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K Number
K031660
Device Name
FERRIS POLYMEM STERILE BREAST PAD
Manufacturer
FERRIS MFG. CORP.
Date Cleared
2005-02-22

(636 days)

Product Code
NTX
Regulation Number
880.5630
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Over the Counter Use: To be worn inside the bra to:

  • Soothe tender, sore, irritated, cracked or painful nipples caused by breastfeeding .
  • Absorb milk leakage .
  • Protect the nipple from abrasion and friction damage caused by bra or clothing .
  • Help alleviate discomfort .
  • Protect clothing from milk leakage .
Device Description

FERRIS PolyMem® STERILE BREAST PAD

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Ferris PolyMem® STERILE BREAST PAD". It does not describe acceptance criteria, a study proving device performance, or any of the other information requested in the prompt related to an AI/algorithm-based device.

Therefore, I cannot provide the requested information from the given text.

The document is a regulatory approval for a physical medical device (breast pad), not a software or AI-driven device that would involve performance metrics like accuracy, sensitivity, specificity, or studies with test sets, ground truth, or expert adjudications.

§ 880.5630 Nipple shield.

(a)
Identification. A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.(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 § 880.9.