The vPatch is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse.

Device Description

The vPatch is a single-use disposable patch designed to manage premature ejaculation. The vPatch contains electrodes that deliver electrical muscle stimulation (EMS) to the perineal muscles and nerves during intercourse to help the user postpone ejaculation. The patch works by delivering short duration. low intensity EMS to the target muscles and nerves. The stimulation contracts the pelvic floor muscles, which consequently, delays the rhythmic contractions of ejaculation. This increases the time between arousal and ejaculation. The vPatch is intended to be applied by the user to the perineum prior to intercourse and removed immediately after intercourse.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the vPatch device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Effectiveness)	Reported Device Performance (Active vs. Sham Arm, ITT Population)
Average change from baseline IELT at least 50% higher in active arm	Met: Average improvement of IELT over baseline among vPatch subjects was 50.2 sec, which was more than 50% greater than the 16.9 sec improvement among sham subjects (Difference: 33.3 sec, p=0.0073).
Proportion of subjects with improvement in CGIC at least 50% higher in active arm	Not Met in ITT: 62.5% of active arm subjects experienced improvement vs. 42.11% in sham. Met in mITT and PP: Improvement percentage for active subjects was significantly higher than sham subjects (mITT: 73.53% vs 44.44%, p=0.0371; PP: 73.53% vs 41.18%, p=0.0274).

Safety Acceptance Criteria (Implicitly met by low AE rate):

Low incidence of adverse events, with any AEs being mild and resolving upon cessation of device use.

Reported Safety Performance:

AE rate: 1.08% (2/186 sessions) in the active arm vs. 0% (0/70 sessions) in the sham arm (not a statistically significant difference).
Both AEs were mild and resolved upon cessation of use (discomfort due to device vibration, pain/discomfort in pelvic area).

2. Sample Size and Data Provenance

Test Set (Clinical Study):
- Screened: 70 male subjects
- Eligible: 62 subjects
- Randomized/Enrolled (ITT Analysis Set): 59 subjects (40 Active, 19 Sham)
- mITT Analysis Set: 52 subjects (34 Active, 18 Sham)
- Per-Protocol (PP) Analysis Set: 51 subjects (34 Active, 17 Sham)
Data Provenance: Multi-center, international, prospective clinical investigation.

3. Number of Experts and Qualifications for Test Set Ground Truth

The provided text does not specify the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for Test Set

The provided text does not specify any adjudication method for establishing ground truth for the test set. Ground truth for IELT was measured by the patient's partner using a stopwatch. Other endpoints (CGIC, PEP, Orgasmometer) were patient-reported outcomes via questionnaires.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study evaluated the clinical effectiveness of the device itself (device with human user) against a sham, not the improvement of human readers with AI assistance. The vPatch is an electrical stimulation device, not an AI-powered diagnostic or assistive tool for human interpretation.

6. Standalone (Algorithm Only) Performance

Not applicable. The vPatch is a physical electrical stimulation device, not an algorithm or software-only device in the traditional sense of "standalone performance" for AI-driven systems. Its software is embedded and controls the stimulation; its performance is intrinsically linked to its physical application and interaction with the user.

7. Type of Ground Truth Used

Intravaginal Ejaculatory Latency Time (IELT): Measured objectively by the patient's partner using a stopwatch during the home-use phase. This can be considered a direct, objective measurement.
Clinical Global Impression of Change (CGIC): Patient-reported outcome (PRO).
Premature Ejaculation Profile (PEP): Patient-reported outcome (PRO).
Orgasmic Intensity (Orgasmometer): Patient-reported outcome (PRO).
Adverse Events (AEs): Reported by patients and verified by investigators.

8. Sample Size for Training Set

The provided text does not mention a separate training set in the context of an algorithmic or AI model. The "training" in the clinical study refers to subjects receiving training on how to use the device. The study itself served as the primary data collection for validating the device's efficacy and safety.

9. How Ground Truth for Training Set Was Established

As there is no mention of a separate training set for an AI/algorithm, this question is not applicable. The clinical study data was used to assess overall device performance.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR VPATCH

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Non-implanted electrical stimulation device for management of premature ejaculation. A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.

