(48 days)
My Breast Friend Breast Self-exam Pad is indicated as an aid for performing breast selfexamination.
The My Breast Friend Breast Self-exam Pad is a thin polyurethane bladder containing a small quantity of silicone and air fluids. The very thin nature of the material allows the pad to conform to the patient's breast tissue and for the patient to observe a reduction in friction. The very thin and flexible bladder provides easy sliding between the upper and lower surfaces of the bladder and allows the patient to sense subtle tissue density variations.
The provided text is related to a 510(k) submission for the "My Breast Friend Breast Self-exam Pad." The submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting novel performance studies and acceptance criteria as would be required for new device approvals.
Therefore, the document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or the other requested information such as sample sizes, expert qualifications, or ground truth establishment.
Instead, the submission states:
- Performance Standard: "No mandatory or voluntary standards are applicable."
- Substantial Equivalence: "The My Breast Friend Self-exam Pad is substantially equivalent to the currently marketed devices, Sensor Pad (K973450) and Aware Pad (K991469)."
The FDA's letter confirms their review and determination of substantial equivalence based on the indications for use. This pathway implies that the new device's safety and effectiveness are considered equivalent to a legally marketed predicate device, and thus, extensive new clinical performance data demonstrating specific acceptance criteria are not typically required in the same way as for a PMA or novel device.
§ 892.1940 Radiologic quality assurance instrument.
(a)
Identification. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.