(116 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Viberect™ Penile Vibratory Stimulation Device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantifiable acceptance criteria for the Viberect™ device beyond "substantially equivalent" to predicate devices. The performance data is primarily focused on demonstrating this substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic and no adverse reaction when implanted (for patient-contacting material). | The polyurethane (patient-contacting material) was shown to be nontoxic and did not cause an adverse reaction when implanted for five days in USP In Vivo Biological Reactivity Tests (Class VI Plastics Tests), including Intracutaneous and Systemic Toxicity testing. |
| Functional Equivalence: Actual penile stimulation. | The Viberect™ has been shown to be substantially equivalent to the predicate device (Ferticare Personal Therapeutic Vibrator, K955589) in terms of actual penile stimulation (i.e., amount of penis actually stimulated) for spinal cord injured men. |
| Safety: Benefit outweighs potential risks. | A comprehensive Risk Analysis confirmed that the benefits of the Viberect™ Device outweigh all potential risks. |
| Indications for Use: Ability to provoke erections and ejaculation based on predicate uses. | The Viberect™ IFU encompasses those listed for the predicate devices, both provoking penile erection and ejaculation in men with erectile dysfunction and men with spinal cord injuries. The document states that "any differences in technological characteristics... do not raise issues of safety and effectiveness." This implies the device must effectively achieve these indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document only mentions "spinal cord injured men" in the context of the performance testing but does not specify the sample size for this test.
- Data Provenance: Not explicitly stated. Given the context of a 510(k) submission, it is likely the data was generated specifically for this application, but whether it was retrospective or prospective, or the country of origin, is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study's methodology for determining "actual penile stimulation" or the outcome of the risk analysis is not detailed enough to identify the involvement or qualifications of experts.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone algorithm performance study was not done. The Viberect™ is a medical device, not an AI algorithm. The performance testing described relates to the device's physical and functional capabilities.
7. Type of Ground Truth Used
The "ground truth" for the device's performance appears to be established through:
- Biocompatibility testing: Laboratory assays (USP In Vivo Biological Reactivity Tests).
- Functional performance: Comparison to a predicate device in terms of "actual penile stimulation." The method for objectively measuring this "actual penile stimulation" is not described, so the specific ground truth (e.g., physiological measurements, expert assessment) is unclear.
- Risk Analysis: Expert assessment based on industry standards and engineering principles.
8. Sample Size for the Training Set
This information is not applicable/provided. The Viberect™ is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided as there is no training set for a medical device in this context.
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JUN 2 4 2011
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: 717-267-1155
Fax: 717-267-0368 e-mail: Kambiz123@hotmail.com
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/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 (800) 638-2041 or (301) 796-7100 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
§ 884.5960 Genital vibrator for therapeutic use.
(a)
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).(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 884.9.