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. It contains electrodes that deliver electrical muscle stimulation (EMS) to the perineal muscles during intercourse to help the user postpone ejaculation. The patch works by delivering shortduration, low-intensity EMS to the perineal muscles and nerves during intercourse. The stimulation contracts the pelvic floor muscles, which consequently delays rhythmic contractions of ejaculation. This increases the time between arousal and ejaculation. The vPATCH is comprised of several layers which include the cover, electrical circuit board including batteries, and adhesive electrodes. The skin-contacting materials are hydrogel, polyolefin foam, and thermoplastic elastomer (TPE). The vPATCH is available in two intensity levels (High and Low).

AI/ML Overview

The provided text describes a 510(k) submission for the vPATCH device, which manages premature ejaculation, to expand its indication from prescription use (Rx) to over-the-counter (OTC) use. The key study supporting this expansion is a Human Factors (HF) validation study that included label comprehension and self-selection components.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria for the vPATCH relate primarily to demonstrating its safety and effectiveness for OTC use, specifically that users can understand how to use it safely and effectively without a healthcare professional's guidance. The core performance is derived from the Human Factors study.

Acceptance Criterion (Implicit)	Reported Device Performance and Study Findings
Label Comprehension: Intended users can correctly understand the instructions for use (IFU) and labeling without healthcare professional guidance. This includes understanding the indications, contraindications, warnings, and how to use the device.	The human factors validation study included a label comprehension study. The results supported the expanded indication, demonstrating that the intended user population is able to correctly identify themselves as intended users and correctly use the device. While specific quantitative metrics (e.g., % correct responses) are not provided in this summary, the conclusion states that the study demonstrates users "are able to correctly identify themselves as intended users as well as correctly use the device without the need for guidance or intervention of a healthcare professional."
Self-Selection: Users can correctly identify whether the device is appropriate for them based on the labeling, including recognizing if they are an intended user, not intended user, or contraindicated user.	The human factors validation study included a self-selection study. The study was completed using representative users from three groups: Indicated, Not Indicated, and Contraindicated. The results supported the expanded indication, demonstrating that the intended user population is able to correctly identify themselves as intended users.
Usability (Safe & Effective Use without Professional Intervention): Users can safely and effectively perform the tasks necessary to use the vPATCH as intended in a real-world (simulated) environment without errors that could lead to harm or ineffective treatment.	The human factors validation study was conducted in a simulated-use format. Participants had access to the patch, IFU, and accessories. The study's purpose was to identify root causes of difficulties or use errors. The conclusion states, "The vPATCH has been found to be safe and effective for the intended users, uses, and use environments," and that users can "correctly use the device without the need for guidance or intervention of a healthcare professional." A supplemental study was conducted for a minor design change to further improve usability.
Biocompatibility: The device materials in contact with the body are biocompatible and do not cause adverse reactions (cytotoxicity, sensitization, irritation). (This is a general safety criterion for the device itself, reinforced due to minor device differences, and implicitly part of "safe and effective.")	Biocompatibility tests were repeated: Cytotoxicity, Sensitization, and Irritation. These were performed in accordance with FDA Guidance ISO 10993-1. The successful completion of these tests (implied by the submission's conclusion of safety and effectiveness) means the materials meet acceptance criteria for biological safety.
Non-Clinical Performance (Device Functionality and Integrity): The device functions as intended over its shelf-life and in various specified conditions (e.g., dimensional integrity, bonding strength, liquid ingress protection, power performance). (Again, a general safety/effectiveness criterion for the device itself, not specific to OTC.)	Non-clinical performance tests were performed: Shelf-Life testing (packaging integrity and functionality), Dimensional validation (critical measurements), Cover bonding strength, Liquid ingress protection, and Power performance. The successful completion of these tests (implied by the submission's conclusion of safety and effectiveness) means the device meets acceptance criteria for its physical and electrical performance.

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

Sample Size for the Test Set: Not explicitly stated in the provided text. The text only mentions "representative users of the vPATCH from three (3) groups (Indicated, Not Indicated, Contraindicated)."
Data Provenance: Not explicitly stated in the provided text. It is implied to be prospective, as it describes a study conducted for the submission. The country of origin for the data is also not explicitly stated, though the applicant's address is Israel and the regulatory consultant is in the US.

