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K Number
K023305
Device Name
KEGELMASTER 2000
Manufacturer
KEGELMASTER 2000 LTD.
Date Cleared
2002-12-26

(84 days)

Product Code
HIR
Regulation Number
884.1425
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
Predicate For
K122800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Kegelmaster 2000 is intended to assist women in performing Kegel Exercises, which may help control stress urinary incontinence.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification decision letter from the FDA regarding the KegelMaster™ 2000. This document primarily focuses on the regulatory aspects of device approval based on substantial equivalence to a predicate device, rather than detailing specific acceptance criteria and the results of a scientific study proving those criteria were met for this particular device.

Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving those criteria were met. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination, not a summary of performance data from a specific study against predefined acceptance criteria for the KegelMaster™ 2000 itself.

The document includes:

  • Regulatory information: Device name, regulation number, regulatory class, product code, and the FDA's determination of substantial equivalence.
  • Indications for Use: "The Kegelmaster 2000 is intended to assist women in performing Kegel Exercises, which may help control stress urinary incontinence."

However, it lacks:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Details about experts for ground truth establishment.
  4. Adjudication method for a test set.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Results from a standalone algorithm performance study.
  7. Type of ground truth used in a study.
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

Without a detailed study report, which is not part of this 510(k) clearance letter, I cannot provide the requested information.

§ 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).