(84 days)
The Kegelmaster 2000 is intended to assist women in performing Kegel Exercises, which may help control stress urinary incontinence.
Not Found
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Details about experts for ground truth establishment.
- Adjudication method for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone algorithm performance study.
- Type of ground truth used in a study.
- Sample size for a training set.
- 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.
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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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 __
§ 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).