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 Description

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.

AI/ML Overview

The provided text does not contain specific acceptance criteria with numerical thresholds, nor does it detail a clinical study with a control group and effect sizes to prove that the Tenscare KegelFit device meets such criteria. Instead, the submission focuses on establishing substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics, intended use, and safety documentation.

Here's an breakdown of the information that can be extracted from the document, organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria with specific numerical targets (e.g., "sensitivity > 90%") for the device's clinical performance are not provided in this document. The document focuses on demonstrating substantial equivalence to predicate devices, rather than meeting novel performance criteria through new clinical endpoints.

Instead of formal "acceptance criteria," the document outlines areas of comparison to establish substantial equivalence. The "reported device performance" is framed in terms of its similarity to predicates and successful safety testing.

Feature/Function (Analogous to Acceptance Criteria)	Tenscare KegelFit Performance (Reported Device Performance)	Comparison to Predicate A (itouch Sure)	Comparison to Predicate C (Apex)
Intended Use	Non-implanted muscle stimulator for female stress urinary incontinence, applies stimulation to pelvic floor muscles to improve strength and support.	Substantially equivalent (after removing Urge and Mixed incontinence programs, and modifying label for OTC).	Identical
Indications for Use	Treats female stress urinary incontinence by applying stimulation to pelvic floor muscles.	Substantially equivalent (removed non-stress incontinence indications).	Identical
Primary Function	Delivery of electrical stimulation.	Identical	Identical
Safety - Software	"Moderate" level of concern. Passed V&V.	Identical	Identical
Safety - Electrical	Complies with IEC 60601-1 and IEC60601-1-11. EMC tested to EN60601-1-2:2007.	Identical (to itouch Sure, concerning 21 CFR 898 for cable/lead).	Substantially equivalent (Apex has no leads for comparison).
Safety - Biocompatibility	Vaginal electrode material (ABS, stainless steel) tested per ISO 10993-5:2009 and ISO 10993-10:2002.	Identical (same electrode as itouch Sure).	Substantially equivalent (different materials, but both cleared).
Labeling Clarity for OTC Use	Designed for self-diagnosis of SUI and identification of contraindications, and effective use based on instructions.	Substantially equivalent (operating instructions based on itouch Sure, revised for usability).	Substantially equivalent (based on Apex for self-diagnosis, contraindications, warnings).
Usability/Ease of Use (for OTC)	Instructions easy to follow/device easy to use without training.	Supported by customer reviews of itouch Sure.	Supported by customer reviews of itouch Sure.
Output Modes	Two (TRAIN / 50Hz Stress, 35Hz Tone).	Substantially Equivalent (Reduced from four in itouch Sure, matching altered Intended Use).	Substantially equivalent (increased from one in Apex).
Max Output Voltage (500Ω)	45V	Identical	Substantially equivalent (Apex 34.2V, both deemed safe/effective).
Max Output Current (500Ω)	90mA	Identical	Substantially equivalent (Apex 68.2mA, both deemed safe/effective).
Max Phase Charge (500Ω)	18.6 μC	Identical	Substantially equivalent (Apex 13.6 μC; Apex is monophasic).
Max Current Density	10.46 mA/cm2	Identical	Substantially equivalent (Apex 11.6 mA/cm2; both deemed safe/effective).
Max Average Power Density (500Ω)	5.84 mW/cm2	Identical	Substantially equivalent (Apex 3.95 mW/cm2; no special requirement for home use).

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

The "testing" mentioned is not a human clinical trial test set in the traditional sense, but rather a combination of:

Customer Reviews Analysis:
- Sample Size: 13,758 OTC sales of the predicate device "itouch Sure" through Amazon UK.
- Data Provenance: Retrospective, derived from customer reviews in the UK (EU market at the time).
Customer Questionnaires:
- Sample Size: 21 responses received from 120 users of "itouch Sure" who purchased OTC through eBay UK.
- Data Provenance: Prospective (questionnaires sent out), with data from UK (EU market).
Labeling Comparison: Not a "test set" in terms of subject count, but a comparison of documents.
Clinical Literature Evaluation: Not a specific test set, but a review of existing literature.

