TensCare KegelFit

K142506 · Tenscare, Ltd. · KPI · Apr 20, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K142506
• Device Name: TensCare KegelFit
• Applicant: Tenscare, Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Apr 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K142506 · Apr 20, 2015	TensCare KegelFit	Tenscare, Ltd.	Customer reviews from 13,758 OTC sales of the predicate device (itouch Sure) via Amazon UK; Customer questionnaires sent to 120 users of the predicate device (itouch Sure)	The sponsor analyzed retrospective customer feedback and survey data from users of the predicate device to demonstrate that lay users can safely and effectively use the device for stress urinary incontinence without professional training.	Usability; OTC use; Customer feedback; Postmarket experience

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Analysis of Customer Reviews and Questionnaires; Retrospective analysis of customer reviews and user survey; Follow-up/Duration: 4 years; Study Period: 4 years	OTC users of the predicate device (itouch Sure) in the UK; Sample Size: 13,758 sales (reviews) and 120 survey recipients (21 responses); Number of Sites: Not applicable	Not applicable for this study	Usability, ease of use, and ability to follow instructions without training

Indications for Use

KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support. The KegelFit is intended for OTC sale.

Device Story

Hand-held, battery-powered neuromuscular stimulator for home use; treats female stress urinary incontinence. Device includes vaginal probe with two stainless steel electrodes; connects to control unit via cable. User inserts probe; device delivers electrical stimulation to pelvic floor muscles to induce contraction. Stimulation strengthens muscles; helps user identify target muscles for self-directed exercises. User controls stimulation intensity via manual push-buttons. Features include two preset treatment programs, timer, compliance monitor, and open-circuit detectors. Device intended for OTC use; patient operates independently without professional training. Output helps patient strengthen pelvic floor, improving urinary control and reducing incontinence symptoms.

Clinical Evidence

No clinical trials performed. Evidence consists of a clinical literature evaluation supporting electrical stimulation for stress urinary incontinence, plus usability analysis of 13,758 OTC sales and 21 user questionnaires from the predicate device (itouch Sure) to demonstrate safe lay-user operation.

Technological Characteristics

Battery-powered (2 AA) neuromuscular stimulator. Materials: ABS plastic (housing/probe), stainless steel (electrodes). Biocompatibility per ISO 10993. Waveform: Bi-phasic, rectangular. Output: Regulated current, max 90mA, 45V. Connectivity: Wired probe. Standards: IEC 60601-1, IEC 60601-1-11, EN 60601-1-2. Software: Moderate level of concern, firmware-controlled.

Indications for Use

Indicated for female patients with stress urinary incontinence to improve pelvic floor muscle strength and support. Contraindications include pregnancy, attempting to get pregnant, cardiac demand pacemaker or implanted defibrillator, active urinary tract infections, vaginal infections, localized lesions, extra-urethral or overflow incontinence, severe urine retention, poor pelvic sensation, cognitive disabilities (e.g., Alzheimer's, dementia), inability to properly insert the trainer, active pelvic cancer, intestinal clamp, or being less than 6 weeks post-pelvic surgery or vaginal childbirth.

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

• Apex (K141158)
• itouch Sure Pelvic Floor Exerciser (K103698)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

April 20, 2015

Tenscare Ltd. % Linda Stamschor US Agent Akos (Meddiquest) 17957 615th Street Kellogg, MN 55945

Re: K142506 Trade/Device Name: Tenscare KegelFit Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: November 6, 2014 Received: March 11, 2015

Dear Linda Stamschor,

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 (reporting of medical device

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

**Herbert P. Lerner -S**

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K142506

Device Name Tenscare KegelFit

Indications for Use (Describe)

KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence.

It applies stimulation to the pelvic floor muscles to improve strength and support.

The KegelFit is intended for OTC sale.

