KEGELMASTER 2000

K023305 · Kegelmaster 2000 , Ltd. · HIR · Dec 26, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K023305
• Device Name: KEGELMASTER 2000
• Applicant: Kegelmaster 2000 , Ltd.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Dec 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

KegelMaster 2000 is a perineometer used by women to assist in performing pelvic floor muscle (Kegel) exercises. The device provides resistance to aid in muscle strengthening, which may help control stress urinary incontinence. It is intended for over-the-counter use. The device functions as a mechanical aid for exercise; it does not involve electronic signal processing, software, or automated analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Perineometer; mechanical resistance device for pelvic floor muscle exercise. No electronic components, software, or energy sources.

Indications for Use

Indicated for women seeking to perform Kegel exercises to assist in the control of stress urinary incontinence.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

DEC 2 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KegelMaster 2000 Ltd. c/o Ms. Yolanda Smith Smith Associates P.O. Box 4341 CROFTON MD 21114

## Re: K023305

Trade/Device Name: KegelMaster™ 2000 Regulation Number: 21 CFR §884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: 85 HIR Dated: September 30, 2002 Received: October 3, 2002

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy Crozdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known):

Device Name: Kegelmaster 2000

Classification Panel: 884.1425

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

or

**Over the Counter Use**

Nancy C hoadon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __