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 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. 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.

AI/ML Overview

The TensCare itouch Sure Pelvic Floor Exerciser (K103698) is a Class II device intended to provide electrical stimulation and neuromuscular re-education for the rehabilitation of weak pelvic floor muscles to treat stress, urge, and mixed urinary incontinence in women.

The submission does not include a separate study that establishes acceptance criteria and proves the device meets them in the way clinical performance studies with specific endpoints would. Instead, the FDA's "substantial equivalence" determination for this 510(k) submission is based on a technological comparison to predicate devices. This means the device is deemed safe and effective because its technological characteristics and intended use are similar to those of devices already legally marketed, and any differences do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" here are inherent to the regulatory process for substantial equivalence, focusing on whether the new device is as safe and effective as its predicates based on a comparison of their features and performance characteristics.

Here’s an interpretation of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not explicit numerical targets from a performance study but rather the demonstration that the TensCare itouch Sure's technical specifications and safety profile are comparable to the predicate devices.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported TensCare itouch Sure Performance (as stated in the document)
Intended Use Equivalence: Treatment of urinary incontinence	"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." (Same as predicates)
Technological Equivalence (Key Parameters):	(See detailed comparison table in the "Technological Comparison" section of the 510(k) summary)
Frequency (Hz)	10/20/35/50 (Comparable to predicates, e.g., K941911: 12.5/50; K81480: 2-100)
Pulse Width (uS)	200/250/300 (Comparable to predicates, e.g., K941911: 300; K81480: 50-450)
Output Current/Voltage	0-45V = 0-90mA over 500 Ohm; Constant current 160-500 Ω, Constant voltage 500-1500 Ω (Comparable to predicates, e.g., K941911: 0-60mA (100mA override); K81480: 0-90 mA nominal)
Waveform Type & Shape	Bi-phasic, Rectangular at positive (Substantially equivalent to Kegel 8; difference in negative phase not clinically significant)
Biocompatibility: Probe materials are safe for patient contact.	Materials (ABS, Stainless Steel) are the same as Kegel 8 probe. Biocompatibility tests (ISO 10993-5:2009 and -10:2002) showed no cytotoxicity, negligible vaginal irritation, no sensitization.
Safety: Compliance with relevant safety standards, controlled output energy, no new safety hazards.	Designed to comply with recognized consensus standards. Output energy controlled within safety/effectiveness ranges. Test results, Risk Analysis, FMEA show it is safe. Device controls output at constant voltage > 500 Ω and pseudo-constant current < 500 Ω, reliably making it safe. No significant complaints or adverse events reported during European market experience (since April 2009). EMC tested to EN60601-1-2:2007.
Labelling Equivalence: Consistent with predicate devices.	"The Labelling is substantially equivalent to that of the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

This submission does not discuss a clinical "test set" in the traditional sense of a performance study with patient data. The evaluation primarily relies on engineering tests, comparisons to existing devices, and a review of post-market experience in Europe.

Sample Size: Not applicable in terms of a clinical test set. The "sample" is the device itself and its components.
Data Provenance:
- Engineering Test Data: Originates from internal testing conducted by Tenscare Ltd. (United Kingdom) and EasyMed Instrument Ltd. (China) to verify physical and electrical specifications (e.g., frequency, pulse width, output current, EMC testing).
- Biocompatibility Data: Results from tests performed according to ISO 10993 standards. The location of the testing lab is not specified but is likely external or internal testing related to the manufacturing process.
- Post-Market Data: Retrospective review of customer complaints, returned products, and post-market feedback since April 2009 (European market).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is not a study that involved expert interpretation or ground truth establishment from clinical cases. The "ground truth" for substantial equivalence is primarily defined by the performance and safety profiles of the legally marketed predicate devices, as well as validated engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or data, which is not relevant for this electrical stimulator.

6. Standalone (Algorithm Only) Performance Study

No. This device is an electrical stimulator, not an algorithm, so a standalone performance study in that context is not applicable. Its performance is assessed through its physical outputs and safety characteristics.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established by:

Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (EMPI Innova K941911 and Kegel 8 K81480).
Engineering and Safety Standards: Compliance with recognized consensus standards like IEC 60601-1-2:2007 for EMC and ISO 10993-5:2009 and -10:2002 for biocompatibility.
Manufacturing Specifications: The device reliably performs according to its documented technical specifications.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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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 : +44(0)1372 723 434 Tel Fax : +44(0)1372 745 434 : E-Mail sales@tenscare.co.uk 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: 603 4476086 ext Fax: 734 4236086 Email: grcassoc@aol.com

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 –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. K941911Kegel 8 Pelvic Muscle Trainer by NE Services. K81480

The class of the predicate Devices: Class II

Device Description:

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

Technological Comparison:

	Itouch Sure	EMPI InnovaK941911	Kegel 8K81480
Intended Use	Treatment of urinaryincontinence	Treatment of urinaryincontinence	Treatment of urinaryincontinence
Programmablefeatures	Intensity, programsession length	Intensity, 12.5/50 Hz,Duty cycle: 5-5/5-10session length	Intensity,session length, Hz, us,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 = 0-90mAover 500 Ohm	0-60mA (100mAoverride)	0-90 mA nominal
Intensity steps	200	Rotary	100
Timing control		Continuous/15/30 min
Output type	Constant current160-500 Ω,Constant voltage500-1500 Ω	Nominally constantcurrent up to 1kΩ	Nominally constantcurrent
No of electrodes	1	1 (optional anal probe)	2
Usage conditions	Intermittent	Intermittent	Intermittent
Controls	6 Push buttons +lock button on side	Two rotary intensityDuty cycle slider switchIntensity overrideswitch	6 Push buttons + 2concealed 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 atpositive	Irregular Rectangular	Rectangular at positive

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Output waveforms:	The Sure output waveform is substantially equivalent to that of theKegel 8. The difference in shape of negative phase is not clinicallysignificant.
Biocompatibility	The materials of the vaginal electrode are exactly the same as thematerials of the Kegel 8 probe by NE Systems.Body material: Acrylonitrile-Butadiene-Styrene copolymer (ABS)Conductor Material: Stainless steelBiocompatibility tests to ISO 10993-5:2009 and -10:2002 on thevaginal electrode have shown no cytotoxicity, negligible vaginalirritation, and no sensitisation.
Labelling Comparison:	The Labelling is substantially equivalent to that of the predicatedevices.
Safety information:	Designed to comply with relevant safety applicable recognizedconsensus standards; the output energy is controlled well within thesafety and effectiveness ranges specified by relevant FDA guidance.Detailed and strictly controlled testing has been carried out.Test results, Risk Analysis, and FMEA analysis show that the new unititouch Sure is safe with no hazard.itouch Sure has been marketed in Europe since April 2009. During thisperiod a review of Customer Complaints, Returned Product and theresults of Post Market Feedback, has demonstrated that the producthas performed as intended, to its' Specified Requirements.The new device itouch Sure controls the output at constant voltageabove 500 Ω load. Below this it controls the output at a pseudoconstant current, with output voltage reducing to zero as load reduces.This characteristic reliably makes the device safe.
EMC testing:	The Sure has been tested to EN60601-1-2:2007 and found to besuitable for use in domestic establishments and in establishmentsdirectly connected to a low voltage power supply network whichsupplies 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 predicatedevices and any differences between the devices do not pose anynew 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 (800) 638-2041 or (301) 796-7100 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

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)

Regulation Number and Section

§ 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).