(108 days)
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
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
The provided text is a 510(k) summary for the 'Kegel8' Pelvic Muscle Trainer. It states that "Performance testing was conducted on the Kegel8 Pelvic Muscle Trainer to demonstrate the integrity, suitability and substantial equivalence of the device." However, it does not include any specific acceptance criteria or the results of the performance study itself. Instead, it concludes that the device is substantially equivalent to a predicate device (Athena Pelvic Muscle Trainer II - K033256) based on its indications for use and general performance studies.
Therefore, the requested information cannot be fully extracted from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that performance testing was conducted, but it does not specify any acceptance criteria (e.g., specific thresholds for electrical output, safety limits, or clinical effectiveness metrics) nor does it report the actual performance results of the device against any such criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "performance studies" but gives no details about the sample size, type of study (e.g., clinical trial, bench test), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided and is not applicable. This type of information is typically relevant for studies involving diagnostic or screening devices where expert interpretation is crucial for establishing ground truth. The 'Kegel8' is a therapeutic device (pelvic muscle trainer), so "ground truth" would likely be objective physiological measurements or patient-reported outcomes rather than expert consensus on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided and is not applicable. Similar to point 3, adjudication methods are usually applied in expert review scenarios for diagnostic outputs, which is not the primary function of this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided and is not applicable. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The 'Kegel8' is a physical device for muscle stimulation, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided and is not applicable. This concept applies to AI algorithms. The 'Kegel8' is an electrical stimulation device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be explicitly provided, but inferred not applicable to the context. For a pelvic muscle trainer, "ground truth" in a clinical study would typically involve objective measurements of pelvic floor muscle strength (e.g., using manometry or electromyography) or patient-reported outcomes related to incontinence symptoms. The document does not specify what type of data was collected in its "performance studies."
8. The sample size for the training set
- Cannot be provided and is not applicable. The device is a physical electromyostimulator, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Cannot be provided and is not applicable. As mentioned in point 8, this device does not utilize a training set in the context of AI.
{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 Ltd14D iParkInnovation DriveHU5 1SGUKTel +44 (0) 1482 873377Fax+44 (0) 1482 873570 |
| Manufacturer: | Mantra International (HK) LtdRegistration 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
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 _
Page 1 of 1
§ 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).