(108 days)
Not Found
No
The summary describes a standard electrical stimulation device for pelvic floor muscles and does not mention any AI or ML capabilities.
Yes.
The device is intended for "rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women", which is a therapeutic purpose.
No.
The device is described as a 'Pelvic Muscle Trainer' that provides electrical stimulation and neuromuscular re-education for rehabilitation of weak pelvic floor muscles, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is a "small lightweight battery powered dual channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe," indicating it includes hardware components beyond just software.
Based on the provided information, the 'Kegel8' Pelvic Muscle Trainer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide electrical stimulation and neuromuscular re-education for the rehabilitation of weak pelvic floor muscles and treatment of urinary incontinence. This is a therapeutic and rehabilitative purpose, not a diagnostic one.
- Device Description: The device is described as a neuromuscular stimulation device with a probe. This aligns with a physical therapy or rehabilitation device, not a device that analyzes biological samples (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition based on in vitro analysis.
Therefore, the 'Kegel8' Pelvic Muscle Trainer falls under the category of a therapeutic or rehabilitation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 'Kegel8' Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women
Product codes
KPI
Device Description
The 'Kegel8' Pelvic Muscle Trainer is a small lightweight battery powered dual channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe
The probe connects to the control unit by cable and plug The 'Kegel8' is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Federal (USA) law restricts this device to sale by or on the order of a physician
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
Performance testing was conducted on the Kegel8 Pelvic Muscle Trainer to demonstrate the integrity, suitability and substantial equivalence of the device
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
NE Services Ltd 14D iPark Innovation Drive HUS ISG UK
510(k) Summary
General Information 1.
| Trade Name of Device: | 'Kegel8' |
|---|---|
| Common/Usual Name: | Pelvic muscle trainer |
| Classification Name: | Non-implanted electrical continence device |
| Submitters Name and Address: | NE Services Ltd |
| 14D iPark | |
| Innovation Drive | |
| HU5 1SG | |
| UK | |
| Tel +44 (0) 1482 873377 | |
| Fax+44 (0) 1482 873570 | |
| Manufacturer: | Mantra International (HK) Ltd |
| Registration number 3003741750 |
2. Device Description
The 'Kegel8' Pelvic Muscle Trainer is a small lightweight battery powered dual channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe
The probe connects to the control unit by cable and plug The 'Kegel8' is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women
3. Indications for Use
The 'Kegel8' Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women
- Substantial Equivalence The 'Kegel8' Pelvic Muscle Trainer is substantially equivalent to: Athena Pelvic Muscle Trainer II (K033256).
Kog1480 Page
1
5. Performance Studies
Performance testing was conducted on the Kegel8 Pelvic Muscle Trainer to demonstrate the integrity, suitability and substantial equivalence of the device
6. Conclusion
Based upon the Indications for use and performance studies Kegel8 has been shown to be substantially equivalent for its intended use
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services (USA). The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2008
NE Services Ltd. % Mr. Brent Reider President International Trade Group, Inc. 4663 Kate Lane OXFORD OHIO 45056
Re: K081480
Trade/Device Name: 'Kegel8' Pelvic Muscle Trainer Regulation Number: 21 CFR 876.5320 Regulation Name: Non-implanted electrical continence device Regulatory Class: II Product Code: KPI Dated: August 28, 2008 Received: September 5, 2008
Dear Mr. Reider:
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 such 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 may publish further announcements concerning your device in the Federal Register.
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Page 2
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.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: 'Kegel8'
Indications For Use:
The 'Kegel8' Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvice floor muscles for the treatment of stress urge and mixed urinary incontinence in women
Federal (USA) law restricts this device to sale by or on the order of a physician
Prescription Use X (21 CFR 801 Subpart D) _ AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Hubert Lemon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number _
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