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.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ICI P and S Series IR Camera(s) and IR Flash Software version 1.0:

It's important to note that this document is a 510(k) summary for a Telethermographic System (Adjunctive Use), not a typical diagnostic AI device that would undergo rigorous clinical trials for sensitivity and specificity. The acceptance criteria here primarily focus on demonstrating substantial equivalence to a predicate device and adherence to electrical safety and software validation standards, rather than clinical performance metrics like accuracy, sensitivity, or specificity against a ground truth.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (ICI P and S Series IR Cameras)	Reported Device Performance (ICI P and S Series IR Cameras)	Predicate Device (A20M) Performance
Intended Use	Adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature.	Meets stated intended use.	Matches predicate device.
Environment of Use	Hospitals, sub-acute healthcare settings, public areas (e.g., airport).	Meets stated environment of use.	Matches predicate device.
Technology	FPA uncooled Microbolometer	FPA uncooled Microbolometer	FPA uncooled Microbolometer
Material	Vanadium Oxide	Vanadium Oxide	Amorphous Silica (Difference noted)
Spectral Response	8 - 14 um	8 - 14 um	7.5 - 13 um (Difference noted)
Contrast/Brightness	Software Controlled	Software Controlled	Manual or Software Controlled (Difference noted)
Spatial Resolution IFOV	1.13 mrad	1.13 mrad	2.7 mrad (Superior performance)
Data Output	Digital USB 2.0	Digital USB 2.0	RS170 EIA/NTSC or CCIR/PAL composite (Difference noted)
Thermal Time Constant	14 ms	14 ms	Unknown
Thermal Sensitivity	0.038C @ 25C	0.038C @ 25C	0.120C @ 30C (Superior performance)
Accuracy	+2C or 2%	+2C or 2%	+2C or 2%
Emissivity Correction	Computer Controlled	Computer Controlled	Variable from 0.1 to 1.0 (Difference noted)
Performance (NETD)	38 mK NETD	38 mK NETD	Under <80mK (Superior performance)
Frame Rate	S Series: 50-60fps; P Series: < 9fps	S Series: 50-60fps; P Series: < 9fps	60 fps (P Series lower, S Series comparable)
Pitch Size	25 um	25 um	Unknown
Encapsulation	IP54	IP54	IP40 (Superior performance)
Optics	25mm with 22° FOV	25mm with 22° FOV	25mm with 19° FOV (Difference noted)
Vibration	3G's	3G's	2G's (Superior performance)
Shock	30G's	30G's	25G's (Superior performance)
Array size	320 x 240 array	320 x 240 array	320 x 240 array
Weight	5.2oz (148g) w/lens	5.2oz (148g) w/lens	1.7lbs (0.8 kg) (Lighter weight)
Tripod Mount	1/4" -20 female thread	1/4" -20 female thread	1/4" -20 female thread
Operating Temperature	-20C to +50C	-20C to +50C	-15C to +50C (Broader range)
Storage Temperature	-40C to +70C	-40C to +70C	-40C to +70C
Dimensions	2.1"x3.2"x0.5"	2.1"x3.2"x0.5"	6.2"x2.9"x3.1" (Smaller size)
Focus	Manual	Manual	Manual or Software Controlled (Difference noted)
Special Computer Hardware	USB 2.0 compatible, Windows XP/Vista (32-bit only)	USB 2.0 compatible, Windows XP/Vista (32-bit only)	Ethernet, Video capture device (RS-170), Firewire (Difference noted)
Power Supply	5 VDC @ 500ma max draw from USB (motorized focus 12 VDC @ 1A max)	5 VDC @ 500ma max draw from USB (motorized focus 12 VDC @ 1A max)	AC adaptor 110/220 vac, 50/60hz input to 12/24vdc nominal, <6w output (Difference noted)
Electrical Safety	Compliance with IEC-60601-1 and IEC 60601-1-2	Tested and found to comply.	(Not explicitly stated for predicate, but assumed to meet standards)
Software Validation	Validation performed for IR Flash Software v1.0	Performed.	(Not explicitly stated for predicate, but assumed to have been validated)