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

Customer Reviews/Questionnaires: No medical experts established "ground truth" for the usability and self-diagnosis aspects derived from customer feedback. The "truth" in this context is the aggregated perception and experience of lay users.
Labeling Comparison: The comparison was performed by the submission authors (Tenscare Ltd.). The qualifications of these individuals are not specified in the provided text.
Clinical Literature Review: This implies an expert review, but the number and specific qualifications of the individuals who conducted this review are not stated.

4. Adjudication Method for the Test Set

Customer Reviews/Questionnaires: There is no mention of a formal adjudication method by experts. The analysis involved reviewing customer feedback.
Labeling Comparison: This was a direct comparison done by the submitter, not requiring an adjudication panel.
Clinical Literature Review: No specific adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an electrical muscle stimulator, not an AI-powered diagnostic tool requiring human reader interpretation of images or other data. This type of study is not relevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Tenscare KegelFit is a physical medical device (muscle stimulator) intended for home use by patients, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable. The device's performance is inherently linked to its use by a human operator. Its "standalone" performance might refer to its functional specifications (e.g., electrical parameters) which were tested in electrical safety and EMC tests, but not in a "standalone algorithm" context.

7. The Type of Ground Truth Used

For safety and effectiveness: The "ground truth" relies on:
- Substantial equivalence to predicate devices: The established safety and effectiveness of the existing itouch Sure and Apex devices (which presumably had their own ground truth established in prior clearances).
- Clinical literature evaluation: Existing medical literature on the efficacy of electrical stimulation for stress urinary incontinence.
For usability and self-selection for OTC use: The "ground truth" was established by:
- Customer feedback/reviews: Direct user experience and statements regarding ease of use and understanding of instructions and contraindications. This serves as a proxy for "ground truth" in the context of user comprehension for an OTC product.

8. The Sample Size for the Training Set

Not Applicable. The Tenscare KegelFit is not an AI/ML algorithm that requires a "training set" of data. It is a hardware medical device with pre-programmed settings.

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

Not Applicable. As there is no AI/ML algorithm or training set, this question does not apply.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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	:	+44(0)1372 723 434
Fax	:	+44(0)1372 745 434
E-Mail	:	andrew.brown@tenscare.co.uk
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: 507 767 2258 Email: wallisfowler@gmail.com

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 –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, LLC3225 Gateway Road, Ste. 250Brookfield, WI 53045 USA
Secondary Predicate
K103698	itouch SurePelvicFloorExerciser	KPI	II	Prescription	Tenscare Ltd9 Blenheim Road, Epsom,Surrey,KT19 9BE, UK

