The MOR System is indicated for the stimulation of healthy perineal muscles and nerves in adult males to improve or enhance sexual performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

Device Description

The MOR System is a drug-free wearable patch system with single-use electrode patches, a reusable pulse generator, and a smartphone app. Together, these components deliver user-defined electrical stimulation to the perineal region.

AI/ML Overview

The provided text is a 510(k) premarket notification document for a medical device called the "MOR System," a non-implanted electrical stimulation device intended to improve or enhance male sexual performance.

This document describes the device, its intended use, and its similarities to a predicate device (vPATCH). It details non-clinical testing performed, including electrical safety, EMC testing, software verification and validation (per IEC 62304), and biocompatibility testing (per ISO 10993-1).

However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/algorithm performance metrics like sensitivity, specificity, or AUC, or comparative effectiveness studies with human readers.

The questions in the prompt refer to criteria and studies typically associated with the evaluation of AI/ML-driven medical devices, especially those involving image analysis or diagnostic aid, which require quantitative performance metrics and rigorous validation against expert ground truth.

Since the provided text does not contain the information required to answer the prompt's specific questions about acceptance criteria, performance studies, AI training/test sets, or ground truth establishment, I must state that this information is not available in the provided document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and non-clinical safety testing, rather than reporting on the performance of an AI/ML algorithm or its impact on human reader performance.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 11, 2025

Morari, Inc. % Hrishikesh Gadagkar Sr. Princpal Ram+ 2790 Mosside Blvd, Suite 800 Monroeville, Pennsylvania 15146

Re: K241897 Trade/Device Name: MOR Regulation Number: 21 CFR 876.5026 Regulation Name: Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation Regulatory Class: II Product Code: ORC Dated: January 12, 2025 Received: January 13, 2025

Dear Hrishikesh Gadagkar:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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

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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 R. Kreitz -S

for 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)	K241897
Device Name	MOR
Indications for Use (Describe)	The MOR System is indicated for the stimulation of healthy perineal muscles and nerves in adult males to improve or enhance sexual performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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DATE PREPARED

June 28, 2024

MANUFACTURER AND 510(k) OWNER

Morari, Inc. 6501 Zircon Lane Maple Grove, MN 55311, USA Telephone: +763-226-9962

Official Contact: Jeff Bennett, CEO and Founder

REPRESENTATIVE/CONSULTANT

Hrishikesh Gadagkar, Sr. Principal RQM+ 2790 Mosside Blvd #800, Monroeville, PA 15146 Telephone: +1 (410) 245-0501 Email: hgadagkar@rqmplus.com

DEVICE INFORMATION

ProprietaryName/Trade Name:	MOR
Common Name:	Non-Implanted Electrical Stimulation Device for Management ofPremature Ejaculation
Classification Name:	Non-Implanted Electrical Stimulation Device for Management ofPremature Ejaculation
Regulation Number:	876.5026
Class:	II
Product Code:	QRC
Premarket Review:	DHT3B: Division of Reproductive, Gynecology and UrologyDevices.OHT3: Office of GastroRenal, ObGyn, General Hospital andUrology Devices
Review Panel:	Gastroenterology/Urology

PREDICATE DEVICE IDENTIFICATION

The MOR is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K223595	vPATCH / Virility Medical, Ltd.	✓

The predicate devices have not been subject to a design-related recall.

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DEVICE DESCRIPTION

The MOR System is intended for stimulation of healthy perineal muscles and nerves to improve or enhance sexual performance.

The MOR Patch is indicated for the stimulation of healthy perineal muscles and nerves in adult males to improve or enhance sexual performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

Technological Characteristics

The MOR System consists of the following major components:

. Single-Use Patch - Applies the stimulation to skin of the user. Singleuse with four electrodes.
. Pulse Generator - Generates the stimulation. Reusable.
Smartphone App Used by the user to control the stimulation. .
Charger - Charges the battery in the Pulse Generator.
Charging Cable Connects a Charging Power Supply to the Battery ● Charger
Cloud Backend Stores de-identified data collected from the Pulse . Generator and Smart Phone App.
- 1. Pulse Generator Connection
- 1. Single-Use Patch
- 1. On/Off Button and LED Indica
- 1. Pulse Generat
- Smartphone App (downlo
- 1. Charger
- 1. Charging Cable
- 1. Storage Pouch

Image /page/5/Picture/21 description: The image shows a medical device and a smartphone displaying an application. The medical device consists of a blue patch with a black sensor in the center, and a separate black sensor with a blue light. The smartphone screen displays an application with adjustable parameters such as amplitude, frequency, pulse width, and slope, with numerical values and adjustment buttons visible.