Study Information

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable/Not provided. The submission focuses on substantial equivalence based on technical specifications and non-clinical testing (electrical safety, software validation), rather than clinical performance against a specific test set of cases.
- Data Provenance: Not applicable, as there was no clinical study involving a test set of patient data described.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No ground truth establishment by experts for a clinical test set is described in this 510(k) summary.
Adjudication Method for the Test Set:
- Not applicable. No clinical test set or adjudication process is described.
If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Discussion of Clinical Tests Performed: Not applicable." This indicates no clinical performance study involving human readers with or without AI assistance was conducted or submitted.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- No, a standalone clinical performance study was not done. The device (ICI P and S Series IR Cameras and IR Flash Software) is a telethermographic system intended for adjunctive use. This means it provides data (skin surface temperature) to be interpreted in conjunction with other clinical diagnostic procedures by a human clinician. It is not an algorithm that autonomously diagnoses or provides a primary screening outcome. The software validation mentioned is likely for functional correctness and safety, not for diagnostic accuracy.
The Type of Ground Truth Used:
- Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used in the context of this 510(k) submission, as it did not involve clinical performance testing against a disease state. The "ground truth" implicitly referred to would be instrument calibration standards for thermal accuracy and engineering specifications for other technical parameters.
The Sample Size for the Training Set:
- Not applicable. This device is a thermal imaging system with visualization and reporting software, not an AI/ML diagnostic algorithm that requires a training set of labeled data in the conventional sense for clinical performance. The software validation would rely on test cases to ensure functionality, not a "training set" for an AI model.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there was no training set for an AI model. The validation of the device would involve testing against known physical standards (e.g., blackbody radiators for temperature accuracy) and software functional requirements.

Summary

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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: 409-861-0788 FAX: 409-866-7229 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: +1 800 322.3731 Fax: +1 503.498.3904 510(k) number: K033967

5. Device Description:

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 skinsurface temperature of any part of the body, and the IR FlashSoftware version 1.0, which provides visualization and reportingfunctionalities, are intended for use as an adjunct to other clinicaldiagnostic procedures in the diagnosis, quantifying, and screening ofrelative skin surface temperature.
	Environment of use: hospitals, sub-acute healthcare settings, publicareas, 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 50-60fpsP 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-bitoperating 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:

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 IRCamera(s) and the IR FlashSoftware version 1.0	A20M(K033967)
Intended Use	The ICI Series P and S IR Cameras,which provides capture of skinsurface temperature of any part of thebody, and the IR Flash Softwareversion 1.0, whichprovides visualization and reportingfunctionalities, are intended for use asan adjunct to other clinical diagnosticprocedures in the diagnosis,quantifying, and screening of relativeskin surface temperature.Environment of use: hospitals, sub-acute healthcare settings, publicareas, i.e., airport.	The Flir devices are intended for useas an adjunct to other clinicaldiagnostic procedures in thediagnosis, quantifying, and screeningof differences in skin surfacetemperature changes. It canvisualize, document temperaturepatterns and changes. Environmentof use: hospital, sub-acute, publicareas, 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/PALcomposite
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 50-60fpsSeries 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 ComputerHardware	USB 2.0 Compatible runningWindows XP or Windows Vista. 64-bit operating systems are notsupported at this time.	Ethernet connection, Video capturedevice to vonvert RS-170 video,Firewire 8/16-bit monochrome and 8-bit color
Power Supply	5 VDC @ 500ma max draw fromUSB. Systems with motorized focushave an additional 12 VDC supply @1 A max.	AC adaptor 110/220 vac, 50/60hzinput to 12/24vdc nominal, <6woutput

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 (240) 276-3150 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:

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 _

Regulation Number and Section

§ 884.2980 Telethermographic system.

(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)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.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.