Device Description: IV

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
TreatmentTimer	Default 20 min ,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.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/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 UseAn explicitdescription of allclinical functionsperformed bythe device,		The Itouch Sure is a non-implantedelectrical stimulator indicated foruse in the treatment of femaleurinary incontinence. It applieselectricalstimulation to the pelvic floormusculature and surroundingstructures
Indications forUseExplain when thedevice is to beclinically usedand the intendedpatientpopulation	KegelFit is a non-implantedmuscle stimulator designed totreat female stress urinaryincontinence. It appliesstimulation to the pelvic floormuscles to improve strengthand support.	The Itouch Sure is indicated foracute and ongoing treatment ofstress, urge or mixed urinaryincontinence and where thefollowing results may improveurinary control:• Improvement of urethralsphincter closure• Strengthening of pelvic floormuscles• Inhibition of the detruser(bladder) muscle through reflexivemechanisms	Apex is a non-implanted musclestimulator designed to treatfemale stress urinaryincontinence.It applies stimulation to the pelvicfloor muscles to improve strengthand support.	Substantiallyequivalent	None:Both devices applyelectrical stimulation tostrengthen the pelvicfloor muscles, assupported by literature,see Section20.1 ClinicalEvaluation Report	Identical	None:
Features/Function	A Kegelfit	B Itouch Sure	C Apex K141158	ComparisonA/B	Impact on safety andperformance	ComparisonA/C	Impact on safety andperformance
PrimaryFunction	Delivery of electricalstimulation	Delivery of electrical stimulation	Delivery of electrical stimulation	Identical	None	Identical	None
Warnings orPrecautions	(See product labeling)		(See product labeling)			SubstantiallyEquivalent	The Warnings andCautions were based onthe predicate Apexwhich was validatedthrough human factorsand Usability Testing.Only minor changeswere made to allow forthe technical differencebetween the products
Contra-indicationsExplain when thedevice is notto be clinicallyused	• Do not use if you arepregnant.• Do not use if you areattempting to get pregnant• Do not use if you have acardiac demand pacemakeror implanted defibrillator.• Do not use if you havesymptoms of active urinary	ContraindicationsShould not be used if you have anyof the following conditions:• If you are pregnant or trying tobecome pregnant• If you have a heart pacemaker ora heart rhythm problem• If you have:An active urinary tract infectionInfections or lesions in the area ofelectrode placement	• Do not use if you are pregnant• Do not use if you areattempting to get pregnant• Do not use if you have a cardiacdemand pacemaker or implanteddefibrillator• Do not use if you havesymptoms of active urinary tractinfection, vaginal infections, orlocalized lesions	Substantiallyequivalent	None	Identical	None
	infections, or localized lesions• Do not use if you have adiagnosis of extra-urethral oroverflow incontinence• Do not use if you havesevere urine retention• Do not use if you have poorsensation in the pelvic region• Do not use if you havecognitive disabilities, i.e.;Alzheimer's disease ordementia• Do not use if you are unableto properly insert the Trainer• Do not use if you haveactive pelvic cancer• Do not use it you have anintestinal clamp• You must be 6 weeks postpelvic surgery or vaginalchildbirth to use this device• Do not use this device fordiagnostic purposes or criticalpatient monitoring• This device is not (external)defibrillator-proof	History of urinary retention orpost-void residual volume greaterthan 200cc• Diminished sensory perception• Inability to understand thedirections for use or operate thedevice correctly• If you have been diagnosed ortreated for cervical, or any pelvic,cancer• Recent history of vaginal bleedingbetween menstrual periods• If you have, or have had epilepsy	• Do not use if you have adiagnosis of extra-urethral oroverflow incontinence• Do not use if you have severeurine retention• Do not use if you have poorsensation in the pelvic region• Do not use if you have cognitivedisabilities, i.e.; Alzheimer'sdisease or dementia• Do not use if you are unable toproperly insert the device perinstructions• Do not use if you have activepelvic cancer• Do not use if you have anintestinal clamp• You must be 6 weeks post-pelvic surgery or vaginalchildbirth to use this device• Do not use this device fordiagnostic purposes or criticalpatient monitoring• This device is not (external)defibrillator-proof