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

This information is not provided in the text. For a Human Factors study, "experts" typically establish the study design and analysis, rather than the ground truth of a medical condition itself. The "ground truth" in this context would be the correct performance of tasks and understanding of information, as defined by the device's intended use and labeling. The text mentions "analyzed to identify root causes of any difficulties or use errors observed during testing," implying a standard HF evaluation process.

4. Adjudication Method for the Test Set

This information is not provided in the text. For Human Factors studies, adjudication often involves observation and structured debriefing rather than traditional "reader" adjudication. Errors or difficulties are recorded and categorized, then analyzed by the HF team.

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, an MRMC comparative effectiveness study was not done. This type of study is pertinent for diagnostic AI devices where human readers (e.g., radiologists) interpret images with or without AI assistance. The vPATCH is a direct-to-consumer electrical stimulation device, not an AI diagnostic tool.

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

Not applicable directly. The vPATCH is an active medical device, not an AI algorithm. Its performance is intrinsically tied to human use. However, the "non-clinical performance testing" and "biocompatibility testing" can be considered analogous to "standalone" testing in that they evaluate the device itself (components, electrical performance, materials) independent of a human user's interaction beyond applying the patch.

7. The Type of Ground Truth Used

For the Human Factors study (label comprehension and self-selection), the "ground truth" was defined by the device's intended use, labeling (Instructions for Use - IFU), and the design of the tasks. For example, the ground truth for a comprehension question would be the correct answer as stated in the IFU/labeling. For a self-selection task, the ground truth would be whether the participant accurately categorized themselves (e.g., "indicated user" if they met the criteria, "contraindicated" if they had a contraindication).
For the biocompatibility and non-clinical performance tests, the "ground truth" was established by recognized international standards (e.g., ISO 10993-1) and internal design specifications of the device.

8. The Sample Size for the Training Set

Not applicable. The vPATCH is not an AI/machine learning device that requires a "training set."

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

Not applicable. As above, there is no training set for this type of device.

Summary

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May 1, 2023

Virility Medical, Ltd. % Bosmat Friedman Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, NC 28269

Re: K223595

Trade/Device Name: vPATCH Regulation Number: 21 CFR§ 876.5026 Regulation Name: Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation Regulatory Class: II Product Code: QRC Dated: April 3, 2023 Received: April 3, 2023

Dear Bosmat Friedman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mark J. Antonino -S

Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K223595

Device Name vPATCH

Indications for Use (Describe)

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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510(K) SUMMARY [as required by section 807.92(c)] vPATCH 510(k) Number K223595

5.1. SUBMITTER

Applicant's Name and Address:

Virility Medical, Ltd. 24 Hanagar St. Hod-Hasharon 4527713 Israel Phone: +972 97447780

Primary Contact:

Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 980-308-1636 bosmat.f(@promedoss.com

5.2. DEVICE

Trade Name: vPATCH

Classification: Name: Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation Product Code: QRC Regulation No: 876.5026 Class: 2 Medical Specialty: Gastroenterology/Urology Review Panel: GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3) Reproductive, Gynecology and Urology Devices (DHT3B)

PREDICATE DEVICE 5.3.

vPATCH, manufactured by Virility Medical, Ltd., De-Novo granted DEN210012; Product Code: ORC.

This predicate has not been subject to a design-related recall.

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5.4. -DEVICE DESCRIPTION

The vPATCH is comprised of several layers which include the cover, electrical circuit board including batteries, and adhesive electrodes. The skin-contacting materials are hydrogel, polyolefin foam, and thermoplastic elastomer (TPE).

The vPATCH is available in two intensity levels (High and Low).

5.5. 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.

OTC use

SUBSTANTIAL EQUIVALENCE 5.6.

The subject and predicate devices are both single use patches applied to perinium for the management of premature ejaculation.

