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K Number
K982306
Device Name
POLYTUBE
Manufacturer
FERRIS MFG. CORP.
Date Cleared
1998-09-22

(83 days)

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

For the management, including cushioning of, and absorption of fluid around: Tracheostomy tube sites drainage tube sites Gastrointestinal tube sites feeding tube sites

Device Description

FERRIS POLYMEM POLYTUBE TUBE SITE DRESSING

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria. The text is a regulatory letter from the FDA regarding the 510(k) clearance of the Ferris Mfg. Corporation's Polytube device. It discusses the device's classification, marketing limitations, and general regulatory compliance. There is no mention of specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input.

N/A