		• If any discomfort occurs when
		inserting the probe, consult yourtreating physician.
Features/Function	A Kegelfit	B Itouch Sure	C Apex K141158	ComparisonA/B	Impact on safety andperformance	ComparisonA/C	Impact on safety andperformance
LabelingSummaryClarity to insuresafer or more	User ManualRetail BoxContraindications insert		User ManualRetail BoxContraindications insert	Substantiallyequivalent	None:The operatinginstructions part of theuser manual is based onthe predicate, itouchSure,with references toUrge and Mixedprograms removed.Illustrations and QuickStart guide were addedto further improveusability	Substantiallyequivalent	None.See comparison table ofthe self-diagnosis,contraindications andwarnings.
effective use	Device controls		Device controls
Environ-mentalSpecific-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 wasvalidated throughanalysis of customerreviews
Method of linecurrentisolation	N/A (battery)	N/A (battery)	N/A (battery)	Identical	None	Identical	None
Patientleakagecurrent	N/A (battery)	N/A (battery)	N/A (battery)	Identical	None	Identical	None
Number ofOutput Modes	Two	Four	One	SubstantiallyEquivalent.	NoneMatches alteration inIntended Use	Substantiallyequivalent	None. Customer reviewsindicate no difficulty inusing more than oneprogram
Number ofoutputchannels	1	1	1	Identical	None	Identical	None
Regulatedcurrent orvoltage?	Regulated current	Regulated current	Regulated voltage	Identical	None	Substantiallyequivalent	NoneBoth regulated currentand voltage have beenshown to be safe andeffective
Firmwarecontrolled?	Yes	Yes	Yes	Identical	None	Identical	None
AutomaticOverload Trip?	No	No	No	identical	None:	identical	None:
Automatic No-Load Trip?	Yes	Yes	No	identical	None:	Substantiallyequivalent	None:KegelFit offers additionaluser protection
AutomaticShut Off?	Yes	Yes	No	Identical	None	SubstantiallyEquivalent.	Apex user must switchoff at end of session
Patient OverrideControl?	Yes	Yes	No	Identical	None	SubstantiallyEquivalent.	None. Customer reviewsindicate no difficulty inusing this facility
IndicatorDisplay• On/Off Status• Low Battery	YesYes	YesYes	Yes (via display illumination)No	Identical	None	Substantiallyequivalent	None:Kegelfit offers additionalinformation.Message is easilyunderstood andcustomer reviewsindicate no difficulty inusing this facility
Display- Voltage/CurrentLevel?	Yes LCD	Yes LCD	Yes combination of two LEDs	Identical	None	Substantiallyequivalent	LCD readout is muchsimpler thancombination of staticand flashing LEDs
Waveform,	Bi-phasic	Bi-phasic	Monophasic, alternating polarity,	Identical	None	Substantiallyequivalent	None.Both waveforms are
shape	Rectangular at positive	Rectangular at positive	square pulse	Identical	None	Substantiallyequivalent	approved in predicatedevices
Frequency• Mixed• Stress• Urge	- Hz50 Hz-Hz	20 Hz50 Hz10 Hz	50 Hz	Substantiallyequivalent	None	Substantiallyequivalent	None.Both predicate deviceshave been approved assafe and effective.
• Tone	35 Hz	35Hz
Pulse width							No special requirementdemonstrated for homeuse
• Mixed		250μs
• Stress	300μs	300μs	200 μs
• Urge		250μs
• Tone	250μs	250μs
Time On +ramp				Substantiallyequivalent	Programs removed inline with change inintended use	Substantiallyequivalent	None.All settings have beenapproved for use onpredicate devices
• Mixed		7 seconds on
• Stress	7 seconds on	7 seconds on	1 second on
• Urge		7 seconds on
• Tone	5 seconds on	5 seconds on
Time Off				Substantiallyequivalent	Programs removed inline with change inintended use	Substantiallyequivalent	None.All settings have beenapproved for use onpredicate devices
• Mixed		10 seconds off	2 seconds off
• Stress	10 seconds off	10 seconds off
• Urge		10 seconds off
• Tone	6 seconds off	6seconds off
Total SessionTime	Default 20 minutesAdjustable to 10 minutes.	Default 20 minutesAdjustable to 10,20,30,45,60 and 90minutes	Total session time of 10-15minutes• 5-10 minutes electricalstimulation• 5 minutes self-directedcontraction (recommended)	Substantiallyequivalent	None.Longer session timesremoved in response tocustomer feedback	Substantiallyequivalent	None
Compliance*with 21 CFR 898Cable and leadrequirements.	Yes	Yes	N/A	Identical	None	SubstantiallyEquivalent.	NoneNo leads in Apex device