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Section5 510(k) Summary

Date of Summary prepared: 7th April 2015

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

# Address of the manufacturing facility:

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

FDA Establishment registration no: 3004049909

# Address of American Representative:

Linda Stamschror 17957 615th Street Kellogg Minnesota 55945 USA

Phone: [phone] Email: [e-mail]

#### ll Submitted Device:

| Generic name: | Pelvic Floor Stimulator |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Trade name: | TensCare KegelFit |
| Common name: | KegelFit 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 |

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#### ��� Predicate Devices:

| 510(k) | Name | Product Code | Class | Use | Manufacturer |
|---------------------|---------------------------------------------|--------------|-------|--------------|-----------------------------------------------------------------------------------|
| Primary Predicate | | | | | |
| K141158 | Apex | KPI | II | OTC | InControl Medical, LLC<br>3225 Gateway Road, Ste. 250<br>Brookfield, WI 53045 USA |
| Secondary Predicate | | | | | |
| K103698 | itouch Sure<br>Pelvic<br>Floor<br>Exerciser | KPI | II | Prescription | Tenscare Ltd<br>9 Blenheim Road, Epsom,Surrey,<br>KT19 9BE, UK |

#### Device Description: IV

The KegelFit is a hand-held, home-use device designed to treat female stress urinary incontinence. The device is supplied with a vaginal two electrode stimulation probe (Trainer). The trainer connects to the control unit by cable and plug and is inserted into the vagina by the end user. Electrical stimulation is delivered via stainless steel electrodes on the trainer to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.

The device is battery powered single channel home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.

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

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#### V The intended use of the device:

KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support.

The intended use and indications for use of the new device are the same as those of the predicate device Apex K141158

KegelFit for over-the-counter use was evaluated for safety in two ways:-

-Ability to self-diagnose and identify whether contraindication apply was established by detailed comparison with labeling and instructional packaging of the predicate device Apex K141158

-Ability to use effectively was established by analysis of customer reviews over 4 years and 13758 OTC sales of the predicate device itouch Sure K103698 through Amazon UK. The user manual was revised three times over this period in response to customer feedback and to comply with EN60601-1-11.

The device labeling and packaging (which includes a box, detailed instructions for use, and laminated quick reference guide) allow the end user to accurately self-diagnose and use the product to treat stress urinary incontinence.

#### VI Equivalence Comparison to the Predicate Devices

Electrical muscle stimulation is the technological principle for both KeqelFit and the predicate devices, Apex (K141158) and itouch Sure (K103698). It is based on the use of the electrical muscle stimulator to strengthen the pelvic floor muscles.

Table 6 below summarizes the shared and unique technological elements between the KegelFit, itouch Sure, and Apex devices. The technology, engineering, performance and user interface for KegelFit is substantially equivalent to the predicate devices.

Intended Use has been changed from prescription to OTC and from all types of incontinence only, and the available settings and labeling have been modified to allow for this change. The intended use, labeling and user interface for KegelFit is substantially equivalent to the predicate device Apex.

The KegelFit is a relabelled version of the itouch Sure(K103698). The components, electronics, and accessories are identical. The display and software have been modified in line with the change in Intended Use. The physical differences between the two versions of the product are:

| | KegelFit | Itouch Sure | Explanation |
|--------------------|---------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Program name | TRAIN | STRES | To be less technical, and stress the need for Kegel exercises. |
| Program name | X | URGE | Removed as Urge and Mixed are not included in the Intended Use |
| Program name | X | MIXED | Removed as Urge and Mixed are not included in the Intended Use |
| Treatment<br>Timer | Default 20 min ,<br>10 min selectable | Default 20 min, up to 60 min selectable | Only adverse report received was of over-use leading to muscle cramping. IFU amended.<br>Longer treatment times removed. |
| Keypad | On/Off Colour coded | | ON/OFF buttons colour coded to clarify operation |

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The KegelFit is substantially equivalent to the itouch Sure, which has been approved for home and hospital use on prescription.

Safety and effectiveness for home use with professional instruction is therefore established.

The KegelFit packaging and instructions for use are substantially equivalent to that of the Apex for the relevant criteria:-

- . How well the lay user can self-select themselves as being appropriate users
- Whether the lay user can understand all indications, contraindications, warnings and . precautions, and be able to identify whether they are within any contraindicated group.

This Substantial Equivalence is established by detailed comparison of labeling in Section 12. The KegelFit uses identical or substantially equivalent wording, frequency of use, and positioning of Intended Audience, Contraindications, Warnings and Cautions.

