Viberect Penile Vibratory Stimulation Device

K142304 · Reflexonic, LLC · KXQ · Oct 3, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K142304
• Device Name: Viberect Penile Vibratory Stimulation Device
• Applicant: Reflexonic, LLC
• Product Code: KXQ · Obstetrics/Gynecology
• Decision Date: Oct 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5960
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Viberect Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction. For Over-the-Counter (OTC) use.

Device Story

Hand-held vibratory device; stimulates penile nerves to initiate erection/rigidity. Input: user-applied pressure; user-controlled frequency/mode via touch pad. Operation: two motors provide simultaneous vibratory stimulation to upper and lower penile surfaces; pulsatile motion; 70-110 Hz frequency; 2-3 mm amplitude. Power: rechargeable NiMH batteries. Usage: home setting; patient self-use; 3-10 minute sessions. Safety: automatic shut-off upon release of hand pressure. Output: mechanical vibration; facilitates sexual response. Benefit: non-invasive erectile dysfunction management.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability, shipping, drop, and cleaning testing.

Technological Characteristics

Hand-held vibratory device; 10 inches long, 2 inches wide. Materials: Polyurethane/Polyurethane Foam (IROGRAN) for vibrating pads. Power: Rechargeable NiMH batteries. Frequency: 70-110 Hz; Amplitude: 2-3 mm. Pulsatile motion. Connectivity: None. Sterilization: Non-sterile. Safety: Auto-shutoff. Complies with ISO 10993-1, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for men experiencing erectile dysfunction to provoke erections. OTC use.

Regulatory Classification

Identification

A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).

Predicate Devices

• Viberect Penile Vibratory Stimulation Device (K110566)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3. 2014

Reflexonic, LLC % Julie Powell Vice President, Ouality Assurance Emergo Group 816 Congress Ave., Suite 1400 Austin, TX 78701

Re: K142304

> Trade/Device Name: Viberect Penile Vibratory Stimulation Device Regulation Number: 21 CFR& 884.5960 Regulation Name: Genital Vibrator for Therapeutic Use Regulatory Class: II Product Code: KXQ Dated: August 15, 2014 Received: August 18, 2014

Dear Julie Powell.

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. 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 mav publish further announcements concerning your device in the Federal Register.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

### K142304

Device Name Viberect® Penile Vibratory Stimulation Device

Indications for Use (Describe)

Viberect® Penile Vibratory Stimulation Device is a hand held medical to provoke erections for men who experience erectile dysfunction.

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)

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# 510(k) Summary

# for

# Viberect® Penile Vibratory Stimulation Device

# 1. Submission Sponsor

Reflexonic, LLC 915 Toll House Avenue, Suite 205 Frederick, MD 21701 USA Phone: [phone] Fax: [phone] Contact: Dr. Kambiz Tajkarimi, President

## 2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: PHONE Office Phone: [phone] Fax: [phone] Contact: Julie Powell, VP, QA Email: [e-mail]

# 3. Date Prepared

August 15, 2014

#### 4. Device Identification

Viberect® Penile Vibratory Stimulation Device (Viberect) Trade/Proprietary Name: Common/Usual Name: Vibrator Classification Name: Vibrator for Therapeutic Use Classification Regulation: 884.5960 Product Code: KXQ Device Class: Class II Classification Panel: Obstetrics /Gynecology

#### 5. Legally Marketed Predicate Device(s)

Viberect® Penile Vibratory Stimulation Device Manufactured by Reflexonic, LLC 510(k) K110566

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### 6. Device Description

The Viberect® device is a hand held medical device intended for use by the person at home for the purpose of stimulating the nerves of the penis for the purpose of activating several nerve reflexes which are responsible for initiation of penile erection and rigidity. This device is unique in that it has two gentle vibrating motors that allow simultaneous vibratory stimulation of both the upper and lower surfaces of the penis. As each side of the male penis is supplied by different nerves, simultaneous stimulation of the upper and lower surfaces increases sexual response.

The device is held by one hand easily, like holding a hair straightener. The penis is placed between the vibrating 'soft pads'. As pressure is increased to the device, it is automatically activated. The device can be deactivated by releasing the hand pressure which immediately shuts off the vibrating 'soft pads'. The touch pad on the Viberect provides further control by the user whereby the user can increase and decrease the frequency of vibration according to comfort and response. Finally, there are individual modes for the vibratory movement of the upper housing only, lower housing only, and both. The device is powered by rechargeable batteries. Vibratory stimulation for approximately 3-10 minutes is recommended.

## 7. Indication for Use Statement

Viberect " Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction. For Over-the-Counter (OTC) use.

