The device 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 and to maintain urinary continence in women.

Device Description

The Applicant device, YARLAP, is a precision Class II device housed in a sturdy lightweight cabinet. The device is battery powered with a backlit Liquid Crystal Display (LCD) and offers the user a choice of six (6) pre-set Neuromuscular Electrical Stimulation (NMES) programs. The NMES programs are Work/Rest modes of operation. The Applicant device has no TENS programs. The Applicant device is supplied with a vaginally inserted electrode specifically designed in 2003 for the hardware, circuit and software used in device to stimulate the female pubococcvgeus (PC) muscle. The Applicant device control unit connects directly to the design-specific electrode by cable and plug (extant for the industry). Sold as a kit, the YARLAP kit consists of: One (1) Battery Powered Muscle Stimulator (Control Unit), One (1) vaginally inserted electrode specifically designed for the hardware. circuit and software used in the Control Unit to stimulate the female pubococcvgeus (PC) muscle, One (1) user's manual, One (1) case.

AI/ML Overview

This document describes the Yarlap device, a non-implanted electrical continence device, comparing it to predicate devices to establish substantial equivalence for FDA 510(k) clearance. The focus is on demonstrating that Yarlap is as safe and effective as existing legally marketed devices.

Here's an analysis of the provided information concerning acceptance criteria, device performance, and the relevant study:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal acceptance criteria with numerical targets for clinical performance (e.g., a specific percentage reduction in incontinence episodes). Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices. This means the Yarlap device's performance, safety profile, and technological characteristics must be comparable to already cleared devices.

The reported device performance is primarily a comparison of its technical specifications and proposed use against the predicate devices, and a usability study to support over-the-counter (OTC) use.

Here's a table summarizing the implicit acceptance criteria (based on substantial equivalence) and the reported performance:

Acceptance Criterion (Implicit for Substantial Equivalence and OTC use)	Reported Device Performance (Yarlap)
Intended Use: Same as predicate devices	The device is intended to provide electrical stimulation and neuromuscular re-education for rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women and to maintain urinary continence in women. This is stated as "reasonably consistent" with predicate IFU and 21 CFR 876.5320.
Technological Characteristics: Same or substantially similar to predicate devices	Maximum Output Current: 80mA (vs. 90mA for predicates). Deemed substantially equivalent as it's within the range of general characteristics. Pulse Width: 200 µS – 250 µS (vs. 50 µS – 450 µS for predicates). Limited to commonly used intermediate levels found in predicates. Frequency: 10 Hz - 35 Hz (vs. 2 Hz - 100 Hz for predicates). Limited to commonly used intermediate levels found in predicates. Net Charge @ 500 ohms: Zero (asymmetrical DC zero), same as one predicate and similar to the other. Maximum (Peak) Phase Charge: 20 µC (vs. 27.9 µC and 40.5 µC for predicates). Maximum (peak) Current Density (Vaginal): 12.5 mA/sq. cm (vs. 14.1 for predicates). Maximum Power Density @ 500 ohms: 3.5 mW/sqcm (vs. 41.8 and 28 for predicates for custom settings). However, when comparing pre-set intermediate programs at recommended intensity levels (30mA and 45mA), the average power densities are shown to be "substantially equivalent." Biocompatible materials, circuit, hardware, software, construction, and vaginally inserted electrode: "Identical" to Predicate (I) (K081480) for materials, circuit, hardware, software, construction, and electrode. "Identical" for biocompatible materials, safety features, and electrode to Predicate (II) (K083704), with hardware, software, and construction being "substantially similar." The vaginally inserted electrode is specifically designed for these devices and does not introduce "different technological characteristics."
Raises no new questions about safety or effectiveness	The limitations of output levels to the most widely used intermediate levels of predicate devices are argued to demonstrate comparable efficacy, safety, and reduced risk compared to predicates.
Safety for OTC Use (layperson without medical oversight)	Usability Study: Demonstrated that racially diverse incontinent adult females unfamiliar with the device could use it correctly, achieve strong tolerable pelvic floor contractions, understood labeling, selected appropriate intensity, and stored the device correctly. No adverse events or potentially hazardous situations were observed.
FDA Compliant Labeling	"The labelling of the applicant device is concordant with the predicate and FDA compliant."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Usability Study (test set): The document states "racially diverse incontinent adult females unfamiliar with the device." However, a specific numerical sample size is not provided.
Data Provenance: The country of origin and whether the study was retrospective or prospective are not specified. It can be inferred it was a prospective study, as unfamiliar users were instructed on device use and observed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