NEW REGULATION NUMBER: 21 CFR 876.5026

CLASSIFICATION: Class II

PRODUCT CODE: ORC

BACKGROUND

DEVICE NAME: vPatch

SUBMISSION NUMBER: DEN210012

DATE DE NOVO RECEIVED: March 30, 2021

SPONSOR INFORMATION:

Virility Medical 3521 Hatwynn Road Charlotte, North Carolina 28269

INDICATIONS FOR USE

The vPatch is indicated as follows:

LIMITATIONS

The sale, distribution and use of the device are restricted to prescription use in accordance with 21 CFR 801.109. Limitations on device use are provided in the Instructions for Use Manual:

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Contraindications

Do not prescribe the vPatch if your patient:

. has been diagnosed with, or is receiving treatment for, pelvic cancer
. has an implanted electronic device (e.g., pacemaker, neurostimulator, etc.)
. suffers from perineal dermatological diseases, irritations, or lesions
had surgery in the area of the genitals or anus .
. requires any muscle rehabilitation in the area
. has diabetes with peripheral neuropathy

Warnings and Precautions

Instruct your patient:

. To contact you before using the device if he experiences any pain in the area
Not to apply the vPatch to any area other than the male perineum .
That the vPatch is a single-user device and should not be transferred between . users
. To stop stimulation and cease using the device if pain occurs in the pelvis
To stop stimulation and cease using the device if allergic reaction occurs .

PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

The vPatch is composed of the following components:

Flexible Printed Circuit Board (f-PCB) with embedded software .
. Adhesive electrodes (single channel)
. Batteries
Foam housing .
. Removable liner

Figure 1 is an image of the front and back of vPatch.

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Image /page/2/Picture/0 description: The image shows a white device with labels pointing to different parts of it. On the left, the labels point to the skin electrodes, quick removal tips, scrotum side positioning edge, removable liner, anus side positioning edge, and the front of the device. On the right, the label points to the power button location.

Figure 1 Front and back of vPatch

By pressing the activation button located on top of the device, the vPatch can deliver up to 15 minutes of stimulation at maximal intensity. The stimulation intensities of the vPatch are preconfigured and are labeled as Low and High, as shown below:

Intensity	Label
14.3 mA	High
9.9 mA	Low

vPatch Technological Specifications

Table 1 describes the key technological specifications of the vPatch.

Table 1: vPatch Technological Specifications
Physical Measurements	MainDimensions	Width 42 mm; Length 38 mm; Thickness 4.8mm
	ElectrodeContactingArea	Minimal size 475 mm²
	Weight	Approximately 4 gr
Power Supply		LR721 Silver-oxide 2x 1.5VDC Non-rechargeable batteries
Number of Channels		1
Stimulation Current		HIGH Intensity: 14.3 mA ± 10%LOW Intensity: 9.9 mA ± 10%
Stimulation Voltage		HIGH voltage: 90 V ± 10%LOW voltage: 60 V ± 10%
Waveform		Symmetrical Biphasic Pulse
Pulse Duration		400 μs ± 10%
Frequency		30 Hz ± 10%
Electrodes		Hydrogel electrodes

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Range of Impedance	$1 k\Omega - 6 k\Omega \pm 10%$
Current Density	Exceeds $2 mA/cm^2$
Ramp time	10 seconds
Interphase Interval	$10 \mu s$
Maximal Stimulation Duration	15 minutes

SUMMARY OF NONCLINICAL/BENCH STUDIES

BIOCOMPATIBILITY/MATERIALS

vPatch is categorized as a surface device in contact with intact skin for prolonged duration (>24 hours to 30 days, due to the likelihood of repeat use). The vPatch components that are in direct contact with intact skin in the perineum are the conductive hydrogel and foam medical tape.

The biocompatibility testing summarized below was performed in accordance with FDA's "Guidance Document titled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,"" and demonstrated that the device is biocompatible for its intended use.

Endpoint	Test Method
Cytotoxicity	ISO Agarose OverlayISO 10993-5 (2009)
Sensitization	ISO Closed Patch in Guinea PigsISO 10993-10 (2010)
Irritation	ISO Skin Irritation Study in RabbitsISO 10993-10 (2010)

SHELF LIFE/STERILITY

vPatch is a non-sterile, single-use device.

