(15 days)
Not Found
No
The description mentions "algorithmic interpretation" and "algorithmic derivative" for converting infrared data to temperature data and generating images, but does not mention or imply the use of AI or ML techniques. The lack of information on training or test sets further supports this.
No
The device is described as an "adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes," indicating it aids in diagnosis rather than directly treating, mitigating, or preventing disease, which are characteristics of a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "for use as an adjunct to other clinical diagnostic procedures." This explicitly identifies its role in the diagnostic process.
No
The device description explicitly states it is a "thermal imaging system" and describes the process of a camera capturing infrared radiation, which is then converted to temperature data by software. This indicates the device includes a hardware component (the camera) in addition to the software.
Based on the provided information, the MedHot MTI 2000 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.
- MedHot MTI 2000 Function: The MedHot MTI 2000 is a thermographic imaging device that captures and interprets infrared radiation emitted from the skin surface. It is a non-contact, non-invasive device.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly measures and images the temperature of the skin.
Therefore, because the device operates by imaging the external surface of the body and does not involve the analysis of in vitro samples, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for qualified healthcare personnel who are trained in its use; The MedHot MTI 2000 is a non-contact, non-invasive, non-radiating, thermographic imaging device for use as an adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes.
The device can digitally render quantitative images of thermal data via the capture and algorithmic interpretation of relative infrared information from the imaging camera in collaborative use with a compatible computer system which provides a user interface and image storage.
Patient populations and environmental use includes all age groups from adult to pediatric and neonatal in hospital, sub acute and public areas i.e. airports.
Product codes (comma separated list FDA assigned to the subject device)
LHQ
Device Description
The MedHot MTI 2000 thermal imaging system is a non-invasive system that provides the user a visual representation of thermal temperature data in the form of a quantitative image on the users computer screen. The process begins by the cameras' capture of a data array representative of infrared radiation naturally emitted by the object being imaged; the data array is converted to a temperature data array using an algorithmic derivative. Once the infrared data is in the form of temperature data, software on the user's computer is used to generate an image from the rendered temperature data. The user can use this image in a number of ways to quantify the temperature of objects imaged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Thermal Imaging
Anatomical Site
Skin surface
Indicated Patient Age Range
all age groups from adult to pediatric and neonatal
Intended User / Care Setting
qualified healthcare personnel ... in hospital, sub acute and public areas i.e. airports.
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)
Non-Clinical Testing:
Camera unit was successfully tested for EMC and EMI compliance as per IEC 60601-1-2 requirements. Power supply also conforms to appropriate medical grade stines on
Clinical Testing:
Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KO63047
Exhibit C
510(k) Summary
0C1 1 9 2006
| Name and address of sponsor of the
| 510(k) submission: | MedHot Thermal Imaging, Inc. |
|---|---|
| 315 Doris Drive, Lakeland. Florida - 33813 | |
| Official contact person for all | |
| correspondence: | Carol Chandler (address as above) |
| Phone: 863 709 9565, Fax: 863 619 7525 | |
| E-mail: infrared@tampabay.rr.com | |
| Date Prepared: | Sept 27, 2006 |
| Device Name: | MedHot MTI 2000 Thermal Imaging System |
| Generic name of the device: | Telethermographic System (Adjunctive) |
| Classification, Product Code and | |
| CFR Regulation Number: | Class I, LHQ and 21 CFR 884.2980 |
| Classification Panel: | Obstetrics/Gynecology |
| Predicate Device Name: | Telethermographic camera Series A, E, P, and S |
| Predicate 510(k) Number: | K033967 |
Device Description:
The MedHot MTI 2000 thermal imaging system is a non-invasive system that provides the user a visual representation of thermal temperature data in the form of a quantitative image on the users computer screen. The process begins by the cameras' capture of a data array representative of infrared radiation naturally emitted by the object being imaged; the data array is converted to a temperature data array using an algorithmic derivative. Once the infrared data is in the form of temperature data, software on the user's computer is used to generate an image from the rendered temperature data. The user can use this image in a number of ways to quantify the temperature of objects imaged.
014
1
| MedHot MTI 2000 | A20M | |
|---|---|---|
| Technology / Detector | FPA UC Microbolometer | FPA UC Microbolometer |
| Material | Amorphous Silicon | Amorphous Silicon |
| Spectral Response | 7-14 µm | 7.5-13 µm |
| Thermal Sensitivity |