(270 days)
The InTouch Thermal Camera is intended to view, measure and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by profession. This device is intended for use by qualified technical personnel trained in its use. Clinical judgment and experience are required to review and interpret the information transmitted.
The InTouch Thermal Camera is only for use in addition to other medical devices (i.e. Thermometer, Ultrasound, Mammography). It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition.
The InTouch Thermal Camera™ is a hardware and software package that enables thermographic imagery and data during a real-time telemedicine consultation. The system includes a 320-pixel-wide thermal camera and a USB cable that allows connection of the camera to a Windows-based computer, which serves as the patientside InTouch Health Telemedicine Device.
The InTouch Thermal Camera software consists of two components. The first is installed on a Windows-based system to serve as the InTouch Health Telemedicine Device. The second component is installed on a Windows or iOS-based system serving as the InTouch Health Provider Access device, enabling a healthcare professional access to the InTouch Health Telemedicine Device. The core software serves as a telecommunications platform that enables real-time videoconferencing and clinical communications, and provides a means of transmitting, receiving, and storing real-time audio and video data.
The InTouch Health Telemedicine System software provides a real-time link between the patient and the healthcare professional(s). The link occurs over a wired or wireless broadband connection, and includes real-time audio and video to facilitate communication between the patient-side healthcare professionals, and remote healthcare professional(s). The InTouch Health software further provides an ability to toggle between an InTouch Health Telemedicine Device's optical camera and the InTouch Thermal Camera, or to view both simultaneously.
When utilizing the InTouch Thermal Camera, the clinician is provided with interface controls to allow a variety of options in the visualization of the thermal imagery.
The basic purpose of the InTouch Thermal Camera is to allow a physician to view the heat pattern of a patient, while engaged in a telemedicine consultation. When the InTouch Thermal Camera is engaged, the InTouch Health software provides the physician with a variety of controls for visualizing temperature patterns and temperature differences.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (InTouch Thermal Camera) | Predicate Device Performance (Med-Hot Thermal Imaging System) |
|---|---|---|
| Imaging | ||
| Detector Type | Uncooled VOx microbolometer | Uncooled VOx microbolometer |
| Array Format | 320 x 256 | 320 x 240 |
| Pixel Pitch | 12 μm | 25 μm (Detector Pitch) |
| Spectral Range | Longwave infrared; 7.5 μm to 13.5 μm | Longwave infrared; 7.5 um to 13 um |
| Frame Rate | 60 Hz | 60 Hz |
| 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.