(90 days)
The SafeTouch sheet and marking pen are used to mark the location of breast lumps that a woman may find while doing her monthly breast selfexamination.
SafeTouch® Breast Exam Recording Sheet
The provided FDA 510(k) summary for the "SafeTouch® Breast Exam Recording Sheet"does not contain information about acceptance criteria or a study proving device performance against such criteria.
This document is a letter from the FDA determining substantial equivalence for marketing the device. It typically does not include detailed performance studies, which are usually found in the original 510(k) submission itself or in separate technical documentation.
Therefore, I cannot extract the requested information from the provided text.
To answer your questions, I would need access to the actual 510(k) submission document, which would detail any performance testing conducted for the SafeTouch® device.
§ 884.2990 Breast lesion documentation system.
(a)
Identification. A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination.(b)
Classification. Class II (special controls). The device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document.