(211 days)
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
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 provided text is a 510(k) summary for the 'NuTrac™ Pelvator' Pelvic Muscle Trainer. It does not contain specific acceptance criteria, detailed study results, or information typically found in a clinical trial report.
Based on the provided text, here's what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria are mentioned in the provided text. The document refers to "Performance testing [...] to demonstrate the integrity, suitability and substantial equivalence of the device" but does not detail what those performance tests were, nor does it provide any quantitative results or metrics against which acceptance criteria would be measured.
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a "test set" sample size or data provenance is provided. The document states "Performance testing was conducted," but no details about the datasets used are given.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. No information about expert review or ground truth establishment is mentioned in the context of performance studies.
4. Adjudication Method:
Not applicable. No information about adjudication methods is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not mentioned. The document focuses on demonstrating "substantial equivalence" to a predicate device, which typically involves comparing technical characteristics and indications for use, rather than a direct comparison of human reader performance with or without AI assistance. The device in question is a pelvic muscle trainer, not an AI-assisted diagnostic tool.
6. Standalone Performance Study (Algorithm Only):
Not applicable. The 'NuTrac™ Pelvator' is a physical device (an electrical stimulator) for pelvic muscle training, not a standalone algorithm. Therefore, "algorithm only" performance is not relevant in this context. The document mentions "Performance testing" of the device itself.
7. Type of Ground Truth Used:
Not applicable. The concept of "ground truth" as typically used in the context of AI or diagnostic device performance evaluation is not relevant here. The device's performance likely relates to electrical stimulation parameters, safety, and functionality, rather than diagnostic accuracy against a definitive "truth."
8. Sample Size for the Training Set:
Not applicable. There is no mention of a "training set" as this device is not an AI-driven diagnostic or analytical tool that undergoes machine learning training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned.
Summary of Available Information from the Provided Text:
The provided document is a 510(k) summary from 2009 for the 'NuTrac™ Pelvator' Pelvic Muscle Trainer. Its primary purpose is to demonstrate substantial equivalence to a predicate device ("Kegel8" Pelvic Muscle Trainer, K0181480).
- Study: Performance testing was conducted on the device to demonstrate its integrity, suitability, and substantial equivalence.
- Conclusion: Based on the indications for use and performance studies, the device was deemed substantially equivalent for its intended use.
- Missing Information: The document explicitly lacks the detailed clinical study design, acceptance criteria, specific performance metrics, sample sizes, data provenance, expert involvement, or any information related to ground truth that would be necessary to answer the questions posed. The focus is on regulatory equivalence rather than a detailed scientific performance report.
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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:
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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.
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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.
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).