TENSCARE ITOUCH SURE MODEL ITS

K103698 · Tenscare, Ltd. · KPI · Jun 21, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103698
• Device Name: TENSCARE ITOUCH SURE MODEL ITS
• Applicant: Tenscare, Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Jun 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The itouch Sure 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

Device Story

TensCare itouch Sure is a battery-powered, single-channel neuromuscular electrical stimulation (NMES) device for home use. It utilizes a vaginal probe with two stainless steel electrodes to deliver bi-phasic, rectangular electrical pulses to pelvic floor muscles. The device features four preset treatment programs, adjustable intensity (200 steps), and an adjustable timer. It operates in intermittent mode to facilitate muscle re-education. The patient controls the device via push buttons; a compliance monitor tracks usage. The device incorporates open circuit detectors and controls output at constant voltage (above 500 Ω) or pseudo-constant current (below 500 Ω) to ensure safety. By stimulating pelvic floor muscles, the device aims to strengthen musculature, thereby assisting in the management of urinary incontinence. Healthcare providers prescribe the device, and patients operate it independently at home.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (EN60601-1-2:2007), biocompatibility testing (ISO 10993-5:2009 and -10:2002), risk analysis, and FMEA. Post-market feedback from European distribution since 2009 was used to support safety and performance claims.

Technological Characteristics

Battery-powered (2x1.5V AA) NMES device. Vaginal probe constructed of ABS plastic and stainless steel electrodes. Bi-phasic, rectangular waveform. Output: 0-45V (0-90mA over 500 Ω). Constant voltage (>500 Ω) and pseudo-constant current (<500 Ω) control. 4 preset programs. Connectivity: None. Sterilization: Not specified. Software: Embedded firmware for program control and compliance monitoring.

Indications for Use

Indicated for women with weak pelvic floor muscles requiring rehabilitation for the treatment of stress, urge, and 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

• Innova Pelvic Floor Stimulation System by EMPI (K941911)
• Kegel 8 Pelvic Muscle Trainer by NE Services (K81480)

Submission Summary (Full Text)

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K103698 PG 1/3

# 510(k) Summary

JUN 2 1 2011

Date of Summary prepared: April 27th, 2011

: Submitter Tenscare Ltd 9 Blenheim Road, Longmead Business Park, Epsom, Surrey, KT19 9BE, Address . United Kingdom : [phone] Tel Fax : [phone] : E-Mail [e-mail] FDA Establishment registration no: 3003446042 Contact person: Andrew Brown

#### Address of the manufacturing facility:

EasyMed Instrument Ltd 5F/6F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, Shunde, Foshan, Guangdong, China, Zip: 528300

FDA Establishment registration no: 3004049909

#### Address of American Representative:

DEBORAH IAMPIETRO QRC CONSULTING ASSOCIATES 130 Gotzens Rd Conway, NH 03818 Phone: [phone] ext Fax: [phone] Email: [e-mail]

## Submitted Device:

| Generic name: | Pelvic Floor Stimulator |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Trade name: | TensCare itouch Sure |
| Common name: | itouch Sure Pelvic Floor Exerciser |
| Classification name: | Stimulator, Electrical, Non-implantable, for Incontinence –<br>Title 21, Code of Federal Regulations Sec.876.5320 ProCode: 78 KPI |
| Device Classification: | Class II |
| Predicate Devices: | Innova Pelvic Floor Stimulation System by EMPI. K941911<br>Kegel 8 Pelvic Muscle Trainer by NE Services. K81480 |

#### The class of the predicate Devices: Class II

#### Device Description:

The itouch Sure is a small lightweight battery powered single channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug.

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The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has four preset treatment programs, an adjustable treatment timer, a compliance monitor, and open circuit detectors.

#### The intended use of the device:

The itouch Sure 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 intended use and indications for use of the new device are the same as those of the predicate devices.

