AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301

K101641 · Ag Digital Technology Corp. · LHQ · Jun 16, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K101641
• Device Name: AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
• Applicant: Ag Digital Technology Corp.
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Jun 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1

Intended Use

The AG Thermographic Camera (Model no.: ATIR-M301) is intended to use as an adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes. It can visualize and digitalize body surface temperature distribution and temperature changes. The device is intended for use by qualified healthcare personnel trained in its use.

Device Story

Non-contact, non-invasive infrared system; captures passive infrared emission from human body surface via uncooled microbolometer FPA; processes thermal data through proprietary PC-based software; displays temperature distribution patterns as images. Used by qualified healthcare personnel in hospitals, clinics, nursing homes, or home settings. Output consists of digital thermal images and temperature statistics; assists clinicians in visualizing surface temperature changes as an adjunct to other diagnostic procedures. Benefits include non-radiating, non-contact assessment of skin temperature distribution.

Clinical Evidence

Bench testing only. Performance validated via EN 60601-1 and EN 60601-1-2 electrical safety standards. Functional performance testing included temperature accuracy, environmental temperature factor, focus, distanced object temperature, thermal image handling, small area temperature statistics, two-area comparison, and patient history record handling.

Technological Characteristics

Uncooled microbolometer FPA (Amorphous Silicon); spectral response 8-14um; 320x240 array resolution; thermal sensitivity <0.1°C; electric motor focus (0.5M-infinity); USB 2.0 data output; PC-based processing and GUI display; AC power supply (110/240VAC).

Indications for Use

Indicated for use as an adjunct to clinical diagnostic procedures to visualize and quantify skin surface temperature changes and distribution in adult human patients. Intended for use by trained healthcare personnel in clinical, hospital, or home 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, Model No. SERIES A, E, S AND P (K033967)
• TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, Model No. SPECTRUM 9000MB (K020783)

Submission Summary (Full Text)

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### 510(K) SUMMARY

1 :: :

K101641

This summary of 510(k) safety and effectiveness information is being submitted in دccordance with the requirements of SMDA and 21 CFR §807.92

JUN 1 6 2011

REV.【C】

| 1. Submitter's Name: | AG Digital Technology Corp. |
|----------------------|---------------------------------------------------------|
| Address: | 11F, No.15, Sec.1, Chi-Nan Road Taipei, TAIWAN (CHINA) |
| | 10051 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Mr. Telvin Ju / Genral Manager |
| 2. Device Name : | |
| Trade Name: | AG Thermographic Camera, |
| | Model no.: ATIR-M301 |
| Common Name: | Telethermographic system |
| Classification name | Telethermographic system (adjunctive use) |
| 3. DEVICE CLASS | The AG Thermographic Camera (Model no.: |
| | ATIR-M301) has been classified as |
| | Regulatory Class: I |
| | Product Code: LHQ |
| | Regulation Number: 21 CFR 884.2980 |
| 4. Predicate Device: | The predicate device is the |
| | TELETHERMOGRAPHIC CAMERA , Model No. SERIES |
| | A, E, S AND P (K033967) marketed by FLIR SYSTEMS |
| | TELESIS DIGITAL INFRARED THERMAL IMAGE |
| | SYSTEM , Model No. SPECTRUM 9000MB (K020783) |
| | marketed by TELESIS TECHNOLOGIES INC. |
| Intended Use: | The AG Thermographic Camera (Model no.: ATIR |
| | Product: AG Thermographic Camera (Model no.: ATIR-M301) |

Section 4 - 510(k) Summary

Page 1 of 5

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M301) is intended to use as an adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes. It can visualize and digitalize body surface temperature distribution and temperature changes. The device is intended for use by qualified healthcare personnel trained in its use.

#### 6. Device Description: The AG Thermographic Camera (Model no.:

ATIR-M301) consists of an infrared camera, accessories, and PC visualization/analysis software. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image. It is suitable for imaging adult human targets and can be used in hospitals, acute and sub-acute healthcare settings, nursing homes, clinics, homes, public areas such as airports, and any environment where healthcare is provided by a healthcare professional.

### 7. Comparison to 510(k) Predicate Devices

The AG Thermographic Camera (Model no.: ATIR-M301) have the same intended use, principles of operation, and similar technological characteristics વડ predicate devices. Please find Technological Characteristics as follows

