Smile-100 System

K212965 · Niramai Health Analytix Private Limited · LHQ · Mar 10, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K212965
• Device Name: Smile-100 System
• Applicant: Niramai Health Analytix Private Limited
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Mar 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

SMILE-100 System is intended to review, measure and record skin temperature patterns and variations emitted from the human body. It is intended for use as adjunctive diagnostic imaging for thermally significant indications in the breast region. The significance of the value of these thermal patterns is determined by professional investigation. This device is intended for use by qualified healthcare personnel trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

Device Story

Breast thermography system; captures passive infrared emissions via off-the-shelf thermal camera; processes data via cloud-hosted SMILE-100 software. Used in hospitals, acute care, or outpatient settings by imaging technicians and expert thermologists. Technician captures images; software performs quality checks; expert reviews images, applies temperature thresholds to highlight thermal activity, and interprets patterns. Output includes annotated images and quantitative thermal parameters. Assists clinicians in identifying thermally significant breast regions; does not provide absolute temperature measurements or diagnostic determinations; intended for adjunctive use only.

Clinical Evidence

Bench testing only. Verification activities included product development testing, system output parameter verification, interoperability testing across multiple thermal camera models, and comparison of temperature values between the camera and software. No clinical data provided.

Technological Characteristics

Telethermographic system using off-the-shelf infrared cameras (uncooled microbolometer FPA, <50mK sensitivity, ±2°C accuracy). System includes laptop/desktop, thermal camera, and SMILE-100 software. Connectivity via cloud-hosted server. Standards followed: ISO 14971:2019 (risk management), IEC 62304:2015 (software lifecycle).

Indications for Use

Indicated for use by qualified healthcare personnel as adjunctive diagnostic imaging for thermally significant indications in the breast region.

Regulatory Classification

Identification

A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Med-Hot Thermal Imaging System (K171928)

Reference Devices

• FLIR Exx series (K033967)
• Spectron IR's TyTron C-500 IR (K032471)
• Infrared Cameras Inc.'s 9640P (K073581)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.

Niramai Health Analytix Private Limited % Yolanda Smith Consultant Smith Associates 1468 Harvell Avenue CROFTON MD 21114

#### Re: K212965

Trade/Device Name: Smile-100 System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic System Regulatory Class: Class I, reserved Product Code: LHQ Dated: January 31, 2022 Received: February 2, 2022

Dear Yolanda Smith:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

March 10, 2022

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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 mediation-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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K212965

Device Name SMILE-100 System

#### Indications for Use (Describe)

SMILE-100 System is intended to review, measure and record skin temperature patterns and variations emitted from the human body. It is intended for use as adjunctive diagnostic imaging for themally significant indications in the breast region. The significance of the value of these thermal patterns is determined by profession. This device is intended for use by qualified healthcare personnel trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

Type of Use (Select one or both, as applicable)

| <div> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# 510(k) Summary — K212965

# 5.1 Submitter

Niramai Health Analytix Private Limited, Innova Pearl, Ground Floor, No. 17, 5th Block, Koramangala Industrial Layout, Koramangala, Bangalore - 560095, Karnataka, India

Contact Person: Dr. Geetha Manjunath Email id: [e-mail]

Date Prepared: 9 March 2022

# 5.2 Device Details

| Trade Name | SMILE-100 System |
|----------------------|--------------------------------------------|
| Common or Usual Name | Telethermographic System |
| Classification Name | System, Telethermographic (Adjunctive Use) |
| Regulation Number | 21 C.F.R. 884.2980 |
| Device Class | Class I |
| Product Code | LHQ |

### 5.3 Predicate Device Details

| Product Name | Med-Hot Thermal Imaging System |
|---------------|--------------------------------|
| Manufacturer | Med-Hot Thermal Imaging, Inc. |
| 510(k) Number | K171928 |

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### 5.4 Device Description

The SMILE-100 System is a breast thermography device with a visualization tool that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It is intended to be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel.

SMILE-100 System consists of the following:

- An off-the-shelf FDA cleared thermal camera with its associated camera control software (i) provided by the thermal camera vendor for capturing and viewing thermal images
- An off the shelf laptop/desktop computer system with display, keyboard and mouse. (ii)
- SMILE-100 Software for viewing thermal patterns in thermal images (iii)

The SMILE-100 Software takes thermal images captured using off-the-shelf FDA-cleared thermal camera and provides various visualization options in multiple customizable views/palettes and also generates a report with quantitative thermal parameters and annotated images. The Software supports two user roles (i) a thermographer or imaging technician role and (ii) Expert thermologist role. The imaging technician captures thermal images and uploads them to the cloud-hosted SMILE-100 Software which performs image quality checks and submits to Expert. The Expert can select a temperature threshold for the SMILE-100 Software to highlight areas with thermal activity above the threshold in thermal images. The software makes no estimation of the thermal threshold. The software makes no determination regarding what the thermal patterns or relative temperature values mean. Expert thermologist needs to infer the meaning of high thermal activity and other areas of interest based on his/her visual interpretation of those patterns and thermal values.

