(41 days)
The IRIS XP is a thermal based imaging device intended for measuring relative skin temperature generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. (for adjunctive use only)
The IRIS XP provides for use with both laptop and desktop computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her of the patient's medical condition and requirements. The patient populations include all assessment age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use.
The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.
IRIS-XP shows an image analysis on the display to measure the amount of infrared rays radiated from the patient. The appropriate color image according to the temperature difference is shown on the screen. The IRIS XP is intended for relative skin temperature measurements (temperature mapping) for adjunctive use only.
The provided text is a 510(k) summary for the IRIS-XP device, which is a thermal based imaging device. It primarily focuses on demonstrating substantial equivalence to a predicate device (MEDITHERM MED2000) rather than presenting a detailed study proving the device meets specific acceptance criteria in the format requested.
Therefore, many of the requested categories cannot be directly extracted from the provided document. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the IRIS-XP to its predicate device." This means that a clinical study designed to prove the device meets acceptance criteria as typically understood for performance metrics (like sensitivity, specificity, accuracy against a ground truth) was not performed.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, or image quality against a predefined benchmark for a diagnostic task). Instead, it relies on demonstrating that its technical characteristics (specifications) are substantially equivalent to a predicate device.
The closest to "acceptance criteria" and "reported performance" are the technical specifications compared in Table 1 (page 6-7). The implicit acceptance criterion for this submission is that its technical specifications and indications for use are similar enough to the predicate device to not raise new questions of safety or effectiveness.
| Acceptance Criterion (Implicitly by comparison to predicate) | Reported Device Performance (IRIS-XP) | Predicate Device (MEDITHERM MED2000) | Rationale for Substantial Equivalence (from Table 2/text) |
|---|---|---|---|
| Indications for Use | Measuring relative skin temperature, adjunctive use, clinical/hospital/acute care settings, by qualified healthcare professionals, for all age groups, providing thermal images; not for absolute temperature measurements or as a thermometry device. | Viewing and digitally storing thermal patterns; adjunctive use, clinical/hospital/acute care settings, by qualified healthcare professionals, for all age groups, providing thermal images. | The indications for use are the same. |
| Temperature Range | 14.5°C to 40°C | 0°C to 50°C | "The most important temperature range is same to predicate device." (Implies overlap/sufficiency) |
| Relative Temperature Measurement Accuracy |
§ 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.