VIBERECT PENILE VIBRATORY STIMULATION DEVICE

K110566 · Reflexonic, LLC · KXQ · Jun 24, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K110566
• Device Name: VIBERECT PENILE VIBRATORY STIMULATION DEVICE
• Applicant: Reflexonic, LLC
• Product Code: KXQ · Obstetrics/Gynecology
• Decision Date: Jun 24, 2011
• 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 and to provoke ejaculation for spinal cord injured men.

Device Story

Hand-held penile vibratory stimulation device; used at home by patient. Device features two vibrating motors within polyurethane gel pads; provides simultaneous stimulation to upper and lower penile surfaces. User activates/deactivates device via hand pressure; touch pad allows adjustment of vibration frequency and selection of vibration modes (upper, lower, or both). Recommended use duration is 7-10 minutes. Device powered by rechargeable batteries. Stimulates nerves to initiate erection or ejaculation; benefits include improved sexual response and therapeutic stimulation for spinal cord injured patients.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on thermoplastic polyurethane per USP Class VI Plastics Tests (intracutaneous, systemic toxicity, five-day implant). Bench studies confirmed substantial equivalence to the Ferticare Personal Therapeutic Vibrator regarding the amount of penile tissue stimulated.

Technological Characteristics

Hand-held device; thermoplastic polyurethane patient-contacting pads; dual vibrating motors; rechargeable battery power; manual pressure-sensitive activation/deactivation; adjustable frequency and mode control; biocompatibility per USP Class VI.

Indications for Use

Indicated for men with erectile dysfunction to provoke erections and for men with spinal cord injuries to provoke ejaculation.

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

• Vibrector (K851646)
• Ferticare Personal Therapeutic Vibrator (K955589)

Submission Summary (Full Text)

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JUN 2 4 2011

K110566

## 510(k) Summary

(per 21 CFR 807.92(c))

### 1. Applicant

Reflexonic, LLC 5504 Skye Avenue Chambersburg, PA 17202

Contact Person: Kambiz Tajkarimi, MD Tel: [phone]

Fax: [phone] e-mail: [e-mail]

Date Prepared: February 28, 2011

#### 2. Device Name and Classification

## Viberect™ Penile Vibratory Stimulation Device

| Primary | |
|-------------------------|---------------------------------------|
| Device: | vibrator for therapeutic use, genital |
| Regulation Description: | Genital vibrator for therapeutic use |
| Product Code: | KXQ |
| Regulation Number: | 884.5960 |
| Classification: | 2 |
| Panel: | Obstetrics/Gynecology |
| | |
| Secondary | |
| Device: | monitor, penile tumescence |
| Regulation Description: | Unclassified (Pre-Amendment) |
| Product Code: | LIL |
| Regulation Number: | Unclassified (Pre-Amendment) |
| Classification: | Unclassified (Pre-Amendment) |
| Panel: | Gastroenterology/<br>Urology |

### 3. Predicate Devices

The Viberect™ Penile Vibratory Stimulation Device is substantially equivalent to the following devices:

| 510(k) Number | Device | Manufacturer |
|---------------|-----------|---------------|
| K851646 | Vibrector | Multicept APS |

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| 510(k) Number | Device | Manufacturer |
|---------------|-----------------------------------------|---------------|
| K955589 | Ferticare Personal Therapeutic Vibrator | Multicept APS |

#### 4. Description of the Device

The Viberect™ Penile Vibratory Stimulation 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, as a form of sexual aid, or for the purpose of activating several nerve reflexes that men are born with 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 gel pads, made up of polyurethane 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 heads. Therefore, the user activates and deactivates the device by hand pressure alone (i.e., no switches need to be pushed). Vibratory stimulation for approximately 7-10 minutes is recommended. The touch pad 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.

#### 5. Indications for Use (IFU)

Viberect device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction and to provoke ejaculation for spinal cord injured men.

#### 6. Summary of Performance Data

#### Biocompatibility Testing

Biocompatibility testing was performed to validate the patient contacting material (Thermoplastic Polyurethane) used for the Viberect™ Penile Vibratory Stimulation. These tests were conducted in accordance with USP In Vivo Biological Reactivity Tests (Class VI Plastics Tests) and included Intracutaneous and Systemic Toxicity testing plus Five Day Implant testing. The polyurethane was shown to be nontoxic and did not cause an adverse reaction when implanted for five days.

#### Performance Testing - Bench Studies

The Viberect has been shown to be substantially equivalent to the predicate device, the Ferticare Personal Therapeutic Vibrator (K955589), in terms of actual penile stimulation (i.e., amount of penis actually stimulated) for spinal cord Injured men. In addition, a comprehensive Risk Analysis confirmed that the benefits of the Viberect Device outweigh all potential risks.

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### 7. Safety & Effectiveness

The Viberect™ Penile Vibratory Stimulation Device is substantially equivalent to the predicate devices listed in this 510(k) submission. More specifically, the IFU of the Viberect encompasses those listed for the predicate devices as it both provokes penile erection and ejaculation in men with erectile dysfunction and men with spinal cord injuries which inhibit these functions. In addition, all three devices utilize penile vibratory stimulation and any differences in technological characteristics between the Viberect™ Penile Vibratory Stimulation Device and the predicate devices do not raise issues of safety and effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's three main goals: health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

Reflexonic, LLC c/o Ms. Caroline Tontini Emergo Group, Inc. 611 West 5th Street Third Floor AUSTIN TX 78701

# JUN 2 4 2011

Re: K110566

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: KXO Dated: June 2, 2011 Received: June 9, 2011

Dear Ms. Tontini:

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 may 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Hubert Lehman, MD

Herbert P. Lerner, M.D., Director (Acting) 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): K110564

Device Name: Viberect™ Penile Vibratory Stimulation Device

Indications for Use:

Viberect™ Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction and to provoke ejaculation for spinal cord injured men.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-On)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110566