(205 days)
The Infrared Sciences BreastScan IR™ System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.
The BreastScan IR ™ System is a new, non-invasive procedure offered to women, of any age, to determine current breast health by measuring various temperature parameters in the breast. Designed exclusively by Infrared Sciences Corp., BreastScan IR ™ System has demonstrated its effectiveness as an adjunctive tool for the doctor to use along with mammography, ultrasound, or clinical examination. The entire procedure takes approximately 10 minutes with the results immediately available, to assist in the doctor's determination of breast health. The results are analyzed by proprietary algorithms and then presented in a non-subjective report. The procedure does not involve any compression of the breast, or touching of the breast in any way. The patient simply sits in a chair, facing an infrared camera for a few minutes.
Components of the system include:
Infrared System Device
Color Inkjet Printer
TVNCR
Medical Cart
BreastScan IR Server
Air Cooling Device
Patient Chair
The provided text is a 510(k) summary for the Infrared Sciences BreastScan IR™ System. It discusses the device's description, intended use, and comparison to a predicate device. However, it explicitly states "Discussion of Clinical Tests Performed: Not applicable."
Therefore, based only on the provided document, the following information cannot be extracted:
- Acceptance criteria and reported device performance (Table 1): No clinical performance data or acceptance criteria are discussed.
- Sample size for the test set and data provenance: No clinical studies were performed.
- Number of experts and their qualifications for ground truth establishment: No clinical studies were performed.
- Adjudication method for the test set: No clinical studies were performed.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No clinical studies were performed.
- Standalone (algorithm-only) performance: No clinical studies were performed.
- Type of ground truth used: No clinical studies were performed.
- Sample size for the training set: No information on algorithm training data is provided.
- How ground truth for the training set was established: No information on algorithm training data is provided.
The document only discusses non-clinical tests for substantial equivalence, such as compliance with IEC-60601-1 and IEC 60601-1-2, and software validation. It concludes that the device is substantially equivalent to the predicate device based on its intended use and similar characteristics, and that differences in technological characteristics do not raise new questions of safety or effectiveness.
§ 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.