#### 5.5 Indications for Use

SMILE-100 System is intended to review, measure and record skin temperature patterns and variations emitted from the human body. It is intended for use as adjunctive diagnostic imaging for thermally significant indications in the breast region. The significance of the value of these thermal patterns is determined by professional investigation. This device is intended for use by qualified healthcare personnel trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

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| Table 1: Indications for Use Statement Comparison | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SMILE-100 System | Predicate Device | Comment |
| SMILE-100 System is intended<br>to review, measure and record<br>skin temperature patterns and<br>variations emitted from the<br>human body. It is intended for<br>use as adjunctive diagnostic<br>imaging for thermally significant<br>indications in the breast region.<br>The significance of the value of<br>these thermal patterns is<br>determined by professional<br>investigation. This device is<br>intended for use by qualified<br>healthcare personnel trained in<br>its use. The system is not<br>intended for absolute<br>temperature measurements.<br>The system is not intended to<br>be used as a thermometry<br>device. | The Med-Hot Thermal Imaging<br>Systems are intended to review,<br>measure and record skin<br>temperature patterns and<br>variations emitted from the<br>human body. They are intended<br>for use as adjunctive diagnostic<br>imaging for thermally significant<br>indications in the regions of the<br>head and neck, breast, chest,<br>abdomen, back and extremities.<br>The significance of the value of<br>these thermal patterns is<br>determined by professional<br>investigation. This device is<br>intended for use by qualified<br>technical personnel trained in its<br>use. | Different<br><br>The indications for use of<br>both devices are the same<br>except that the SMILE-100<br>System covers one<br>anatomical site (breast)<br>while the Predicate Device<br>supports breast and other<br>parts of the body. |

# 5.6 Comparison of SMILE-100 System with the Predicate Device

| Table 2: Predicate Product Comparison of Regulatory Parameters | | | |
|----------------------------------------------------------------|------------------|------------------------------------|-------------|
| Parameters | SMILE-100 System | Med-Hot Thermal Imaging<br>Systems | Equivalence |
| Product code | LHQ | LHQ | Same |
| Regulation No. | 21 CFR 884.2980 | 21 CFR 884.2980 | Same |
| Classification | Class I | Class I | Same |

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| Regulation Name | Telethermographic System | Telethermographic System | Same |
|-----------------|--------------------------|--------------------------|------|
|-----------------|--------------------------|--------------------------|------|

| Table 3: Comparison of Technological characteristics | | | |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameters | SMILE-100 System | Predicate Device | Equivalence |
| Principle of<br>operation | Telethermography | Telethermography | Same |
| Method of<br>Data<br>Collection | Non-contact measurement<br>of passive<br>infrared emissions | Non-contact measurement<br>of passive<br>infrared emissions | Same |
| Temperature<br>Measuring<br>instrument | An infrared camera.<br>FLIR A315, FLIR A310, FLIR<br>E75, FLIR E76, FLIR Axxx<br>series, FLIR Exx series (Ref<br>K033967),<br>Spectron IR's TyTron C-500<br>IR (Ref K032471),<br>Infrared Cameras Inc.'s<br>9640P (Ref K073581) | An infrared camera.<br>MAX 076 (FLIR A325sc) or<br>MAX 307 (FLIR A655sc) | Similar<br>Both devices use infrared<br>cameras as the<br>temperature measuring<br>instruments. Though the<br>camera model numbers are<br>different, they have<br>equivalent specifications<br>(detailed below) |
| Table 3.a Technological Characteristics of Infrared/Thermal Camera | | | |
| Detector Type | Focal Plane Array (FPA),<br>uncooled Microbolometer | FPA, Uncooled<br>Microbolometer | Same |
| Thermal<br>sensitivity | < 50 mK | < 50 mK | Same |
| Accuracy | ±2°C or ±2% of reading | ±2°C or ±2% of reading | Same |
| IR Resolution | Minimum 320 × 240 pixels | 320 × 240 pixels | Same |
| Field of view | 25°×18.8° | 25°×18.8° | Same |
| Emissivity | from 0.01 to 1.0 | from 0.01 to 1.0 | Same |

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| Table 3.b Technological Characteristics of the System | | | |
|---------------------------------------------------------------------------------|---------------------|--------------------------------|-----------------------------------------------------------------------------------------|
| Display Device | Laptop | Laptop | Same |
| Record thermal<br>images to hard<br>disk | Yes | Yes | Same |
| Infrastructure<br>for analysis and<br>data storage | Secure cloud server | Hard Disk | Different |
| Thermal Image<br>Visualization<br>Software Used | SMILE-100 Software | MedHot TotalVision<br>Software | The two software's have<br>similar characteristics as<br>detailed in Table 3.c<br>below |
| Table 3.c Technological Characteristics of Thermal Image Visualization Software | | | |
| Manual marking<br>of regions that<br>have high<br>thermal activity | Yes | Yes | Similar |
| Input image<br>quality check | Yes | No | Different |
| Temperature<br>value display for<br>every pixel | Yes | Yes | Same |
| Support for role-<br>based access<br>control | Yes | No | Different |
| Thermal<br>Parameters<br>generated in the<br>output | Yes | Yes | Additional thermal<br>parameters shown. |
| Compatibility<br>with standard<br>imaging format<br>(DICOM) | Yes | No | Different |

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## 5.7 Performance Testing

The overall verification activities performed for SMILE-100 Software includes the following:

- Verification during Product Development
- Verification of SMILE-100 System Output Parameters
- . Interoperability Testing with different Thermal Camera Models
- Comparison of the equivalence of temperature values between thermal camera and . SMILE-100 Software

The following standards were followed-in the development of the SMILE-100 System:

- ISO 14971: 2019 Medical Devices Application of Risk Management to Medical Devices .
- . IEC 62304: 2015 Medical Device Software - Software Life Cycle Processes

#### 5.8 Conclusion

The SMILE-100 System is a breast thermography device with a visualization tool. The SMILE-100 System is only an adjunctive diagnostic imaging modality. From the discussion above, it is determined that SMILE-100 System is substantially equivalent to the Predicate Device, and there are no new concerns of safety and efficacy. The device has also been described and tested to prove the same.