MIMOSA Imager

K190334 · Mimosa Diagnostics, Inc. · MUD · Nov 1, 2019 · Cardiovascular

Device Facts

• Record ID: K190334
• Device Name: MIMOSA Imager
• Applicant: Mimosa Diagnostics, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Nov 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: AI/ML

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.

Device Story

MIMOSA Imager is a non-contact, cordless, battery-powered tissue oximeter. It captures spatially-resolved images of superficial tissue using multispectral LED illumination (visible and NIR wavelengths). The device is triggered via a smartphone app interface; it processes spectral signatures of dominant chromophores to calculate StO2. Results are displayed as a spatially registered heatmap on an Android device screen. Used by healthcare professionals in clinics, hospitals, and EMS to assess tissue oxygenation. The output assists clinicians in evaluating circulatory or perfusion status, aiding in the detection of compromised circulation. Benefits include non-invasive, real-time visualization of tissue oxygenation distribution.

Clinical Evidence

Comparative clinical study (n=39, ages 21-70, Fitzpatrick skin types 1-5) performed during vascular occlusion tests (VOT) on thenar eminence and forearm. Primary endpoint: statistical agreement of StO2 measurements between MIMOSA Imager and predicate. Results showed 95% CI of the line of best fit slope between 0.998 and 1.02. No adverse events reported.

Technological Characteristics

Non-contact, cordless, battery-powered (Li-polymer, IEC 62133/UN 38.3). Materials: Nylon 12/PETG enclosure, front-glass, aluminum body, PVC sheath. Light source: LED chips (620, 630, 700, 810, 880, 980 nm). Connectivity: Android device interface. Non-sterile. Software-based spectral analysis.

Indications for Use

Indicated for patients requiring monitoring during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation in medical environments.

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

• ODISsey Tissue Oximeter (K042657)

Reference Devices

• Kent Camera (K113507)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

K190334

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: | [phone] |
| Primary Email: | [e-mail] |
| Secondary Email: | [e-mail] |
| 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<br>IMAGER | Predicate Device<br>(ODISsey) | Comparison |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k # | This Submission | K042657 | |
| Indications<br>for Use | The MIMOSA Imager is<br>intended to non-invasively<br>estimate the spatial<br>distribution of percent<br>oxygen saturation in a<br>volume of tissue (StO2).<br>This is performed in<br>medical environments<br>including physician offices,<br>hospitals, ambulatory care<br>and Emergency Medical<br>Services. | The ViOptix ODISsey<br>Tissue Oximeter is<br>intended to non-invasively<br>estimate the percent<br>oxygen saturation in a<br>volume of tissue (StO2).<br>This is performed in<br>medical environments<br>including physician offices,<br>hospitals, ambulatory care<br>and Emergency Medical<br>Services. | Similar: only difference is<br>"spatial distribution of." |
| | The MIMOSA Imager is<br>indicated for use in<br>monitoring patients during<br>circulatory or perfusion<br>examinations of skeletal<br>muscle or when there is a<br>suspicion of compromised<br>circulation. | The ODISsey Tissue<br>Oximeter is indicated for<br>use in monitoring patients<br>during circulatory or<br>perfusion examinations of<br>skeletal muscle or when<br>there is a suspicion of<br>compromised circulation. | |
| Measured<br>Parameters | Tissue oxygen saturation<br>(StO2) information | Tissue oxygen saturation<br>(StO2) information | Same |
| Operating<br>Principle | Spectrophotometric<br>oximetry | Spectrophotometric<br>oximetry | Same |
| Light Source | Near-infrared light Source:<br>LED chips Wavelengths:<br>620, 630, 700, 810, 880,<br>980 nm | Near-infrared light Source:<br>laser diodes Wavelengths:<br>690, 830 nm | Similar: the MIMOSA<br>Imager delivers<br>additional wavelengths of<br>light to the tissue in order<br>to improve measurement<br>reliability and providing a<br>more robust dataset. The<br>additional wavelengths<br>have been assessed<br>based on IEC 62471 and<br>were found to not pose<br>any safety concerns and<br>effectiveness<br>demonstrated through<br>performance (bench and<br>clinical) testing . This<br>does not raise any new<br>questions in safety or<br>efficacy. |
| Reusable | Yes | Yes | Same |
| Contact | Non-Contact | Direct Contact | Different: The MIMOSA<br>Imager is a non-contact<br>device while the<br>predicate is not. Other<br>devices within the MUD<br>class, including<br>reference device (Kent<br>Camera, K113507) is<br>non-contacting. In our<br>performance testing, this<br>difference raises no new<br>questions regarding<br>either safety or efficacy. |
| Power Source | Powered with a<br>rechargeable Li-polymer<br>battery. | AC power-operated with<br>30-minute lithium-ion<br>battery backup. | Different: The MIMOSA<br>lmager is powered by a<br>lithium-polymer battery<br>certified to IEC 62133<br>and UN 38.3. This raises<br>no new questions in<br>safety or efficacy. |
| Measurement<br>Range | 1-99% StO2 | 1-99% StO2 | Same |
| Display | Attached Android Device<br>Display | Computer console display<br>module | Similar |
| Materials | Plastic (Nylon 12 / PETG)<br>Enclosure connected to a<br>front-glass, aluminum body<br>smartphone with a PVC<br>cover sheath USB<br>connector cable. | Plastic Enclosure, Metal<br>and Epoxy probe head.<br>PVC cable cover sheath. | Similar |
| Internal<br>Storage | 32000 MB | 2000 MB | Similar |
| Ambient Light | Insignificant contribution to<br>image (relative to NIR<br>LEDs) due to short<br>exposure time | Probe must physically<br>block out all ambient light. | Different: Both devices<br>compensate for ambient<br>light. The MIMOSA<br>lmager uses a short<br>exposure time and a<br>background light<br>compensation algorithm.<br>The predicate device<br>physically attempts to<br>block out light by putting<br>the probe in contact with<br>the imaged tissue. This<br>change in filtering of light<br>had no effect on<br>performance and does<br>not present any<br>additional safety or<br>effectiveness concerns. |
| Patient<br>Population<br>and<br>Environment | Healthcare environment for<br>patient population with<br>potential circulatory<br>compromise | Healthcare environment for<br>patient population with<br>potential circulatory<br>compromise | Same |
| Control<br>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