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K Number
K210764
Device Name
Flyte
Manufacturer
Pelvital USA, Inc.
Date Cleared
2021-04-13

(29 days)

Product Code
HIR
Regulation Number
884.1425
Type
Special
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Pelvital Flyte™ System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the Pelvital Flyte™ System, a device intended for strengthening pelvic floor muscles to help women with stress urinary incontinence.

Unfortunately, the document does not contain any information regarding the following:

  • Acceptance criteria for device performance.
  • The study that proves the device meets acceptance criteria.
  • Reported device performance metrics.
  • Sample size used for the test set or data provenance.
  • Number of experts used to establish ground truth or their qualifications.
  • Adjudication method.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of AI assistance on human readers.
  • Whether standalone (algorithm only) performance was done.
  • The type of ground truth used.
  • The sample size for the training set.
  • How the ground truth for the training set was established.

This document is primarily a regulatory clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices and outlining the regulatory requirements for the manufacturer. It does not delve into the specific details of performance studies or acceptance criteria.

To obtain the information requested, one would typically need to refer to the 510(k) summary or other supporting documentation submitted by the manufacturer to the FDA, which would detail the performance data and testing conducted for the device. This information is not present in the provided FDA clearance letter.

§ 884.1425 Perineometer.

(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).