Feature	Subject DevicevPATCH	Predicate DevicevPATCH (DEN210012)	Comparison to Predicate
Reg. Number	876.5026	876.5026	Same
Product Code	QRC	QRC	Same
Indication forUse	The vPATCH indicated formanagement of prematureejaculation in males who ejaculateafter intromission. It is designed toincrease the time between arousaland ejaculation by delivery of shortduration, low-intensity electricalstimulation to the perineal musclesand nerves during intercourse.* OTC use	The vPATCH indicated formanagement of prematureejaculation in males who ejaculateafter intromission. It is designed toincrease the time between arousaland ejaculation by delivery of shortduration, low-intensity electricalstimulation to the perineal musclesand nerves during intercourse.* Rx use	Same wording of indicationsfor use; The proposedvPATCH has OTC indicationvs. Rx indication of thepredicate; HF testingincluding labelingcomprehension and self-selection support theexpanded indication
Principle ofOperation	Patch is applied to the perineum priorto intercourse and switched on to	Patch is applied to the perineumprior to intercourse and switched on	Same

The following table provides a comparison with the predicate:

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Feature	Subject DevicevPATCH	Predicate DevicevPATCH (DEN210012)	Comparison to Predicate
	induce stimulation	to induce stimulation
Biocompatibility	The vPATCH underwentcytotoxicity, sensitization andirritation testing	The vPATCH underwentcytotoxicity, sensitization andirritation testing	Same
Single use	Yes	Yes	Same
Sterility	Not sterile	Not sterile	Same
PackagingConfiguration	Available in two packageconfigurations for high and lowintensities; each package typecontains 4 patches of the sameintensity.	Available in three packageconfigurations. The high and lowintensity patches are provided inpackages that include 4 patches withthe same intensity. The newvPATCH starter kit includes onelow intensity patch and one highintensity patch to allow the user todecide which intensity is right forhim.	A new starter kit wasdeveloped to support the OTCindication and allow the userto identify the correctintensity for him.
StimulationCurrent	HIGH Intensity: 14.3mA LOWIntensity: 9.9mA	HIGH Intensity: 14.3mA LOWIntensity: 9.9mA	Same
MaximalStimulationDuration	15 minutes	15 minutes	Same

Any differences in technological characteristics do not raise different questions of safety or effectiveness.

5.7. PERFORMANCE DATA

As a result of some minor device differences, the following pre-clinical tests were repeated/performed:

Biocompatibility:

The following biocompatibility tests were repeated in accordance with FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process" (September 2020) and the applicable recognized standards:

-Cytotoxicity
Sensitization -
Irritation -

Non-Clinical Performance Testing:

The following non-clinical performance tests were performed:

Shelf-Life testing To demonstrate the packaging integrity and functionality of the -

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vPATCH is maintained over its claimed shelf-life duration

Dimensional validation To demonstrate that critical measurements of the vPATCH are maintained and are consistent during production
Cover bonding strength To demonstrate the suitability of the bonding strength of the vPATCH cover
Liquid ingress protection To demonstrate the adequate level of protection of the vPATCH against liquid ingress
Power performance To demonstrate the satisfactory power performance of the vPATCH device throughout its claimed shelf-life

Usability Testing:

The human factors validation study was combined with a self-selection study and label comprehension study. The combined study was completed using representative users of the vPATCH from three (3) groups (Indicated, Not Indicated, Contraindicated).

The human factors validation study was conducted in a simulated-use format in which intended users performed the tasks that are necessary to use the vPATCH as intended.

Participants had access to the patch itself, the instructions for use (IFU), and any relevant accessories. The results of the study were analyzed to identify root causes of any difficulties or use errors observed during testing. After the validation study concluded, a supplemental study was conducted to gather data to corroborate a minor design change made to further improve usability of the Product.

The yPATCH has been found to be safe and effective for the intended users, uses, and use environments.

5.8. CONCLUSION

The main reason for this submission is to expand the current Rx indication of the vPATCH to an OTC indication. In support of this change, the company has conducted a Human Factors study which included label comprehension and self-selection demonstrating that the intended user population are able to correctly identify themselves as intended users as well as correctly use the device without the need for guidance or intervention of a healthcare professional. With respect to technological differences, the minor modifications implemented to the device have been verified via pre-clinical testing supporting our claim that the vPATCH is as safe and effective as its predicate. The company has provided sufficient pre-clinical and usability testing to demonstrate substantial equivalency to the predicate device. Consequently, it is clear that the vPATCH device is as safe and effective as its predicate and the proposed modifications do not raise any new safety and/or effectiveness concerns.

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.