Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use in the device description or performance studies.
No.
The device's intended use explicitly states, "It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind."
No
The "Intended Use / Indications for Use" states that the device is for "stimulation of healthy perineal muscles and nerves in adult males to improve or enhance sexual performance." It explicitly says, "It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind," which would rule out a diagnostic purpose.
No
The device description explicitly states it is a "wearable patch system with single-use electrode patches, a reusable pulse generator, and a smartphone app," indicating it includes hardware components (patches and pulse generator) in addition to the software (smartphone app). The performance studies also mention hardware testing.
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 stimulation of healthy perineal muscles and nerves to improve sexual performance. This is a direct interaction with the body for a physiological effect, not for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is a wearable patch system that delivers electrical stimulation. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
IVDs are specifically designed to be used in vitro (outside the body) to analyze samples and provide information about a person's health status. This device operates in vivo (within the body) to stimulate tissues.
N/A
Intended Use / Indications for Use
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.
Product codes
QRC
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.
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.
-
- Pulse Generator Connection
-
- Single-Use Patch
-
- On/Off Button and LED Indica
-
- Pulse Generat
- Smartphone App (downlo
-
- Charger
-
- Charging Cable
-
- Storage Pouch
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 is provided within a sealed foil pouch. The MOR mobile app is available for download on user mobile devices.
- Storage Pouch
-
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
perineal muscles and nerves
Indicated Patient Age Range
adult males
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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"
1
(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
2
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
3
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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4
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
| Proprietary
| Name/Trade Name: | MOR |
|---|---|
| Common Name: | Non-Implanted Electrical Stimulation Device for Management of |
| Premature Ejaculation | |
| Classification Name: | Non-Implanted Electrical Stimulation Device for Management of |
| Premature Ejaculation | |
| Regulation Number: | 876.5026 |
| Class: | II |
| Product Code: | QRC |
| Premarket Review: | DHT3B: Division of Reproductive, Gynecology and Urology |
| Devices. | |
| OHT3: Office of GastroRenal, ObGyn, General Hospital and | |
| Urology 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.
5
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.
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.
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.
-
- Pulse Generator Connection
-
- Single-Use Patch
-
- On/Off Button and LED Indica
-
- Pulse Generat
- Smartphone App (downlo
-
- Charger
-
- Charging Cable
-
- 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
6
is provided within a sealed foil pouch. The MOR mobile app is available for download on user mobile devices.
INDICATIONS FOR USE
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.
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 |
| Regulation
Number | 876.5026 | 876.5026 |
| Product Code | QRC | QRC |
| Indications for
Use | 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. | The vPATCH 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. |
| Type of Use | OTC | OTC |
| Principle of
Operation | Patch is applied to the
perineum prior to
intercourse and switched on
to induce stimulation. | Patch is applied to the
perineum prior to intercourse
and switched on to induce
stimulation. |
7
| Biocompatibility | The MOR patch underwent
cytotoxicity, sensitization
and irritation testing. | The vPATCH underwent
cytotoxicity, sensitization and
irritation testing. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Single Use | Yes | Yes |
| Sterility | Not sterile | Not sterile |
| Packaging
Configuration | Starter kit to include: 1
reusable Pulse Generator, 6
single-use disposable
patches, 1 charging station.
and 1 travel pouch, along
with an IFU and quick
reference guide. | Available in two package
configurations for high and
low intensities; each package
type contains 4 patches of
the same intensity. |
| Stimulation
Current | 10.5mA @140Hz
7.5mA@200Hz | HIGH Intensity: 14.3mA
LOW Intensity: 9.9mA |
| Maximal
Stimulation
Duration | 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.