MEDHOT MTI 2000 THERMAL IMAGING SYSTEM

K063047 · Medhot Thermal Imaging, Inc. · LHQ · Oct 19, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K063047
• Device Name: MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
• Applicant: Medhot Thermal Imaging, Inc.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Oct 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Intended for qualified healthcare personnel who are trained in its use, the MedHot MTI 2000 is a non-contact, non-invasive, non-radiating, thermographic imaging device for use as an adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes. The device can digitally render quantitative images of thermal data via the capture and algorithmic interpretation of relative infrared information from the imaging camera in collaborative use with a compatible computer system which provides a user interface and image storage. Patient populations and environmental use includes all age groups from adult to pediatric and neonatal in hospital, sub acute and public areas i.e. airports.

Device Story

MedHot MTI 2000 is a non-invasive telethermographic system; captures infrared radiation via FPA microbolometer camera; converts data array to temperature data using algorithmic derivative; renders quantitative thermal images on computer screen. Operated by trained healthcare personnel in hospitals, sub-acute, or public areas (e.g., airports). System includes camera and computer with onboard CPUs; provides GUI for image visualization, quantification, and storage. Used as adjunct to clinical diagnostic procedures; assists providers in screening and quantifying skin surface temperature differences; aids clinical decision-making by providing visual thermal data.

Clinical Evidence

No clinical data. Bench testing only; device successfully tested for EMC and EMI compliance per IEC 60601-1-2.

Technological Characteristics

FPA UC microbolometer detector; amorphous silicon material; spectral response 7-14 µm; thermal sensitivity < 100 mK; 160x120 array resolution; manual focus; analog NTSC video output; 20 fps refresh rate; emissivity correction 0.1-1.0; connectivity via computer interface; power 100 VAC.

Indications for Use

Indicated for use by trained healthcare personnel for non-contact, non-invasive, non-radiating thermographic imaging as an adjunct to clinical diagnostic procedures. Used for capture, quantification, and screening of skin surface temperature changes in all age groups, including adults, pediatric, and neonatal patients in hospital, sub-acute, and public settings.

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

• Telethermographic camera Series A, E, P, and S (k033967)

Submission Summary (Full Text)

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# KO63047

## Exhibit C

510(k) Summary

0C1 1 9 2006

| Name and address of sponsor of the<br>510(k) submission: | MedHot Thermal Imaging, Inc. |
|------------------------------------------------------------|------------------------------------------------|
| | 315 Doris Drive, Lakeland. Florida - 33813 |
| Official contact person for all<br>correspondence: | Carol Chandler (address as above) |
| | Phone: [phone], Fax: [phone] |
| | E-mail: [e-mail] |
| Date Prepared: | Sept 27, 2006 |
| Device Name: | MedHot MTI 2000 Thermal Imaging System |
| Generic name of the device: | Telethermographic System (Adjunctive) |
| Classification, Product Code and<br>CFR Regulation Number: | Class I, LHQ and 21 CFR 884.2980 |
| Classification Panel: | Obstetrics/Gynecology |
| Predicate Device Name: | Telethermographic camera Series A, E, P, and S |
| Predicate 510(k) Number: | k033967 |

#### Device Description:

The MedHot MTI 2000 thermal imaging system is a non-invasive system that provides the user a visual representation of thermal temperature data in the form of a quantitative image on the users computer screen. The process begins by the cameras' capture of a data array representative of infrared radiation naturally emitted by the object being imaged; the data array is converted to a temperature data array using an algorithmic derivative. Once the infrared data is in the form of temperature data, software on the user's computer is used to generate an image from the rendered temperature data. The user can use this image in a number of ways to quantify the temperature of objects imaged.

014

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| | MedHot MTI 2000 | A20M |
|---------------------------|------------------------------------------------|------------------------------------------------|
| Technology / Detector | FPA UC Microbolometer | FPA UC Microbolometer |
| Material | Amorphous Silicon | Amorphous Silicon |
| Spectral Response | 7-14 µm | 7.5-13 µm |
| Thermal Sensitivity | < 100 mK | < 80 mK |
| Contrast / Brightness | Software Controlled | Software Controlled |
| Data Output | Analog NTSC Video | IEEE-1394 usb firewire |
| Refresh Rate | 20 fps Refresh | 60 fps Refresh |
| Optics | 8.5mm with 50°x 35° | 24° x 18°/ 0.3 m |
| Array Resolution | 160x120 array | 320x240 array |
| Focus | manual | manual |
| Power Supply | 2.0 amps @100 VAC | AC adapter 110/220 VAC,<br>50/60Hz |
| Weight | 2.5 pounds | 1.7 pounds |
| Size | 7.6" / 5.0" / 2.2" | 6.2" / 2.9" / 3.1" |
| Operating Temperatures | "-20°C to +60°C (-4°F<br>to<br>+140°F)" | "-40°C to +70°C (-40°F to<br>+158°F)" |
| Emissivity Correction | Variable from 0.1 to 1.0 | Variable from 0.1 to 1.0 |
| Method of Data Collection | collection instrumentation | |
| data processing | camera and computer each<br>have onboard cpu's | camera and computer each<br>have onboard cpu's |
| Measurement Parameters | | |
| storage | data storage on computer | data storage on computer |
| Camera Output | | |
| display | GUI on computer | GUI on computer |
| user interface | Software on computer | Software on computer |

## Comparison of Technological Characteristics to Predicate Device:

#### Intended Use:

Intended for qualified healthcare personnel who are trained in its use; The MedHot MTI 2000 is a non-contact, non-invasive, non-radiating, thermographic imaging device for use as an adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes.

The device can digitally render quantitative images of thermal data via the capture and algorithmic interpretation of relative infrared information from the imaging camera in collaborative use with a compatible computer system which provides a user interface and image storage.

Patient populations and environmental use includes all age groups from adult to pediatric and neonatal in hospital, sub acute and public areas i.e. airports.

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## Non-Clinical Testing:

Camera unit was successfully tested for EMC and EMI compliance as per IEC 60601-1-2 requirements. Power supply also conforms to appropriate medical grade stines on

#### Clinical Testing:

Not applicable

#### Conclusion:

MedHot MTI 2000 is substantially equivalent to the predicate device and arguments given in the submission show that the differences don't bring up any new questions regarding the safety and effectiveness of the subject device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MedHot Thermal Imaging, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

## OCT 1 9 2006

Re: K063047

Trade/Device Name: MedHot MTI 2000 Thermal Imaging System Regulation Number: 21 CFR §884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHQ Dated: September 27, 2006 Received: October 4, 2006

Dear Mr. Mosenkis:

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 practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image shows a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906 - 2006" are displayed. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by a dotted circle.

coling Public .

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Page 2 -

Please be advised that I'DA'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); good 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

Page _ 1 of 1

K063047

## 510(k) Number (if known): No

#### Device Name: MedHot MTI 2000 Thermal Imaging System

#### Indications for Use:

Intended for qualified healthcare personnel who are trained in its use, the MedHot MTI 2000 is a non-contact, non-invasive, non-radiating, thermographic imaging device for use as an adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes.

The device can digitally render quantitative images of thermal data via the capture and algorithmic interpretation of relative infrared information from the imaging camera in collaborative use with a compatible computer system which provides a user interface and image storage.

Patient populations and environmental use includes all age groups from adult to pediatric and neonatal in hospital, sub acute and public areas i.e. airports.

Prescription Use (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Seymon
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063