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K Number
K974116
Device Name
PELVX INCONTINENCE RING
Manufacturer
DESCHUTES MEDICAL PRODUCTS, INC.
Date Cleared
1998-04-27

(178 days)

Product Code
HHW
Regulation Number
884.3575
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PelvX Incontinence Ring Vaginal Pessary is a vaginal pessary intended for treatment of of a sourinary incontinence.

Device Description

PelvX Incontinence Ring Vaginal Pessary

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the PelvX Incontinence Ring Vaginal Pessary. It confirms substantial equivalence to a predicate device for the treatment of urinary incontinence. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested table or answer the specific questions about the device's acceptance criteria and the study that proves it meets them based on the text provided. This letter is a regulatory approval, not a scientific study report.

§ 884.3575 Vaginal pessary.

(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).