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K Number
K212655
Device Name
Flyte
Manufacturer
Pelvital USA, Inc.
Date Cleared
2021-09-21

(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 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

This is an FDA premarket notification (510(k)) letter for the Pelvital USA, Inc. Flyte™ System. The letter itself does not contain detailed information about acceptance criteria or the study that proves the device meets those criteria. It primarily states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar intended use and technological characteristics as a device already on the market.

To answer your request, I would need access to the actual 510(k) submission (K212655) or accompanying clinical study documentation, which is not provided in these FDA letters. The provided text only confirms the clearance of the device and its intended use: "The Pelvital System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence."

Without the actual study data, I cannot provide the requested information regarding:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method
  5. Multi-reader multi-case (MRMC) comparative effectiveness study results
  6. Standalone performance
  7. Type of ground truth used
  8. Sample size for the training set
  9. How the ground truth for the training set was established

For this specific FDA letter, the requested details are not present.

§ 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).