(371 days)
Not Found
No
The document describes standard thermographic imaging and analysis software, with no mention of AI, ML, or related concepts.
No
The device is described as an adjunct to other clinical diagnostic procedures and is used to quantify differences in skin surface temperature changes, visualizing and digitalizing body surface temperature distribution. It does not provide treatment or directly apply therapy to the body.
Yes
The "Intended Use / Indications for Use" section states: "The AG Thermographic Camera... is intended to use as an adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes." This clearly indicates its role in supporting diagnosis.
No
The device description explicitly states that the device "consists of an infrared camera, accessories, and PC visualization/analysis software," indicating it includes hardware components (the infrared camera and accessories) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AG Thermographic Camera measures and visualizes skin surface temperature changes using infrared technology. It is a non-contact, non-invasive method that does not involve analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's an "adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes." This indicates it's a tool for observation and measurement of a physical characteristic (temperature) on the body's surface, not a test performed on a biological sample.
Therefore, while it's a medical device used for diagnostic purposes, it falls under the category of in vivo (performed on a living organism) rather than in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LHQ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
Skin surface/body surface
Indicated Patient Age Range
adult human targets
Intended User / Care Setting
qualified healthcare personnel trained in its use.
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 were conducted to ensure the device can work as the intended performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Thermal Sensitivity:
§ 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
1 :: :
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: | +886-2- 23575809 |
| Fax: | +886-2-23575845 |
| 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
1
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
ATIR-M301 | FLIR A20M | TELESIS
SPECTRUM
9000MB |
|---------------------------|------------------------------------------|--------------------------------------|----------------------------------------|
| Technology | FPA uncooled
Mircrobolometer | FPA uncooled
Mircrobolometer | FPA uncooled
Mircrobolometer |
| Material | Amorphous
Silicon | Amorphous
Silicon | VOx |
| Spectral
Response | 8 ~ 14um | 7.5 ~ 13 um | 7 ~ 14 um |
| Array
Resolution | 320x240 | 160x120 | 320x240 |
| Thermal
Sensitivity |