The shelf-life for vPatch has been established at 2 years based on an accelerated aging study per ASTM F1980-16. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

To support the 2-year shelf life, the sponsor conducted package integrity testing and functional testing. Package integrity testing consisted of the following:

. Visual inspection (per ASTM F1886/F1886M-16: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection)
Dye penetration (per ASTM F1929-15, Standard Test Method for Detecting Seal . Leaks in Porous Medical Packaging by Dye Penetration)
Bubble leak (ASTM F2096-11(2019). Standard Test Method for Detecting Gross . Leaks in Packaging by Internal Pressurization (Bubble Test))

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Seal strength (ASTM F88/F88M-15, Standard Test Method for Seal Strength of . Flexible Barrier Materials)
The sponsor conducted functional testing after accelerated aging consisting of evaluation of stimulation parameters and shear testing as described in the Performance Testing -Bench section below.

The results demonstrate that vPatch has acceptable package integrity and functional performance over the duration of its 2-year shelf life.

ELECTROMAGNETIC CAPABILITY & ELECTROMAGNETIC SAFETY

Electrical safety and electromagnetic compatibility testing were conducted on vPatch in accordance with the following standards:

. IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015 (Second Edition), Medical electrical equipment Part 1-11: . General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-10: 2012, AMD1: 2016, Particular requirements for the basic safety . and essential performance of nerve and muscle stimulator
. IEC 60601-1-2: 2014, General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

vPatch passed electrical safety and electromagnetic compatibility testing consistent with the acceptance criteria outlined in these standards.

SOFTWARE

vPatch has a moderate level of concern (LOC), because a malfunction of the software could result in minor injury to the patient.

Software information corresponding to a moderate LOC as outlined in the FDA's guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) was provided and is acceptable. The sponsor provided adequate documentation describing the software development program. In addition, the sponsor provided documentation that they performed a hazard analysis to characterize software risks, including device malfunction. The submission included verification and validation (V&V) testing to address the potential hazards with satisfactory results. Adequate documentation describing the software, firmware, software specifications, architecture design, software development environment, traceability, revision level history, and unresolved anomalies provides the foundation that the software will operate in a manner as described in the specifications.

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PERFORMANCE TESTING - BENCH

vPatch underwent the following bench performance tests:

· Dimensional Validation Test: Demonstrated that critical measurements of vPatch are maintained and are consistent during production.
Stimulation Parameters and Battery Performance Test: Verified vPatch can . operate within its stimulation parameters during simulated use for its 15-minute use duration and ensured the battery life supports the 15-minute use duration.
Shear Testing: Verified acceptable adhesion shear performance of yPatch in . accordance with ASTM D6463 (2012), Standard Test Method for Time to Failure of Pressure Sensitive Articles Under Sustained Shear Loading.

The results of this testing demonstrate that vPatch performs as intended under anticipated conditions of use.

SUMMARY OF CLINICAL INFORMATION

USABILITY STUDY

Human factors (HF) validation testing was conducted following the FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices. [000] male subjects between the ages of 18-60 participated in the study, Participants had access to vPatch and all accompanying labeling and documentation. Participants completed simulated use tasks with the vPatch and answered knowledge tasks (a total of critical tasks) to evaluate the usability of the entire user interface.

A total of use difficulties and user errors were observed for one task (turning off the device). There are no major safety implications from this finding. The patient labeling describes how to turn off the device textually and using images.

CLINICAL STUDY

The sponsor conducted a pivotal study "Evaluation of the safety and effectiveness of the vPatch device for the management and treatment of premature ejaculation."

The pivotal study was a multi-center, international, prospective, 2:1 randomized, double-blind, two-arm, sham-controlled, clinical investigation to evaluate the safety and effectiveness of vPatch.

The active device group was given fully functioning vPatch devices pre-configured to deliver stimulation intensity according to the subjective motor threshold intensity (electrical intensity

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threshold for sensory and motor activation for increased perineal stimulation) reported by the patients during the initial clinical visit. The sham device group received vPatch devices preconfigured to deliver stimulation that is ineffective for muscle activation according to the patient's subjective sensory threshold. Except for the intensity level preconfigured in each arm, all devices (and packaging) were completely identical to ensure subjects and clinical staff could not distinguish between the active and sham devices.

The study objectives included the following:

To assess the safety profile of the vPatch device and its effectiveness in delaying . ejaculation when used in patients suffering from premature ejaculation.
. To assess the patient's perception of the ease of use of the vPatch device and treatment. through the use of a dedicated questionnaire.
To assess the patient's perception of the changes in his Premature Ejaculation Profile . (PEP) under different aspects with the use of device, through the use of a dedicated questionnaire (Control and Distress Domains of the Premature Eiaculation Profile (PEP) Questionnaire).
. To assess the patient's perceived intensity of orgasm by using the vPatch device, through the use of a validated tool (Orgasmometer).