For the usability study, there is no mention of experts establishing ground truth in the traditional sense of medical diagnosis or clinical outcomes. The "ground truth" for this study was successful task completion, user understanding, and achievement of "strong tolerable pelvic floor contractions" and lack of observed hazards, which was assessed by an "observer" and "subject participants." The qualifications of the observer are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

None in the context of expert adjudication for clinical ground truth. The usability study involved "the observer and subject participants" annotating possible improvements and documenting hazards. This suggests a direct observation and participant feedback method, rather than a formal expert adjudication of medical findings.

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 MRMC comparative effectiveness study was done. The Yarlap device is a therapeutic electrical stimulation device, not an AI diagnostic tool that assists human readers. Therefore, this type of study and effect size calculation is not applicable.

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

This question is not applicable as the Yarlap device is an electrical stimulation device intended for direct human use (with a human-in-the-loop) and does not involve a standalone algorithm for diagnostic or interpretative purposes. The "standalone" performance here refers to the device itself providing the therapeutic stimulation. Its performance is characterized by its technical output parameters (current, pulse width, frequency) and its demonstrated safe and correct use by a layperson.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the usability study, the "ground truth" was related to user behavior and subjective experience: successful task completion, comprehension of instructions, appropriate intensity selection, proper storage, and the observation of "strong tolerable pelvic floor contractions" without adverse events or hazards. This is closer to process observation and participant self-reporting combined with simple physiological feedback (contractions). It is not expert consensus for diagnosis, pathology, or long-term clinical outcomes data typically seen in drug trials or complex medical device efficacy studies.

8. The sample size for the training set

Not applicable / not explicitly mentioned. The Yarlap device is not an AI/machine learning device that requires a "training set" in the computational sense. The "training" for the device's design and functionality would come from engineering principles and the existing knowledge base of similar predicate devices, verified through testing and comparisons.

9. How the ground truth for the training set was established

Not applicable. As explained above, there isn't a "training set" or corresponding ground truth in the AI sense for this device. The design and validation relied on comparison to established predicate devices and standard engineering and safety testing.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

April 24, 2015

International Trade Group, Inc. Brent C. Reider President 4663 Katie Lane, Suite O Oxford, OH 45056

Re: K141643 Trade/Device Name: Yarlap Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: March 31, 2015 Received: April 1, 2015

Dear Brent C. Reider,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Joyce M. Whang -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) K141643

Device Name

YARLAP

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)
[X] Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

General Information	As Required by 21 CFR 807.92(c)
Date Prepared	31 March 2015
Applicant & Spec. Dev. Name:Applicant & Spec. Dev. Address:	International Trade Group, Incorporated4663 Katie Lane, Suite “O”Oxford, OH 45056 USA
Applicant & Spec. Dev. Tele.:Applicant & Spec. Dev. FAX:Applicant & Spec. Dev. Contact:Applicant & Spec. Dev. e-mail:	614-568-7000614-568-7001Brent C. Reider, Presidentinfo@internationaltradegroup.info
Trade Name of Device:	YARLAP
510(k):	K141643
Common/Usual Name:	Battery Powered Muscle Stimulator with VaginalElectrode, Non-Implantable,For Pelvic Floor Muscle Conditioning, Prescriptionand Over-The-Counter (OTC).
Classification Group:	KPI
Classification Name:	Stimulator, Electrical, Non-Implanted forincontinence.
Classification regulation:	21 CFR 876.5320

Predicate Devices:

●

Per 21 CFR 807.92(a)(3), the two predicate (ProCode: KPI) devices are:

