ICI P AND S SERIES IR CAMERAS

K073581 · Texas Infrared · LHQ · Jul 11, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K073581
• Device Name: ICI P AND S SERIES IR CAMERAS
• Applicant: Texas Infrared
• Product Code: LHQ · Obstetrics/Gynecology
• Decision Date: Jul 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2980
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature. Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airport.

Device Story

ICI P and S Series IR Cameras capture skin surface temperature; IR Flash Software v1.0 provides visualization and reporting. System uses uncooled microbolometer (vanadium oxide) to detect infrared radiation (8-14 um). Data output via USB 2.0 to a PC running Windows XP/Vista. Used in hospitals, sub-acute settings, and public areas (e.g., airports) by clinicians or trained operators. Output displays thermal patterns; assists healthcare providers in screening or quantifying relative temperature changes as an adjunct to other diagnostic procedures. Benefits include non-invasive, real-time thermal monitoring.

Clinical Evidence

No clinical data. Bench testing only, including compliance with IEC-60601-1 and IEC 60601-1-2, and software validation.

Technological Characteristics

FPA uncooled microbolometer; Vanadium Oxide material; 8-14 um spectral response; 320x240 array; 1.13 mrad IFOV; 38 mK NETD; USB 2.0 connectivity; IP54 encapsulation; manual focus; 5 VDC power via USB; Windows XP/Vista compatible software.

Indications for Use

Indicated for use as an adjunct to clinical diagnostic procedures for the diagnosis, quantification, and screening of relative skin surface temperature in any part of the body. Suitable for use in hospitals, sub-acute healthcare settings, and public areas (e.g., airports).

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

• A20M FLIR Systems, Inc. (K033967)

Submission Summary (Full Text)

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#### 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

510(k) number:

#### 1. Submitter's Identification:

JUL 11 2008

Texas Infrared 2105 West Cardinal Drive Beaumont, TX 77705 Contact: Gary Strahan President/CEO Phone: [phone] FAX: [phone] Date Summary Prepared: 7-27-2007

# 2. Name of the Device:

Common Name: Telethermographic System (Adjunctive Use) Trade or Proprietary Name: ICI P and S Series IR Camera(s) and the IR Flash Software version 1.0 Device Class: 1 Product Code: LHQ Regulation Number: 884.2980

### 4. Predicate Device Information:

Trade Name: A20M FLIR Systems, Inc. 27700A SW Parkway Avenue Wilsonville, OR 97070 USA Phone: [phone] Fax: [phone](k) number: K033967

# 5. Device Description:

The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature.

Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airport.

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| ICI P and S Series Cameras | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Base IR Camera | ICI P and S series Cameras |
| Intended Use | The ICI Series P and S IR Cameras, which provides capture of skin<br>surface temperature of any part of the body, and the IR Flash<br>Software version 1.0, which provides visualization and reporting<br>functionalities, are intended for use as an adjunct to other clinical<br>diagnostic procedures in the diagnosis, quantifying, and screening of<br>relative skin surface temperature. |
| | Environment of use: hospitals, sub-acute healthcare settings, public<br>areas, i.e., airport. |
| Technology | FPA uncooled Microbolometer |
| Material | Vanadium Oxide |
| Spectral Response | 8 - 14 um |
| Contrast/Brightness | Software Controlled |
| Spatial Resolution IFOV | 1.13 mrad |
| Data Output | Digital USB 2.0 |
| Thermal Time Constant | 14 ms |
| Thermal Sensitivity | 0.038C @ 25C |
| Accuracy | +2C or 2% |
| Emissivity Correction | Computer Controlled |
| Performance | 38 mK NETD |
| Frame Rate | S Series Camera 50-60fps<br>P Series Camera < 9 fps |
| Pitch Size | 25 um |
| Encapsulation | IP54 |
| Optics | 25mm with 22° FOV |
| Vibration | 3G's |
| Shock | 30G's |
| Array size | 320 x 240 array |
| Weight | 5.2oz (148g) w/lens |
| Tripod Mount | 1/4" - 20 female thread |
| Operating Temperature | -20C to +50C |
| Storage Temperature | -40C to +70C |
| Dimensions | 2.1"x3.2"x0.5" |
| Focus | Manual |
| Special Computer Hardware | USB 2.0 Compatible running Windows XP or Windows Vista. 64-bit<br>operating systems are not supported at this time. |
| Power Supply | 5 VDC @ 500ma max draw from USB. Systems with motorized focus have an additional 12 VDC supply @ 1A max. |

:

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#### Components of the system include:

ICI P or S Series IR Camera USB Cable Tripp-Lite model IS250HG isolation transformer

### 6. Intended Use:

The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature.

Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airport.

