(84 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, or related concepts, and the device description (though not found) and intended use suggest a simple mechanical device.
Yes
The device is intended to assist in performing Kegel exercises which "may help control stress urinary incontinence," indicating a therapeutic purpose to alleviate a medical condition.
No
The device's intended use is to assist in performing Kegel exercises to help control stress urinary incontinence, which is a therapeutic or assistive function, not a diagnostic one.
No
The provided 510(k) summary does not contain enough information to determine if the device is software-only. The "Device Description" section is missing, which is crucial for understanding the nature of the device. The intended use suggests a physical device used for exercise, not necessarily software.
Based on the provided information, the Kegelmaster 2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist women in performing Kegel Exercises to help control stress urinary incontinence. This is a physical therapy/exercise aid, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Device Description: While the description is "Not Found," the intended use clearly points away from IVD functionality.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic information, or any of the typical characteristics of an IVD.
Therefore, the Kegelmaster 2000 falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Kegelmaster 2000 is intended to assist women in performing Kegel Exercises, which may help control stress urinary incontinence.
Product codes
85 HIR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings or feathers. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
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.
1
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
2
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 __