| Item | AG Digital<br>ATIR-M301 | FLIR A20M | TELESIS<br>SPECTRUM<br>9000MB |
|---------------------------|------------------------------------------|--------------------------------------|----------------------------------------|
| Technology | FPA uncooled<br>Mircrobolometer | FPA uncooled<br>Mircrobolometer | FPA uncooled<br>Mircrobolometer |
| Material | Amorphous<br>Silicon | Amorphous<br>Silicon | VOx |
| Spectral<br>Response | 8 ~ 14um | 7.5 ~ 13 um | 7 ~ 14 um |
| Array<br>Resolution | 320x240 | 160x120 | 320x240 |
| Thermal<br>Sensitivity | < 0.1 °C | 0.09~0.12°C | 0.07°C |
| Optics | 50mm F=0.7<br>FOV= 18.1°(H)<br>×13.7°(V) | F=1.2<br>FOV= 24°(H)<br>×18°(V) | 50mm F=0.83<br>FOV=<br>18.7°(H)×14°(V) |
| Focus | Electric motor<br>driving 0.5M -∞ | Manual, 0.3M - ∞ | Manual, 0.6M - ∞ |
| Spatial<br>Resolution | ≤ 1 mrad | 2.7mrad | 1 mrad |
| Temperature<br>Range | 30°C ~40°C | -20-+250 °C<br>(-4-+482 °F) | 10°C to 40°C |
| Temperature<br>Resolution | 0.1°C | 0.1°C | 0.1°C |
| Accuracy | < ±1°C | ± 2 °C or ± 2 %<br>of reading | - |
| Refresh Rate | 30 Frames/sec | 60 Frames/sec | 60 Frames/sec |
| Working<br>temperature | 20 - 26°C | -15°C ~ 50°C | 18°C~28°C |
| Operating<br>Temperature | 24°C ± 2°C | -15°C ~ 50°C | 20-22.2°C |
| Data Output | USB2.0 | RS-232,<br>IEEE-1394,<br>TCP/IP | RS-170 |
| Data<br>processing | personal<br>computer | Camera and<br>personal<br>compute | personal<br>compute |
| Display | GUI on PC | GUI on PC | GUI on PC |
| User<br>interface | Software on PC | Software on PC | Software on PC |
| Power Supply | AC adapter<br>110/240VAC,50/<br>60Hz | AC adapter<br>110/220VAC,50<br>/60Hz | 115~230 VAC<br>50~60 Hz |
| Weight | 1.3 Kgs | 1.7 LB | 3 LB |

Product: AG Thermographic Camera (Model no.: ATIR-M301) Section 4 - 510(k) Summary REV.【C】 Page 2 of 5

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Product: AG Thermographic Camera (Model no.: ATIR-M301) Section 4 – 510(k) Summary Page 3 of 5 REV.【C】

ﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﺘﻲ ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1999 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1999 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1999 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

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- 8. Substantial Equivalence Discussion
AG Thermographic Camera (Model no.: ATIR-M301) has the same general design with the predicate devices

Since the Applicant has selected Legally Marketed Devices

- TELETHERMOGRAPHIC CAMERA , Model No. SERIES . ● A, E, S AND P (K033967) marketed by FLIR SYSTEMS
- TELESIS DIGITAL INFRARED THERMAL IMAGE ● SYSTEM , Model No. SPECTRUM 9000MB (K020783) marketed by TELESIS TECHNOLOGIES INC.

The has the following similarities to the predicate devices in:

- · having the same intended use.
- · using similar operating principle..
- using similar technological characteristics

In summary, the AG Thermographic Camera (Model no.: ATIR-M301) described in this submission are, in our opinion, substantially equivalent to the predicate devices.

## 9. Performance AG Thermographic Camera (Model no.: ATIR-M301) meets EN 60601-1 (IEC 60601-1), EN 60601-1-2 (IEC Data 60601-1-2), and Performance tests including · Temperature accuracy • Environment temperature factor test · Focus test · Distanced object temperature test · Thermal image handling · Small area temperature statistics and two-area comparison

- · Patient history record handling
Product: AG Thermographic Camera (Model no.: ATIR-M301) Page 4 of 5 Section 4 - 510(k) Summary REV. [C)

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### 10. Safety and

#### Effectiveness

ATIR-M301) meet electrical Safety standard such as EN 60601-1 (IEC 60601-1), EN 60601-1-2 (IEC 60601-1-2). so it is safe for human body. Additionally, Performance tests including

- · Temperature accuracy
- Environment temperature factor test

The AG Thermographic Camera (Model no .:

- Focus test
- Distanced object temperature test
- · Thermal image handling
- · Small area temperature statistics and two-area comparison
- · Patient history record handling

were conducted to ensure the device can work as the intended performance.

Therefore, the device is of safety and effectiveness.

#### Conclusion

AG Thermographic Camera (Model no.: ATIR-M301) have the same intended use, principles of operation, and similar technological characteristics as predicate devices. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the AG Thermographic Camera (Model no.: ATIR-M301) are substantially equivalent to the predicate devices.

Product: AG Thermographic Camera (Model no.: ATIR-M301) Section 4 - 510(k) Summary REV.【C】 Page 5 of 5

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

AG Digital Technology Corp. % Ms. Jennifer Reich Senior Consultant Harvest Consulting Corp. 2904 N. Boldt Drive FLAGSTAFF AZ 86001

JUN 1 6 201

Re: K101641

Trade/Device Name: AG Thermographic Cmaera, Model no: ATIR-M301 Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHQ Dated: January 26, 2011 Received: January 7, 2011

Dear Ms. Reich:

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 class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K101641

Device Name: AG Thermographic Camera, Model no.: ATIR-M301 AG Digital Technology Corp.

Indications For Use:

The AG Thermographic Camera(Model no.: ATIR M301) is intended to use as an adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes. It can visualize and digitalize body surface temperature distribution and temperature changes. The device is intended for use by qualified healthcare personnel trained in its use.

Prescription Use AND/OR ﺳﮯ (Part 21 CFR 801 Subpart D)

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)

Michael D'Orazio
(Division Sign Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101 641