Kegel8 Pelvic Muscle Exerciser Model OPH 400 by N.E. Services, Limited o K-081480
. NuTrac Pelvator Model PEL 200 by Verity Scientific Limited o K-083704

Applicant Device Description:

Traditional 510(K) Notification of a New Device: YARLAP Model Number: ECS 323

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Sold as a kit, the YARLAP kit consists of:

One (1) Battery Powered Muscle Stimulator (Control Unit)
One (1) vaginally inserted electrode specifically designed for the hardware. circuit and software used in the Control Unit to stimulate the female pubococcvgeus (PC) muscle.
One (1) user's manual

One (1) case

Individual components that may be lost (e.g., battery compartment door) or which must be replaced throughout normal usage (e.g., battery and electrode(s) can be re-ordered individually (see User's Manual).

Indications for Use:

Differences in Indications for Use Discussion:

A comparison of the applicant and predicate(s) stated Indications for Use (IFU) is below:

Table of Comparative Indications for Use
Predicate Device(s)	Applicant Device
The device is intended to provide electricalstimulation and neuromuscular re-education forthe purpose of rehabilitation of weak pelvic floormuscles for the treatment of treat stress, urge andmixed incontinence in women.	The device is intended to provide electricalstimulation and neuromuscular re-education for thepurpose of rehabilitation of weak pelvic floormuscles for the treatment of stress, urge and mixedurinary incontinence in women and to maintainurinary continence in women.

The indications for use treat stress, urge and mixed incontinence in women and to maintain urinary continence in women may be considered reasonably consistent with the use described under 21 CFR 876.5320 in maintaining "continence" because in the conveyance of electrical stimulation to treat stress. urge and mixed incontinence in women and the mutual promotion continence by posture of the visceral organs and response to inter-abdominal pressure are concordant and do not introduce "different technological characteristics," and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device (see below). "

Device Substantial Equivalence and Safety

The primary function of the PC muscle is postural (i.e., muscle tone affects postural control - keeping the visceral organs in position [see stress incontinence below] and postural stability). Additionally, the PC muscle responds to inter abdominal (urinary) cues (e.g., start and stop).

1 "While a new device must have the same intended use as a predicate device in order to be SE, the Centre does not require that a new device be labelled with precise therapeutic statements identical to those that appear on predicate device labelling in order for the new device to have the same intended use" 21 U.S.C. §§ 360(n), 360c(f)(1) & 360c(i); 21 CFR 807.92(a)(3)) per extant Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3.

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The FDA has cleared many substantially equivalent devices for the treatment of stress, urge and mixed urinary incontinence in women using the NMES modes with a vaginally inserted electrode. This is the exact mode of action in the applicant device and of the Predicate (1) device: KEGEL8 Pelvic Muscle Exerciser Model OPH 400 (K081480) and Predicate (II) device: NuTrac Pelvator Model PEL 200 (K083704).

The biocompatible materials, circuit, hardware, software, construction and vaginally inserted electrode in the Applicant device. YARLAP, are identical to those used in the Predicate (I) device, KEGEL8 (K081480). As such, the Applicant device, "YARLAP," is substantially equivalent to:

. Kegel8 Pelvic Muscle Exerciser Model OPH 400 by N.E. Services, Limited o K-081480
- o Product Code: KPI

The biocompatible materials, safety features and vaginally inserted electrode in the Applicant device. YARLAP, are identical to those used in the Predicate (II) device. NuTrac Pelvator Model PEL 200 (K083704). The hardware, software and construction are substantially similar. As such, the Applicant device, "YARLAP," is substantially equivalent:

NuTrac Pelvator Model PEL 200 by Verity Scientific Limited . o K-083704
- o Product Code: KPI

The applicant device uses only pre-set substantially equivalent programs at only the most common (and intermediate) out-put levels of the cited predicates (see tables 1 & 2 below).