### Technological Comparison:

| | Itouch Sure | EMPI Innova<br>K941911 | Kegel 8<br>K81480 |
|--------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------|
| Intended Use | Treatment of urinary<br>incontinence | Treatment of urinary<br>incontinence | Treatment of urinary<br>incontinence |
| Programmable<br>features | Intensity, program<br>session length | Intensity, 12.5/50 Hz,<br>Duty cycle: 5-5/5-10<br>session length | Intensity,<br>session length, Hz, us,<br>Work, Rest, Ramp |
| Preset Programs | 4 | | 9 +manual |
| Power source | 2x1.5V AA | 9V PP3 | 9V PP3 |
| Mode of operation | Intermittent | Intermittent | Intermittent |
| Frequency Hz | 10/20/35/50 | 12.5/50 | 2-100 |
| Pulse Width uS | 200/250/300 | 300 | 50-450 |
| Duty cycle | 5/10 and 3/6 | 5-5/5-10 | Selectable |
| Output current | 0-45V = 0-90mA<br>over 500 Ohm | 0-60mA (100mA<br>override) | 0-90 mA nominal |
| Intensity steps | 200 | Rotary | 100 |
| Timing control | | Continuous/15/30 min | |
| Output type | Constant current<br>160-500 Ω,<br>Constant voltage<br>500-1500 Ω | Nominally constant<br>current up to 1kΩ | Nominally constant<br>current |
| No of electrodes | 1 | 1 (optional anal probe) | 2 |
| Usage conditions | Intermittent | Intermittent | Intermittent |
| Controls | 6 Push buttons +<br>lock button on side | Two rotary intensity<br>Duty cycle slider switch<br>Intensity override<br>switch | 6 Push buttons + 2<br>concealed buttons |
| Probe length mm | 88 | | 87 |
| Probe diameter mm | 28 | | 26 |
| Electrode orientation | Axial | | Axial |
| Electrode material | Stainless Steel | | Stainless Steel |
| Electrode placement | Vaginal | | Vaginal |
| Waveform Type | Bi-phasic | Bi-phasic | Bi-phasic |
| Waveform Shape | Rectangular at<br>positive | Irregular Rectangular | Rectangular at positive |

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| Output waveforms: | The Sure output waveform is substantially equivalent to that of the<br>Kegel 8. The difference in shape of negative phase is not clinically<br>significant. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | The materials of the vaginal electrode are exactly the same as the<br>materials of the Kegel 8 probe by NE Systems.<br><br>Body material: Acrylonitrile-Butadiene-Styrene copolymer (ABS)<br>Conductor Material: Stainless steel<br><br>Biocompatibility tests to ISO 10993-5:2009 and -10:2002 on the<br>vaginal electrode have shown no cytotoxicity, negligible vaginal<br>irritation, and no sensitisation. |
| Labelling Comparison: | The Labelling is substantially equivalent to that of the predicate<br>devices. |
| Safety information: | Designed to comply with relevant safety applicable recognized<br>consensus standards; the output energy is controlled well within the<br>safety and effectiveness ranges specified by relevant FDA guidance.<br>Detailed and strictly controlled testing has been carried out.<br>Test results, Risk Analysis, and FMEA analysis show that the new unit<br>itouch Sure is safe with no hazard.<br><br>itouch Sure has been marketed in Europe since April 2009. During this<br>period a review of Customer Complaints, Returned Product and the<br>results of Post Market Feedback, has demonstrated that the product<br>has performed as intended, to its' Specified Requirements.<br>The new device itouch Sure controls the output at constant voltage<br>above 500 Ω load. Below this it controls the output at a pseudo<br>constant current, with output voltage reducing to zero as load reduces.<br>This characteristic reliably makes the device safe. |
| EMC testing: | The Sure has been tested to EN60601-1-2:2007 and found to be<br>suitable for use in domestic establishments and in establishments<br>directly connected to a low voltage power supply network which<br>supplies buildings used for domestic purposes. |
| Submitted times: | This is the first submission to FDA for this new device |
| Conclusion: | The itouch Sure unit is substantially equivalent to the predicate<br>devices and any differences between the devices do not pose any<br>new questions of safety and effectiveness. |

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Andrew Brown Regulatory Affairs Manager Tenscare Ltd. 9 Blenheim Road Epsom. Surrey UNITED KINGDOM KT19 9BE

#### JUN 2 1 2011

Re: K103698

Trade/Device Name: Tenscare itouch Sure Pelvic Floor Exerciser Regulation Number21 CFR §876.5320 Regulation Name: Non-implanted electrical continence device Regulatory Class: II Product Code: KPI Dated: May 18, 2011 Received: May 18, 2011

Dear Mr. Brown:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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.

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

Strict are 607) productionDevices/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,

Hubert Lenoir MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4 Indications for Use

510(k) Number (if known):

Device Name

: Tenscare itouch Sure Pelvic Floor Exerciser

#### Indications for Use

The itouch Sure 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

Halum

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103698

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)