All subjects gave written informed consent before any study assessment commenced. Screening included review of patient demographic and medical information, including age, previous medical history and disease etiology, risk factors, etc. All screened patients were subject to physical examination and selected according to eligibility criteria. Eligible subjects were randomized to their study arm and received the vPatch or the sham device (n-4 per subject), a notebook, an Orgasmometer, and a stopwatch to record the ejaculation time from erection. Prior to device or sham use, the subjects received training on the device at the clinical site. The patients were then asked to measure and record their baseline intravaginal ejaculatory latency time (IELT) using a stopwatch. The patients were also asked to measure their premature ejaculation profile (PEP) and orgasmic intensity (using an Orgasmometer) at baseline. The patients were expected to use the vPatch or the sham device four times over the course of the study. Following each use of vPatch or the sham device. IELT measurements, premature ejaculation profile (PEP) and orgasmic intensity were recorded. The patients filled out a safety questionnaire within 72 hours of each use. Subjects returned to the site for further follow-up assessment at the end of 12 weeks. During this visit. the patients underwent physical examination (height, weight, evaluation of the perineal area), measurement of vital signs (temperature, heart rate and blood pressure), and completed the Clinical Global Impression of Change (CGIC) questionnaire. Patients were also interviewed by the investigators, and the list of medications taken by the patients and all the adverse events experienced were reported.

Inclusion/Exclusion Criteria:

Inclusion	Exclusion
Male, age range 18-60	Patients with history of cardiovascular disorders
Patients who are diagnosed withclinical premature ejaculation or withself-perceived ELT < 3 minutes.	Patients with history of other sexual dysfunctions(other than premature ejaculation).
Patients with stable, heterosexual,monogamous, sexual relationship forat least 3 months at the time of theenrollment.	Patients suffering from erectile dysfunction.
Patients planning to maintain therelationship for the whole duration ofthe study.	Patients carrying any type of implantedpacemaker/defibrillator.
Patients with 75% of IELT baselinemeasurement < 2 minutes and 25% ofIELT baseline measurement < 3minutes at Visit 2.	Patients suffering from diagnosed Diabetes Mellituswith peripheral neuropathy.
Patients with Premature EjaculationDiagnostic Tool (PEDT) measurement≥ 11 at the time of enrollment.	Patients suffering from perineal dermatologicaldiseases.
Patients with International Index ofErectile Function (IIEF-5)measurement ≥ 22 at the time ofenrolment.	Patients suffering from perineal skin irritation /lesions.
Patients understanding the nature ofthe study and providing their informedconsent to participation.	Patients suffering from any psychiatric major disease(axis 1) and/or taking any relevant medications.
Patients willing and able to attend thefollow-up visits and proceduresforeseen by study protocol.	Patients taking antidepressant therapy, topicalanesthetic agents or sexual-related cognitivebehavioral therapy within the 4 weeks before theenrollment.
	Patients with past occurrences of ejaculation beforeintromission.
	Patients with history of genital or anorectal neoplasticillness in the 2 years before the enrollment.
	Patients with pregnant partner.
	Patients who are participating or have participated inother clinical studies within the 30 days before thestudy enrollment.
	Patients with any medical incidence where the use ofthe device may jeopardize the patient's safety perInvestigator's discretion.

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Safety Endpoint:

The safety endpoint was the incidence and frequency of Adverse Events (AEs) in general and by seriousness, severity and relation to the study device.

Effectiveness Endpoints:

Two primary performance endpoints were defined as follows:

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. The average change from baseline IELT is at least 50% higher in the active arm than in the sham arm.
The proportion of subjects with improvement in clinical global impression of change . (CGIC) in the active arm is at least 50% higher than in the sham arm.

The secondary performance endpoints defined include:

. Patient's subjective outcome assessment of the PEP from baseline to the end of the study.
. Evaluation of patient's subjective outcome assessment of orgasmic intensity via Orgasmometer from baseline to the end of the study.

Additional performance endpoints included:

Proportion of subjects with any increase. 10%, 20%, 30%, and 50% increase from . baseline in IELT.

