NUTRAC PELVATOR, MODEL PEL 200

K083704 · Verity Scientific , Ltd. · KPI · Jul 14, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083704
• Device Name: NUTRAC PELVATOR, MODEL PEL 200
• Applicant: Verity Scientific , Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Jul 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

NuTrac™ Pelvator is a battery-powered, dual-channel neuromuscular stimulation device; includes vaginal two-electrode probe connected via cable to control unit. Device delivers electrical stimulation to pelvic floor muscles for neuromuscular re-education; intended for rehabilitation of weak muscles to treat urinary incontinence. Used by women under physician prescription. Output provides targeted electrical pulses to stimulate muscle contraction; assists in strengthening pelvic floor, potentially reducing incontinence symptoms.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Battery-powered, dual-channel neuromuscular electrical stimulation device. Includes vaginal two-electrode probe. Non-implanted electrical continence device (21 CFR 876.5320).

Indications for Use

Indicated for women with weak pelvic floor muscles requiring rehabilitation for stress, urge, or mixed urinary incontinence.

Regulatory Classification

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).

Predicate Devices

• Kegel8 Pelvic Muscle Trainer (K018148)

Submission Summary (Full Text)

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SECTION 5.0

K083704/

JUL 1 4 2009

Verity Scientific Ltd, Unit 2A, Chilbolton Down Farm Stockbridge SO20 6BU Hampshire . England UK Tel: [phone] 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: [phone]

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 [phone] or [phone] 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):

K083704

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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