(211 days)
K0181480
Not Found
No
The summary describes a standard electrical stimulation device for pelvic muscle training and does not mention any AI or ML components or 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 indicates a therapeutic rather than a diagnostic purpose.
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.
Based on the provided information, the 'NuTracTM Pelvator' 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 to treat urinary incontinence. This is a therapeutic and rehabilitative purpose, not a diagnostic one.
- Device Description: The device is a neuromuscular stimulation device with a probe for electrical stimulation. It does not involve the examination of specimens (like blood, urine, or tissue) outside the body, which is a key characteristic of IVDs.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the 'NuTracTM Pelvator' Pelvic Muscle Trainer falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 'NuTrac™ Pelvator' 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 'NuTrac™ Pelvator' 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 'NuTrac™ Pelvator' 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
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
Prescription Use
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 NuTrac™ Pelvator Pelvic Muscle Trainer to demonstrate the integrity, suitability and substantial equivalence of the device
Key Metrics
Not Found
Predicate Device(s)
K0181480
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
SECTION 5.0
JUL 1 4 2009
Verity Scientific Ltd, Unit 2A, Chilbolton Down Farm Stockbridge SO20 6BU Hampshire . England UK Tel: +44 (0)1264 810 102 510(k) Summary
1. General Information
Trade Name of Device:
Common/Usual Name:
Classification Name:
Submitters Name and Address:
Manufacturer:
Pelvic muscle trainer
'NuTrac™ Pelvator'
Non-implanted electrical continence device
Verity Scientific Ltd. Unit 2A, Chilbolton Down Farm Stockbridge SO20 6BU, Hampshire England UK Tel: +44 (0)1264 810 102
Mantra International (HK) Ltd. 1504 Vigor Industrial bldg Block B, 14-20 Cheung Tat Road Tsing Yi, Hong Kong, China Registration Number: 3003741750
2. Device Description
The 'NuTrac™ Pelvator' 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 'NuTrac™ Pelvator' 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
3. Indications for Use
The 'NuTracTM Pelvator' 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
4. Substantial Equivalence
The 'NuTrac™ Pelvator' Pelvic Muscle Trainer is substantially equivalent the "Kegel8" Pelvic Muscle Trainer (K0181480) to:
1
5. Performance Studies
.
Performance testing was conducted on the NuTrac™ Pelvator 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 NuTrac™ Pelvator has been shown to be substantially equivalent for its intended use
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Verity Scientific Ltd. % Mr. Brent Reider President International Trade Group, Inc. 4663 Kate Lane OXFORD OHIO 45056
JUL 1 4 2009
Re: K083704
Trade/Device Name: NuTrac™ Pelvator, Model PEL 200 Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: Class II Product Code: KPI Dated: June 30, 2009 Received: July 6, 2009
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 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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
3
Page 2 - Mr. Brent Reider
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Helon Lemun
Janine M. Morris Acting Director, Division of Reproductive Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: 'NuTrac™ Pelvator'
Indications For Use:
The 'NuTracTM Pelvator' 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
Federal (USA) law restricts this device to sale by or on the order of a physician
AND/OR Over-The-Counter Use X Prescription Use (21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Heiler Peum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number.
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