Analysis sets

1. Intent to Treat analysis set (ITT)
  The ITT analysis set includes all subjects enrolled in the study. According to the ITT principle, all subjects will be analyzed in the group as assigned by randomization.
1. Modified Intent to Treat analysis set (mITT) The mITT analysis set consists of all subjects from the ITT analysis set who have received at least one study treatment during the home usage stage and who met the study eligibility criteria. In the mITT set, all subjects will be analyzed in the group as treated.

3. Per-Protocol Analysis set (PP)

The PP analysis set will consist of all subjects from the mITT analysis set without major protocol violations.

The ITT analysis set served as the main analysis set for the efficacy and safety assessments. The primary and secondary efficacy assessments were also be performed on the mITT and the PP analysis sets as a sensitivity analysis.

Study Results:

Subject Disposition

A total of 70 male subjects were screened. 62 subjects were found eligible, and 59 subjects were randomized and enrolled in the study (ITT population). Seven subjects did not use the vPatch or sham device at all, and 1 subject in the sham arm used the sham device twice. Fifty-one subjects used the vPatch 3 or 4 times during the study. The 7 subjects did not use vPatch either due to reluctance or not being able to visit the clinic because of the official health rules due to the COVID-19 pandemic. The missing values were treated as failures or zero.

Tables 2 and 3 summarize the subject accountability and treatment allocation, respectively.

Table 2: Summary of accountability
N	%

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Subjects Screened	70	100%
Subjects Eligible (% from screened)	62	88.57%
ITT Analysis Set (% from eligible)	59	95.16%
mITT Analysis Set (% from ITT)	52	88.14%
Subjects for Per Protocol AnalysisSet	51	86.44%

Table 3: Treatment allocation	Study Arm
	Active		Sham
	N	%	N	%
ITT Analysis Set	40	67.80%	19	32.20%
mITT Analysis Set	34	65.38%	18	34.62%
Subjects for Per ProtocolAnalysis Set	34	66.67%	17	33.33%

Study Demographics

Table 4 summarizes the study demographics. Except for height, most subject demographic characteristics were balanced between the two arms.

		Active	Sham	p-value
Age	N	40	19	0.7989 (*)
(years)	Mean (SD)	39.8 (9.28)	40.4 (9.69)
	Median [min;max]	40.5 [21;56]	40.0 [26;54]
Height	N	40	19	0.0519 (*)
(cm)	Mean (SD)	178.8 (5.94)	175.7 (4.74)
	Median [min;max]	180.0 [165;190]	175.0 [168;187]
Weight	N	40	19	0.4969 (*)
(kg)	Mean (SD)	81.0 (13.7)	78.5 (10.78)
	Median [min;max]	77.5 [56;120]	76.0 [64;110]
BMI	N	40	19	0.9149 (*)
(kg/m²)	Mean (SD)	25. 3 (3.86)	25.4 (3.15)
	Median [min;max]	24.8 [16.5;35.1]	25.2 [22.1;35.9]
Race	White % (n/N)	100% (40/40)	100% (19/19)	1.0000 (#)

Note: p-values are unadjusted for multiple comparisons.

(*) t-test

(#) chi-square test

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Safety Analysis:

Two AEs occurred in 2 sessions with the vPatch from a total of 186 sessions (52 training sessions, and 134 during the treatment period).

Therefore, the AE rate is 1.08% (2/186) in the active arm, versus 0% (0/70) in the sham arm, which is not a statistically significant difference.

The two AEs included discomfort due to device vibration in inguinal scar site and pain and discomfort during sexual intercourse in the pelvic area, and both were related to the study device. One of the AEs occurred during the stimulation intensity tuning phase, and the subject withdrew consent before using the vPatch during intercourse. Both AEs were considered mild and resolved upon cessation of use.

Effectiveness Analysis:

Primary effectiveness analyses

IELT is defined as the time from vaginal penetration to ejaculation. In this study, the patient's IELT was measured by their partner (using a stopwatch) during the home phase sessions of the clinical trials.

CGIC is defined as clinical global impression of change. The CGIC questionnaire was given to the patients to report their subjective sense of improvement with vPatch.