Additional Information Request Table 1
Basic UnitCharacteristics	Predicate (II) DeviceNuTrac Pelvator	Predicate (I) DeviceKegel 8	Applicant DeviceYARLAP
510(k)	K083704	K081480	K141643
Maximum Output Currentpulse peak @ 500 Ohms	90mA +0/- 8%	90mA +0/- 8%	80mA +0/- 8%
Maximum Output Currentpulse peak @ 2K Ohms	50mA +/-10%	50mA +/-10%	50mA +/-10%
Maximum Output Currentpulse peak @ 10K Ohms	19mA +/-10%And thus shuts off	19mA +/-10%And thus shuts off	19mA +/-10%And thus shuts off
Pulse Width (µS)	50 µS – 330 µS,program dependent	50 µS – 450 µS,program dependent	200 µS – 250 µS,program dependent
Frequency (Hz)	2 Hz - 100 Hz, programdependent	2 Hz - 100 Hz, programdependent	10 Hz - 35Hz, programdependent
Net Charge @ 500 ohms(µC per pulse)(If zero, state method ofachieving zero netcharge.)	Zero- positive pulse isequal and opposite tonegative pulse.Symmetrical DC zero(Transformer output)	Zero- positive pulse isequal and opposite tonegative pulse.Asymmetrical DC zero(Transformer output)	Zero- positive pulse isequal and opposite tonegative pulse.Asymmetrical DC zero(Transformer output)
Maximum (Peak) PhaseCharge, (µC) at 500 ohms	$90mA x 330 µS = 27.9 µC$This corresponds to thelongest pulse at thehighest current.	$90mA x 450 µS = 40.5 µC$This corresponds to thelongest pulse at thehighest current.	$80mA x 250 µS = 20 µC$This corresponds to thelongest pulse at thehighest current.

Traditional 510(K) Notification of a New Device: YARLAP Model Number: ECS 323

Submission: S003 Per 21 CFR 807.92(a)(3)(4)(5)(6)(b(1)(2)(3)(c)(d)

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SECTION 5.0 510(k) Summary

Maximum (peak) CurrentDensity, (mA/cm²)Vaginal	14.1 mA/sq. cmSurface = 6.4 cm²	14.1 mA/sq. cmSurface = 6.4 cm²	12.5 mA/sq. cmSurface = 6.4 cm²
Maximum (peak) CurrentDensity, (mA/cm²) 2 X 2	3.6 mA/sq. cmSurface = 25 cm² (2X2)	3.6 mA/sq. cmSurface = 25 cm² (2X2)	3.2 mA/sq. cmSurface = 25 cm² (2X2)
Maximum Power Density,(W/cm²)at 500 ohms	41.8 mW/sqcmAt maximum frequencyof 100Hz, pulse width330µS and current of90mA (Custom: PC1,PC2, & PC3)PC Electrode area: 6.4cm²	28 mW/sqcmAt maximum frequencyof 100Hz, pulse width450µS and current of90mA (Custom: PC1,PC2, & PC3)PC Electrode area: 6.4cm²	3.5 mW/sqcmAt maximum frequencyof 35Hz pulse width200µS and current of80mA.(P06)PC Electrode area: 6.4cm²

So, while Maximum Power Density is a near ten fold difference (tables above) the true comparative Maximum Power Density for the Applicant device is established by comparing the out-put of the pre-set intermediate programs of the predicate with the corresponding pre-set programs of the applicant device. As the table below demonstrates, the values are substantially equivalent when comparing the power density of the pre-set programs at the recommended starting/ beginners intensity level of 30mA, as well as at the user intensity level of 45mA or at the maximum possible intensity level of each comparative program (see the three columns to the far right of the Table 2 below).