There are four electrodes on the device that are covered with a medical adhesive and electrically conductive hydrogel that aid in electrode attachment to the perineal area and allow transfer of current to the pelvic floor muscles.

The device is intended to be used by a single user. The device is powered by a single Li-ion battery. The housing includes one push button that allows the user to cycle between stimulation intensity levels and turn stimulation off. The MOR patch and pulse generator are available as individual components and as part of a starter kit. The starter kit includes 1 reusable Pulse Generator, 6 single-use disposable patches, 1 charging station, and 1 travel pouch, along with an IFU and quick reference guide. Each MOR patch

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is provided within a sealed foil pouch. The MOR mobile app is available for download on user mobile devices.

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Morari believes that the MOR is substantially equivalent to the predicate devices vPATCH (K223595) based on the information summarized here:

The subject device has the same intended use as the predicate device ● cleared in K223595, i.e., a non-implanted electrical stimulation device intended to manage premature ejaculation.
. The subject device and the predicates include a patch that is applied to the perineum before intercourse and switched on to induce stimulation.
. The subject device and predicate (K223595) are non-sterile devices that include a single-use patch, and the device is used for a duration of 15 minutes.

Device Name(Manufacturer)	MOR System (Morari, Inc.)	vPATCH (Virility Medical,Ltd.)
510k Number		K223595
RegulationNumber	876.5026	876.5026
Product Code	QRC	QRC
Indications forUse	The MOR System isindicated for the stimulationof healthy perineal musclesand nerves in adult males toimprove or enhance sexualperformance. It is notintended to be used inconjunction with therapy ortreatment of medicaldiseases or medicalconditions of any kind.	The vPATCH indicated formanagement of prematureejaculation in males whoejaculate after intromission. Itis designed to increase thetime between arousal andejaculation by delivery ofshort duration, low-intensityelectrical stimulation to theperineal muscles and nervesduring intercourse.
Type of Use	OTC	OTC
Principle ofOperation	Patch is applied to theperineum prior tointercourse and switched onto induce stimulation.	Patch is applied to theperineum prior to intercourseand switched on to inducestimulation.

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Biocompatibility	The MOR patch underwentcytotoxicity, sensitizationand irritation testing.	The vPATCH underwentcytotoxicity, sensitization andirritation testing.
Single Use	Yes	Yes
Sterility	Not sterile	Not sterile
PackagingConfiguration	Starter kit to include: 1reusable Pulse Generator, 6single-use disposablepatches, 1 charging station.and 1 travel pouch, alongwith an IFU and quickreference guide.	Available in two packageconfigurations for high andlow intensities; each packagetype contains 4 patches ofthe same intensity.
StimulationCurrent	10.5mA @140Hz7.5mA@200Hz	HIGH Intensity: 14.3mALOW Intensity: 9.9mA
MaximalStimulationDuration	15 Minutes	15 Minutes

SUMMARY OF NON-CLINICAL TESTING

Hardware physical and functional testing was completed, including basic electrical safety and EMC testing. Software verification and validation testing were performed per IEC 62304:2006+A1:2015, and, therefore, the methods are acceptable. Biocompatibility testing on the MOR patch was performed to demonstrate conformity to ISO 10993-1:2018.

CONCLUSION

Based on the Substantial Equivalence summary provided above, it is evident that MOR (subject device) shares technological characteristics with vPATCH (primary predicate). These devices are designed to be non-implanted electrical stimulation devices to improve or enhance sexual performance by delivery of electrical stimulation to the perineal muscles and nerves. The minor technological differences identified between the subject device and the primary predicate are apparent in the different electrical stimulation modes. Any differences in technological characteristics do not raise different questions of safety or effectiveness.

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.