# 7. Comparison to Predicate Devices:

# Technical characteristics of the device(s) compared to the predicate device:

| Base IR Camera | ICI P and S Series IR<br>Camera(s) and the IR Flash<br>Software version 1.0 | A20M<br>(K033967) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ICI Series P and S IR Cameras,<br>which provides capture of skin<br>surface temperature of any part of the<br>body, and the IR Flash Software<br>version 1.0, which<br>provides visualization and reporting<br>functionalities, are intended for use as<br>an adjunct to other clinical diagnostic<br>procedures in the diagnosis,<br>quantifying, and screening of relative<br>skin surface temperature.<br>Environment of use: hospitals, sub-<br>acute healthcare settings, public<br>areas, i.e., airport. | The Flir devices are intended for use<br>as an adjunct to other clinical<br>diagnostic procedures in the<br>diagnosis, quantifying, and screening<br>of differences in skin surface<br>temperature changes. It can<br>visualize, document temperature<br>patterns and changes. Environment<br>of use: hospital, sub-acute, public<br>areas, i.e., airports |
| Technology | FPAuncooled Microbolometer | FPA uncooled Microbolometer |
| Material | Vanadium Oxide | Amorphous Silica |
| Spectral Response | 8-14 um | 7.5-13um |
| Contrast/Brightness | Software Controlled | Manual or Software Controlled |
| Spatial Resolution IFOV | 1.13 mrad | 2.7 mrad |
| Data Output | Digital USB 2.0 | RS170 EIA/NTSC or CCIR/PAL<br>composite |
| Thermal Time Constant | 14 ms | Unknown |
| Thermal Sensitivity | 0.038C @ 25C | 0.120C @ 30C |
| Accuracy | +2C or 2% | +2C or 2% |
| Emissitivity Correction | Computer Controlled | Variable from 0.1 to 1.0 |
| Performance | 38 mK NETD | Under <80mK |

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| Frame Rate | S Series Camera 50-60fps<br>Series Camera < 9fps | 60 fps |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Pitch Size | 25 um | Unknown |
| Encapsulation | IP54 | IP40 |
| Optics | 25mm with 22° FOV | 25mm with 19° FOV |
| Vibration | 3G's | 2G's |
| Shock | 30G's | 25G's |
| Array size | 320 x 240 array | 320 x 240 array |
| Weight | 5.2oz (148g) w/lens | 1.7lbs (0.8 kg) |
| Tripod Mount | 1/4" -20 female thread | 1/4" -20 female thread |
| Operating Temperature | -20C to +50C | -15C to +50C |
| Storage Temperature | -40C to +70C | -40C to +70C |
| Dimensions | 2.1"x3.2"x0.5" | 6.2"x2.9"x3.1" |
| Focus | Manual | Manual or Software Controlled |
| Special Computer<br>Hardware | USB 2.0 Compatible running<br>Windows XP or Windows Vista. 64-<br>bit operating systems are not<br>supported at this time. | Ethernet connection, Video capture<br>device to vonvert RS-170 video,<br>Firewire 8/16-bit monochrome and 8-<br>bit color |
| Power Supply | 5 VDC @ 500ma max draw from<br>USB. Systems with motorized focus<br>have an additional 12 VDC supply @<br>1 A max. | AC adaptor 110/220 vac, 50/60hz<br>input to 12/24vdc nominal, <6w<br>output |

### 8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The devices have been tested and found to comply with IEC-60601-1 and IEC 60601-1-2. Software validation was performed.

### 9. Discussion of Clinical Tests Performed:

Not applicable

#### 10. Conclusions:

The subject device(s) has the same intended use and similar characteristics as the predicate device. Moreover, documentation supplied in this submission demonstrates that any difference in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the ICI P and S Series IR Camera(s) and the IR Flash Software version 1.0 are substantially equivalent to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an 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 fashion around the bird symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 11 2008

Texas Infrared % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K073581

Trade/Device Name: ICI P and S Series IR Camera(s) and the IR Flash Software version 1.0 Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic System Regulatory Class: I Product Code: LHO Dated: June 27, 2008 Received: June 30, 2008

#### Dear Mr. Lehtonen:

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 (PMA), 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.

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#### Page 2

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 Aut or any Federal statutes and regulations administered by other Federal agencies. Ynoundus of comply with all the Act's requirements, including, but not limited to: registration and liasting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the lectronic 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, permoits 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 Center for Devices and Radiological Health's (CDRH's) Of Crice of Compliance a to one of the following numbers, based on the regulation number at the top of this Utter

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 241-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max cobtain other general information on your responsibilities under the Division of Simil Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-241 or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html

Sincerely yours,

Nancy C Brogdon

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

#### K073581 510(k) Number (if known):

Device Name : ICI P and S Series IR Camera(s) and the IR Flash Software version 1.0

#### Indications for Use:

The ICI Series P and S IR Cameras, which provides capture of skin surface temperature of any part of the body, and the IR Flash Software version 1.0, which provides visualization and reporting functionalities, are intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature. Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airports.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

hozu Mnhany

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