Table 5 summarizes the IELT and CGIC results for the ITT populations. The average improvement of IELT score over baseline among vPatch subjects was more than 50% greater than the average improvement among sham subjects in the ITT, mITT, and PP populations. For CGIC, the proportion of vPatch subjects experiencing an improvement was not 50% greater than the proportion among sham subjects in the ITT population; however, the 50% threshold was reached in the mITT and PP populations. Baseline IELT was 67.2 seconds in the vPatch arm and 62.1 seconds in the sham arm in the ITT population.

Table 5: IELT and CGIC: ITT, mITT, and PP Population
			n	AdjustedMeans*	StandardError	95%ConfidenceIntervals	p-values
Improvementof IELT overBaseline	ITT	Active	40	50.2 sec	8.37	[33.4; 67.0]	<0.0001
		Sham	19	16.9 sec	11.09	[-5.3; 39.2]	0.1335
		Difference(Active-Sham)	--	33.3 sec	11.94	[9.4; 57.2]	0.0073
mITT	Active	34	55.5 sec	9.11	[37.2; 73.8]	<0.0001
	Sham	18	18.0 sec	11.78	[-5.7; 41.7]	0.1324
	Difference	--	37.5 sec	12.71	[11.9; 63.1]	0.0050

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		(Active-Sham)
	PP	Active	34	55.3 sec	9.23	[36.7; 73.9]	<0.0001
		Sham	17	17.0 sec	12.09	[-7.3; 41.4]	0.1653
		Difference(Active-Sham)	--	38.2 sec	12.88	[12.3; 64.2]	0.0047
			n	%		95%ConfidenceIntervals	p-values
PatientsExperiencinganyImprovementin CGIC	ITT	Active	25	62.5		[45.8;77.27]	0.1477
		Sham	8	42.11		[20.25;66.50]
	mITT	Active	25	73.53		[55.64;87.12]	0.0371
		Sham	8	44.44		[21.53;69.24]
	PP	Active	24	73.53		[55.64;87.12]	0.0274
	Sham		7	41.18		[18.44;67.08]

*Means were adjusted for baseline values, age, and center.

Secondary effectiveness analyses

The secondary effectiveness endpoints did not have pre-specified success criteria; only the PP population was evaluated.

PEP: PEP stands for premature ejaculation profile. PEP is measured through the use of a questionnaire. The questionnaire assesses the patient's perception of changes in PEP under different aspects with the use of vPatch. The vPatch patients had higher PEP scores compared to the sham patients.

Table 6: Premature Ejaculation Profile (PEP): Per Protocol Population, Improvementsover Baseline
		AdjustedMean*	Standard Error
Perceived control overejaculation	Active	1.2	0.18
	Sham	0.3	0.25
	Difference (Active-Sham)	0.9	0.29
Satisfaction withsexual intercourse	Active	0.9	0.20
	Sham	0.4	0.26

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	Difference (Active-Sham)	0.5	0.33
Personal distressrelated to ejaculation	Active	1.1	0.20
	Sham	0.4	0.28
	Difference (Active-Sham)	0.7	0.33
Interpersonal difficultyrelated to ejaculation	Active	1.5	0.21
	Sham	0.5	0.31
	Difference (Active-Sham)	0.9	0.36

Means were adjusted for baseline values, age, and center.

Orgasmic Intensity: A patient's orgasmic intensity is measured using an Orgasmometer. An Orgasmometer is a validated tool to quantitively measure the intensity of orgasmic pleasure. This endpoint evaluates the patient's subjective outcome assessment of orgasmic intensity from baseline to the end of the study. The vPatch patients had higher orgasmic intensity scores compared to the sham patients.

Table 7: Orgasmic Intensity: Per Protocol Population, Improvements over Baseline
	Adjusted Mean*	Standard Error
Active	0.3	0.37
Sham	-0.6	0.53
Difference (Active-Sham)	0.8	0.62

Means were adjusted for baseline values, age, and center.

Additional performance analysis

Table 8 represents the data from the additional endpoint indicating the number and proportion of subjects with improvement in IELT from baseline. At each percentage level, a greater proportion of vPatch patients experienced improvement compared to the sham arm.

