(204 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the device description focuses on basic image capture and visualization.
No.
The device is used for diagnosis, quantifying, and screening of relative skin surface temperature, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature." This directly indicates a diagnostic purpose.
No
The device description explicitly lists hardware components (ICI P or S Series IR Camera, USB Cable, Tripp-Lite model IS250HG isolation transformer) in addition to the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this system captures skin surface temperature of any part of the body. This is a measurement taken directly from the body, not from a specimen (like blood, urine, tissue, etc.).
- The purpose is to measure skin surface temperature. While this information can be used as an adjunct to clinical diagnosis, it is not a test performed on a biological sample to detect or measure substances within that sample.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LHQ
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.
Components of the system include:
ICI P or S Series IR Camera
USB Cable
Tripp-Lite model IS250HG isolation transformer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
any part of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of use: hospitals, sub-acute healthcare settings, public areas, i.e., airport.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
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.
1
| 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 |
| 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. | |
| 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 |
| P Series Camera |