Max outputvoltage (500Ω)	45V	45V	34.2 V	Identical	None	Substantiallyequivalent	None.Both predicate devices
Max outputcurrent (500Ω)	90mA	90mA	68.2 mA	Identical	None	Substantiallyequivalent	have been approved assafe and effective.
Maximumphase charge(500Ω)	18.6 μC	18.6 μC	13.6 μC	Identical	None	Substantiallyequivalent	Apex is monophasic, sonet charge=max charge
Electrodesurface area	8.58 cm2	8.58 cm2	5.88 cm2	Identical	None	Substantiallyequivalent	None.Both predicate devices
Max currentdensity	10.46 mA/cm2	10.46 mA/cm2	11.6 mA/cm2	Identical	None	Substantiallyequivalent	have been approved assafe and effective.
Max averagepower density(500Ω)	5.84 mW/cm2	5.84 mW/cm2	3.95 mW/cm2	Identical	None	Substantiallyequivalent	No special requirementfor home use
Dimensions(Insertion Unit)	TrainerWeight: 0.7 oz (20 gm)Length:2.87" (73 mm)(inserted part)Width:1.1" (28mm) dia(widest point)	TrainerWeight: 0.7 oz (20 gm)Length:2.87" (73 mm) (insertedpart)Width:1.1" (28mm) dia (widestpoint)	Overall Insertion Unit: 12.2"x2.5"x 4.0"	Identical	None	Substantiallyequivalent	None
Controlhousingmaterial	ABS plastics	ABS plastics	N/A	Identical	None	N/A
Insertionmaterial	ABS plasticsStainless steel	ABS plasticsStainless steel	Silicone, plasticsStainless steel	Identical	None	Substantiallyequivalent
Packaging orExpiration	N/A	N/A	1 year for insertion unit	Identical	None	Substantiallyequivalent	None:Expiration dating is not
Dating							needed based on the
							stability of thematerials chosen.
Sterilization	N/A	N/A	N/A	Identical	None	Identical	None
Features/Function	A Kegelfit	B Itouch Sure	C Apex K141158	ComparisonA/B	Impact on safety andperformance	ComparisonA/C	Impact on safety andperformance
OperationalMethod:ClinicalUsee.g., ambulatoryuse, home use	Home use, Over-the-counter	Clinic or Home use, under directionof physician	Home use, Over-the-counter	Substantiallyequivalent	None:An over-the-counterindication does notimpact safety becausethe stimulation iscontrolled by the enduser per end userresponse.Safety features are builtinto the design of thedevice for the maximumoutput, overload andshort circuit, andautomatic shut-off.	Identical	None
PatientInteraction:FunctionsControllable:An explanation ofhow the deviceinteracts withthe patient.	The end user can control theelectrical stimulation levelsand the starting and stoppingof each session. However, thedevice will stop on its ownonce the session is normallycompleted.	The patient can control theelectrical stimulation levels and thestarting and stopping of eachsession. However, the device willstop on its own once the session isnormally completed.	The end user can control theelectrical stimulation levels andthe duration of the stimulationsession.	Substantiallyequivalent	None.Option to increasetreatment time has beenremoved to improvesimplicity of use.User feedback indicatedthat some users weretempted to over-use tospeed recovery	Substantiallyequivalent	None:Control is by pushbuttonin both devices.Customer Reviews showthat the additionalbuttons in the KegelFitare clear and easy tounderstand.KegelFit also displaysintensity, treatment timeremaining, and lowbattery warning.
PatientInteraction:ProgrammingCapabilityWhether thedevice can beprogrammed andto what extent	Electrical stimulation levelsare set by the end userEnd user can choose betweentwo stimulation programs.End user can reduce thesession timer	Electrical stimulation levels are setby the end userEnd user can choose between fourstimulation programs.End user can reduce or increase thesession timer	Electrical stimulation levels areset by the end user	Substantiallyequivalent	None.Both stimulationprograms are provensafe and effective.Reduced timer setting isthe same as thatrecommended for theApex.	Substantiallyequivalent	None.Although Kegelfit offersa choice of programs,both are effective forstress incontinence.
PatientInteraction:OperatorRequirementsKnowledge ortraining requiredof the operator,	Intended as part of acomplete therapyprogram with physiciancoaching. No specialknowledge or training;instruction manual provided	Over-the-counter device. No special knowledge or training required;instruction manual provided	Over-the-counter device. Nospecial knowledge or trainingrequired; instruction manualprovided	Substantiallyequivalent	None:The KegelFit device hasfewer optional settings.In both cases, no specialknowledge or training isrequired.	Identical	None
Software Levelof Concern	Moderate	Moderate	Moderate	Identical	None	Identical	None