Table 8: Improvement in IELT from baseline – Per Protocol Population
	Active		Sham
	N	%	N	%
Any Improvement	31	91.18%	9	52.94%
Improvement by at least 10%	30	88.24%	8	47.06%
Improvement by at least 20%	27	79.41%	7	41.18%
Improvement by at least 30%	22	64.71%	6	35.29%
Improvement by at least 40%	21	61.76%	5	29.41%
Improvement by at least 50%	19	55.88%	4	23.53%

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Pediatric Extrapolation

For medical devices, the Federal Food, Drug, and Cosmetic Act defines pediatric patients as persons before their 22nd birthday. Because few patients were evaluated within the age range of 18-21, it was unclear whether there were enough data to support effectiveness in this population. However, patients aged 18 to 21 do not carry additional differences or risks relative to the adult patient population studied, and this device has a likely benefit for this group.

LABELING

The vPatch labeling consists of the package label (high and low intensity), patient labeling, and physician labeling. The labeling documents are consistent with the clinical data and covers all the hazards and other clinically relevant information that may impact use of the device. The labeling is sufficient and satisfies the requirement of 21 CFR 801.109 for prescription devices. Both the physician and patient labeling include the indications for use, device description, contraindications, warnings, precautions, summary of the clinical study, and instructions for use.

RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of the nonimplanted electrical stimulation device for management of premature ejaculation:

Identified Risks to Health	Mitigation Measures
Use error leading to patient pain.discomfort, or injury	Labeling
Electrical, mechanical or thermalfault, system malfunction, or otherdevice failure resulting in lack oftreatment or patientdiscomfort/injury (e.g., electricalshock, burn, tissue damage, orinterference from other medicaldevices or electrical equipment)	Non-clinical performance testingElectrical safety testingElectromagnetic compatibility testingSoftware validation, verification, and hazard analysisShelf-life testingLabeling
Adverse tissue reaction	Biocompatibility evaluationLabeling

SPECIAL CONTROLS

In combination with general controls of the Food Drug & Cosmetic Act, the non-implanted electrical stimulation device for management of premature ejaculation is subject to the following special controls:

The device must be demonstrated to be biocompatible. (1)

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(2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
- (i) Mechanical performance;
- (ii) Electrical stimulation parameters; and
- (ii) Battery performance.
(4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life.
Software verification, validation, and hazard analysis must be performed. (5)
(6) Labeling must include:
- Specific instructions regarding safe placement and correct use of the device; (i)
- Warning(s) against use by patients with active implanted medical devices: and (ii)
- (iii) A shelf life.

BENEFIT-RISK DETERMINATION

The benefits and risks of the device are based on data collected in the pivotal clinical study described above.

Regarding the probable risks, 2 AEs were reported in the pivotal study, both of which related to discomfort (1 subject reported pain in an inguinal scar and the other subject reported pelvic discomfort during to intercourse). Both AEs were mild and resolved after cessation of device usage.

Regarding the probable benefits, in the pivotal study, there was a mean improvement in IELT of in the vPatch arm versus (b)+1 in the sham arm (a factor of 0). Also, the (DE) CGIC was higher in the treatment arm versus the sham arm.

PATIENT PERSPECTIVES

The pivotal clinical study used the following validated Patient Reported Outcome (PROs):

. Clinical Global Impression of Change (CGIC): This questionnaire was used to assess the primary endpoint. This questionnaire captured the proportion of patients that reported an improvement from baseline when using vPatch.
Premature Ejaculation Profile (PEP): This questionnaire was used to assess a secondary . endpoint. This questionnaire captured perceived control over ejaculation, satisfaction

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with sexual intercourse, personal distress related to ejaculation and interpersonal difficulty related to ejaculation.

Based on the CGIC questionnaires, a greater proportion of the subjects who used vPatch experienced improvement compared to patients the sham arm. The subjects who used vPatch reported a higher average PEP score compared to the sham arm.

The patient perspectives from this study are favorable for the vPatch.

BENEFIT/RISK CONCLUSION

In conclusion, given the available information above, for the following indication statement:

The probable benefits outweigh the probable risks for the vPatch. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.

CONCLUSION

The De Novo request for the vPatch is granted and the device is classified as follows:

Product Code: ORC Device Type: Non-implanted electrical stimulation device for management of premature ejaculation Regulation Number: 21 CFR 876.5026 Class: II

Regulation Number and Section

§ 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation.

(a)
Identification. A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical performance;
(ii) Electrical stimulation parameters; and
(iii) Battery performance.
(4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include:
(i) Specific instructions regarding safe placement and correct use of the device;
(ii) Warning(s) against use by patients with active implanted medical devices; and
(iii) A shelf life.