endurance. The following core tests are administered on a random sample of our manufactured devices:
- -Spectral response to varying amperage
- -Transmittance profile, as a function of wavelength
- -Stress testing device for endurance, consistency and maximum output
Software documentation and testing have been provided per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Clinical: A comparative study was performed for the MIMOSA Imager and predicate device with side-byside comparison of clinical performance in order to demonstrate substantial equivalence. The objective of the study was to compare StO2 measurements for MIMOSA Imager and the Vioptix ODISsey in order to demonstrate substantial equivalence between the two devices. In terms of methodology, the study monitor tissue oxygen saturation in the thenar eminence and forearm during a vascular occlusion test (VOT) using both devices. The study population included a total of 39 individuals ranging from 21 to 70 years of age and (1-5) Fitzpatrick skin types. The study results in terms of the 95% confidence interval of the line of best fit narrowly constrains the slope of the line between 0.998 and 1.02. MIMOSA Imager measures were in statistical agreement with Vioptix for thenar eminence and forearm for age between 21-70 and range of Fitzpatrick skin types. The statistical agreement between the two devices support substantial equivalence of MIMOSA Imager and Vioptix, and no adverse events or complications were encountered during or after clinical testing.
Conclusion
The MIMOSA Imager has the same intended use as the predicate, has similar technology that does not raise new types of questions of safety or effectiveness. Bench data demonstrates acceptable accuracy of the MIMOSA Imager with respect to the clinical/industrial gold standard in estimating StO2%. Furthermore, precision data demonstrates substantial equivalence between MIMOSA Imager and the predicate device. Overall, the performance data shows that this device provides reasonable assurance of safety and effectiveness to demonstrate substantial equivalence.
REFERENCES:
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Image /page/8/Picture/3 description: The image shows the word "MIMOSA" in a sans-serif font, with each letter in a dark blue color. To the left of the word is a stylized flower-like graphic. The graphic consists of six teardrop-shaped petals arranged in a circular pattern around a central point. The petals are colored with a gradient that transitions from yellow to orange.
[1] Section VI. Specifications: Ranges and Precision (Table). T.Ox™ Operator's Manual, ViOptix Inc. http://www.vioptix.com/wp-content/uploads/2015/10/OXY-2-USM-1-Rev-I-ViOptix-Tissue-(2016). Oximeter-Manual1.pdf