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VII Testing Summary

The following performance testing was provided in support of the substantial equivalence. The testing for KegelFit included software, electrical safety, biocompatibility and clinical. KegelFit successfully passed all testing.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, We determine that the level of concern of the new device KegelFit is Moderate; the decision-making process is as follows:

Prior to mitigation of hazards, a failure of the Software Device cannot result in death or serious injury, either to a patient or to a user of the device. Therefore not level of concern is not Major.

But, prior to mitigation of hazards, a failure of the Software Device can result in Minor injury, such as electrical shock, either to a patient or to a user of the device.

We determine that the level of concern of the new device KegelFit is Moderate.

Electrical Safety Testing:

Electrical safety testing was conducted on KegelFit. The device complies with the IEC 60601-1 and IEC60601-1-11 standards for safety

The KegelFit has been tested to EN60601-1-2:2007 and found to be EMC testing: suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.

Biocompatibility Testing:

The same vaginal electrode is used as with the itouch Sure Bodv material:

Acrylonitrile-Butadiene-Styrene copolymer (ABS) GE MG47 Conductor Material: Stainless steel

The biocompatibility evaluation for the itouch Sure vaqinal electrode (KeqelFit Trainer) was conducted in accordance with International Standard ISO 10993:2009 biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity and ISO 10993:2002 biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity. See section 14.

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Clinical Testing: A clinical literature evaluation was conducted to provide evidence of the safety and efficacv of electrical stimulation for the treatment of female stress urinary incontinence. See section 20.1 Labelling Comparison: The Labelling is substantially equivalent to that of the predicate device Apex for self diagnosis and identification of contraindications and to the predicate device itouch Sure for operating instructions. A detailed comparison of labeling between the KegelFit and the predicate device Apex was conducted to assess the safety of the KegelFit device for over-the-counter use. The objectives of this comparison were to: 1) determine if a subject can self-identify as having stress urinary incontinence using package labeling 2) self-limit usage if a contraindication is present

Customer Review Analysis:

An analysis of customer reviews of the predicate device itouch Sure from 13758 OTC sales in the EU was used to determine whether the subject can safely use the KeqelFit device using only the instructions for use (IFU) provided. A questionnaire was sent to a further 120 Ebay UK OTC customers.

Risk Management Summary

KeqelFit has been designed according to EasyMed's internal procedures with traceability between the design inputs, design outputs, verification and validation activities. KegelFit has been evaluated for risks according to EasyMed's internal procedures based on ISO 14971. The risks associated with KegelFit were reduced to as low as possible and the risk/benefit analysis was acceptable.

Conclusion

The non-clinical data supports the safety of the device, and the hardware and software verification and validation demonstrates thatKegelFit performs as intended in the specified use conditions.

The clinical literature evaluation, as well as the technological comparison to the predicate device, supports the use of electrical stimulation as an effective treatment of stress urinary incontinence in women.

Both KeqelFit and the predicate device Apex are intended for over-the-counter use. A comparison of labeling and instructions was completed to support the safety of the product labeling for selfdiagnosis and use.

An analysis of Customer Reviews of OTC sales in the EU of the predicate device itouch Sure was completed to support the Usability of the device without training. In addition, customer questionnaires were sent to 120 users of itouch Sure who purchased OTC through ebay UK, and 21 responses were received and analysed. The data included within this submission supports the use of KegelFit for over-the-counter as safe and effective. The KegelFit unit is substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.

Submitted times: This is the first submission to FDA for this new device

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).