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K Number
K241899
Device Name
Pelvic Floor Stimulator (Intrelief PFE)
Manufacturer
EasyMed Instruments Co., Ltd.
Date Cleared
2024-11-27

(152 days)

Product Code
KPI
Regulation Number
876.5320
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Device Description

Not Found

AI/ML Overview

I apologize, but this document does not contain the information you requested regarding acceptance criteria and the comprehensive study details.

The document is an FDA 510(k) clearance letter for a "Pelvic Floor Stimulator (Intrelief PFE)." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

However, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes for test or training sets.
  • Information on data provenance (country of origin, retrospective/prospective).
  • Number or qualifications of experts used for ground truth.
  • Adjudication methods.
  • Results of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
  • Results of a standalone (algorithm-only) performance study.
  • The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
  • How ground truth for any training set was established.

This letter focuses on the regulatory clearance process rather than providing a detailed technical or clinical study report.

§ 876.5320 Nonimplanted electrical continence device.

(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).