# 8. Substantial Equivalence Discussion

The following table compares the Viberect OTC device to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

| Table 12A – Device Comparison Chart: Similarities and Differences | | | |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| | Proposed Device | Predicate Device | |
| Manufacturer | Reflexonic, LLC | Reflexonic, LLC | Significant Differences |
| Trade Name | Viberect Penile Vibratory<br>Stimulation Device | Viberect Penile Vibratory<br>Stimulation Device | |
| 510(k) Number | NA | K110566 | N/A |
| Product Code | KXQ | KXQ | Same |
| Regulation Number | 884.5960 | 884.5960 | Same |
| Regulation Name | Vibrator for Therapeutic Use | Vibrator for Therapeutic Use | Same |
| Indications for Use | Viberect Penile Vibratory<br>Stimulation Device is a hand<br>held medical device indicated<br>to provoke erections for men<br>who experience erectile<br>dysfunction. | Viberect Penile Vibratory<br>Stimulation Device is a hand<br>held medical device indicated<br>to provoke erections for men<br>who experience erectile<br>dysfunction and to provoke<br>ejaculation for spinal cord<br>injured men. | Removed the indication for use in<br>spinal cord injured men, as<br>recommended by the FDA |
| Intended for<br>Prescription or OTC | OTC | Prescription | For OTC use; Usability study<br>performed (per discussion with |
| | Proposed Device | Predicate Device | |
| Manufacturer | Reflexonic, LLC | Reflexonic, LLC | Significant Differences |
| Trade Name | Viberect Penile Vibratory<br>Stimulation Device | Viberect Penile Vibratory<br>Stimulation Device | |
| Use | | | the FDA); refer to Section 18 and<br>Exhibit 18-D and 18-E for<br>Usability Protocol and Report |
| Class | II | II | Same |
| Provided Sterile or<br>Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Basic Design | Hand held vibratory device<br>which upon activation<br>stimulates the nerves of the<br>penis. This device has two<br>gentle vibrating motors that<br>allow simultaneous vibratory<br>stimulation of both surfaces<br>(top and bottom) of the penis. | Hand held vibratory device<br>which upon activation<br>stimulates the nerves of the<br>penis. This device has two<br>gentle vibrating motors that<br>allow simultaneous vibratory<br>stimulation of both surfaces<br>(top and bottom) of the<br>penis. | Same |
| Length | Approximately 10 inches | Approximately 10 inches | Same |
| Width | Approximately 2 inches (at<br>widest point) | Approximately 2 inches (at<br>widest point) | Same |
| Reusable | Yes – provided with cleaning<br>instructions | Yes - provided with cleaning<br>instructions | Same |
| Power Source | Rechargeable Nickel Metal<br>Hydride (NiMH) batteries.<br>Rechargeable (Ni-Cd)<br>6/1.2V/0.35Ah. The battery<br>will last a minimum of 20<br>minutes (at 100hz and 2.5mm). | Rechargeable Nickel Metal<br>Hydride (NiMH) batteries.<br>Rechargeable (Ni-Cd)<br>6/1.2V/0.35Ah. The battery<br>will last a minimum of 20<br>minutes (at 100hz and<br>2.5mm). | Same |
| Patient Contacting<br>Materials | Vibrating Soft Pads<br>Polyurethane/ Polyurethane<br>Foam<br>(IROGRAN®) | Vibrating Soft Pads<br>Polyurethane/ Polyurethane<br>Foam<br>(IROGRAN®) | Same |
| Frequency | 70-110 Hz | 70-110 Hz | Same |
| Amplitude Range<br>(peak to valley) | 2 – 3 mm | 2 – 3 mm | Same |
| Adjustability of above<br>parameters | Full range by touch pad control | Full range by touch pad<br>control | Same |
| Type of motion | Pulsatile | Pulsatile | Same |
| Auto safety shut off | Yes | Yes | Same |
| Complies with ISO<br>10993-1 | Yes | Yes | Same |
| Charger, main voltage | 100-120 / 200-240 volts | 100-120 / 200-240 volts | Same |
| Electrical Safety<br>Testing Passed | Yes | Yes | Same |

Device Comparison Chart: Similarities and Differences

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## 9. Non-Clinical Performance Data

The following testing has been performed and determined to be acceptable to support substantial equivalence:

- Biocompatibility testing in accordance with ISO 10993-1 .
- . Electrical Safety testing in accordance with IEC 60601-1
- Electromagnetic Compatibility testing in accordance with IEC 60601-1-2 ●
- Usability testing

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- Shipping testing
- Drop testing
- Cleaning testing

As part of demonstrating safety and effectiveness of Viberect device and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, Reflexonic, LLC completed a number of tests. The Viberect device meets all the requirements for overall design, biocompatibility, and electrical safety, and has been confirmed that the output meets the design inputs and specifications. The Viberect device passed all testing stated above as shown by the acceptable results obtained.

The Viberect device complies with the applicable voluntary standards for biocompatibility, electrical safety and electromagnetic compatibility. The device passed all the testing in accordance with national and international standards.

# 10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The predicate device, Viberect has been on the market for several years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

Usability testing was performed and determined to be acceptable to support OTC indications for use.

# 11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The Viberect device has reduced the indications for use from the predicate device and has the identical technological characteristics as the predicate device. The new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.