The final comparison is that of the ability of the lay user to be able to apply the treatment safely and correctly according to the instructions for use without training.

TensCare presents analysis of Customer Reviews from OTC sales of 13,768 units of itouch Sure through Amazon UK and 21 customer questionnaires sent to 120 users of itouch Sure as evidence that the lay user finds the device easy to use and the instructions easy to follow.

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# Table 6. Substantial Equivalence Comparison Table

| Features/<br>Function | A KegelFit K142506 | B Itouch Sure | C Apex K141158 | Comparison A/B | Impact on safety and performance | Comparison A/C | Impact on safety and performance |
|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>An explicit<br>description of all<br>clinical functions<br>performed by<br>the device, | | The Itouch Sure is a non-implanted<br>electrical stimulator indicated for<br>use in the treatment of female<br>urinary incontinence. It applies<br>electrical<br>stimulation to the pelvic floor<br>musculature and surrounding<br>structures | | | | | |
| Indications for<br>Use<br>Explain when the<br>device is to be<br>clinically used<br>and the intended<br>patient<br>population | KegelFit is a non-implanted<br>muscle stimulator designed to<br>treat female stress urinary<br>incontinence. It applies<br>stimulation to the pelvic floor<br>muscles to improve strength<br>and support. | The Itouch Sure is indicated for<br>acute and ongoing treatment of<br>stress, urge or mixed urinary<br>incontinence and where the<br>following results may improve<br>urinary control:<br>• Improvement of urethral<br>sphincter closure<br>• Strengthening of pelvic floor<br>muscles<br>• Inhibition of the detruser<br>(bladder) muscle through reflexive<br>mechanisms | Apex is a non-implanted muscle<br>stimulator designed to treat<br>female stress urinary<br>incontinence.<br>It applies stimulation to the pelvic<br>floor muscles to improve strength<br>and support. | Substantially<br>equivalent | None:<br>Both devices apply<br>electrical stimulation to<br>strengthen the pelvic<br>floor muscles, as<br>supported by literature,<br>see Section20.1 Clinical<br>Evaluation Report | Identical | None: |
| Features/<br>Function | A Kegelfit | B Itouch Sure | C Apex K141158 | Comparison<br>A/B | Impact on safety and<br>performance | Comparison<br>A/C | Impact on safety and<br>performance |
| Primary<br>Function | Delivery of electrical<br>stimulation | Delivery of electrical stimulation | Delivery of electrical stimulation | Identical | None | Identical | None |
| Warnings or<br>Precautions | (See product labeling) | | (See product labeling) | | | Substantially<br>Equivalent | The Warnings and<br>Cautions were based on<br>the predicate Apex<br>which was validated<br>through human factors<br>and Usability Testing.<br>Only minor changes<br>were made to allow for<br>the technical difference<br>between the products |
| Contra-<br>indications<br>Explain when the<br>device is not<br>to be clinically<br>used | • Do not use if you are<br>pregnant.<br>• Do not use if you are<br>attempting to get pregnant<br>• Do not use if you have a<br>cardiac demand pacemaker<br>or implanted defibrillator.<br>• Do not use if you have<br>symptoms of active urinary | Contraindications<br>Should not be used if you have any<br>of the following conditions:<br>• If you are pregnant or trying to<br>become pregnant<br>• If you have a heart pacemaker or<br>a heart rhythm problem<br>• If you have:<br>An active urinary tract infection<br>Infections or lesions in the area of<br>electrode placement | • Do not use if you are pregnant<br>• Do not use if you are<br>attempting to get pregnant<br>• Do not use if you have a cardiac<br>demand pacemaker or implanted<br>defibrillator<br>• Do not use if you have<br>symptoms of active urinary tract<br>infection, vaginal infections, or<br>localized lesions | Substantially<br>equivalent | None | Identical | None |