Additional Information Request Table 2
Utility	K141643Applicant80mA	K081480Predicate90mA	Rate	Pulse	Work	Rest	Time	Max.W/cm²80 vs 90	Ave.W/cm²30mA	Ave.W/cm²45mA
Mixed	Program 1		12	200	5	5	15	1.2	0.17	0.38
		Program 5	10	200	5	5	20	1.3	0.14	0.32
Mixed	Program 2		20	250	8	8	20	2.5	0.35	0.79
		Program 9	20	250	5	5	20	3.2	0.35	0.79
Urge	Program 3		12	200	5	10	15	1.2	0.17	0.38
		Program 2	10	250	5	5	20	1.6	0.18	0.39
Urge	Program 4		10	200	6	12	20	1.0	0.14	0.32
		Program 5	10	200	5	5	20	1.3	0.14	0.32
Stress	Program 5		12	250	5	15	15	1.5	0.21	0.47
		Program 2	10	250	5	5	20	1.6	0.18	0.40
Stress	Program 6		35	200	6	18	20	3.5	0.50	1.11
		Program 3	40	200	6	15	20	5.1	0.56	1.26
For the Applicant [K141643] programs chart see page 14 of the Yarlap manual.
For the Predicate [K081480] programs chart see page 12 of the Kege8 manual.

As such:

the applicant device has the same technological characteristics as the predicate; and 2. the information submitted to the FDA for the applicant device does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.

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The predicates provide safe and effective stimulation to treat stress, mixed and urge incontinence in women using pre-set and custom [programmable] settings. The custom [programmable] settings in the predicate have broad out-put capabilities and as such the Maximum Power Density for the predicates reflect this fact (i.e., for the K081480; 28 mW/cm² at a maximum frequency of 100Hz, pulse width 450uS and current of 90mA). While all the programs of the predicate are unquestionably safe and effective; the higherlevel power out-puts of the predicate custom [programmable] settings are rarely used. Indeed, the most widely used programs in the predicate are the pre-set intermediate output level programs. So, limiting the out-put levels in the applicant [OTC] device to the most widely used intermediate levels found in the pre-set programs of the predicate device(s) gives the applicant device the same technological characteristics as the predicate with commensurate efficacy, safety and reduced risk.

Vaginal Electrodes Substantial Equivalence and Safety:

The vaginally inserted electrode cited with both Applicant and Predicate devices was designed specifically for these devices. As such the electrode does not introduce "different technological characteristics" when used for treating urinary incontinence or when avoiding it.

Usability Study to Support OTC Use

Safety and efficacy of the device among racially diverse incontinent adult females unfamiliar with the device was collected demonstrating that users were able to use the device correctly (successful task completion) and in a manner that produced strong tolerable pelvic floor contractions. Both the observer and subject participants were charged with annotating possible improvements to the device itself or its labelling as well as documenting any specified or unspecified actual or potential hazard(s) concerning use, including, but not limited to the user's understanding of the device from the packaging, the user's comprehension of the instructions, the user's selection of an appropriate intensity level, or cleaning and storage.

All aspects of OTC usability were positive including, but not limited to the user's operative understanding of the device, the user's comprehension of the labelling, including the packaging and instructions, the user's selection of an appropriate intensity level and storing the device after completion of treatment. No adverse events were observed nor were potentially hazardous situations observed or prognosticated when the participants followed the provided labelling on an OTC basis.

Conclusion

. The applicant device is substantially equivalent to the predicate because it has the same intended use as the predicate:
The applicant device has the same technological characteristics as the predicate;
. The labelling of the applicant device is concordant with the predicate and FDA compliant and
. The information submitted to the FDA for the applicant device does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.

Traditional 510(K) Notification of a New Device: YARLAP Model Number: ECS 323

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. The results of the Usability Study demonstrate the device can be used by a layperson without medical professional oversight on an OTC basis for the rehabilitation of weak pelvic floor muscles to treat stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
The YARLAP device meets the FDA's definition of Substantial Equivalency under the relationships cited above (21 U.S.C. §§ 360(n), 360c(f)(1) & 360c(i); 21 CFR 807.92(a)(3) and the indications suggest, when obtained over-the-counter and used by a layperson without oversight by a healthcare practitioner in a non-clinical environment, the applicant device can be used correctly, safely and in a manor that produces strong tolerable pelvic floor muscle contractions appropriate for the user's condition to treat stress, urge or mixed incontinence in women and/or to maintain urinary continence in women.

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).