(238 days)
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No
The device description and performance studies focus on electrical muscle stimulation and its physiological effects, with no mention of AI or ML algorithms for control, analysis, or prediction.
Yes.
The device is intended for the "management of premature ejaculation" and delivers "electrical stimulation to the perineal muscles and nerves" to "increase the time between arousal and ejaculation", which clearly indicates a therapeutic purpose.
No
The device is designed to treat premature ejaculation by delivering electrical muscle stimulation to prolong the time between arousal and ejaculation; it does not diagnose a condition.
No
The device description explicitly states it is a "single-use disposable patch" that "contains electrodes that deliver electrical muscle stimulation (EMS)". This indicates a physical hardware component responsible for delivering the therapy, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of premature ejaculation by delivering electrical stimulation to the perineal muscles and nerves. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a patch that delivers electrical stimulation. This is a physical treatment method, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), chemical reactions, or any other processes typically associated with in vitro diagnostics.
- Performance Study: The performance study focuses on clinical outcomes related to ejaculation time and patient satisfaction, not on the accuracy or reliability of a diagnostic test.
In summary, the vPatch is a therapeutic device that uses electrical stimulation to treat a medical condition, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ORC
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.
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
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
perineum
Indicated Patient Age Range
Male, age range 18-60
Intended User / Care Setting
The device is restricted to prescription use in accordance with 21 CFR 801.109.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study:
A multi-center, international, prospective, 2:1 randomized, double-blind, two-arm, sham-controlled, clinical investigation was conducted to evaluate the safety and effectiveness of vPatch.
Sample Size: 70 male subjects were screened, 62 eligible, 59 randomized (ITT population).
- Active device group: 40 subjects
- Sham device group: 19 subjects
Primary effectiveness analyses:
- IELT (Intravaginal Ejaculatory Latency Time): 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.
- Active arm: 50.2 seconds improvement (ITT)
- Sham arm: 16.9 seconds improvement (ITT)
- Difference (Active-Sham): 33.3 seconds (ITT), p-value 0.0073
- CGIC (Clinical Global Impression of Change): 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.
- Active arm: 62.5% improvement (ITT)
- Sham arm: 42.11% improvement (ITT)
- p-value 0.1477 (ITT)
Secondary effectiveness analyses (PP population):
- PEP (Premature Ejaculation Profile): vPatch patients had higher PEP scores compared to the sham patients across various domains (perceived control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, interpersonal difficulty related to ejaculation).
- Perceived control over ejaculation: Active 1.2, Sham 0.3, Difference 0.9
- Satisfaction with sexual intercourse: Active 0.9, Sham 0.4, Difference 0.5
- Personal distress related to ejaculation: Active 1.1, Sham 0.4, Difference 0.7
- Interpersonal difficulty related to ejaculation: Active 1.5, Sham 0.5, Difference 0.9
- Orgasmic Intensity (Orgasmometer): vPatch patients had higher orgasmic intensity scores compared to the sham patients.
- Active 0.3, Sham -0.6, Difference 0.8
Additional performance analysis (PP Population for IELT improvement):
- Any Improvement: Active 91.18%, Sham 52.94%
- Improvement by at least 10%: Active 88.24%, Sham 47.06%
- Improvement by at least 20%: Active 79.41%, Sham 41.18%
- Improvement by at least 30%: Active 64.71%, Sham 35.29%
- Improvement by at least 40%: Active 61.76%, Sham 29.41%
- Improvement by at least 50%: Active 55.88%, Sham 23.53%
Safety Analysis:
- AE rate: 1.08% (2/186 sessions) in the active arm, versus 0% (0/70) in the sham arm (not statistically significant).
- Two AEs were reported: discomfort due to device vibration in inguinal scar site and pain/discomfort during sexual intercourse in the pelvic area. Both were mild and resolved upon cessation of use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics reported are changes in IELT and proportion of subjects with improvement in CGIC.
- Average improvement of IELT over Baseline (ITT): Active 50.2 sec, Sham 16.9 sec.
- Patients Experiencing any Improvement in CGIC (%) (ITT): Active 62.5%, Sham 42.11%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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:
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.
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 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.
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 | Main | |
| Dimensions | Width 42 mm; Length 38 mm; Thickness 4.8 | |
| mm | ||
| Electrode | ||
| Contacting | ||
| Area | 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 Overlay |
| ISO 10993-5 (2009) | |
| Sensitization | ISO Closed Patch in Guinea Pigs |
| ISO 10993-10 (2010) | |
| Irritation | ISO Skin Irritation Study in Rabbits |
| ISO 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 with | |
| clinical premature ejaculation or with | |
| self-perceived ELT |