| | infections, or localized lesions<br>• Do not use if you have a<br>diagnosis of extra-urethral or<br>overflow incontinence<br>• Do not use if you have<br>severe urine retention<br>• Do not use if you have poor<br>sensation in the pelvic region<br>• Do not use if you have<br>cognitive disabilities, i.e.;<br>Alzheimer's disease or<br>dementia<br>• Do not use if you are unable<br>to properly insert the Trainer<br>• Do not use if you have<br>active pelvic cancer<br>• Do not use it you have an<br>intestinal clamp<br>• You must be 6 weeks post<br>pelvic surgery or vaginal<br>childbirth to use this device<br>• Do not use this device for<br>diagnostic purposes or critical<br>patient monitoring<br>• This device is not (external)<br>defibrillator-proof | History of urinary retention or<br>post-void residual volume greater<br>than 200cc<br>• Diminished sensory perception<br>• Inability to understand the<br>directions for use or operate the<br>device correctly<br>• If you have been diagnosed or<br>treated for cervical, or any pelvic,<br>cancer<br>• Recent history of vaginal bleeding<br>between menstrual periods<br>• If you have, or have had epilepsy | • Do not use if you have a<br>diagnosis of extra-urethral or<br>overflow incontinence<br>• Do not use if you have severe<br>urine retention<br>• Do not use if you have poor<br>sensation in the pelvic region<br>• Do not use if you have cognitive<br>disabilities, i.e.; Alzheimer's<br>disease or dementia<br>• Do not use if you are unable to<br>properly insert the device per<br>instructions<br>• Do not use if you have active<br>pelvic cancer<br>• Do not use if you have an<br>intestinal clamp<br>• You must be 6 weeks post-<br>pelvic surgery or vaginal<br>childbirth to use this device<br>• Do not use this device for<br>diagnostic purposes or critical<br>patient monitoring<br>• This device is not (external)<br>defibrillator-proof | | | | |
| | | • If any discomfort occurs when | | | | | |
| | | inserting the probe, consult your<br>treating physician. | | | | | |
| Features/<br>Function | A Kegelfit | B Itouch Sure | C Apex K141158 | Comparison<br>A/B | Impact on safety and<br>performance | Comparison<br>A/C | Impact on safety and<br>performance |
| Labeling<br>Summary<br>Clarity to insure<br>safer or more | User Manual<br>Retail Box<br>Contraindications insert | | User Manual<br>Retail Box<br>Contraindications insert | Substantially<br>equivalent | None:<br>The operating<br>instructions part of the<br>user manual is based on<br>the predicate, itouch<br>Sure,with references to<br>Urge and Mixed<br>programs removed.<br>Illustrations and Quick<br>Start guide were added<br>to further improve<br>usability | Substantially<br>equivalent | None.<br>See comparison table of<br>the self-diagnosis,<br>contraindications and<br>warnings. |
| effective use | Device controls | | Device controls | | | | |
| Environ-<br>mental<br>Specific-<br>ations | For indoor use only | For indoor use only | For indoor use only | Identical | None | Identical | None |
| Power Source | 2 AA Alkaline battery | 2 AA Alkaline battery | 4 AAA Alkaline battery | Identical | None | Substantially | None |
| | | | | | | equivalent | Battery insertion was<br>validated through<br>analysis of customer<br>reviews |
| Method of line<br>current<br>isolation | N/A (battery) | N/A (battery) | N/A (battery) | Identical | None | Identical | None |
| Patient<br>leakage<br>current | N/A (battery) | N/A (battery) | N/A (battery) | Identical | None | Identical | None |
| Number of<br>Output Modes | Two | Four | One | Substantially<br>Equivalent. | None<br>Matches alteration in<br>Intended Use | Substantially<br>equivalent | None. Customer reviews<br>indicate no difficulty in<br>using more than one<br>program |
| Number of<br>output<br>channels | 1 | 1 | 1 | Identical | None | Identical | None |
| Regulated<br>current or<br>voltage? | Regulated current | Regulated current | Regulated voltage | Identical | None | Substantially<br>equivalent | None<br>Both regulated current<br>and voltage have been<br>shown to be safe and<br>effective |
| Firmware<br>controlled? | Yes | Yes | Yes | Identical | None | Identical | None |
| Automatic<br>Overload Trip? | No | No | No…